State of Indiana Medicaid DUR Annual Report

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1 State of Indiana Medicaid DUR Annual Report For Federal Fiscal Year 2008 (October 1, 2007 to September 30, 2008) Presented to: Centers for Medicare and Medicaid Services (CMS) By: State of Indiana Office of Medicaid Policy and Planning Approved by the Indiana Medicaid DUR Board, May 15, 2009 Prepared by: ACS Government Healthcare Solutions, PBM Group Primary Author: Felice Slaughter, B.S, R.Ph. Report Date:

2 TABLE OF CONTENTS I. EXECUTIVE SUMMARY... 3 II. CMS SURVEY... 4 III. TABLE 1. PROSPECTIVE DUR CRITERIA INDIANA MEDICAID... 8 A. TABLE 1.A. PROSPECTIVE DUR CRITERIA - DETAILED... 9 B. TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA C. TABLE 1.C. MISCELLANEOUS PRIOR AUTHORIZATION PROGRAMS IV. TABLE 2. RETROSPECTIVE DUR SUMMARY FFY V. ATTACHMENT 1. PHARMACY SURVEY INFORMATION VI. ATTACHMENT 2. PROSPECTIVE DUR (PRODUR) ACTIVITY A. ATTACHMENT 2.1.A. PRODUR ACTIVITY SUMMARY BY DUR SCREEN REPORT B. ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL BY THERAPEUTIC CLASS...43 C. ATTACHMENT 2.1.C. PRODUR ACTIVITY DETAIL: DUR SCREEN BY INTERVENTION SUMMARY...64 D. ATTACHMENT 2.1.D. PRODUR ACTIVITY DETAIL: DUR SCREEN BY OUTCOME SUMMARY...65 E. ATTACHMENT 2.1.E. PRODUR REPORT OF PHARMACIST INTERVENTION & OUTCOME OVERRIDES...66 F. ATTACHMENT 2.2. PA ACTIVITY SUMMARY...67 G. ATTACHMENT 2.2.A. DETAILED PA ACTIVITY BY PA TYPE: REGULAR & MISC. PA...68 H. ATTACHMENT 2.2.B. DETAILED PA ACTIVITY BY PA TYPE: PDL PA...69 VII. ATTACHMENT 3. RETRODUR ACTIVITY FFY A. ATTACHMENT 3.1. INDIANA RETRODUR PROCEDURES...73 B. ATTACHMENT 3.2. RETRODUR INTERVENTIONS BY PROBLEM CATEGORY...74 C. ATTACHMENT 3.3. RETRODUR ACTIVITY BY MONTH...74 D. ATTACHMENT 3.4. RETRODUR EXCEPTIONS (PATIENTS SCREENED) & INTERVENTIONS BY THERAPEUTIC CLASS...75 E. ATTACHMENT 3.5. RETRODUR INTERVENTIONS PERFORMED-DESCRIPTION...84 VIII. ATTACHMENT 4. SUMMARY OF DUR BOARD ACTIVITIES A. ATTACHMENT 4.1. PROSPECTIVE DUR CRITERIA CHANGES...89 B. ATTACHMENT 4.2. RETRODUR CRITERIA CHANGES (& ADDITIONS)...90 C. ATTACHMENT 4.3. INDIANA DUR BOARD CONDENSED MEETING MINUTES...91 D. ATTACHMENT 4.4. DUR BOARD NEWLETTERS Page IX. ATTACHMENT 5. POLICIES ON USE OF THERAPEUTICALLY EQUIVALENT GENERIC DRUGS A. ATTACHMENT 5.1. GENERIC UTILIZATION B. ATTACHMENT 5.2. GENERIC SUBSTITUTION LAW C. ATTACHMENT 5.3. ADMINISTRATIVE CODE 405 IAC X. ATTACHMENT 6. DUR PROGRAM EVALUATION: SAVINGS ANALYSES A. ATTACHMENT 6.1. PRODUR SAVINGS SUMMARY B. ATTACHMENT 6.2. ALL RETRODUR PROGRAMS SAVINGS SUMMARY The preparation of this document was financed under an agreement with Indiana OMPP. Page 2

3 State of Indiana Medicaid DUR Annual Report For Federal Fiscal Year 2008 (October 1, 2007 through September 30, 2008) I. EXECUTIVE SUMMARY The State of Indiana s governing bodies and the Office of Medicaid Policy and Planning (OMPP) have always been interested in the impact that the DUR programs have upon quality of care as well as upon pharmacy and medical costs. Prospective DUR (ProDUR) and Retrospective DUR (RetroDUR) each serve a unique purpose in alerting practitioners and pharmacists with specific, focused and comprehensive drug information available from no other source. For FFY 2008, the drug savings from DUR programs yielded a return on investment (ROI) of 2136%, meaning that for every $1 dollar spent on the DUR program, the State of Indiana received $22.36 in drug savings. In addition, portions of the RetroDUR program resulted in improved patient drug therapy, as designed. The total estimated net savings for FFY 2008 for ProDUR and RetroDUR programs for Indiana Medicaid is $14.09 million. This was a decrease from the previous year by $2.16 million. In FFY 2008, total drug spend was $306.1 million versus $299.3 million in FFY The RetroDUR savings for FFY 2008 was $219,458 while the ProDUR savings was $14.50 million. The total savings for the RetroDUR program and the ProDUR program is approximately $14.72 million. The cost to administer both programs is $0.63 million which results in a net savings of approximately $14.09 million. Costs avoided as a result of Indiana Medicaid ProDUR edits were estimated to be $14.50 million in FFY 2008 versus $16.65 million for FFY The number of claims denied due to ProDUR was approximately 390,000 (down by 2% versus FFY 2007). A negative drug savings is expected when the focus of RetroDUR interventions is medication adherence. Successful medication adherence interventions usually result in increased use of medication by the intervention group. The benefit of this type of intervention is positive health outcomes and a decrease in medical expenditures. RetroDUR savings varies from year to year based on the number of interventions and whether the focus was cost containment, appropriate drug therapy or combination of the two. The Indiana Medicaid DUR program has been shown to be beneficial to the State, the provider community, and the beneficiary population served. OMPP will continue to monitor and improve the RetroDUR and ProDUR programs. The preparation of this document was financed under an agreement with Indiana OMPP. Page 3

4 II. CMS SURVEY I. STATE CODE IN DRUG UTILIZATION REVIEW (DUR) ANNUAL REPORT FEDERAL FISCAL YEAR 2008 II. MEDICAID AGENCY STAFF PERSON RESPONSIBLE FOR DUR ANNUAL REPORT PREPARATION Name Michael Sharp, R.Ph., OMPP Pharmacy Director Street Address Office of Medicaid Policy & Planning, Room W-382 Indiana Government Center South, 402 West Washington Street City/State/ZIP Indianapolis, Indiana AreaCode/Phone Number (317) Name Marc Shirley, R.Ph., OMPP Pharmacy Operations Manager Street Address Office of Medicaid Policy & Planning, Room W-382 Indiana Government Center South, 402 West Washington Street City/State/ZIP Indianapolis, Indiana Area Code/Phone Number (317) III. PROSPECTIVE DUR 1. During Federal Fiscal Year 2008 prospective DUR was conducted: (check those applicable) a) By individual pharmacies on-site. b) On-line through approved electronic drug claims management system. c) X Combination of (a) and (b). 2. a) States conducting prospective DUR on-site have included as ATTACHMENT 1 (check one): Results of a random sample of pharmacies within the State pertaining to their compliance with OBRA 1990 prospective DUR requirements. The preparation of this document was financed under an agreement with Indiana OMPP. Page 4

5 X Results of State Board of Pharmacy monitoring of pharmacy compliance with OBRA 1990 prospective DUR requirements. Results of monitoring of prospective DUR conducted by State Medicaid agency or other entities. b) States conducting prospective DUR on-line have included as ATTACHMENT 1 a report on State efforts to monitor pharmacy compliance with the oral counseling requirement. Yes X No 3. States conducting prospective DUR on-site plans with regards to establishment of an ECM system. State: Has no plan to implement an ECM system with prospective DUR capability. Plans to have an operational ECM system with prospective DUR in FFY 2008 or later. STATES PERFORMING PROSPECTIVE DUR ON-SITE SKIP QUESTIONS States conducting prospective DUR through an operational on-line POS system provide the following information: a) Operational date 09/95 (MM/YY) on which on-line POS system began accepting drug claims for adjudication from providers. b) Operational date 03/96 (MM/YY) on which on-line POS system began conducting prospective DUR screening. c) Percentage of Medicaid prescriptions processed by ECM system (where applicable) in FFY % by EDS. d) Identify ECM vendor. Electronic Data Systems (EDS) 09/26/ /30/2008 (company, academic institution, other organization) 1) Was system developed in house? Yes X No 2) Is vendor Medicaid Fiscal agent? Yes X No e) Identify prospective DUR (source of criteria). First Data Bank with review and approval of DUR Board (company, academic institution, other organization) 5. With regard to prospective DUR criteria from the vendor identified in 4 (d) above, the DUR Board: (Check one) a) Approved in FFY 2008 all criteria submitted by the vendor. The preparation of this document was financed under an agreement with Indiana OMPP. Page 5

6 b) X Chose to approve selected criteria submitted by the vendor. 6. States checking 5 (b) have provided DUR criteria data requested on enclosed Table 1. Yes X No 7. State prospective DUR screening includes screens run before obtaining DUR Board approval of criteria. Yes No X 8. States conducting prospective DUR using an ECM system have included ATTACHMENT 2. Yes X No IV. RETROSPECTIVE DUR 1. Identify your retrospective DUR vendor during FFY Affiliated Computer Services (ACS) Government Healthcare Solutions (company, academic institution or other organization) a) Is the retrospective DUR vendor also the Medicaid fiscal agent? Yes No X b) Is your current retrospective DUR vendor contract subject to re-bid in FFY 2008? Yes No X If your vendor changed during FFY 2008, identify your new vendor. No Changes in FFY RetroDUR contract re-awarded to ACS, Inc. (company, academic institution or other organization) c) Is this retrospective DUR vendor also the Medicaid fiscal agent? Yes No X d) Is this retrospective DUR vendor also the developer/supplier of your retrospective DUR criteria? Yes X No 2. If your answer to question 1(c) or 1(d) above is no, identify the developer/supplier of your retrospective DUR criteria. Affiliated Computer Services (ACS) Government Healthcare Solutions (company, academic institution, or other organization) 3. Did DUR Board approve all retrospective DUR criteria supplied by the criteria source identified in questions 1(c) and 2 above? Yes X No 4. States performing retrospective DUR have provided DUR Board approved criteria data requested on enclosed hardcopy Table 2. Yes X No The preparation of this document was financed under an agreement with Indiana OMPP. Page 6

7 5. States conducting retrospective DUR have included ATTACHMENT 3. Yes X No V. DUR BOARD ACTIVITY 1. States have included a brief description of DUR Board activities during FFY 2008 as ATTACHMENT 4. Yes X No 2. States have included a brief description of policies used to encourage the use of therapeutically equivalent generic drugs as ATTACHMENT 5. Yes X No VI. PROGRAM EVALUATION/COST SAVINGS 1. Did your State conduct a DUR program evaluation/cost savings estimate in FFY 2008? Yes X No 2. Did you use Guidelines for Estimating the Impact of Medicaid DUR as the basis for developing your program evaluation/cost savings estimate? Yes X No 3. Who conducted your program evaluation/cost savings estimate? Affiliated Computer Services (ACS) Government Healthcare Solutions (company, academic institution, or other organization) 4. States have provided as ATTACHMENT 6 the program evaluations/cost savings estimates. Yes X No The preparation of this document was financed under an agreement with Indiana OMPP. Page 7

8 III. TABLE 1. PROSPECTIVE DUR CRITERIA Indiana Medicaid Approval Process FOR EACH PROBLEM TYPE BELOW, LIST (DRUGS/ DRUG CATEGORY/ DISEASE COMBINATIONS) FOR WHICH DUR BOARD CONDUCTED IN- DEPTH REVIEWS. PLEASE INDICATE WITH AN ASTERISK (*) THOSE FOR WHICH CRITERIA WERE ADOPTED. * Adoption & Implementation Dates were all prior to FFY 2003 or FFY 2005 (Growth Hormone) ^ Adoption & Implementation Date was FFY 2006 (acetaminophen) + Adoption & Implementation Date was FFY 2007 (Jan07-Therapeutic Duplication. Jun07-Dose Op. of Certain Mental Health Drugs) INAPPROPRIATE DOSE or DOSE OPTIMIZATION THERAPEUTIC DUPLICATION DRUG ALLERGY INTERACTION 1. *Triptans (Qty Limits; >Qty needs PA) 1. *See Table 1.A *+Certain Mental Health Drugs (Qty 2. *+Certain Mental Health Drugs (TD needs 2. Limits; >Qty needs PA) See Table 1.B PA) See Table 1.B INAPPROPRIATE DURATION DRUG/ DRUG INTERACTIONS DRUG DISEASE CONTRAINDICATION 1. *Over-utilization (Early Refill) All Drug Products (Requires PA) 2. *Under-utilization (Late Refill) Anti-Convulsants, Oral Hypoglycemics, ACE Inhibitors, Xanthines 3. *34-Day Supply for Non-Maintenance (Requires PA) 1. *Severity Level 1 (Requires PA) 1. *See Table 1.A *Growth Hormone (Requires PA) OTHER OTHER OTHER DRUG PREGNANCY (specify) HIGH DOSE (specify) DRUG-AGE/PEDIATRIC (specify) 1. *Severity Level X 1. *All Drug Products 1. *Severity Level 1 2. *Severity Level D 2. * ^Plan Limits: All Drugs containing 2. acetaminophen > 3 grams/day requires PA (PA for only 10 days and only for up to 4 grams/day) 3. *Severity Level The preparation of this document was financed under an agreement with Indiana OMPP. Page 8

9 TABLE 1.A. PROSPECTIVE DUR CRITERIA - DETAILED TABLE 1.A.1. Drug-Disease Criteria The DUR Board chose NDCs that infer a disease instead of using medical claims and ICD-9 diagnosis codes. Below are the criteria that were approved. INFERRED DISEASE INFERRING DRUG(S) DISEASE DURATION CONTRAIND DRUG(S) Alcoholism Disulfiram Lifetime Benzamphetamine Diethylpropion Fenfluramine MAO-Is Mazindol Phenmetrazine Phendimetrazine Phentermine Methotrexate Bexarotene Alzheimer s Tacrine Lifetime Aluminum Arrhythmias Procainamide Lifetime Dopamine Probucol Bepridil Itraconazole Ibutilide Dofetilide Calcium Renal Calculi Cellulose sodium Lifetime Calcium phosphate Prophylaxis phosphate Calcium carbonate Chronic Angina Pectoris Bepridil Lifetime Serotonin 5-HT1 Agonists Yohimibine Aldesleukin Congestive Heart Failure Amrinone Lifetime Cyclobenzaprine Milrinone Lifetime MAO-Is Pargyline Procarbazine Sodium phos laxatives Propranolol Iothalamate Albumin Hetastarch Corticotropin Gold salt compounds Doxorubicin Metformin Itraconazole Daunorubicin Iodixanol Sibutramine Cilostazol The preparation of this document was financed under an agreement with Indiana OMPP. Page 9

10 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.1. Drug-Disease Criteria (continued) INFERRED DISEASE INFERRING DRUG(S) DISEASE DURATION CONTRAIND DRUG(S) Cushing s Syndrome Trilostane Lifetime Corticotropin Diabetes Mellitus Acetohexamide Lifetime Lactulose Glipizide Glyburide Tolbutamide Tolazamide, etc Insulin Diarrhea Attapulgite Finite Magnesium Diphenoxylate/Atropine Magaldrate Kaolin/pectin/belladonna Irinotecan Opium/paregoric Poliovirus vaccine Loperamide Epilepsy Mephenytoin Lifetime Bupropion Doxapram Maprotiline Metoclopramide Piperazine Hyperkalemia Sodium polystyrene Lifetime Amiloride Sulfonate Potassium/sodium citrate Spironolactone Methazolamide Triamterene Acetazolamide Mesoridazine Dichlorphenamide Hypertension Alseroxylon Lifetime Benzamphetamine Benazapril-Amlopdipine Diethylpropion B-Blockers plus: Fenfluramine Bendroflumethiazide Mazindol Chlorthalidone Methylergonovine HCTZ Phentermine Losarten Sodium phos laxatives Moexipril Dozapram Phenmetrazine Phendimetrazine Dextrothyroxine Anistlepase Corticotropin Gold salt compounds The preparation of this document was financed under an agreement with Indiana OMPP. Page 10

11 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.1. Drug-Disease Criteria (continued) INFERRED DISEASE INFERRING DRUG(S) DISEASE DURATION CONTRAIND DRUG(S) Hyperthyroidism Methimazole Lifetime Benzamphetamine Propylthiouracil Cyclobenzaprine Diethylproprion Phendimetrazine Phenmetrazine Phentermine Ritodrine Midodrine Arbutamine Mental Depression Amoxapine Lifetime Flurazepam Bupropion Diazepam MAO-I Clomiphene Nortriptyline Metoclopramide Venlafaxine Interferon-Alpha 2B Myasthenia gravis Ambenonium Lifetime Orphenadrine Streptomycin Gentamicin Tobramycin Amikacin Netilmicin Doxacurium Parkinsonism Carbidopa/Levodopa Lifetime Haloperidol Levodopa Streptomycin Pergolide Gentamicin Selegiline Tobramycin Amikacin Netilmicin Gramicidin Peripheral Vascular Pentoxiphylline Lifetime Methylergonovine Disease Dihydroergotamine Serotonin 5-HT1 Agonists Pheochromocytoma Metyrosine Lifetime MAO-Is Metoclopramide Pargyline Droperidol Dopamine Metoclopramide Midodrine The preparation of this document was financed under an agreement with Indiana OMPP. Page 11

12 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.1. Drug-Disease Criteria (continued) INFERRED DISEASE INFERRING DRUG(S) DISEASE DURATION CONTRAIND DRUG(S) Prostatic Cancer Busereline Lifetime Fluoxymesterone Estramustine Methyltestosterone Flutamide Nadrolone Oxandrolone Oxymetholone Prasterone Testosterone HCG Hormone Psychotic disorders Acetophenazine Lifetime Mazindol Molindone Flurazepam Promazine Thiothixene Trifluoperazine Tuberculosis Capreomycine Lifetime Infliximab Pyrazinamide Urinary tract infection Cinoxacine Finite BCG live Methenamine Potassium/Sodium citrate Naladixic acid Nitrofurantoin Ventricular arrhythmias Encainide Lifetime Bepridil Esmolol Dopamine Flecainide Probucol Mexiletine Itraconazole Moricizine Ibutilide Sotalol Dofetilide Tocainide Wilson s Disease Turpentine Lifetime Copper supplements The preparation of this document was financed under an agreement with Indiana OMPP. Page 12

13 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.2. Therapeutic Duplication Alert Criteria Class Code A1C A2A A4A A4B A4C A4E A4Y A7A A7B A7C A7D Z4D A4D A4F A4K A9A D4E D4F Z2D H2G H2I H2J H2K H2N H2S H2U H2W H2X H2Y H7A H7B H7C H7D H7E H7F H7G H7H H7I Description Cardiovascular Agents Inotropic Drugs Antiarrythmics Hypotensives, Vasodilators Hypotensives, Sympatholytic Hypotensives, Ganglionic Blockers Hypotensives, Veratrum Alkaloids Hypotensives, Miscellaneous Vasoconstrictors, Arteriolar Vasodilators, Coronary Vasodilators, Peripheral Vasodilators, Peripheral (continued) Prostacyclines ACE Inhibitors and Antagonists Hypotensives, ACE Inhibitors Hypotensives, Angiotensin Receptor Antagonists ACE Inhibitor/Calcium Channel Blocker Combination Calcium Channel Blocking Agents Calcium Channel Blockers H2-Antagonists Anti-Ulcer Preparations Anti-Ulcer H. Pylori Agents Histamine H2-Receptor Inhibitors Phenothiazines Anti-Psychotics, Phenothiazines Anti-Psychotics, Phenothiazines (continued) Antidepressants Antidepressants Antidepressants Combinations Antidepressants (continued) Serotonin Specific Reuptake Inhibitors (SSRIs) Tricyclic Antidepressants & Rel. Non-Sel. Reuptake Inhibitors Tricyclic Antidepressants/Phenothiazine Comb Tricyclic Antidepressants/Benzodiazepine Comb Tricyclic Antidepressants/Non-Phenothiazine comb. Tricyclic ADP/Phenothiazine/Benzodiazepines Alpha-2 Receptor Antagonist Antidepressants Serotonin-Norepinephrine Reuptake Inhibitors Norepinephrine & Dopamine Reuptake Inhibitors Serotonin 2-Antagonist/Reuptake Inhibitors Selective Norepinephrine Reuptake Inhibitors Serotonin and Dopamine Reuptake Inhibitors Serotonin Specific Reuptake Inhibitor/Ergot Comb Antidepressant/Barb/Belladonna Alkaloid Comb The preparation of this document was financed under an agreement with Indiana OMPP. Page 13

14 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.2. Therapeutic Duplication Alert Criteria (continued) Class Code H7J H7K H7L H7M H3A H3B H3H H3C H3E H3F H3G J7A J7B J7C J7D J7E M4E M4F R1B R1C R1D R1E R1F R1G R1H R1J R1K R1L R1M S2B S2D S2E S2H S2I S2L S7C H3D Description Antidepressants - continued MAOIs-Non Selective and Irreversible MAOIs-A Selective and Reversible (RIMA) MAOIs N-S & Irreversible/Phenothiazine Comb Antidepressant/Carbamate Anxiolytic Combination Narcotic Analgesics Analgesics, Narcotics Analgesics, Narcotics (continued) Analgesics Narcotic, Anesthetic Adjunct Agents Non-Narcotic Analgesics Analgesics, Non-Narcotics Analgesics/Antipyretics, Non-Salicylates Antimigraine Preparations Analgesics, Miscellaneous Alpha and Beta Blockers Alpha/Beta-Adrenergic Blocking Agents Alpha-Adrenergic Blocking Agents Beta-Adrenergic Blocking Agents Beta-Adrenergic Blocking Agents (continued) Alpha-Adrenergic Blocking Agent/Thiazide Comb Anti-Lipidemics Lipotropics Lipotropics (continued) Diuretics Osmotic Diuretics Inorganic Slat Diuretics Mercurial Diuretics Carbonic Anhydrase Inhibitors Thiazide and Related Diuretics Thiazide and Related Diuretics (continued) Potassium Sparing Diuretics Aminouracil Diuretics Diuretics, Miscellaneous Potassium Sparing Diuretics in Combination Loop Diuretics NSAIDS and Salicylates NSAIDS, Cyclooxygenase Inhibitor Type NSAIDS, Cyclooxygenase Inhibitor Type (continued) NSAIDS, Cyclooxygenase Inhibitor Type (continued) Anti-Inflammatory/Antiarthritic Agents, Misc. Anti-Inflammatory, Pyrididine Synthesis Inhibitors NSAIDS, Cyclooxygenase 2 Inhibitor Type Skeletal Muscle Relaxant & Salicylates Combination Analgesics/Antipyretics, Salicylates The preparation of this document was financed under an agreement with Indiana OMPP. Page 14

15 TABLE 1.A. PRODUR CRITERIA DETAILED (continued) TABLE 1.A.2. Therapeutic Duplication Alert Criteria (continued) Class Code W1A W1B W1C W1D W1E W1F W1G W1H W1I W1J W1K W1L W1M W1N W1O W1P W1Q W1R W1S W1T W1U W1V W1W W1X W1Y W2A W2B W2C W2E W2Y Description Antimicrobial Products Penicillins Cephalosporins Tetracyclines Macrolides Chloramphenicol and Derivatives Aminoglycosides Antitubercular Antibiotics Aminocyclitols Penicillins (continued) Vancomycin and Derivatives Lincosamides Antibiotics, Miscellaneous, Other Streptogramins Polymyxin and Derivatives Oxazolidinones Betalactams Quinolones Beta-Lactamase Inhibitors Carbapenams (Thienamycins) Cephalosporins (continued) Quinolones (continued) Steroidal Antibiotics Cephalosporins 1 st Generation Cephalosporins 2 nd Generation Cephalosporins 3 rd Generation Absorbable Sulfonamides Nonabsorbable Sulfonamides Absorbable Sulfonamides (continued) Nitrofuran Derivatives Anti-Infectives, Misc. (Antibacterials) The preparation of this document was financed under an agreement with Indiana OMPP. Page 15

16 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA DD Drug-Drug Interaction PA Criteria The DUR Board approved a transition to hard edits that required PA for Severity Level 1 interactions beginning 1/15/2003. ER - Early Refill Alert PA Criteria Implemented 7/1/2002, Early Refill editing is in place and all edits are hard edits except for those drugs or drug classes in the table below. Hard edits require a Prior Authorization before claims payment. Exceptions to this (online override [A] and Ignore / Inactive [I]) are in the table below: Class Description Q6I Eye Antibiotic-Corticoid Combinations Q6R Eye Antihistamines Q6P Eye Anti-inflammatory Agents Q6Y Eye Preparations, Miscellaneous (OTC) Q6S Eye Sulfonamides M0F Factor IX Preparations Q6G Miotics/Other Intraoc. Pressure Reducers Q6W Ophthalmic Antibiotics Q6U Ophthalmic Mast Cell Stabilizers Q6A Ophthalmic Preparations, Miscellaneous WG8 Antiseptics, General X5B/X5E Bandages and Related Supplies Y5A Braces and Related Devices W1I Chemotherapy Rescue/Antidote Agents Y9A Diabetic Supplies C5F/C5T Dietary Supplement, Miscellaneous Y3A Durable Medical Equipment, Misc. (Group 1) Y3C Durable Medical Equipment, Misc. (Group 2) Y0A Durable Medical Equipment, Miscellaneous X4B Incontinence Supplies C5C Infant Formulas W8F Irrigants X5A, X5C, X6A, X8P, X8V Medical Supplies X2A Needles/Needle less Devices C5U Nutritional Therapy, Med Cond Special Formulation X3A Ostomy Supplies Y7A Respiratory Aids, Devices, Equipment X2B Syringes and Accessories Alert Status (A-POS Override; I-Inactive) A A A A A A A A A A I I I I I I I I I I I I I I I I I I The preparation of this document was financed under an agreement with Indiana OMPP. Page 16

17 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) TD Therapeutic Duplication PA Criteria (Implemented 7/22/2003; Removed from PA to pharmacist overridable edit on 6/2004) Angiotensin Converting Enzyme Inhibitors (ACEIS) Angiotensin Receptor Blockers (ARBS) Calcium Channel Blocking Agents Anti-Hyperlipidemics Osmotic Diuretics Inorganic Salt Diuretics Mercurial Diuretics Carbonic Anhydrase Inhibitors Thiazide and Related Diuretics Potassium-Sparing Diuretics Aminouracil Diuretics Potassium-Sparing Diuretics in Combination Loop Diuretics Penicillins Tetracyclines Macrolides Chloamphenicol and Derivatives Aminoglycosides Antitubercular Antibiotics Streptogramins Aminocyclitols Vancomycin and Derivatives Lincosamides Polymyxin and Derivatives Oxazolidinediones Betalactams Quinolones Beta-Lactamase Inhibitors Carbapenems (Thienamycins) Cephalosporins 1 st Generation Cephalosporins 2 nd Generation Cephalosporins 3 rd Generation Cephalosporins 4 th Generation Absorbable Sulfonamides Non-Absorbable Sulfonamides The preparation of this document was financed under an agreement with Indiana OMPP. Page 17

18 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) HD High Dose PA Criteria (Implemented 3/28/2003: Removed from PA to pharmacist overridable edit on 6/2004; Switched back to hard edit: acetaminophen > 3 grams per day implemented June 2006) Exceptions (covered by specific PDL or hard edit) : Acetaminophen (APAP) >3g per day All Drugs containing APAP >3g per day Exemptions from Hard Edits or PAs (Soft Overridable Edits at Point of Sale by Pharmacists): Class or GCN Code Descriptions J5D Beta-Adrenergic Agents Q8B Ear Preparations, Misc Anti-infectives Q8W Ear Preparations, Antibiotics Q8H Ear Preparations, Local Anesthetics Q6I Eye Antibiotic-Corticoid Combinations Q6R Eye Antihistamines Q6P Eye Anti-inflammatory Agents Q6V Eye Antivirals Q6H Eye Local Anesthetics Q6S Eye Sulfonamides Q6C Eye Vasoconstrictors (Rx only) Q6G Miotics/Other Intraoc. Pressure Reducers H2A Central Nervous System Stimulants J1B Cholinesterase Inhibitors 32480, Guanfacine HCl 01390, 01391, Clonidine HCl H2H, H7L, H7K, H7J Monoamine Oxidase (MAO) Inhibitors H2E, H2Q Selective-Hypnotics, Non-Barbiturate H2S, H7H Serotonin Specific Reuptake Inhibitor H7E Serotonin-2 Antagonist/Reuptake Inhibitors H7C Serotonin-Norepinephrine Reuptake-Inhibitor H2X Tricyclic Antidepressant/Benzodiazepine Combinations H2W Tricyclic Antidepressant/Phenothiazine Combinations H2U Tricyclic Antidepressant & Rel. Non-Sel. Reuptake Inhibit H2L, H2O Anti-Psychotics, Non-Phenothiazines H2G, H2I Anti-Psychotics, Phenothiazines H4B, H4C Anticonvulsants H7P Barbiturates A9A Calcium Channel Blocking Agents Q6W Ophthalmic Antibiotics Q6U Ophthalmic Mast Cell Stabilizers Q6A Ophthalmic Preparations, Miscellaneous H2F, H2P Anti-Anxiety Drugs H2M Anti-Mania Drugs H2V Anti-Narcolepsy/Anti-Hyperkinesis Agents The preparation of this document was financed under an agreement with Indiana OMPP. Page 18

19 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) MX Inappropriate Duration PA Criteria 34-Day Supply Limit for Non-Maintenance Medications PA Criteria (Implemented 7/1/2002) All non-maintenance drug claims associated with the PDL requiring quantities greater than a 34-day supply will deny and require PA at the pharmacy POS. As with BMN, two distinct PAs will be required for claim approval, one for the PDL and one for the 34-day supply limitation. PA will not be granted unless an extenuating circumstance exists to substantiate the need to dispense greater than a 34-day supply of the product. All non-maintenance drug claims not associated with the PDL that require quantities greater than a 34-day supply deny at the pharmacy POS and PA is required. PA will not be granted unless an extenuating circumstance exists to substantiate the need to dispense greater than the 34-day supply of the product. The preparation of this document was financed under an agreement with Indiana OMPP. Page 19

20 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) 2008 Mental Health Quality Advisory Committee Initiatives (MHQAC) Implementation of additional MHQAC Quality Edits were added to Therapeutic Duplication Criteria during FFY2008. Hard edits that required a prior authorization before claims payment are listed below: Edits Prior Authorization Requirements Implementation Date PA Criteria Patient receiving two or more sedativehypnotics, including trazodone March 3, 2008 Patient receiving two or more SSRI and/or SNRI March 3, 2008 antidepressants, excluding bupropion and mirtazapine Patients, ages 18 64, receiving 25mg or 50mg March 3, 2008 quetiapine dosages* * Quetiapine daily dosages between 51mg and 299mg will be monitored to ensure appropriate utilization, that is not being used for induction of sleep or treatment of insomnia) 2007 Mental Health Quality Advisory Committee Initiatives (MHQAC) Therapeutic Duplication -- Implementation of MHQAC Quality Edits Implementation of the MHQAC Quality Edits in January 2007 were Therapeutic Duplication Criteria. Hard edits that required a prior authorization before claims payment are listed below: Prior Authorization Requirement Descriptions Three or more antipsychotic medications Two or more typical antipsychotics medications Three or more atypical antipsychotics medications Three or more antidepressant medications, excluding trazodone Two or more tricyclic antidepressnt medications Three or more benzodiazepine medications The preparation of this document was financed under an agreement with Indiana OMPP. Page 20

21 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Dose Optimization Implementation of MHQAC Utilization Edits Implementation of the MHQAC Utilization Edits in June 2007 were Dose Optimization Criteria. Hard edits that exceed quantity require a prior authorization before claims payment are listed below: Mental Health Medication ABILIFY 1MG/ML SOLUTION ABILIFY 2MG TABLET ABILIFY 5MG TABLET ABILIFY 10MG TABLET ABILIFY 15MG TABLET ABILIFY 20MG TABLET ABILIFY 30MG TABLET ABILIFY DISCMELT 10MG TABLET ABILIFY DISCMELT 15MG TABLET ADDERALL XR 5MG CAPSULE SA ADDERALL XR 10MG CAPSULES ADDERALL XR 15MG CAPSULES ADDERALL XR 20MG CAPSULES ADDERALL XR 25MG CAPSULES ADDERALL XR 30MG CAPSULES ALPRAZOLAM 0.25MG TABLET ALPRAZOLAM 0.5MG TABLET ALPRAZOLAM 1MG TABLET ALPRAZOLAM 2MG TABLET ALPRAZOLAM 1MG/ML ORAL CON ALPRAZOLAM XR 0.5MG TABLET ALPRAZOLAM XR 1MG TABLET ALPRAZOLAM XR 2MG TABLET ALPRAZOLAM XR 3MG TABLET AMBIEN 5MG TABLET AMBIEN 10MG TABLET AMBIEN CR 6.25MG TABLET AMBIEN CR 12.5MG TABLET AMITRIPTYLINE HCL 10MG TAB AMITRIPTYLINE HCL 25MG TAB AMITRIPTYLINE HCL 50MG TAB AMITRIPTYLINE HCL 75MG TAB AMITRIPTYLINE HCL 100MG TAB AMITRIPTYLINE HCL 150MG TAB AMPHETAMINE SALTS 5MG TAB AMPHETAMINE SALTS 7.5MG TAB Utilization Edit 30ml/day 1.5/day 4/day 4/day 4/day 4/day 4ml/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 21

22 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication AMPHETAMINE SALTS 10MG TAB AMPHETAMINE SALTS 12.5MG TAB AMPHETAMINE SALTS 15MG TAB AMPHETAMINE SALTS 20MG TAB AMPHETAMINE SALTS 30MG TAB ARICEPT 5MG TABLET ARICEPT 10MG TABLET ARICEPT ODT 5MG TABLET ARICEPT ODT 10MG TABLET BUPROPION HCL 75MG TABLET BUPROPION HCL 100MG TABLET BUPROPION SR 100MG TABLET BUPROPION SR 150MG TABLET BUPROPION HCL SR 200MG TAB BUSPIRONE HCL 5MG TABLET BUSPIRONE HCL 7.5MG TABLET BUSPIRONE HCL 10MG TABLET BUSPIRONE HCL 15MG TABLET BUSPIRONE HCL 30MG TABLET BUTISOL SODIUM 30MG/5 ML BUTISOL SODIUM 30MG TABLET BUTISOL SODIUM 50MG TABLET CHLORAL HYDRATE 250MG/5ML CHLORAL HYDRATE 500MG/5 ML CHLORAL HYDRATE 500MG CAP CHLORAL HYDRATE 500MG SUPP CHLORDIAZEPOXIDE 5MG CAP CHLORDIAZEPOXIDE 10MG CAP CHLORDIAZEPOXIDE 25MG CAP CHLORPROMAZINE 10MG TABLET CHLORPROMAZINE 25MG TABLET CHLORPROMAZINE 50MG TABLET CHLORPROMAZINE100MGTABLET CHLORPROMAZINE200MGTABLET CITALOPRAM 10MG/5 ML SOLUTION CITALOPRAM HBR 10MG TABLET CITALOPRAM HBR 20MG TABLET CITALOPRAM HBR 40MG TABLET CLOMIPRAMINE 25MG CAPSULE CLOMIPRAMINE 50MG CAPSULE CLOMIPRAMINE 75MG CAPSULE CLONAZEPAM.125MG DIS TAB CLONAZEPAM.25MG DIS TAB CLONAZEPAM 0.5MG DIS TAB Utilization Edit 4/day 4/day 20ml/day 10ml/day 4/day 4/day 4/day 4/day 4/day 4/day 4/day 4/day 20ml/day 5/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 22

23 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication CLONAZEPAM 1MG DIS TABLET CLONAZEPAM 2MG DIS TABLET CLONAZEPAM 0.5 MG TABLET CLONAZEPAM 1MG TABLET CLONAZEPAM 2MG TABLET CLONIDINE HCL 0.1MG TABLET CLONIDINE HCL 0.2MG TABLET CLONIDINE HCL 0.3MG TABLET CLORAZEPATE 3.75MG TABLET CLORAZEPATE 7.5MG TABLET CLORAZEPATE 15MG TABLET CLOZAPINE 12.5MG TABLET CLOZAPINE 25MG TABLET CLOZAPINE 50MG TABLET CLOZAPINE 100MG TABLET CLOZAPINE 200MG TABLET COGNEX 10MG CAPSULE COGNEX 20MG CAPSULE COGNEX 30MG CAPSULE COGNEX 40MG CAPSULE CONCERTA 18MG TABLET SA CONCERTA 27MG TABLET SA CONCERTA 36MG TABLET SA CONCERTA 54MG TABLET SA CYMBALTA 20MG CAPSULE CYMBALTA 30MG CAPSULE CYMBALTA 60MG CAPSULE D-AMPHETAMINE 5MG CAP SA D-AMPHETAMINE 15MG CAP SA D-AMPHETAMINE SULFATE, 5MG/5ML SOLUTION DAYTRANA 10MG/9 HR PATCH DAYTRANA 15MG/9 HR PATCH DAYTRANA 20MG/9 HOUR PATCH DAYTRANA 30MG/9 HOUR PATCH DESIPRAMINE 10MG TABLET DESIPRAMINE 25MG TABLET DESIPRAMINE 50MG TABLET DESIPRAMINE 75MG TABLET DESIPRAMINE 100MG TABLET DESIPRAMINE 150MG TABLET DEXEDRINE SPANSULES, 5MG CAPSULE DEXEDRINE SPANSULES, 15MG CAPSULE DEXTROAMPHETAMINE 5MG TAB Utilization Edit 10/day 10/day 8/day 4/day 4/day 4/day 6/day 4/day 4/day 4/day 4/day 40ml/day 4/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 23

24 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication DEXTROAMPHETAMINE 10MG TAB DEXTROAMPHET 10MG SR CAPSULE DIAZEPAM 2MG TABLET DIAZEPAM 5MG TABLET DIAZEPAM 10MG TABLET DIAZEPAM 5MG/ML ORAL CONC DORAL 7.5MG TABLET DORAL 15MG TABLET DOXEPIN 10MG/ML ORAL CONC DOXEPIN 10MG CAPSULE DOXEPIN 25MG CAPSULE DOXEPIN 50MG CAPSULE DOXEPIN 75MG CAPSULE DOXEPIN 100MG CAPSULE DOXEPIN 150MG CAPSULE EFFEXOR XR 37.5MG CAPSULE EFFEXOR XR 75MG CAPSULE EFFEXOR XR 150MG CAPSULE EMSAM 6MG/24 HOURS PATCH EMSAM 9MG/24 HOURS PATCH EMSAM 12MG/24 HOURS PATCH ERGOLOID MESYL 0.5MG TAB SL ERGOLOID MESYL 1MG TAB SL ERGOLOID MESYLATES 1MG TAB ESTAZOLAM 1MG TABLET ESTAZOLAM 2MG TABLET EXELON 2MG/ML ORAL SOLUTION EXELON 1.5MG CAPSULE EXELON 3MG CAPSULE EXELON 4.5MG CAPSULE EXELON 6MG CAPSULE EXELON 4.6MG/24 HOUR PATCH EXELON 9.5MG/24 HOUR PATCH FAZACLO 25MG TABLET FAZACLO 100MG TABLET FLUOXETINE 20MG/5 ML SOLUTION FLUOXETINE HCL 10MG CAPSULE FLUOXETINE HCL 10MG TABLET FLUOXETINE HCL 20MG CAPSUL FLUOXETINE HCL 20MG TABLET FLUOXETINE HCL 40MG CAPSULE FLUPHENAZINE 1MG TABLET FLUPHENAZINE 2.5MG TABLET FLUPHENAZINE 5MG TABLET Utilization Edit 4/day 4/day 4/day 8ml/day 30ml/day 4/day 6ml/day 20ml/day 1.5/day 4/day 4/day 4/day 4/day 4/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 24

25 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication FLUPHENAZINE 10MG TABLET FLURAZEPAM 15MG CAPSULE FLURAZEPAM 30MG CAPSULE FLUVOXAMINE MALEATE 25MG TAB FLUVOXAMINE MALEATE 50MG TAB FLUVOXAMINE MAL 100MG TAB FOCALIN 2.5MG TABLET FOCALIN 5MG TABLET FOCALIN 10MG TABLET FOCALIN XR 5MG CAPSULE FOCALIN XR 10MG CAPSULE FOCALIN XR 15MG CAPSULE FOCALIN XR 20MG CAPSULE GEODON 20MG CAPSULE GEODON 40MG CAPSULE GEODON 60MG CAPSULE GEODON 80MG CAPSULE HALOPERIDOL 0.5MG TABLET HALOPERIDOL 1MG TABLET HALOPERIDOL 2MG TABLET HALOPERIDOL 5MG TABLET HALOPERIDOL 10MG TABLET HALOPERIDOL 20MG TABLET HYDERGINE LC 1MG CAPSULE HYDROXYZINE 10MG/5 ML SYRUP HYDROXYZINE HCL 10MG TABLET HYDROXYZINE HCL 25MG TABLET HYDROXYZINE HCL 50MG TABLET HYDROXYZINE PAM 25MG CAP HYDROXYZINE PAM 50MG CAP HYDROXYZINE PAM 100MG CAP IMIPRAMINE HCL 10MG TABLET IMIPRAMINE HCL 25MG TABLET IMIPRAMINE HCL 50MG TABLET IMIPRAMINE PAMOATE 75MG CAP IMIPRAMINE PAMOATE 100MG CAP IMIPRAMINE PAMOATE 125MG CAP IMIPRAMINE PAMOATE 150MG CAP Utilization Edit 4/day 4/day 100ml/day 4/day 4/day 8/day 4/day 4/day 4/day 6/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 25

26 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication Utilization Edit INVEGA 3MG TABLET INVEGA 6MG TABLET INVEGA 9MG TABLET LEXAPRO 5MG TABLET LEXAPRO 10MG TABLET LEXAPRO 20MG TABLET 1.5/day LEXAPRO 5MG/5 ML SOLUTION 20ml/day LIBRITABS 25MG TABLET 4/day LORAZEPAM 0.5MG TABLET 4/day;max quantity 120 LORAZEPAM 1MG TABLET 4/day;max quantity 120 LORAZEPAM 2MG TABLET 4/day;max quantity 120 LOXAPINE SUCCINATE 5MG CAP 4/day LOXAPINE SUCCINATE 10MG CAP 4/day LOXAPINE SUCCINATE 25MG CAP 4/day LOXAPINE SUCCINATE 50MG CAP 4/day LUNESTA 1MG TABLET LUNESTA 2MG TABLET LUNESTA 3MG TABLET LUVOX CR 100MG CAPSULES LUVOX CR 150MG CAPSULES MARPLAN 10MG TABLET MAPROTILINE 25MG TABLET MAPROTILINE 50MG TABLET MAPROTILINE 75MG TABLET MEPROBAMATE 200MG TABLET 4/day MEPROBAMATE 400MG TABLET 4/day METADATE CD 10MG CAPSULE METADATE CD 20MG CAPSULE METADATE CD 30MG CAPSULE METADATE CD 40MG CAPSULE METADATE CD 50MG CAPSULE METADATE CD 60MG CAPSULE METADATE ER 10MG TABLET METADATE ER 20MG TABLET METHAMPHETAMINE HCL 5MG TAB PA METHYLIN 2.5MG CHEWABLE TAB METHYLIN 5MG CHEWABLE TAB METHYLIN 10MG CHEWABLE TAB METHYLIN 5MG/5 ML SOLUTION 60ml/day METHYLIN 10MG/5 ML SOLUTION 30ml/day METHYLIN ER 10MG TABLET SA METHYLIN ER 20MG TABLET SA The preparation of this document was financed under an agreement with Indiana OMPP. Page 26

27 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication Utilization Edit METHYLPHENIDATE 5MG TABLET METHYLPHENIDATE 10MG TABLET METHYLPHENIDATE 20MG TABLET METHYLPHENIDATE ER 20MG TAB MIRTAZAPINE 7.5MG TABLET MIRTAZAPINE 15MG RPD DISLV MIRTAZAPINE 15MG TABLET MIRTAZAPINE 30MG RPD DISLV MIRTAZAPINE 30MG TABLET MIRTAZAPINE 45MG RPD DISLV MIRTAZAPINE 45MG TABLET MOBAN 5MG TABLET 4/day MOBAN 10MG TABLET 4/day MOBAN 25MG TABLET 4/day MOBAN 50MG TABLET 4/day MOBAN 100MG TABLET NAMENDA 10MG/5 ML SOLUTION 10ml/day NAMENDA 5MG TABLET NAMENDA 10MG TABLET NAMENDA 5-10MG TITRATION Pack NARDIL 15MG TABLET 6/day NEFAZODONE HCL 50MG TABLET NEFAZODONE HCL 100MG TABLET NEFAZODONE HCL 150MG TABLET NEFAZODONE HCL 200MG TABLET NEFAZODONE HCL 250MG TABLET NIRAVAM 0.25MG TABLET NIRAVAM 0.5MG TABLET NIRAVAM 1MG TABLET NIRAVAM 2MG TABLET NORPRAMIN 25MG TABLET NORPRAMIN 50MG TABLET NORTRIPTYLINE 10MG/5 ML SOLN 20ml/day NORTRIPTYLINE HCL 10MG CAP 4/day NORTRIPTYLINE HCL 25MG CAP 4/day NORTRIPTYLINE HCL 50MG CAP NORTRIPTYLINE HCL 75MG CAP ORAP 1MG TABLET 10/day ORAP 2MG TABLET 5/day OXAZEPAM 10MG CAPSULE 4/day;max quantity 120 The preparation of this document was financed under an agreement with Indiana OMPP. Page 27

28 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication Utilization Edit OXAZEPAM 15MG CAPSULE 4/day;max quantity 120 OXAZEPAM 30MG CAPSULE 4/day;max quantity 120 PAMELOR 10MG CAPSULE 4/day PAROXETINE HCL 10MG TABLET PAROXETINE HCL 20MG TABLET PAROXETINE HCL 30MG TABLET PAROXETINE HCL 40MG TABLET PAXIL 10MG/5 ML SUSPENSION 40ml/day PAXIL CR 12.5MG TABLET PAXIL CR 25MG TABLET PAXIL CR 37.5MG TABLET PERPHENAZINE 2MG TABLET 4/day PERPHENAZINE 4MG TABLET 4/day PERPHENAZINE 8MG TABLET 4/day PERPHENAZINE 16MG TABLET 4/day PEXEVA 10MG TABLET PEXEVA 20MG TABLET PEXEVA 30MG TABLET PEXEVA 40MG TABLET PLACIDYL 500MG CAPSULE PLACIDYL 750MG CAPSULE PROTRIPTYLINE 5MG TABLET 4/day PROTRIPTYLINE 10MG TABLET 4/day PROVIGIL 100MG TABLET PROVIGIL 200MG TABLET PROZAC WEEKLY 90MG CAPSULE 4/28 days RAZADYNE 4MG/ML ORAL SOLN 6ml/day RAZADYNE 4MG TABLET RAZADYNE 8MG TABLET RAZADYNE 12MG TABLET RAZADYNE ER 8MG CAPSULE RAZADYNE ER 16MG CAPSULE RAZADYNE ER 24MG CAPSULE RESTORIL 22.5MG CAPSULE RISPERDAL 0.25MG TABLET RISPERDAL 0.5MG TABLET RISPERDAL 0.5 M-TAB RISPERDAL 1MG M-TAB RISPERDAL 1MG TABLET RISPERDAL 2MG M-TAB RISPERDAL 2MG TABLET The preparation of this document was financed under an agreement with Indiana OMPP. Page 28

29 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication Utilization Edit RISPERDAL 3MG M-TAB RISPERDAL 3MG TABLET RISPERDAL 4MG M-TAB RISPERDAL 4MG TABLET RISPERDAL CONSTA 12.5MG SYR 2/28 days RISPERDAL CONSTA 25MG SYR 2/28 days RISPERDAL CONSTA 37.5MG SYR 2/28 days RISPERDAL CONSTA 50MG SYR 2/28 days RITALIN LA 10MG CAPSULE RITALIN LA 20MG CAPSULE RITALIN LA 30MG CAPSULE RITALIN LA 40MG CAPSULE ROZEREM 8MG TABLET SARAFEM 10MG TABLET SARAFEM 20MG TABLET SERAX 15MG TABLET 4/day;max quantity 120 SEROQUEL 25MG TABLET SEROQUEL 50MG TABLET SEROQUEL 100MG TABLET SEROQUEL 200MG TABLET SEROQUEL 300MG TABLET 4/day SEROQUEL 400MG TABLET 4/day SEROQUEL XR 200MG TABLET SEROQUEL XR 300MG TABLET SEROQUEL XR 400MG TABLET 4/day SERTRALINE 20MG/ML ORAL CON. 10ml/day SERTRALINE HCL 25MG TABLET SERTRALINE HCL 50MG TABLET SERTRALINE HCL 100MG TABLET SONATA 5MG CAPSULE SONATA 10MG CAPSULE STRATTERA 10MG CAPSULE STRATTERA 18MG CAPSULE STRATTERA 25MG CAPSULE STRATTERA 40MG CAPSULE STRATTERA 60MG CAPSULE STRATTERA 80MG CAPSULE STRATTERA 100MG CAPSULE SURMONTIL 25MG CAPSULE SURMONTIL 50MG CAPSULE SURMONTIL 100MG CAPSULE SYMBYAX 3-25MG CAPSULE The preparation of this document was financed under an agreement with Indiana OMPP. Page 29

30 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication SYMBYAX 6-25MG CAPSULE SYMBYAX 6-50MG CAPSULE SYMBYAX 12-25MG CAPSULE SYMBYAX 12-50MG CAPSULE TEMAZEPAM 7.5MG CAPSULE TEMAZEPAM 15MG CAPSULE TEMAZEPAM 30MG CAPSULE THIORIDAZINE 10MG TABLET THIORIDAZINE 15MG TABLET THIORIDAZINE 25MG TABLET THIORIDAZINE 50MG TABLET THIORIDAZINE 100MG TABLET THIORIDAZINE 150MG TABLET THIORIDAZINE 200MG TABLET THIOTHIXENE 1MG CAPSULE THIOTHIXENE 2MG CAPSULE THIOTHIXENE 5MG CAPSULE THIOTHIXENE 10MG CAPSULE TRANYLCYPROMINE SULF 10MG TRANXENE SD 11.25MG TABLET TRANXENE SD 22.5MG TAB TRAZODONE 50MG TABLET TRAZODONE 100MG TABLET TRAZODONE 150MG TABLET TRAZODONE 300MG TABLET TRIAZOLAM 0.125MG TABLET TRIAZOLAM 0.25MG TABLET TRIFLUOPERAZINE 1MG TABLET TRIFLUOPERAZINE 2MG TABLET TRIFLUOPERAZINE 5MG TABLET TRIFLUOPERAZINE 10MG TABLET VENLAFAXINE HCL 25MG TAB VENLAFAXINE HCL 37.5MG TAB VENLAFAXINE HCL 50MG TAB VENLAFAXINE HCL 75MG TAB VENLAFAXINE HCL 100MG TAB VYVANSE 20MG CAPSULE VYVANSE 30MG CAPSULE VYVANSE 40MG CAPSULE VYVANSE 50MG CAPSULE Utilization Edit 4/day 4/day 4/day 4/day 4/day 4/day 4/day 6/day 4/day The preparation of this document was financed under an agreement with Indiana OMPP. Page 30

31 TABLE 1.B. PRIOR AUTHORIZATION (PA) CRITERIA (continued) Mental Health Medication VYVANSE 60MG CAPSULE VYVANSE 70MG CAPSULE WELLBUTRIN XL 150MG TABLET WELLBUTRIN XL 300MG TABLET ZYPREXA 2.5MG TABLET ZYPREXA 5MG TABLET ZYPREXA 7.5MG TABLET ZYPREXA 10MG TABLET ZYPREXA 15MG TABLET ZYPREXA 20MG TABLET ZYPREXA ZYDIS 5MG TABLET ZYPREXA ZYDIS 10MG TABLET ZYPREXA ZYDIS 15MG TABLET ZYPREXA ZYDIS 20MG TABLET Utilization Edit The preparation of this document was financed under an agreement with Indiana OMPP. Page 31

32 TABLE 1.C. MISCELLANEOUS PRIOR AUTHORIZATION PROGRAMS Explanatory Note: As referenced in prior DUR Annual Reports, the first formal Indiana Medicaid drug prior authorization program was implemented as the Indiana Rational Drug Program, or IRDP. Subsequently, a Preferred Drug List (PDL) was phased in over Federal Fiscal Years 2003 and 2004, and many of the components of the IRDP were incorporated into the PDL. Some discrete former components of the IRDP have been maintained apart from the PDL, and are referred to as Miscellaneous Prior Authorization Programs, as follows: Carafate (Sucralfate): PA for all sucralfate Growth Hormone: PA for all growth hormones Synagis All products PA approved only between 10/15 4/30 annually for maximum of 6 doses. Brand Medically Necessary (BMN): PA for all innovator, multiple-sourced drugs with State or Federal MAC rate when DAW code = 6. Exclusions: Claims for mental health/cross-indicated drugs per 405 IAC , Coumadin, Provera, Synthroid, Tegretol, Lanoxin, Premarin, Dilantin, and claims with 06 override for BMN, and days supply of 4 or less. The preparation of this document was financed under an agreement with Indiana OMPP. Page 32

33 IV. TABLE 2. RETROSPECTIVE DUR SUMMARY - FFY 2008 INDIANA MEDICAID THERAPEUTIC CATEGORY Medication Adherence- Anti-Diabetic Therapy ID Insuf Dose IDU Duration OU Over Use UU Under Use DRUG PROBLEM TYPE DDI DDC TD AG Drug- Drug- Ther App Drug Dz Dup Gen O 1 Thera Approp May 08 O 2 Dose Op O 3 Coordination of Care Medication Adherence- Anti-Lipotropic Therapy May 08 Medication Adherence- Anti-Hypertensive Therapy June 08 PROBLEM TYPE KEY ID = Insufficient DOSE DDI = Drug/ Drug Interaction IDU = Incorrect Duration DDC = Drug/ Disease Contradiction OU = Over Utilization TD = Therapeutic Duplication UU = Under Utilization AG = Appropriate Use of Generics O = Other Problem Type Specify: (1) Therapeutic Appropriateness (2) Dose Optimization (3) Coordination of Care The preparation of this document was financed under an agreement with Indiana OMPP. Page 33

34 ATTACHMENT 1 PHARMACY SURVEY INFORMATION FFY 2008 The preparation of this document was financed under an agreement with Indiana OMPP. Page 34

35 V. ATTACHMENT 1. PHARMACY SURVEY INFORMATION Monitoring Pharmacy Compliance with OBRA '90 Prospective DUR Requirements Prospective DUR (ProDUR) Indiana Medicaid does not require use of the electronic claims management point-of-sale (POS)/ProDUR system by Indiana Medicaid Pharmacy providers. Those who do use the system benefit from the ProDUR information available at the POS, but must take appropriate action before the claim will pay. ProDUR alerts require review by pharmacy providers and result in a payable claim, depending on action taken by the pharmacist upon posting of a given ProDUR alert. Some ProDUR alerts result in a stopped claim that will not pay unless prior authorization is obtained. Patient counseling portion of ProDUR The Indiana Board of Pharmacy, in coordination with Indiana Medicaid, promulgated patient counseling regulations (see page 37) that became effective January 1, These regulations ensure that pharmacists offer ProDUR counseling. Indiana Board of Pharmacy is the controlling authority over the patient counseling regulations portion of OBRA 90 for the Indiana Medicaid program. The Board of Pharmacy inspects pharmacies and measures conformance with patient counseling requirements. See copy of inspection form (attachment on page 36). The Indiana Board of Pharmacy has requested that the Consumer Protection Division of the Indiana Office of the Attorney General forward all consumer complaints regarding patient counseling activities directly to the Board of Pharmacy. The Indiana Board of Pharmacy reviewed all relevant records and determined that no complaints against pharmacists or pharmacies had been filed due to a lack of patient counseling during FFY2008. The preparation of this document was financed under an agreement with Indiana OMPP. Page 35

36 ATTACHMENT 1. (continued) Inspection Report Used by the Indiana Board of Pharmacy INDIANABOARDOF PHARMACY INSPECTIONREPORT State Form35890 (RA4/3-.95) Name of pharmacy Address (number and street. city. state. ZIP code) Today s date and time County Telephone number DEAnumber CSRnumber I.D. number Type Total weekly hours MANAGER Gen. appearance Open for bus. NAMES OF PHARMACISTS EMPLOYED LICENSE NO. PRESENT ABSENT WEEKLYHOURS LICENSE CURRENT OTHERS 1. Are all certificates property displayed, current and correct? 2. 1s the pharmacy equipped as required bylaw? 3. Are Rx files properly kept? Including name and address of patient filed numerically and chronologically? Retained over a period of 2 years? Indicate type of filing systemused: 4. Are refills of Rx properly recorded? Where? 5. Are Rxs being refilled beyond date of validity? 6. Are refills being properly documented? 7. If Sch. II Emer. Rx filled, are proper records kept? 8. Howdo you handle return medications? 9. Is proper Rx format used (i.e. generic law)? Are generic substitutions properly documented? 10. Date of last inventory: 11. Are federal DEAorder forms properly kept? 12. Pharmacy documents (orders, invoices, sales to doctors) reviewed? Any deficiencies found? If yes, what? 13. Schedule Vregister kept? Entries for the last 3 months: 14. Are Schedule Vsales controlled by the pharmacist? 15. Are current reference books and laws available? 16. Are pharmacy technicians used? Howmany? Are pharmacy technicians operating within the scope of the law / regulations? Records of technicians and training reviewed? 17. Are all pharmaceuticals in date and stored as required? 18. Previous violations been corrected since last inspection? 19. Is computer in use? Type: 20. Are computer records properly kept? Including on line retrieval of Rx status? Printout of Rx order and refill data for each day's dispensing? 21. Are all Rxs verified by pharmacist?. 22. Are Rx transfers properly performed? 23. OBRAcompliance? Are patient profiles maintained? Patient counseling being offered? 24. Is practice of site consistent with permit type? All irregularities in number or type of Rxs on file and other comments:. YES NO Signature of owner, Pharmacist or employee Signature of inspector The preparation of this document was financed under an agreement with Indiana OMPP. Page 36

37 ATTACHMENT 1. (continued) Indiana Administrative Code Re: Counseling ARTICLE 1. PHARMACIES AND PHARMACISTS (Last Updated 2007) 856 IAC Definitions Authority: IC Affected: IC Sec. 1 The following definitions apply throughout this rule: (1) Counseling means appropriate communication, by a pharmacist, to a patient, as defined in subdivision (3), of information for the purpose of improving therapeutic outcomes by maximizing the proper use of drugs and devices dispensed pursuant to prescriptions. (2) Offer means a statement that is verbal or, only if necessary for an individual patient, nonverbal, for example, printed or written, that clearly informs the patient that a pharmacist is available, at the time the offer is made, to counsel the patient, including, but not limited to, giving information to or answering questions, or both, from the patient. (3) Patient means the following: (A) The individual for whom a prescription was issued. (B) The caregiver of the individual for whom a prescription was issued. (C) The agent of the individual for whom a prescription was issued. (Indiana Board of Pharmacy; 856 IAC ; filed Dec 1, 1992, 5:00 p.m.: 16 IR 1176; readopted filed Nov 13, :55 p.m.: 25 IR 1330) 856 IAC Offer requirements Authority: IC Affected: IC Sec. 1.5 The following can satisfy an offer: (1) A pharmacist counseling the patient. (2) A pharmacist intern/extern registered under IC if: (A) Permitted by the pharmacist; and (B) the counseling by the pharmacist intern/extern is followed by a bona fide offer for the pharmacist to counsel the patient and if the patient or patient s representative desires such counseling. (3) A written notice containing the pharmacy s phone number and a bona fide offer when: (A) a patient is not present and has not authorized the giving of information to another; or (B) the drug or device is delivered by the United States Postal Service, parcel delivery, or hand delivery. (4) Any personnel in the prescription department, as defined in 856 IAC (b)(3), making an offer to counsel, as defined in section 1(2) of this rule. (b) The following cannot satisfy an offer: (1) Making an offer for the patient to ask questions. (2) Any other method that serves to shift the responsibility from the pharmacists to the patient for initiating the counseling or for selecting the informational content of the counseling. (3) Relaying information through an intermediary, unless needed for translations, hearing impaired, or other situation beyond the control of the pharmacist. (4) Using signs or other types of written notices or written information given to the patient with each drug dispensed. (Indiana Board of Pharmacy; 856 IAC ) The preparation of this document was financed under an agreement with Indiana OMPP. Page 37

38 ATTACHMENT 1. (continued) 856 IAC Patient counseling requirements Authority: IC Affected: IC Sec. 2. (a) Upon the receipt of a prescription or upon the subsequent refilling of a prescription, and following a review of the patient's prescription medication profile, the pharmacist shall be responsible for the initiation of an offer, as set forth in section 1.5(a) of this rule, to counsel the patient on matters that, in the pharmacist's professional judgment, are significant to optimizing drug therapy. Depending upon the situation, these matters may include, but are not necessarily limited to, the following: (1) The name and description of the medicine. (2) The route, dosage form, dosage, route of administration, and duration of drug therapy. (3) Special directions and precautions. (4) Common adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur. (5) Techniques for self-monitoring drug therapy. (6) Proper storage. (7) Prescription refill information. (8) Action to be taken in the event of a missed dose. (b) Counseling shall be in person, whenever practicable, or through access to a telephone service which is toll free for long distance calls, and be held with the patient, the patient's caregiver, or the patient's representative. (c) Alternative forms of patient information may be used to supplement verbal counseling when appropriate. Examples include written information leaflets, pictogram labels, and video programs. Nothing in this subsection shall be construed to mean that supplements may be a substitute for verbal counseling when verbal counseling is practicable. (d) Nothing in this rule shall be construed as requiring a pharmacist to provide counseling when a patient knowingly declines (waives) the offer to counsel. (e) Requesting or accepting, or both, a waiver for counseling for all prescriptions both present and future is not permitted. An offer must be made with each prescription-dispensing visit. (f) The patient s declining of counseling must be documented in either written or electronic format. The required documentation may be on the same form as or with another pharmacy-related authorization, only if it is clear to the patient that the documentation form also contains the patient s intent to decline (waive) counseling. The documentation subject to this section shall be retained in the pharmacy licensed area or in a secure area under the pharmacy s control, which is readily available for inspection, for a period of not less than two (2) years. (Indiana Board of Pharmacy; 856 IAC ; filed Dec 1, 1992, 5:00 p.m.: 16 IR 1176; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330) The preparation of this document was financed under an agreement with Indiana OMPP. Page 38

39 ATTACHMENT 2 PROSPECTIVE DUR (PRODUR) ACTIVITY FFY 2008 The preparation of this document was financed under an agreement with Indiana OMPP. Page 39

40 VI. ATTACHMENT 2. Prospective DUR (ProDUR) ACTIVITY The attached reports are year-end reports for prospective DUR generated by the claims processor vendor, EDS. Below is a brief narrative of each of the reports and the information they contain. Of note, the word claim and prescription are used interchangeably. Attachment 2.1.A: Report DUR-0011-A-(ProDUR Activity High Level Summary by DUR Screen) This report shows each of the pro-dur screenings that were performed for Indiana Medicaid. It shows the number of alerts that were set for each screen, the number of claims that were overridden by the pharmacist, the number of claims that were canceled due to the pro-dur alert and the number of non-responses. Please note that a pharmacist has three days to respond to a pro-dur alert before the system will remove the claim. After three days, the prescription needs to be resubmitted and the pro-dur alert overridden if the pharmacist still wants to dispense the medication. Attachment 2.1.B: Report DUR-0012-A-(ProDUR Activity Detail: DUR Screen by Therapeutic Class) This report shows up to the top twenty-five therapeutic categories and drugs that are set for each particular alert. Those alerts that list less then twenty-five show all the therapeutic categories approved by the Board. The column titled # Claims Screened is the total number of claims that came in through the POS system for that particular therapeutic category and drug, but not all of them set pro-dur alerts. Attachment 2.1.C: Report DUR-0013-A-( ProDUR Activity: DUR Screen by Intervention Summary) This report shows the percentage of pro-dur alerts that were either overridden or cancelled based upon each of the valid intervention codes for Indiana Medicaid. The only valid intervention codes for Indiana Medicaid are listed in the key on the next page. Intervention codes are: M0 (Prescriber consulted), P0 (Recipient or patient consulted) or R0 (other source consulted). Attachment 2.1.D: Report DUR-0013-B-(ProDUR Activity: DUR Screen by Outcome Summary) This report shows the percentage of pro-dur alerts that were either overridden or cancelled based upon each of the valid outcome codes for Indiana Medicaid. The valid outcome codes for Indiana Medicaid are listed in the key on the next page. Attachment 2.1.E: Report DUR-0014-A-(ProDUR Report: DUR Screen by Pharmacist Intervention and Outcome Overrides) This report shows how many of each of the valid outcome codes were used with specific pro-dur alerts and valid intervention codes. The preparation of this document was financed under an agreement with Indiana OMPP. Page 40

41 DUR Codes KEY Reason for Service Codes (DUR Conflict Codes) Code Meaning Code Meaning AT Additive Toxicity LD Low Dose alert CH Call Help Desk LR Under Use Precaution DA Drug Allergy Alert MC Drug Disease Precaution DC Inferred Drug Disease Precaution MN Insufficient Duration Alert DD Drug-Drug Interaction MX Excessive Duration Alert DF Drug Food Interactions OH Alcohol Precaution DI Drug Incompatibility PA Drug Age Precaution DL Drug Lab conflict PG Drug Pregnancy alert DS Tobacco use precaution PR Prior Adverse drug reaction ER Over Use precaution SE Side effect alert HD High Dose alert SX Drug gender alert IC Iatrogenic condition alert TD Therapeutic Duplication ID Ingredient Duplication Professional Service Codes (Intervention Codes) Code Meaning Code Meaning M0 MD Interface R0 Pharmacist reviewed P0 Patient Interaction Result of Service Codes (DUR Outcome Codes) Code Meaning Code Meaning 1A Filled False Positive 1F Filled Different quantity 1B Filled as is 1G Filled after prescriber approval 1C Filled with different dose 2A Not Filled 1D Filled with different directions 2B Not Filled Directions Clarified The preparation of this document was financed under an agreement with Indiana OMPP. Page 41

42 ATTACHMENT 2.1.A. PRODUR ACTIVITY SUMMARY BY DUR SCREEN REPORT PRODUR ACTIVITY SUMMARY BY DUR CONFLICT or DUR SCREEN EDS ProDUR Report #: DUR-0011-A High Level Summary by DUR Screen Time Period: 10/06/2007 through 10/03/2008^ DUR Screen DUR ALERTS PAID Rxs DENIED Rxs DUR Conflict Code DUR Screen (Description) # Alerts % of All DUR Alerts # Overrides (or # Rx PAID) % Overrides (or % PAID) # of Cancellations & Non-Responses (or # DENIED or Rx Not Filled) % Cancellations & Non-Responses (Rx not Filled) DD DRUG-DRUG INTERACTION* 8, % 3, % 5, % ER OVERUSE - EARLY REFILL ALERT 265, % 21, % 248, % HD OVERUSE - HIGH DOSE ALERT 47, % 43, % 4, % LR LATE REFILL 17, % 14, % 2, % MC DRUG-DISEASE CONTRAINDICATION 194, % 105, % 88, % PA DRUG-AGE 4, % 1, % 2, % PG DRUG-PREGNANCY % % % TD THERAPEUTIC DUPLICATION 342, % 304, % 38, % SUM 881, % 494, ,691 OVERALL PERCENTAGE 56.1% 43.9% ^NOTE: *NOTE: Date range provided by EDS Severity Level 1 Drug-Drug Interaction NOTE: The number of DUR Alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately; therefore, the number of cancellations and non-responses will not equal total number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 42

43 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.1. DRUG-DRUG INTERACTION (DD)* DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides # Cancellations & Non- Responses % Alerts /Total Rx % Cancels /Total Rx DD 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB DD ABSORBABLE SULFONAMIDES DD 1ST GENERATION ANTIHISTAMINE-ANTICHOLINERGIC COMB DD ACNE AGENTS,SYSTEMIC DD ADRENERGICS, AROMATIC, NON-CATECHOLAMINE DD ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS DD AMINOGLYCOSIDES DD ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL AGENTS 2, DD ANALGESICS, NARCOTICS 415, DD ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB DD ANALGESIC/ANTIPYRETICS, SALICYLATES 15, DD ANALGESICS, NARCOTIC AGONIST AND NSAID COMBINATION DD ANTACIDS 2, DD ANTI-ALCOHOLIC PREPARATIONS DD ANTIANGINAL & ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC DD ANTI-ANXIETY DRUGS 335, DD ANTIARRHYTHMICS 3, DD ANTICHOLINERGICS,QUATERNARY AMMONIUM 3, DD ANTICHOLINERGICS/ANTISPASMODICS 5, DD ANTICONVULSANTS 204, DD ANTIDIARRHEALS 16, DD ANTIEMETIC/ANTIVERTIGO AGENTS 14, DD ANTIFUNGAL AGENTS 15, DD ANTIHISTAMINES - 1ST GENERATION 5, DD ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE DD ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 84, DD ANTIMIGRAINE PREPARATIONS 5, DD ANTI-MYCOBACTERIUM AGENTS DD ANTI-NARCOLEPSY & ANTI-CATAPLEXY,SEDATIVE-TYPE AGT DD ANTI-PSYCHOTICS,PHENOTHIAZINES DD ANTICHOLINERGICS,QUATERNARY AMMONIUM DD ANTICHOLINERGICS/ANTISPASMODICS DD ANTINEOPLASTIC - AROMATASE INHIBITORS DD ANTINEOPLASTICS,MISCELLANEOUS DD ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC 23, DD ANTIPARKINSONISM DRUGS,OTHER 18, DD ANTIPSORIATIC AGENTS,SYSTEMIC DD ANTIPSYCH,DOPAMINE ANTAG.,DIPHENYLBUTYLPIPERIDINES DD ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG 199, DD ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES DD ANTI-PSYCHOTICS,PHENOTHIAZINES DD ANTITUBERCULAR ANTIBIOTICS DD ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB DD ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI DD ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITOR COMB DD ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS DD BELLADONNA ALKALOIDS DD BETA-ADRENERGIC AGENTS 89, DD BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS 1, DD BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS 10, DD BETA-ADRENERGIC BLOCKING AGENTS 94, DD CALCIUM CHANNEL BLOCKING AGENTS 45, DD CARBONIC ANHYDRASE INHIBITORS DD CHEMOTHERAPEUTICS, ANTIBACTERIAL, MISC DD DECONGESTANT-EXPECTORANT COMBINATIONS 1, DD ELECTROLYTE DEPLETERS DD GASTRIC ACID SECRETION REDUCERS 92, DD HYPNOTICS, MELATONIN MT1/MT2 RECEPTOR AGONISTS DD HYPOPIGMENTATION AGENTS DD IMMUNOSUPPRESSIVES DD INTESTINAL MOTILITY STIMULANTS DD IV SOLUTIONS: DEXTROSE AND LACTATED RINGERS DD LOOP DIURETICS 33, DD MACROLIDES 34, DD MAOIS - NON-SELECTIVE & IRREVERSIBLE The preparation of this document was financed under an agreement with Indiana OMPP. Page 43

44 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.1. DRUG-DRUG INTERACTION (DD) (continued) DUR Screen # Claims Screened # Alerts # Overrides # Cancellations & Non- Responses % Alerts /Total Rx % Cancels /Total Rx Therapeutic Category/Drug(s) (Hierarchical Ingredient) DD MONOAMINE OXIDASE(MAO) INHIBITORS DD NARC.& NON-SAL.ANALGESIC,BARBITURATE &XANTHINE CMB DD NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB DD NARCOTIC & SALICYLATE ANALGESICS, BARB.& XANTHINE DD NARCOTIC ANALGESIC & NON-SALICYLATE ANALGESIC COMB DD NARCOTIC ANTAGONISTS DD NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE DD NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB DD NARCOTIC ANTITUSSIVE-EXPECTORANT COMBINATION DD NON-NARC ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB DD QUINOLONES 29, DD SEDATIVE-HYPNOTICS,NON-BARBITURATE 19, DD SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) DD SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 129, DD SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 39, DD SKELETAL MUSCLE RELAXANTS 64, DD SYMPATHOMIMETIC AGENTS 2, DD TETRACYCLINES 1, DD TOPICAL ANTIBIOTICS 14, DD TOPICAL IMMUNOSUPPRESSIVE AGENTS DD TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 10, DD TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 4, DD URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG DD URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 20, DD VIRAL/TUMORIGENIC VACCINES DD DRUG-DRUG INTERACTION ALERT (DD) TOTAL 2,221,924 8,748 3,220 5,499 * NOTE: Severity Level 1 Drug-Drug Interaction NOTE: The number of DUR Alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately, therefore, the number of cancellations and non-responses will not equal total number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 44

45 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx % Cancels /Total Rx ER 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB ER 1ST GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS 3, ER 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB ER 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB 5, ER 1ST GENERATION ANTIHISTAMINE AND DECONGEST COMB ER 1ST GENERATION ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB ER 2ND GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS 7, ER 5-LIPOXYGENASE INHIBITORS ER ABSORBABLE SULFONAMIDES 25, ER ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION 6, ER ACE INHIBITOR/THIAZIDE & THIAZIDE-LIKE DIURETIC 14, ER ACNE AGENTS,SYSTEMIC ER ACNE AGENTS,TOPICAL 1, ER ADRENERGIC VASOPRESSOR AGENTS ER ADRENERGICS, AROMATIC, NON-CATECHOLAMINE 47,275 1, , ER AGENTS TO TREAT MULTIPLE SCLEROSIS 3, ER ALKYLATING AGENTS ER ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS 16,868 1, ER ALPHA-ADRENERGIC BLOCKING AGENTS 4, , ER ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 16, ER ALZHEIMER'S THERAPY, NMDA RECEPTOR ANTAGONISTS 2, ER AMINOGLYCOSIDES 1, ER AMMONIA INHIBITORS 3, ER ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL AGENTS 8, ER ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE ER ANALGESIC, NON-SALICYLATE & BARBITURATE COMB ER ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB 1, ER ANALGESIC,NON-SALICYLATE,BARBITURATE,&XANTHINE CMB 7, ER ANALGESIC/ANTIPYRETICS, SALICYLATES 165,125 3, , ER ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 134,929 5, , ER ANALGESICS, NARCOTIC AGONIST AND NSAID COMBINATION 2, ER ANALGESICS, NARCOTICS 415,144 20,994 1,920 19, ER ANAPHYLAXIS THERAPY AGENTS ER ANDROGENIC AGENTS 1, ER ANGIOTENSIN RECEPTOR ANTAG./THIAZIDE DIURETIC COMB 10, ER ANGIOTENSIN RECEPTOR ANTGNST & CALC.CHANNEL BLOCKR ER ANTACIDS 29, ER ANTHELMINTICS ER ANTI-ALCOHOLIC PREPARATIONS 1, ER ANTIANDROGENIC AGENTS ER ANTIANGINAL & ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC ER ANTI-ANXIETY DRUGS 335,387 20,902 2,270 18, ER ANTIARRHYTHMICS 3, ER ANTI-ARTHRITIC AND CHELATING AGENTS ER ANTICHOLINERGICS,QUATERNARY AMMONIUM 3, ER ANTICHOLINERGICS/ANTISPASMODICS 5, ER ANTICOAGULANTS,COUMARIN TYPE 27,184 2, , ER ANTICONVULSANTS 395,709 27,020 2,608 24, ER ANTIDIARRHEALS 9, ER ANTIDIURETIC AND VASOPRESSOR HORMONES 6, ER ANTIEMETIC/ANTIVERTIGO AGENTS 24, ER ANTI-FLAM. INTERLEUKIN-1 RECEPTOR ANTAGONIST ER ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR ER ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR ER ANTIFLATULENTS 3, ER ANTIFUNGAL AGENTS 15, ER ANTIFUNGAL ANTIBIOTICS 5, ER ANTIHEMOPHILIC FACTORS ER ANTIHISTAMINES - 1ST GENERATION 65,439 2, , ER ANTIHISTAMINES - 2ND GENERATION 134,218 5, , ER ANTIHYPERGLY, (DPP-4) INHIBITOR & BIGUANIDE COMB ER ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST) 2, ER ANTIHYPERGLYCEMIC, ALPHA-GLUCOSIDASE INHIB (N-S) The preparation of this document was financed under an agreement with Indiana OMPP. Page 45

46 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx % Cancels /Total Rx ER ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE ER ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS 4, ER ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE 30,324 1, , ER ANTIHYPERGLYCEMIC, INSULIN-RESPONSE ENHANCER (N-S) 18, ER ANTIHYPERGLYCEMIC,BIGUANIDE TYPE(NON-SULFONYLUREA) 46,624 2, , ER ANTIHYPERGLYCEMIC,INSULIN-REL STIM.& BIGUANIDE CMB 2, ER ANTIHYPERGLYCEMIC,INSULIN-RESPONSE & RELEASE COMB ER ANTIHYPERGLYCM,INSUL-RESP.ENHANCER & BIGUANIDE CMB 1, ER ANTIHYPERLIP - HMG-COA&CALCIUM CHANNEL BLOCKER CB 2, ER ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB 11, ER ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 99,466 4, , ER ANTIHYPERLIPIDEMIC-HMG COA REDUCTASE INHIB.&NIACIN ER ANTIHYPERTENSIVES, ACE INHIBITORS 59,202 3, , ER ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 8, ER ANTIHYPERTENSIVES, GANGLIONIC BLOCKERS ER ANTIHYPERTENSIVES, MISCELLANEOUS 2, ER ANTIHYPERTENSIVES, SYMPATHOLYTIC 2,198 2, , ER ANTIHYPERTENSIVES, VASODILATORS 2, ER ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR 2, ER ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR ER ANTIVIRALS, HIV-SPECIFIC, FUSION INHIBITORS ER ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI 1, ER ANTIVIRALS, HIV-SPECIFIC, NUCLEOSIDE ANALOG, RTI 1, ER ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITOR COMB 1, ER ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS 2, ER ANTIVIRALS,HIV-1 INTEGRASE STRAND TRANSFER INHIBTR ER APPETITE STIM. FOR ANOREXIA,CACHEXIA,WASTING SYND. 2, ER ARTIFICIAL TEARS 30,703 1, ER ARTV CMB NUCLEOSIDE,NUCLEOTIDE,&NON-NUCLEOSIDE RTI ER BARBITURATES 24,235 1, , ER BELLADONNA ALKALOIDS 4, ER BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS 8, ER BETA-ADRENERGIC AGENTS 97,102 4, , ER BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS 16,789 1, , ER BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS 26,114 1, , ER BETA-ADRENERGIC BLOCKING AGENTS 94,465 5, , ER BETALACTAMS ER BICARBONATE PRODUCING/CONTAINING AGENTS ER BILE SALT SEQUESTRANTS 1, ER BILE SALTS ER BONE FORMATION STIM. AGENTS - PARATHYROID HORMONE ER BONE RESORPTION INHIBITOR & VITAMIN D COMBINATIONS ER BONE RESORPTION INHIBITORS 15, ER BULK CHEMICALS ER CALCIMIMETIC,PARATHYROID CALCIUM ENHANCER ER CALCIUM CHANNEL BLOCKING AGENTS 52,549 2, , ER CALCIUM REPLACEMENT 141,524 3, , ER CARBAPENEMS (THIENAMYCINS) ER CARBONIC ANHYDRASE INHIBITORS 1, ER CEPHALOSPORINS - 1ST GENERATION 26, ER CEPHALOSPORINS - 2ND GENERATION 5, ER CEPHALOSPORINS - 3RD GENERATION 6, ER CEPHALOSPORINS - 4TH GENERATION ER CHEMOTHERAPEUTICS, ANTIBACTERIAL, MISC ER CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS ER CHOLINESTERASE INHIBITORS 5, ER CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX The preparation of this document was financed under an agreement with Indiana OMPP. Page 46

47 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx % Cancels /Total Rx ER COLCHICINE 1, ER CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC ER CONTRACEPTIVES,INJECTABLE 3, ER CONTRACEPTIVES,ORAL 23,192 1, , ER CONTRACEPTIVES,TRANSDERMAL 1, ER DECARBOXYLASE INHIBITORS ER DECONGESTANT-EXPECTORANT COMBINATIONS 6, ER DENTAL AIDS AND PREPARATIONS 6, ER DIGITALIS GLYCOSIDES 10, ER DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT 1, ER DRUGS TO TREAT HEREDITARY TYROSINEMIA ER DRUGS TO TX CHRONIC INFLAMM. DISEASE OF COLON ER EAR PREPARATIONS ANTI-INFLAMMATORY ER EAR PREPARATIONS, MISC. ANTI-INFECTIVES ER EAR PREPARATIONS,ANTIBIOTICS 5, ER EAR PREPARATIONS,EAR WAX REMOVERS 5, ER EAR PREPARATIONS,LOCAL ANESTHETICS 1, ER ELECTROLYTE DEPLETERS 2, ER ELECTROLYTE MAINTENANCE ER EMOLLIENTS 7, ER ESTROGENIC AGENTS 17, ER EXPECTORANTS 18, ER EYE ANTIBIOTIC-CORTICOID COMBINATIONS ER EYE ANTIHISTAMINES 3, ER EYE ANTIINFLAMMATORY AGENTS 3, ER EYE ANTIVIRALS ER EYE PREPARATIONS, MISCELLANEOUS (OTC) 3, ER EYE SULFONAMIDES 1, ER EYE VASOCONSTRICTORS (OTC ONLY) ER EYE VASOCONSTRICTORS (RX ONLY) ER FACTOR IX PREPARATIONS ER FLUORIDE PREPARATIONS 2, ER FOLIC ACID PREPARATIONS 39,090 1, , ER GASTRIC ACID SECRETION REDUCERS 130,229 5, , ER GASTRIC ENZYMES 2, ER GENERAL ANESTHETICS,INJECTABLE ER GENERAL BRONCHODILATOR AGENTS 22,912 1, , ER GENERAL INHALATION AGENTS ER GERIATRIC VITAMIN PREPARATIONS 6, ER GLUCOCORTICOIDS 64,256 2, , ER GLYCYLCYCLINES ER GRAM POSITIVE COCCI VACCINES ER GROWTH HORMONES ER HEMATINICS,OTHER 2, ER HEMORRHEOLOGIC AGENTS ER HEMORRHOIDAL PREP, ANTI-INFAM STEROID/LOCAL ANESTH ER HEMORRHOIDAL PREPARATIONS ER HEMORRHOIDALS, LOCAL RECTAL ANESTHETICS ER HEPARIN AND RELATED PREPARATIONS 9, ER HEPATITIS B TREATMENT AGENTS ER HEPATITIS C TREATMENT AGENTS 2, ER HISTAMINE H2-RECEPTOR INHIBITORS 18, ER HYPERGLYCEMICS 3, ER HYPERPARATHYROID TX AGENTS - VITAMIN D ANALOG-TYPE ER HYPERURICEMIA TX - PURINE INHIBITORS 5, ER HYPNOTICS, MELATONIN MT1/MT2 RECEPTOR AGONISTS 4, ER HYPOPIGMENTATION AGENTS ER HYPOTENSIVES, ACE INHIBITORS 30,443 1, , ER HYPOTENSIVES,ANGIOTENSIN RECEPTOR ANTAGONIST 4, ER HYPOTENSIVES,MISCELLANEOUS 1, ER HYPOTENSIVES,SYMPATHOLYTIC 13,394 1, , ER HYPOTENSIVES,VASODILATORS 1, ER IMMUNOMODULATORS ER IMMUNOSUPPRESSIVES 7, ER INFLUENZA VIRUS VACCINES ER INOTROPIC DRUGS The preparation of this document was financed under an agreement with Indiana OMPP. Page 47

48 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx % Cancels /Total Rx ER INSULINS 69,482 6, , ER INTESTINAL MOTILITY STIMULANTS 18, , ER IODINE CONTAINING AGENTS ER IRON REPLACEMENT 91,052 2, , ER IRRIGANTS 1, ER IRRITABLE BOWEL SYND. AGENT,5HT-3 ANTAGONIST-TYPE ER IRRITANTS/COUNTER-IRRITANTS 1, ER IV SOLUTIONS: DEXTROSE-SALINE ER IV SOLUTIONS: DEXTROSE-WATER ER KERATOLYTICS 3, ER KETOLIDES ER LAXATIVES AND CATHARTICS 281,430 10,696 1,176 9, ER LAXATIVES, LOCAL/RECTAL 21, ER LEUKOCYTE (WBC) STIMULANTS ER LEUKOTRIENE RECEPTOR ANTAGONISTS 29,690 1, , ER LHRH(GNRH) AGONIST ANALOG PITUITARY SUPPRESSANTS ER LHRH(GNRH)AGNST PIT.SUP-CENTRAL PRECOCIOUS PUBERTY ER LINCOSAMIDES 6, ER LIPOTROPICS 33,494 1, , ER LOCAL ANESTHETICS 1, ER LOOP DIURETICS 56,016 4, , ER MACROLIDES 34, ER MAGNESIUM SALTS REPLACEMENT 5, ER MAOIS - NON-SELECTIVE & IRREVERSIBLE ER MAST CELL STABILIZERS ER METABOLIC DEFICIENCY AGENTS 5, ER METALLIC POISON,AGENTS TO TREAT ER MINERALOCORTICOIDS 1, ER MIOTICS/OTHER INTRAOC. PRESSURE REDUCERS 7, ER MONOCLONAL ANTIBODIES TO IMMUNOGLOBULIN E(IGE) ER MUCOLYTICS 1, ER MULTIVITAMIN PREPARATIONS 215,054 4, , ER MYDRIATICS ER NARC.& NON-SAL.ANALGESIC,BARBITURATE &XANTHINE CMB ER NARCOTIC & SALICYLATE ANALGESICS, BARB.& XANTHINE ER NARCOTIC ANALGESIC & NON-SALICYLATE ANALGESIC COMB 14, ER NARCOTIC AND SALICYLATE ANALGESIC COMBINATION ER NARCOTIC ANTAGONISTS 1, ER NARCOTIC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 5, ER NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT COMB ER NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE 14, ER NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB ER NARCOTIC ANTITUSSIVE-EXPECTORANT COMBINATION 16, ER NASAL ANTIHISTAMINE 1, ER NASAL ANTI-INFLAMMATORY STEROIDS 28,048 1, , ER NASAL MAST CELL STABILIZERS AGENTS ER NIACIN PREPARATIONS 3, ER NITROFURAN DERIVATIVES 7, ER NON-NARC ANTITUS-1ST GEN ANTIHIST-DECONGEST-EXPECT ER NON-NARC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 8, ER NON-NARC ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB ER NON-NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT CMB ER NON-NARCOTIC ANTITUSSIVE AND EXPECTORANT COMB. 19, ER NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 29,977 1, , ER NOSE PREPARATIONS ANTIBIOTICS ER NOSE PREPARATIONS, MISCELLANEOUS (OTC) 5, ER NOSE PREPARATIONS, MISCELLANEOUS (RX) ER NSAIDS (COX NON-SPECIFIC INHIB)& PROSTAGLANDIN CMB ER NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 91,275 3, , ER OPHTHALMIC ANTIBIOTICS 8, ER OPHTHALMIC ANTI-INFLAMMATORY IMMUNOMODULATOR-TYPE ER OPHTHALMIC MAST CELL STABILIZERS The preparation of this document was financed under an agreement with Indiana OMPP. Page 48

49 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx ER OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS 2, ER OXAZOLIDINONES ER OXYTOCICS ER PANCREATIC ENZYMES 3, ER PARASYMPATHETIC AGENTS 1, ER PEDIATRIC VITAMIN PREPARATIONS 7, ER PENICILLINS 71,241 1, , ER PERIODONTAL COLLAGENASE INHIBITORS ER PHOSPHATE REPLACEMENT ER PITUITARY SUPPRESSIVE AGENTS ER PLATELET AGGREGATION INHIBITORS 30,839 1, , ER PLATELET REDUCING AGENTS ER POLYMYXIN AND DERIVATIVES ER POTASSIUM REPLACEMENT 42,045 2, , ER POTASSIUM SPARING DIURETICS 13, ER POTASSIUM SPARING DIURETICS IN COMBINATION 11, ER PRENATAL VITAMIN PREPARATIONS 13, ER PROGESTATIONAL AGENTS 2, ER PROTECTIVES ER PROTON-PUMP INHIBITORS 57,157 2, , ER PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB ER PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST ER PULMONARY ANTIHYPERTENSIVES, PROSTACYCLIN-TYPE ER QUINOLONES 29, ER RECTAL PREPARATIONS 1, ER RENIN INHIBITOR, DIRECT ER RIFAMYCINS AND RELATED DERIVATIVE ANTIBIOTICS ER ROSACEA AGENTS, TOPICAL ER SEDATIVE-HYPNOTICS,NON-BARBITURATE 72,728 3, , ER SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) 1, ER SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 170,528 10, , ER SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) 42,025 3, , ER SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 62,515 4, , ER SKELETAL MUSCLE RELAXANTS 77,625 3, , ER SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) 6, ER SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST 12, ER SMOKING DETERRENTS, OTHER ER SODIUM/SALINE PREPARATIONS 3, ER SOLVENTS 3, ER SOMATOSTATIC AGENTS ER SSRI &ANTIPSYCH,ATYP,DOPAMINE&SEROTONIN ANTAG COMB ER STEROID ANTINEOPLASTICS ER SYMPATHOMIMETIC AGENTS 6, ER SYSTEMIC ENZYME INHIBITORS ER TETRACYCLINES 16, ER THIAZIDE AND RELATED DIURETICS 29,479 1, , ER THYROID FUNCTION DIAGNOSTIC AGENTS ER THYROID HORMONES 54,539 3, , ER TOPICAL ANTIBIOTICS 42, ER TOPICAL ANTIBIOTICS/ANTIINFLAMMATORY,STEROIDAL ER TOPICAL ANTIFUNGALS 30, ER TOPICAL ANTI-INFLAMMATORY STEROIDAL 26, ER TOPICAL ANTI-INFLAMMATORY, NSAIDS ER TOPICAL ANTINEOPLASTIC & PREMALIGNANT LESION AGNTS ER TOPICAL ANTIPARASITICS 7, ER TOPICAL ANTIVIRALS 1, ER TOPICAL IMMUNOSUPPRESSIVE AGENTS ER TOPICAL LOCAL ANESTHETICS 7, ER TOPICAL PLEUROMUTILIN DERIVATIVES ER TOPICAL PREPARATIONS,ANTIBACTERIALS ER TOPICAL PREPARATIONS,MISCELLANEOUS ER TOPICAL SULFONAMIDES 2, ER TOPICAL VIT D ANALOG/ANTIINFLAMMATORY, STEROIDAL % Cancels /Total Rx The preparation of this document was financed under an agreement with Indiana OMPP. Page 49

50 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.2. EARLY REFILL ALERT (ER) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx % Cancels /Total Rx ER TOPICAL/MUCOUS MEMBR./SUBCUT. ENZYMES ER TRICYCLIC ANTIDEPRESSANT/BENZODIAZEPINE COMBINATNS ER TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS ER TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 29,971 1, , ER TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 57,231 2, , ER TX FOR ATTENTION DEFICIT-HYPERACT.(ADHD), NRI-TYPE 15, ER URICOSURIC AGENTS ER URINARY PH MODIFIERS ER URINARY TRACT ANALGESIC AGENTS ER URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE) 2, ER URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG. 1, ER URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 20, ER VAGINAL ANTIBIOTICS 1, ER VAGINAL ANTIFUNGALS 3, ER VAGINAL ESTROGEN PREPARATIONS 1, ER VANCOMYCIN AND DERIVATIVES ER VASODILATORS, COMBINATION ER VASODILATORS,CORONARY 21, ER VASODILATORS,PERIPHERAL ER VEHICLES 10, ER VIRAL/TUMORIGENIC VACCINES ER VITAMIN A DERIVATIVES 1, ER VITAMIN B PREPARATIONS 26, ER VITAMIN B1 PREPARATIONS 7, ER VITAMIN B12 PREPARATIONS 20,575 1, , ER VITAMIN B2 PREPARATIONS ER VITAMIN B6 PREPARATIONS 4, ER VITAMIN C PREPARATIONS 33,393 1, ER VITAMIN D PREPARATIONS 10, ER VITAMIN E PREPARATIONS 8, ER VITAMIN K PREPARATIONS 1, ER WATER ER XANTHINES 4, , ER ZINC REPLACEMENT 10, ER EARLY REFILL ALERT (ER) TOTAL 5,773, ,217 21, ,046 NOTE: The number of DUR Alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately, therefore, the number of cancellations and non-responses will not equal total number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 50

51 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.3. HIGH DOSE ALERT (HD) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx HD 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB HD 1ST GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS HD 1ST GEN ANTIHISTAMINE-DECONGESTANT-EXPECTORANT CMB HD 2ND GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS HD ABSORBABLE SULFONAMIDES HD ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION HD ACE INHIBITOR/THIAZIDE & THIAZIDE-LIKE DIURETIC HD ADRENERGIC VASOPRESSOR AGENTS HD ADRENERGICS, AROMATIC, NON-CATECHOLAMINE 43, HD ADRENOCORTICOTROPHIC HORMONES HD AGENTS TO TREAT MULTIPLE SCLEROSIS 2, HD ALKYLATING AGENTS HD ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 16, HD ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS 5, HD ALPHA-ADRENERGIC BLOCKING AGENTS 1, HD AMINOGLYCOSIDES 1, HD AMMONIA INHIBITORS 3, HD ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL AGENTS 4, HD ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB 1, HD ANALGESIC/ANTIPYRETICS, SALICYLATES 97, HD ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 134, HD ANALGESICS, NARCOTIC AGONIST AND NSAID COMBINATION 2, HD ANALGESICS, NARCOTICS 415, HD ANDROGENIC AGENTS 1, HD ANGIOTENSIN RECEPTOR ANTAG./THIAZIDE DIURETIC COMB 5, HD ANTACIDS 29, HD ANTI-ALCOHOLIC PREPARATIONS HD ANTIANGINAL & ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC HD ANTI-ANXIETY DRUGS 280, HD ANTIARRHYTHMICS 1, HD ANTICHOLINERGICS,QUATERNARY AMMONIUM 3, HD ANTICHOLINERGICS/ANTISPASMODICS 1, HD ANTICOAGULANTS,COUMARIN TYPE 27, HD ANTICONVULSANTS 395, HD ANTIDIARRHEALS 10, HD ANTIDIURETIC AND VASOPRESSOR HORMONES 6, HD ANTIEMETIC/ANTIVERTIGO AGENTS 24, HD ANTI-FLAM. INTERLEUKIN-1 RECEPTOR ANTAGONIST HD ANTIFLATULENTS 3, HD ANTIFUNGAL AGENTS 13, HD ANTIFUNGAL ANTIBIOTICS 4, HD ANTIGENIC SKIN TESTS HD ANTIHISTAMINES - 1ST GENERATION 65, HD ANTIHISTAMINES - 2ND GENERATION 134, HD ANTIHYPERGLY, (DPP-4) INHIBITOR & BIGUANIDE COMB HD ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST) 2, HD ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE HD ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS 2, HD ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE 27, HD ANTIHYPERGLYCEMIC, INSULIN-RESPONSE ENHANCER (N-S) 6, HD ANTIHYPERGLYCEMIC,BIGUANIDE TYPE(NON-SULFONYLUREA) 42, HD ANTIHYPERGLYCEMIC,INSULIN-REL STIM.& BIGUANIDE CMB HD ANTIHYPERGLYCM,INSUL-RESP.ENHANCER & BIGUANIDE CMB HD ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB 8, HD ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 92, HD ANTIHYPERTENSIVES, ACE INHIBITORS 59, HD ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 1, HD ANTIHYPERTENSIVES, MISCELLANEOUS 1, HD ANTIHYPERTENSIVES, SYMPATHOLYTIC 26, HD ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR 1, HD ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR HD ANTIMALARIAL DRUGS HD ANTI-MANIA DRUGS 10, HD ANTIMETABOLITES 4, HD ANTIMIGRAINE PREPARATIONS 9, HD ANTINEOPLASTIC - AROMATASE INHIBITORS HD ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS HD ANTINEOPLASTICS,MISCELLANEOUS The preparation of this document was financed under an agreement with Indiana OMPP. Page 51 % Cancels /Total Rx

52 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.3. HIGH DOSE ALERT (HD) (continued) # Cancellations & Non- Responses % Cancels /Total Rx DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx HD ANTIOXIDANT MULTIVITAMIN COMBINATIONS HD ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC HD ANTIPARKINSONISM DRUGS,OTHER HD ANTIPROTOZOAL DRUGS,MISCELLANEOUS HD ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED HD ANTIPSYCHOTICS, DOPAMINE & SEROTONIN ANTAGONISTS HD ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG HD ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES HD ANTI-PSYCHOTICS,PHENOTHIAZINES HD ANTISERA HD ANTITHYROID PREPARATIONS HD ANTITUSSIVES,NON-NARCOTIC HD ANTI-ULCER PREPARATIONS HD ANTIVIRALS, GENERAL HD ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG HD ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI HD ANTIVIRALS, HIV-SPECIFIC, NUCLEOSIDE ANALOG, RTI HD ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITOR COMB HD ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS HD APPETITE STIM. FOR ANOREXIA,CACHEXIA,WASTING SYND HD ARTIFICIAL TEARS HD BARBITURATES HD BELLADONNA ALKALOIDS HD BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS HD BETA-ADRENERGIC AGENTS HD BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS HD BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS HD BETA-ADRENERGIC BLOCKING AGENTS HD BILE SALT SEQUESTRANTS HD BILE SALTS HD BONE FORMATION STIM. AGENTS - PARATHYROID HORMONE HD BONE RESORPTION INHIBITOR & VITAMIN D COMBINATIONS HD BONE RESORPTION INHIBITORS 15, HD CALCIUM CHANNEL BLOCKING AGENTS 49, HD CALCIUM REPLACEMENT HD CARBAPENEMS (THIENAMYCINS) HD CARBONIC ANHYDRASE INHIBITORS HD CEPHALOSPORINS - 1ST GENERATION 24, HD CEPHALOSPORINS - 2ND GENERATION 5, HD CEPHALOSPORINS - 3RD GENERATION 6, HD CEPHALOSPORINS - 4TH GENERATION HD CHEMOTHERAPEUTICS, ANTIBACTERIAL, MISC HD CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS HD CHOLINESTERASE INHIBITORS HD CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX HD COLCHICINE HD CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC HD CONTRACEPTIVES,ORAL 23, HD CONTRACEPTIVES,TRANSDERMAL 1, HD DECONGESTANT-EXPECTORANT COMBINATIONS 5, HD DENTAL AIDS AND PREPARATIONS 6, HD DIGITALIS GLYCOSIDES 3, HD DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT HD DRUGS TO TX CHRONIC INFLAMM. DISEASE OF COLON HD EAR PREPARATIONS ANTI-INFLAMMATORY HD EAR PREPARATIONS, MISC. ANTI-INFECTIVES HD EAR PREPARATIONS,ANTIBIOTICS 5, HD EAR PREPARATIONS,EAR WAX REMOVERS 5, HD EAR PREPARATIONS,LOCAL ANESTHETICS HD ELECTROLYTE DEPLETERS 1, HD ELECTROLYTE MAINTENANCE HD ESTROGENIC AGENTS 17, HD EXPECTORANTS 13, HD EYE ANTIBIOTIC-CORTICOID COMBINATIONS The preparation of this document was financed under an agreement with Indiana OMPP. Page 52

53 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.3. HIGH DOSE ALERT (HD) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx HD EYE ANTIHISTAMINES 3, HD EYE ANTIINFLAMMATORY AGENTS 3, HD EYE ANTIVIRALS HD EYE LOCAL ANESTHETICS HD EYE SULFONAMIDES 1, HD EYE VASOCONSTRICTORS (OTC ONLY) HD EYE VASOCONSTRICTORS (RX ONLY) HD FLUORIDE PREPARATIONS HD FOLIC ACID PREPARATIONS 23, HD FOLLICLE STIM./LUTEINIZING HORMONES HD GASTRIC ACID SECRETION REDUCERS 130, HD GASTRIC ENZYMES HD GENERAL ANESTHETICS,INJECTABLE HD GENERAL BRONCHODILATOR AGENTS HD GERIATRIC VITAMIN PREPARATIONS 4, HD GLUCOCORTICOIDS HD GLYCYLCYCLINES HD GRAM POSITIVE COCCI VACCINES HD GROWTH HORMONES HD HEMATINICS,OTHER 2, HD HEMORRHEOLOGIC AGENTS HD HEPARIN AND RELATED PREPARATIONS 9, HD HEPATITIS B TREATMENT AGENTS HD HEPATITIS C TREATMENT AGENTS 1, HD HISTAMINE H2-RECEPTOR INHIBITORS 18, HD HYPERGLYCEMICS 1, HD HYPERPARATHYROID TX AGENTS - VITAMIN D ANALOG-TYPE HD HYPERURICEMIA TX - PURINE INHIBITORS HD HYPOTENSIVES, ACE INHIBITORS 30, HD HYPOTENSIVES,ANGIOTENSIN RECEPTOR ANTAGONIST HD HYPOTENSIVES,MISCELLANEOUS HD HYPOTENSIVES,SYMPATHOLYTIC HD IMMUNOMODULATORS HD IMMUNOSUPPRESSIVES HD INFLUENZA VIRUS VACCINES HD INSULINS 69, HD INTESTINAL MOTILITY STIMULANTS 18, HD IODINE CONTAINING AGENTS HD IRON REPLACEMENT 91, HD LAXATIVES AND CATHARTICS 281, HD LAXATIVES, LOCAL/RECTAL 21, HD LEUKOCYTE (WBC) STIMULANTS HD LEUKOTRIENE RECEPTOR ANTAGONISTS 29, HD LINCOSAMIDES 3, HD LIPOTROPICS 33, HD LOCAL ANESTHETICS 1, HD LOOP DIURETICS 13, HD MACROLIDES 34, HD MAGNESIUM SALTS REPLACEMENT 5, HD MAST CELL STABILIZERS HD METABOLIC DEFICIENCY AGENTS HD MINERAL REPLACEMENT,MISCELLANEOUS HD MINERALOCORTICOIDS HD MIOTICS/OTHER INTRAOC. PRESSURE REDUCERS 7, HD MUCOLYTICS 1, HD MULTIVITAMIN PREPARATIONS 231, HD MYDRIATICS HD NARCOTIC & SALICYLATE ANALGESICS, BARB.& XANTHINE HD NARCOTIC ANALGESIC & NON-SALICYLATE ANALGESIC COMB 14, HD NARCOTIC ANTAGONISTS HD NARCOTIC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 4, HD NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT COMB HD NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE 14, HD NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB HD NARCOTIC ANTITUSSIVE-DECONGESTANT COMBINATIONS HD NARCOTIC ANTITUSSIVE-EXPECTORANT COMBINATION 16, % Cancels /Total Rx The preparation of this document was financed under an agreement with Indiana OMPP. Page 53

54 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.3. HIGH DOSE ALERT (HD) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx HD NASAL ANTIHISTAMINE 1, HD NASAL ANTI-INFLAMMATORY STEROIDS 28, HD NASAL MAST CELL STABILIZERS AGENTS HD NEUROMUSCULAR BLOCKING AGENTS HD NIACIN PREPARATIONS HD NITROFURAN DERIVATIVES 4, HD NON-NARC ANTITUS-1ST GEN ANTIHIST-DECONGEST-EXPECT HD NON-NARC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 10, HD NON-NARC ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB HD NON-NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT CMB HD NON-NARCOTIC ANTITUSSIVE AND EXPECTORANT COMB. 19, HD NON-NARCOTIC ANTITUSSIVE-DECONGESTANT COMBINATIONS HD NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 13, HD NOSE PREPARATIONS, MISCELLANEOUS (OTC) 1, HD NOSE PREPARATIONS, MISCELLANEOUS (RX) HD NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 98, HD OPHTHALMIC ANTIBIOTICS 8, HD OPHTHALMIC MAST CELL STABILIZERS HD OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS 2, HD OTIC,ANTIINFECTIVE-LOCAL ANESTHETIC COMBINATIONS HD OXAZOLIDINONES HD OXIDIZING AGENTS HD PANCREATIC ENZYMES 2, HD PEDIATRIC VITAMIN PREPARATIONS 7, HD PENICILLINS 71, HD PERIODONTAL COLLAGENASE INHIBITORS HD PHOSPHATE REPLACEMENT HD PITUITARY SUPPRESSIVE AGENTS HD PLATELET AGGREGATION INHIBITORS 25, HD POLYMYXIN AND DERIVATIVES HD POTASSIUM REPLACEMENT 42, HD POTASSIUM SPARING DIURETICS 1, HD POTASSIUM SPARING DIURETICS IN COMBINATION 2, HD PRENATAL VITAMIN PREPARATIONS 13, HD PROGESTATIONAL AGENTS 2, HD PROTON-PUMP INHIBITORS 57, HD PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB HD QUINOLONES 29, HD RENIN INHIBITOR, DIRECT HD RIFAMYCINS AND RELATED DERIVATIVE ANTIBIOTICS HD SEDATIVE-HYPNOTICS,NON-BARBITURATE 72, HD SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 170, HD SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) 7, HD SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 62, HD SKELETAL MUSCLE RELAXANTS 71, HD SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) 6, HD SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST 10, HD SOMATOSTATIC AGENTS HD SYMPATHOMIMETIC AGENTS 5, HD TETRACYCLINES 9, HD THIAZIDE AND RELATED DIURETICS 9, HD THROMBOLYTIC ENZYMES HD THYROID HORMONES 58, HD TOPICAL ANTI-INFLAMMATORY, NSAIDS HD TOPICAL ANTIPARASITICS 5, HD TOPICAL LOCAL ANESTHETICS 8, HD TOPICAL SULFONAMIDES HD TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS HD TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 27, % Cancels /Total Rx The preparation of this document was financed under an agreement with Indiana OMPP. Page 54

55 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.3. HIGH DOSE ALERT (HD) (continued) DUR Screen # Cancellations & Non- Responses Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx HD TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 52, HD TX FOR ATTENTION DEFICIT-HYPERACT.(ADHD), NRI-TYPE 12, HD URINARY PH MODIFIERS HD URINARY TRACT ANALGESIC AGENTS HD URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE) HD URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG HD URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 20, HD VAGINAL ANTIBIOTICS 1, HD VAGINAL ANTIFUNGALS 3, HD VAGINAL ESTROGEN PREPARATIONS HD VANCOMYCIN AND DERIVATIVES HD VASODILATORS,CORONARY 21, HD VEHICLES 9, HD VIRAL/TUMORIGENIC VACCINES HD VITAMIN A PREPARATIONS HD VITAMIN B PREPARATIONS 26, HD VITAMIN B1 PREPARATIONS 13, HD VITAMIN B12 PREPARATIONS 19, HD VITAMIN B2 PREPARATIONS HD VITAMIN B6 PREPARATIONS 4, HD VITAMIN C PREPARATIONS 14, HD VITAMIN D PREPARATIONS 7, HD VITAMIN E PREPARATIONS 7, HD VITAMIN K PREPARATIONS HD XANTHINES 3, HD ZINC REPLACEMENT 7, HD HIGH DOSE ALERT (HD) TOTAL 5,428,862 47,790 43,243 4,547 % Cancels /Total Rx NOTE: The number of DUR Alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately, therefore, the number of cancellations and non-responses will not equal total number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 55

56 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.4. LATE REFILL (LR) DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides # Cancellations & Non- Responses % Alerts /Total Rx % Cancels /Total Rx LR ABSORBABLE SULFONAMIDES LR ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION LR ACE INHIBITOR/THIAZIDE & THIAZIDE-LIKE DIURETIC LR ADRENERGICS, AROMATIC, NON-CATECHOLAMINE 43, LR AGENTS TO TREAT MULTIPLE SCLEROSIS LR ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS 16, LR ALPHA-ADRENERGIC BLOCKING AGENTS LR ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 16, LR AMMONIA INHIBITORS LR ANALGESIC/ANTIPYRETICS, SALICYLATES 25, LR ANGIOTENSIN RECEPTOR ANTAG./THIAZIDE DIURETIC COMB 2, LR ANTIANGINAL & ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC LR ANTI-ANXIETY DRUGS 26, LR ANTIARRHYTHMICS LR ANTICOAGULANTS,COUMARIN TYPE 27, ` LR ANTICONVULSANTS 395, LR ANTIDIARRHEALS LR ANTIDIURETIC AND VASOPRESSOR HORMONES LR ANTIHISTAMINES - 2ND GENERATION 134, LR ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST) 4, LR ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE LR ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS LR ANTIHYPERGLYCEMIC,BIGUANIDE TYPE(NON-SULFONYLUREA) 35, LR ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB 2, LR ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 59, LR ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE 12, LR ANTIHYPERGLYCM,INSUL-RESP.ENHANCER & BIGUANIDE CMB LR ANTIHYPERTENSIVES, ACE INHIBITORS 59, LR ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 6, LR ANTIHYPERTENSIVES, MISCELLANEOUS LR ANTIHYPERTENSIVES, SYMPATHOLYTIC 26, LR ANTIHYPERTENSIVES, VASODILATORS 2, LR ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR LR ANTIMALARIAL DRUGS LR ANTI-MANIA DRUGS 2, LR ANTIMETABOLITES 6, LR ANTI-MYCOBACTERIUM AGENTS LR ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC 21, LR ANTIPARKINSONISM DRUGS,OTHER 6, LR ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG 199, LR ANTIPSYCH,DOPAMINE ANTAG.,DIPHENYLBUTYLPIPERIDINES LR ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED 2, LR ANTIPSYCHOTICS, DOPAMINE & SEROTONIN ANTAGONISTS LR ANTI-PSYCHOTICS,PHENOTHIAZINES 10, LR ANTITHYROID PREPARATIONS LR ANTI-ULCER PREPARATIONS 2, LR ANTIVIRALS, HIV-SPECIFIC, NUCLEOSIDE ANALOG, RTI LR ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITOR COMB LR ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS LR APPETITE STIM. FOR ANOREXIA,CACHEXIA,WASTING SYND LR BELLADONNA ALKALOIDS LR BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS 1, LR BETA-ADRENERGIC AGENTS 97, LR BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS 16, LR BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS 26, LR BETA-ADRENERGIC BLOCKING AGENTS 101, LR BILE SALTS LR BONE FORMATION STIM. AGENTS - PARATHYROID HORMONE LR BONE RESORPTION INHIBITOR & VITAMIN D COMBINATIONS The preparation of this document was financed under an agreement with Indiana OMPP. Page 56

57 ATTACHMENT 2.1.B. RODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.4. LATE REFILL (LR) (continued) DUR Screen # Cancellations & Non- Responses % Cancels /Total Rx Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx LR BONE RESORPTION INHIBITORS 14, LR CALCIUM CHANNEL BLOCKING AGENTS 52, LR CARBONIC ANHYDRASE INHIBITORS LR COLCHICINE LR CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC LR CONTRACEPTIVES,ORAL 12, LR CONTRACEPTIVES,TRANSDERMAL LR DIGITALIS GLYCOSIDES LR HEMATINICS,OTHER 1, LR HISTAMINE H2-RECEPTOR INHIBITORS 18, LR HYPOTENSIVES, ACE INHIBITORS 30, LR HYPOTENSIVES,ANGIOTENSIN RECEPTOR ANTAGONIST 4, LR HYPOTENSIVES,MISCELLANEOUS LR HYPOTENSIVES,SYMPATHOLYTIC 13, LR HYPOTENSIVES,VASODILATORS 1, LR IMMUNOSUPPRESSIVES 1, LR INSULINS 51, LR IODINE CONTAINING AGENTS LR LAXATIVES AND CATHARTICS 135, LR LEUKOTRIENE RECEPTOR ANTAGONISTS 15, LR LIPOTROPICS 33, LR LOOP DIURETICS 46, LR MAST CELL STABILIZERS LR METABOLIC DEFICIENCY AGENTS LR MINERALOCORTICOIDS LR MIOTICS/OTHER INTRAOC. PRESSURE REDUCERS 7, LR MUCOLYTICS LR MYDRIATICS LR NASAL ANTI-INFLAMMATORY STEROIDS 28,048 1,119 1, LR NASAL ANTIHISTAMINE 1, LR NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 34, LR NOSE PREPARATIONS, MISCELLANEOUS (RX) LR NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 98,949 1, LR PANCREATIC ENZYMES 2, LR PLATELET AGGREGATION INHIBITORS 12, LR POTASSIUM REPLACEMENT 38, LR POTASSIUM SPARING DIURETICS 13, LR POTASSIUM SPARING DIURETICS IN COMBINATION 8, LR PROTON-PUMP INHIBITORS 57, LR PROGESTATIONAL AGENTS 2, LR SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) LR SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 185,406 2,722 2, LR SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) 42, LR SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 62,515 2,273 2, LR SKELETAL MUSCLE RELAXANTS 77, LR THIAZIDE AND RELATED DIURETICS 29, LR THYROID HORMONES 27, LR TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS LR TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 29, LR TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 57, LR TX FOR ATTENTION DEFICIT-HYPERACT.(ADHD), NRI-TYPE 5, LR URINARY PH MODIFIERS LR URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG LR URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 20, LR VAGINAL ESTROGEN PREPARATIONS LR VASODILATORS,CORONARY 21,244 1, LR VITAMIN B12 PREPARATIONS 10, LR VITAMIN D PREPARATIONS LR XANTHINES 2, LR LATE REFILL 2,744,685 17,435 14,387 2,910 NOTE: The number of DUR Alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately, therefore, the number of cancellations and non-responses will not equal total number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 57

58 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.5. DRUG-DISEASE CONTRAINDICATION (MC) # Cancellations & Non- Responses The preparation of this document was financed under an agreement with Indiana OMPP. Page 58 % Cancels /Total Rx DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx MC 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB 6, MC 1ST GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS 4, MC 2ND GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS 6, MC ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION 6, MC ACE INHIBITOR/THIAZIDE & THIAZIDE-LIKE DIURETIC 14, MC ACNE AGENTS,SYSTEMIC MC ADRENERGIC VASOPRESSOR AGENTS MC ADRENERGICS, AROMATIC, NON-CATECHOLAMINE 43, MC AGENTS TO TREAT MULTIPLE SCLEROSIS 3, MC ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS 16,868 1, MC ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 16, MC AMINOGLYCOSIDES 1, MC ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE MC ANALGESIC, NON-SALICYLATE & BARBITURATE COMB MC ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB 1, MC ANALGESIC,NON-SALICYLATE,BARBITURATE,&XANTHINE CMB 7, MC ANALGESIC/ANTIPYRETICS, SALICYLATES 165, MC ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 44, MC ANALGESICS, NARCOTIC AGONIST AND NSAID COMBINATION 2, MC ANALGESICS, NARCOTICS 415,144 76,026 61,980 13, MC ANAPHYLAXIS THERAPY AGENTS MC ANDROGENIC AGENTS 1, MC ANGIOTENSIN RECEPTOR ANTAG./THIAZIDE DIURETIC COMB 10, MC ANTACIDS 29, MC ANTI-ALCOHOLIC PREPARATIONS MC ANTI-ANXIETY DRUGS 335,387 12,072 1,841 10, MC ANTIARRHYTHMICS 3, MC ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR 2, MC ANTI-MANIA DRUGS 12, MC ANTI-PSYCHOTICS,PHENOTHIAZINES 10,410 2,580 1, MC ANTICHOLINERGICS,QUATERNARY AMMONIUM 3, MC ANTICHOLINERGICS/ANTISPASMODICS 5, MC ANTICOAGULANTS,COUMARIN TYPE 27,184 1, , MC ANTICONVULSANTS 395,709 7, , MC ANTIDIARRHEALS 10, MC ANTIDIURETIC AND VASOPRESSOR HORMONES 6, MC ANTIEMETIC/ANTIVERTIGO AGENTS 24, MC ANTIFUNGAL AGENTS 1, MC ANTIHISTAMINES - 1ST GENERATION 65, MC ANTIHYPERGLYCEMIC, INSULIN-RESPONSE ENHANCER (N-S) 17, MC ANTIHYPERGLYCEMIC,BIGUANIDE TYPE(NON-SULFONYLUREA) 43, MC ANTIHYPERGLYCM,INSUL-RESP.ENHANCER & BIGUANIDE CMB MC ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 84, MC ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB 1, MC ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE 13, MC ANTIHYPERTENSIVES, ACE INHIBITORS 59,202 2, , MC ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 8, MC ANTIHYPERTENSIVES, MISCELLANEOUS 2, MC ANTIHYPERTENSIVES, SYMPATHOLYTIC 26,173 2,662 1,239 1, MC ANTILEPROTICS MC ANTIMALARIAL DRUGS 1, MC ANTIMETABOLITES 1, MC ANTIMIGRAINE PREPARATIONS 9, MC ANTI-NARCOLEPSY & ANTI-CATAPLEXY,SEDATIVE-TYPE AGT MC ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS MC ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC 23, MC ANTIPARKINSONISM DRUGS,OTHER 18, MC ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED 42,877 1, , MC ANTIPSYCHOTICS, DOPAMINE & SEROTONIN ANTAGONISTS MC ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG 199,534 6, , MC ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS, THIOXANTHENES 1, MC ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES 9, MC ANTIPSYCHOTICS,DOPAMINE ANTAGONST,DIHYDROINDOLONES MC ANTITUBERCULAR ANTIBIOTICS MC ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI MC APPETITE STIM. FOR ANOREXIA,CACHEXIA,WASTING SYND MC BARBITURATES 24, MC BELLADONNA ALKALOIDS 4,

59 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.5. DRUG-DISEASE CONTRAINDICATION (MC) (continued) # Cancellations & Non- Responses % Cancels /Total Rx DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx MC BETA-ADRENERGIC AGENTS 113,787 2, , MC BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS 16,789 1, MC BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS 26, MC BETA-ADRENERGIC BLOCKING AGENTS 81,943 6,257 2,802 3, MC BICARBONATE PRODUCING/CONTAINING AGENTS MC BULK CHEMICALS MC CALCIUM CHANNEL BLOCKING AGENTS 52, MC CARBONIC ANHYDRASE INHIBITORS 1, MC CHEMOTHERAPEUTICS, ANTIBACTERIAL, MISC MC CHOLINESTERASE INHIBITORS 5, MC CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC MC CONTRACEPTIVES,INJECTABLE 3, MC CONTRACEPTIVES,ORAL 23, MC CONTRACEPTIVES,TRANSDERMAL 1, MC DECONGESTANT-EXPECTORANT COMBINATIONS 5, MC EYE VASOCONSTRICTORS (RX ONLY) MC ESTROGENIC AGENTS 17, MC FOLLICLE STIM./LUTEINIZING HORMONES MC GLUCOCORTICOIDS 64,256 1, , MC HEMATINICS,OTHER 2, MC HEMORRHOIDAL PREPARATIONS MC HEPATITIS C TREATMENT AGENTS 2, MC HYPERURICEMIA TX - PURINE INHIBITORS 5, MC HYPOTENSIVES, ACE INHIBITORS 30,443 1, MC HYPOTENSIVES,ANGIOTENSIN RECEPTOR ANTAGONIST 4, MC HYPOTENSIVES,MISCELLANEOUS 1, MC HYPOTENSIVES,SYMPATHOLYTIC 13,394 1, MC HYPOTENSIVES,VASODILATORS MC IMMUNOMODULATORS MC IMMUNOSUPPRESSIVES 7, MC INOTROPIC DRUGS MC INSULINS 53, MC INTESTINAL MOTILITY STIMULANTS 18, MC IODINE CONTAINING AGENTS MC IRON REPLACEMENT 48, MC LAXATIVES AND CATHARTICS 65, MC LINCOSAMIDES 6, MC LOCAL ANESTHETICS MC MAGNESIUM SALTS REPLACEMENT 5, MC MAOIS - NON-SELECTIVE & IRREVERSIBLE MC MINERALOCORTICOIDS 1, MC MIOTICS/OTHER INTRAOC. PRESSURE REDUCERS 7, MC NARC.& NON-SAL.ANALGESIC,BARBITURATE &XANTHINE CMB MC NARCOTIC & SALICYLATE ANALGESICS, BARB.& XANTHINE MC NARCOTIC ANALGESIC & NON-SALICYLATE ANALGESIC COMB 16, MC NARCOTIC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 5, MC NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT COMB MC NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE 14, MC NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB MC NARCOTIC ANTITUSSIVE-EXPECTORANT COMBINATION 16, MC NON-NARC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 9, MC NON-NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT CMB MC NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 29,977 4,817 3,183 1, MC NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 98,949 5,798 3,185 2, MC NSAIDS (COX NON-SPECIFIC INHIB)& PROSTAGLANDIN CMB MC PARASYMPATHETIC AGENTS MC PHOSPHATE REPLACEMENT MC PLATELET AGGREGATION INHIBITORS 28, MC POTASSIUM REPLACEMENT 50,079 1, , MC POTASSIUM SPARING DIURETICS 13, MC POTASSIUM SPARING DIURETICS IN COMBINATION 11, MC PRENATAL VITAMIN PREPARATIONS 2, The preparation of this document was financed under an agreement with Indiana OMPP. Page 59

60 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.5. DRUG-DISEASE CONTRAINDICATION (MC) (continued) # Cancellations & Non- Responses % Cancels /Total Rx DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx MC PROGESTATIONAL AGENTS 2, MC PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB MC QUINOLONES 26,993 1, MC RECTAL PREPARATIONS 1, MC SEDATIVE-HYPNOTICS,NON-BARBITURATE 72,730 2, ` 2, MC SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 170,528 11,167 7,171 4, MC SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) 39, MC SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 62,515 16,563 12,175 4, MC SKELETAL MUSCLE RELAXANTS 77,625 1, , MC SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) 1, MC SMOKING DETERRENTS, OTHER MC STEROID ANTINEOPLASTICS MC SSRI &ANTIPSYCH,ATYP,DOPAMINE&SEROTONIN ANTAG COMB MC SYMPATHOMIMETIC AGENTS 6, MC THYROID HORMONES 63,211 2, , MC TOPICAL ANTIPARASITICS MC TRICYCLIC ANTIDEPRESSANT/BENZODIAZEPINE COMBINATNS MC TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS MC TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 29,971 2,379 1, MC TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 57, MC URINARY PH MODIFIERS MC URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE) MC URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 20, MC VASODILATORS,CORONARY 6, MC XANTHINES 4, MC DRUG-DISEASE CONTRAINDICATION OR PRECAUTION (MC) TOTAL 3,933, , ,363 88,462 NOTE: The number of DUR alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately; therefore, the number of cancellations and non-responses will not equal the number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 60

61 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.6. DRUG-AGE [PEDIATRIC ALERT] (PA) DUR Screen Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides # Cancellations & Non- Responses % Alerts /Total Rx % Cancels /Total Rx PA 1ST GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS PA 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB 2, PA 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB PA ANALGESIC, NON-SALICYLATE & BARBITURATE COMB PA ANALGESIC,NON-SALICYLATE,BARBITURATE,&XANTHINE CMB 3, PA ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 57, PA ANALGESICS, NARCOTICS 31, PA ANAPHYLAXIS THERAPY AGENTS PA ANTI-ANXIETY DRUGS 335, PA ANTICHOLINERGICS/ANTISPASMODICS 1, PA ANTICONVULSANTS 395, PA ANTIEMETIC/ANTIVERTIGO AGENTS 4, PA ANTIHISTAMINES - 1ST GENERATION 21, PA ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS 15, PA ANTIHYPERTENSIVES, SYMPATHOLYTIC 26, PA ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR PA ANTIMETABOLITES 1, PA ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED 10, PA ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG 199, PA ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI PA BETA-ADRENERGIC AGENTS 79, PA BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS 6, PA CONTRACEPTIVES,INJECTABLE PA DECONGESTANT-EXPECTORANT COMBINATIONS PA EAR PREPARATIONS ANTI-INFLAMMATORY PA GASTRIC ACID SECRETION REDUCERS 35, PA GLUCOCORTICOIDS 64, PA GROWTH HORMONES PA HISTAMINE H2-RECEPTOR INHIBITORS 7, PA HYPOTENSIVES,SYMPATHOLYTIC 13, PA LAXATIVES AND CATHARTICS 281, PA LAXATIVES, LOCAL/RECTAL 21, PA LIPOTROPICS 13, PA NARCOTIC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 3, PA NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE 14, PA NASAL ANTI-INFLAMMATORY STEROIDS 11, PA NITROFURAN DERIVATIVES 2, PA NON-NARC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST 9, PA NON-NARC ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB PA NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 98, PA PENICILLINS 64, PA SEDATIVE-HYPNOTICS,NON-BARBITURATE 72, PA SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 142, PA SKELETAL MUSCLE RELAXANTS 51, PA SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST 3, PA SSRI &ANTIPSYCH,ATYP,DOPAMINE&SEROTONIN ANTAG COMB PA THYROID HORMONES 5, PA TOPICAL ANTI-INFLAMMATORY STEROIDAL 4, PA TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 20, PA TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY 47, PA URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT 8, PA DRUG-AGE [PEDIATRIC](PA) ALERT TOTAL 2,196,649 4,434 1,416 2,995 NOTE: The number of DUR alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately; therefore, the number of cancellations and non-responses will not equal the number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 61

62 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.7. DRUG-GENDER [PREGNANCY ALERT] (PG) DUR Screen # Claims Screened # Overrides # Cancellations & Non- Responses % Alerts /Total Rx % Cancels /Total Rx Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Alerts PG ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 5, PG ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB PG ANALGESIC,NON-SALICYLATE,BARBITURATE,&XANTHINE CMB 1, PG ANALGESICS, NARCOTICS 339, PG ANTI-ANXIETY DRUGS 282, PG ANTICHOLINERGICS/ANTISPASMODICS PG ANTICONVULSANTS 337, PG ANTIDIARRHEALS PG ANTIEMETIC/ANTIVERTIGO AGENTS 5, PG ANTIHISTAMINES - 1ST GENERATION 9, PG ANTIHISTAMINES - 2ND GENERATION 46, PG ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB 1, PG ANTIHYPERTENSIVES, ACE INHIBITORS 26, PG ANTI-ULCER PREPARATIONS PG ANTIVIRALS, GENERAL 1, PG BETA-ADRENERGIC AGENTS 7, PG BETA-ADRENERGIC BLOCKING AGENTS 7, PG CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC PG CONTRACEPTIVES,ORAL 10, PG CONTRACEPTIVES,TRANSDERMAL PG DENTAL AIDS AND PREPARATIONS PG DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT PG FLUORIDE PREPARATIONS PG FOLIC ACID PREPARATIONS 6, PG GASTRIC ACID SECRETION REDUCERS 31, PG GLUCOCORTICOIDS 14, PG HYPOTENSIVES, ACE INHIBITORS 14, PG IMMUNOSUPPRESSIVES PG INTESTINAL MOTILITY STIMULANTS 4, PG LAXATIVES AND CATHARTICS 23, PG LEUKOTRIENE RECEPTOR ANTAGONISTS 7, PG MACROLIDES 19, PG MAST CELL STABILIZERS PG NITROFURAN DERIVATIVES 2, PG NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 5, PG NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 67, PG OPHTHALMIC ANTIBIOTICS PG PENICILLINS 36, PG POTASSIUM SPARING DIURETICS 1, PG PRENATAL VITAMIN PREPARATIONS 3, PG PROGESTATIONAL AGENTS PG PROTON-PUMP INHIBITORS 18, PG SEDATIVE-HYPNOTICS,NON-BARBITURATE 36, PG SKELETAL MUSCLE RELAXANTS 13, PG TETRACYCLINES 1, PG THYROID HORMONES 277, PG TOPICAL ANTIFUNGALS 2, PG TOPICAL ANTIPARASITICS PG VITAMIN B PREPARATIONS 2, PG DRUG-GENDER [PREGNANCY] (PG) ALERT TOTAL 1,678, NOTE: The number of DUR alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately; therefore, the number of cancellations and non-responses will not equal the number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 62

63 ATTACHMENT 2.1.B. PRODUR ACTIVITY DETAIL: BY THERAPEUTIC CLASS (continued) EDS ProDUR Report #: DUR-0012-A ATTACHMENT 2.1.B.8. THERAPEUTIC DUPLICATION (TD) DUR Screen # Cancellations & Non- Responses % Cancels /Total Rx Therapeutic Category/Drug(s) (Hierarchical Ingredient) # Claims Screened # Alerts # Overrides % Alerts /Total Rx TD ABSORBABLE SULFONAMIDES 25, TD ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION 6, TD ALPHA/BETA-ADRENERGIC BLOCKING AGENTS 16,128 1, TD ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS 16,868 2,342 2, TD ALPHA-ADRENERGIC BLOCKING AGENTS 4, TD AMINOGLYCOSIDES 1, TD ANALGESIC/ANTIPYRETICS, SALICYLATES 165,125 3,175 2, TD ANALGESIC/ANTIPYRETICS,NON-SALICYLATE 134,929 4,685 4, TD ANALGESICS, NARCOTICS 415, , ,630 20, TD ANTIARRHYTHMICS 3, TD ANTIHYPERTENSIVES, ACE INHIBITORS 59,202 2,677 2, TD ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST 8, TD ANTIHYPERTENSIVES, MISCELLANEOUS 1, TD ANTIHYPERTENSIVES, SYMPATHOLYTIC 26,173 2,573 2, TD ANTIHYPERTENSIVES, VASODILATORS 2, TD ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR TD ANTIMIGRAINE PREPARATIONS 9, TD ANTI-MYCOBACTERIUM AGENTS TD ANTI-PSYCHOTICS,PHENOTHIAZINES 10,410 3,215 2, TD ANTITUBERCULAR ANTIBIOTICS TD ANTI-ULCER PREPARATIONS 2, TD BETA-ADRENERGIC BLOCKING AGENTS 94,465 6,084 5,049 1, TD BETALACTAMS TD CALCIUM CHANNEL BLOCKING AGENTS 52,569 3,516 2, TD CARBAPENEMS (THIENAMYCINS) TD CARBONIC ANHYDRASE INHIBITORS 1, TD CEPHALOSPORINS - 1ST GENERATION 26, TD CEPHALOSPORINS - 2ND GENERATION 5, TD CEPHALOSPORINS - 3RD GENERATION 6, TD HISTAMINE H2-RECEPTOR INHIBITORS 18, TD HYPOTENSIVES, ACE INHIBITORS 30,443 1,384 1, TD HYPOTENSIVES,ANGIOTENSIN RECEPTOR ANTAGONIST 4, TD HYPOTENSIVES,MISCELLANEOUS TD HYPOTENSIVES,SYMPATHOLYTIC 13,394 1,348 1, TD HYPOTENSIVES,VASODILATORS 1, TD INOTROPIC DRUGS TD LINCOSAMIDES 6, TD LIPOTROPICS 33,494 8,819 7, TD LOOP DIURETICS 56,016 3,828 3, TD MACROLIDES 34, TD NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) 29,977 5,054 4, TD NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE 98,949 6,812 5,562 1, TD OXAZOLIDINONES TD PENICILLINS 771,241 1,711 1, TD POTASSIUM SPARING DIURETICS 13, TD POTASSIUM SPARING DIURETICS IN COMBINATION 11, TD QUINOLONES 29,975 1, TD SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) 170,528 26,821 23,461 3, TD SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) 42,025 3,343 2, TD SEROTONIN-NOREPINEPHRINE REUPTAKE-INHIB (SNRIS) 62,515 19,098 16,934 2, TD TETRACYCLINES 16, TD THIAZIDE AND RELATED DIURETICS 29, TD TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS TD TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB 29,971 3,344 2, TD VANCOMYCIN AND DERIVATIVES 1, TD VASODILATORS,CORONARY 21,244 3,942 3, TD THERAPEUTIC DUPLICATION TOTAL 2,626, , ,433 38,049 NOTE: The number of DUR alerts is comprised of overrides, cancellations, non-responses, and reversals. Reversals are not reported separately; therefore, the number of cancellations and non-responses will not equal the number of alerts. The preparation of this document was financed under an agreement with Indiana OMPP. Page 63

64 ATTACHMENT 2.1.C. PRODUR ACTIVITY DETAIL: DUR SCREEN BY INTERVENTION SUMMARY EDS ProDUR Report #: DUR-0013-A Time Period: 10/06/2007 through 10/06/2008^ DUR Screen or DUR Conflict Code DUR Screen Description OR DUR Conflict Description Prescriber Consulted (M0) % Overrides % Cancellations PHARMACIST'S INTERVENTION CODES Patient Consulted (P0) % Overrides Other Source Consulted (R0) % Cancellations % Overrides % Cancellations DD DRUG-DRUG INTERACTION 38.7% 0.0% 0.0% 0.0% 0.9% 0.2% ER OVERUSE - EARLY REFILL ALERT 6.2% 0.1% 0.0% 0.0% 1.3% 0.8% HD OVERUSE - HIGH DOSE ALERT 30.6% 0.0% 1.3% 0.0% 56% 0.1% LR LATE REFILL 33.5% 0.0% 2.2% 0.0% 49.1% 0.0% MC DRUG-DISEASE CONTRAINDICATION 23.8% 0.0% 1.4% 0.0% 27.8% 0.1% PA DRUG-AGE 9.8% 0.0% 0.4% 0.0% 16.1% 0.1% PG DRUG-PREGNANCY 16.6% 0.0% 0.7% 0.0% 12.5% 0.0% TD THERAPEUTIC DUPLICATION 39.4% 0.0% 2.5% 0.0% 47.3% 0.0% ^NOTE: Date range provided by EDS. The preparation of this document was financed under an agreement with Indiana OMPP. Page 64

65 ATTACHMENT 2.1.D. PRODUR ACTIVITY DETAIL: DUR SCREEN BY OUTCOME SUMMARY EDS ProDUR Report #: DUR-0013-B Time Period: 10/06/2007 through 10/03/2008^ DUR Conflict (or DUR Screen) OUTCOMES (OUTCOME OVERRIDES) 1A 1B 1C 1D 1E 1F 1G FALSE Positive Filled As Is Diff Dose Diff Direct Diff Drug Diff Qty Prescriber Consulted, Approval Drug-Drug Interaction (DD) 4 4, Early Refill - Overuse (ER) , ,103 High Dose Alert (HD) , ,681 Late Refill (LR) , ,490 Drug-Disease (MC) 1,444 83, ,317 Drug- Age (PA) 24 1, Drug-Pregnancy (PG) Therapeutic Duplication (TD) 5, ,683 2, ,819 SUM OF ALL CONFLICTS 7, ,834 3,584 1,170 1, ,697 ^NOTE: Date range provided by EDS The preparation of this document was financed under an agreement with Indiana OMPP. Page 65

66 ATTACHMENT 2.1.E. PRODUR REPORT OF PHARMACIST INTERVENTION & OUTCOME OVERRIDES EDS ProDUR Report #: DUR Conflict Code DUR Conflict (or DUR Screen) Intervention Codes DUR-0014-A Intervention Description OUTCOMES (OUTCOME OVERRIDES) 1A 1B 1C 1D 1E 1F 1G FALSE Positive Filled As Is Diff Dose Diff Direct Diff Drug Diff Qty Prescriber Consulted, Approval Drug-Drug Interaction (DD) Early Refill - Overuse (ER) High Dose Alert (HD) Late Refill - Underuse (LR) DD DD SUM 4 4, M0 Prescriber Consulted 4 4, P0 Patient Consulted R0 Other Source Consulted ER ER SUM , ,103 M0 Prescriber Consulted 38 17, P0 Patient Consulted R0 Other Source Consulted 92 3, HD HD SUM , ,681 M0 Prescriber Consulted ,541 P0 Patient Consulted R0 Other Source Consulted , ,128 LR LR SUM , ,490 M0 Prescriber Consulted 94 3, ,127 P0 Patient Consulted R0 Other Source Consulted 81 8, Drug- MC MC SUM 1,444 83, ,317 Disease M0 Prescriber Consulted , ,000 Contraindication (MC) R0 Other Source Consulted , P0 Patient Consulted 71 2, ,218 Drug-Age or Pediatric Alert (PA) PA PA SUM 24 1, M0 Prescriber Consulted P0 Patient Consulted R0 Other Source Consulted Drug- PG PG SUM Gender or M0 Prescriber Consulted Pregnancy P0 Patient Consulted Alert (PG) R0 Other Source Consulted Therapeutic Duplication (TD) TD TD SUM 5, ,683 2, ,819 M0 Prescriber Consulted 3,369 79, ,490 P0 Patient Consulted 203 6, R0 Other Source Consulted 1, ,119 1, ,994 SUM OF ALL CONFLICTS 7, ,834 3,584 1,170 1, ,697 The preparation of this document was financed under an agreement with Indiana OMPP. Page 66

67 ATTACHMENT 2.2. PA ACTIVITY SUMMARY Reporting Dates: 10/01/2007 through 9/30/2008 Prior Authorization Summary (Represents telephone calls, faxes and mailed requests) PA Request Type Total PA Request Count Regular PA Program* 21,195 Miscellaneous Prior Authorization Programs** 968 PDL PA Program 15,804 SUM: 37,967 * Includes 34-day supply, drug-drug, early refill, high dose, and therapeutic duplication related contacts ** Please refer to page 32 for explanation of this category. The preparation of this document was financed under an agreement with Indiana OMPP. Page 67

68 ATTACHMENT 2.2. PA ACTIVITY SUMMARY (continued) ATTACHMENT 2.2.A. Detailed PA Activity by PA Type: Regular & Misc. PA Regular PA TOTALS Oct 07 through Sept 08 PA Totals Approved Denied Suspended 34-Day Supply Drug-Drug Severity Level One 1, Early Refill 20, High Dose Therapeutic Duplication Totals 21, ,195 Miscellaneous PA Program Totals Oct 07 through Sept 08 PA Totals Approved Denied Suspended Brand Medically Necessary Carafate (Sucralfate) Growth Hormones Revatio Synagis Totals The preparation of this document was financed under an agreement with Indiana OMPP. Page 68

69 ATTACHMENT 2.2. PA ACTIVITY SUMMARY (continued) ATTACHMENT 2.2.B. DETAILED PA ACTIVITY BY PA TYPE: PDL PA INDIANA MEDICAID - PA TOTALS PDL Program (Oct 07 through Sept 08) Oct 07 through Sept 08 - PDL PA Totals Approved Denied ACE Inhibitors ACEI with CCB ACEI with Diuretics 3 2 Acetaminophen Limits Agents to treat COPD 82 2 Alpha Adrenergic Blockers Angiotensin Receptor Blockers (ARBs) Angiotensin Receptor Blockers/Diuretics Angiotensin Receptor Blockers/CCBS 66 3 Antidiabetic Agents Antiemetic - Antivertigo Agents Antifungal Oral 93 1 Antifungal Topical 23 3 Antipsoriatics 14 2 Anti-Ulcer - H Pyloric Agents 75 0 Antiviral Anti-herpetic Agent Antiviral Influenza Agents Benign Prostatic Hypertrophy 22 5 Beta and Alpha/Beta Blockers Beta Adrenergics and Corticosteroids Bile Acid Sequestrants Brand NSAIDS 78 3 Calcium Channel Blockers Calcium Channel Blockers w/hmg CoA Reductase 14 7 Cephalosporins 16 5 Chronic Constipation Agents Cox-2 Inhibitor Cytotec 20 5 Fibric Acids 34 8 Fluoroquinolones 41 2 Forteo 35 2 H2 Antagonists Heparin and Related Products 4 0 Inhaled Glucocorticoids Injectable Hypoglycemics Inspra 5 1 Ketolides 1 0 Leukocyte Stimulants 7 1 Leukotriene Receptor Antagonists Long Acting Beta Agonists Macrolides 59 0 Miotics- OIPR 84 0 Narcotics 2, Narcotics Antitussive 2 0 Nasal Steroids and Antihistamines Non-Sedating Antihistamines 1, Ophthalmic Antibiotics 84 4 Opthalmic Antihistamines 6 3 The preparation of this document was financed under an agreement with Indiana OMPP. Page 69

70 ATTACHMENT 2.2. PA ACTIVITY SUMMARY (continued) ATTACHMENT 2.2.B. DETAILED PA ACTIVITY BY PA TYPE: PDL PA (continued) Cont. --Oct 07 through Sept 08 - PDL PA Totals Approved Denied Otic Antibiotics 17 1 Other Lipotropics 72 6 Platelet Aggregation Inhibitors 14 0 Proton Pump Inhibitors 3, SERMS - Bone Resorption Agents Short Acting Beta Agonists Skeletal Muscle Relaxants Smoking Deterrent Agents 26 8 Thiazolidenediones Topical Estrogen Agents 5 3 Topical Vitamin A Deriv Toradol 3 0 Triptans Urinary Tract Antispasmodics - Antiincontinence Vaginal Antimicrobials 21 0 Wound Care 95 9 PA TOTALS from PDL Program 14,451 1,353 The preparation of this document was financed under an agreement with Indiana OMPP. Page 70

71 ATTACHMENT 3 RETRODUR ACTIVITY FFY 2008 The preparation of this document was financed under an agreement with Indiana OMPP. Page 71

72 VII. ATTACHMENT 3. RETRODUR ACTIVITY FFY2008 ATTACHMENT 3 is a year-end summary report on retrospective DUR screening and interventions. RetroDUR Descriptive Overview RetroDUR interventions were performed as approved by the DUR Board. The DUR Board met monthly to review proposed interventions. The proposed interventions were sometimes modified to meet Board approval. ACS State Healthcare performed RetroDUR interventions only when the DUR Board approved an individual intervention. Attachment 3.1 reports RetroDUR procedures used by the state of Indiana and ACS. As required in the CMS instructions, Attachments 3.2 to 3.4 include the following: 1) Cover all criteria exceptions, and includes a denominator (% criteria exceptions / number of prescription claims adjudicated for a drug class or drug), and the number of interventions undertaken during the reporting period. 2) States that engage in physician, pharmacy profile analysis (i.e., review prescribing or dispensing of multiple prescriptions for multiple patients involving a particular problem type or diagnosis) or engage in patient profiling should report the number of each type of profile (physician, pharmacy, patient) reviewed and identify the subject(s) (diagnosis, problem type, etc.) involved. The State of Indiana used two types of RetroDUR interventions: 1) Standard RetroDUR initiatives, and 2) Intensive Benefits Management (IBM) Standard RetroDUR intervention letters described potential drug therapy problem(s) in patient-specific situations. RetroDUR intervention letters may include the patient s current comprehensive drug history profile. (a) IBM interventions involved ACS pharmacists calling practitioners about targeted drug therapy problems. The IBM pharmacists encouraged practitioners to consider changing targeted recipients therapy to a more appropriate drug therapy and discussed various alternatives with practitioners. The preparation of this document was financed under an agreement with Indiana OMPP. Page 72

73 ATTACHMENT 3.1. INDIANA RETRODUR PROCEDURES ACS State Healthcare assigned a Clinical Account Pharmacist to manage Indiana s DUR programs and to interact with the DUR Board. ACS clinical pharmacists trained and experienced in DUR activities conducted the RetroDUR operations described below. The RetroDUR Program involved both computerized and clinical pharmacist review of medication claims history. An initial computer-based screening of each individual s patient claims history was performed using clinically-based criteria. The purpose of the computerbased screening was to identify potential medication adherence problems. ACS Clinical Account Pharmacist presented the criteria and screening to the DUR Board. The presentation included incidence and prevalence of the drug therapy problem. The DUR Board reviewed the drug therapy problem criteria and educational materials. If the RetroDUR intervention was approved by the DUR Board, ACS clinical pharmacists conducted the intervention. Practitioner responses were requested on the drug therapy intervention and documented in a proprietary case management database. The responses were used to receive feedback to assess the success of initiatives performed. Although ACS collected prescribers responses, evaluation of the impact of letter interventions were measured by actual prescriber behavior. In other words, ACS measured prescribers actions resulting from the letters by measuring claims data. Evaluations of claims were performed 6-months post-intervention to determine the effectiveness of the educational interventions through changes in number of prescriptions and costs. The preparation of this document was financed under an agreement with Indiana OMPP. Page 73

74 = ATTACHMENT 3.2. RETRODUR INTERVENTIONS BY PROBLEM CATEGORY Problem Category or Conflict Code Drug-Drug Interaction Over-Utilization Therapeutic Appropriateness Program Type (IBM*/RetroDUR**) RetroDUR IBM RetroDUR IBM RetroDUR IBM TOTALS # of Patients Reviewed or Screened # of Patients Intervened # of MDs # of Letters or Calls # Pharmacies ,838 6,078 3,712 3, ,838 6,078 3,712 3,712 0 ATTACHMENT 3.3. RETRODUR ACTIVITY BY MONTH Month Intervention Name IBM Retro DUR # of Patients Reviewed or Screened # of Patients Intervened # of MDs # of Letters or Calls Response Rate on Interventions (Letters/Calls) October 2007 to April 2008 No Intervention May-08 Medication Adherence-Anti-Diabetic Therapy X 1,484 1, % Medication Adherence-Anti-Lipotropic Therapy X 1,744 1,111 1,119 1, % June-08 Medication Adherence-Anti-Hypertensive Therapy X 4,610 3,825 1,874 1, % July 2008 To September 2008 No Intervention TOTALS 7,838 6,078 3,712 3,712 * The Intensified Benefits Management (IBM) program focuses on critical evaluation of targeted individual recipient drug treatment plans. Those plans compare actual experience to documented standards to move toward more cost effective and appropriate pharmaceutical care. **Retrospective Drug Utilization Review (DUR) evaluates, after-the-fact, a sampling of individual drug treatment plans to check for costeffectiveness and monitor appropriate patterns of pharmaceutical care. Nine hundred of these were phone calls. ^ Response rate on interventions is equal to the number of returned letters and successful phone calls made divided by the number of mailed letters and successful phone calls made. The preparation of this document was financed under an agreement with Indiana OMPP. Page 74

75 ATTACHMENT 3.4. RETRODUR EXCEPTIONS (PATIENTS SCREENED) & INTERVENTIONS BY THERAPEUTIC CLASS Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month A1A DIGITALIS GLYCOSIDES A1B XANTHINES A1C INOTROPIC DRUGS A1D GENERAL BRONCHODILATOR AGENTS A2A ANTIARRHYTHMICS A2C ANTIANGINAL & ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC Program Type # PT Screened # PT Targeted CA or PDL ED OU A4A ANTIHYPERTENSIVES, VASODILATORS June-08 RetroDUR 4,610 3,825 X A4B ANTIHYPERTENSIVES, SYMPATHOLYTIC June-08 RetroDUR 4,610 3,825 X A4C ANTIHYPERTENSIVES, GANGLIONIC BLOCKERS June-08 RetroDUR 4,610 3,825 X A4D ANTIHYPERTENSIVES, ACE INHIBITORS June-08 RetroDUR 4,610 3,825 X A4F ANTIHYPERTENSIVES, ANGIOTENSIN RECEPTOR ANTAGONIST June-08 RetroDUR 4,610 3,825 X A4H ANGIOTENSIN RECEPTOR ANTGNST & CALC.CHANNEL BLOCKR June-08 RetroDUR 4,610 3,825 X A4I ANGIOTENSIN RECEPTOR ANTAG./THIAZIDE DIURETIC COMB June-08 RetroDUR 4,610 3,825 X A4J ACE INHIBITOR/THIAZIDE & THIAZIDE-LIKE DIURETIC June-08 RetroDUR 4,610 3,825 X A4K ACE INHIBITOR/CALCIUM CHANNEL BLOCKER COMBINATION June-08 RetroDUR 4,610 3,825 X A4T RENIN INHIBITOR, DIRECT June-08 RetroDUR 4,610 3,825 X A4U RENIN INHIBITOR, DIRECT/THIAZIDE DIURETIC COMB June-08 RetroDUR 4,610 3,825 X A4Y ANTIHYPERTENSIVES, MISCELLANEOUS June-08 RetroDUR 4,610 3,825 X A7B VASODILATORS,CORONARY A7C VASODILATORS,PERIPHERAL A7J VASODILATORS, COMBINATION A9A CALCIUM CHANNEL BLOCKING AGENTS June-08 RetroDUR 4,610 3,825 X B0A GENERAL INHALATION AGENTS B1B PULMONARY ANTI-HTN, ENDOTHELIN RECEPTOR ANTAGONIST B1C PULMONARY ANTIHYPERTENSIVES, PROSTACYCLIN-TYPE B1D PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB B3A MUCOLYTICS B3J EXPECTORANTS B3N DECONGESTANT-ANALGESIC-EXPECTORANT COMBINATION 3 3 B3O 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB 2 2 B3Q NARCOTIC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST B3R NON-NARC ANTITUSS-1ST GEN. ANTIHISTAMINE-DECONGEST B3S NON-NARC ANTITUS-1ST GEN ANTIHIST-DECONGEST-EXPECT B3T NON-NARCOTIC ANTITUSSIVE AND EXPECTORANT COMB B3X 1ST GEN ANTIHIST-DECONGEST-ANTICHOLINERGIC COMB B3Y 1ST GEN ANTIHISTAMINE-DECONGESTANT-EXPECTORANT CMB B4C NARCOTIC ANTITUSSIVE-ANTICHOLINERGIC COMB B4D NARCOTIC ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE B4E NON-NARC ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB B4K NARCOTIC ANTITUSSIVE-DECONGESTANT COMBINATIONS B4L NON-NARCOTIC ANTITUSSIVE-DECONGESTANT COMBINATIONS B4Q NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT COMB B4R NON-NARCOTIC ANTITUSS-DECONGESTANT-EXPECTORANT CMB B4S NARCOTIC ANTITUSSIVE-EXPECTORANT COMBINATION B4U DECONGESTANT-ANTICHOLINERGIC COMBINATIONS 8 8 B4W DECONGESTANT-EXPECTORANT COMBINATIONS B4X EXPECTORANT COMBINATIONS OTHER B5S ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE B5T 1ST GENERATION ANTIHISTAMINE-ANTICHOLINERGIC COMB B6B NON-NARCOTIC ANTITUSSIVE-DECONGEST WITH ZINC COMB. 1 1 C0B WATER C0D ANTI-ALCOHOLIC PREPARATIONS C0K BICARBONATE PRODUCING/CONTAINING AGENTS C1A ELECTROLYTE DEPLETERS C1D POTASSIUM REPLACEMENT C1F CALCIUM REPLACEMENT C1H MAGNESIUM SALTS REPLACEMENT C1P PHOSPHATE REPLACEMENT TA DO The preparation of this document was financed under an agreement with Indiana OMPP. Page 75

76 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month C1W ELECTROLYTE MAINTENANCE C3B IRON REPLACEMENT C3C ZINC REPLACEMENT C3H IODINE CONTAINING AGENTS C3M MINERAL REPLACEMENT,MISCELLANEOUS C4F ANTIHYPERGLY, (DPP-4) INHIBITOR & BIGUANIDE COMB Program Type # PT Screened # PT Targeted CA or PDL ED OU C4G INSULINS May-08 RetroDUR 1,484 1,142 X C4H ANTIHYPERGLYCEMIC, AMYLIN ANALOG-TYPE May-08 RetroDUR 1,484 1,142 X C4I ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST) May-08 RetroDUR 1,484 1,142 X C4J ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS May-08 RetroDUR 1,484 1,142 X C4K ANTIHYPERGLYCEMIC, INSULIN-RELEASE STIMULANT TYPE May-08 RetroDUR 1,484 1,142 X C4L ANTIHYPERGLYCEMIC,BIGUANIDE TYPE(NON-SULFONYLUREA) May-08 RetroDUR 1,484 1,142 X C4M ANTIHYPERGLYCEMIC, ALPHA-GLUCOSIDASE INHIB (N-S) May-08 RetroDUR 1,484 1,142 X C4N ANTIHYPERGLYCEMIC, INSULIN-RESPONSE ENHANCER (N-S) May-08 RetroDUR 1,484 1,142 X C4R ANTIHYPERGLYCEMIC,INSULIN-RESPONSE & RELEASE COMB May-08 RetroDUR 1,484 1,142 X C4S ANTIHYPERGLYCEMIC,INSULIN-REL STIM.& BIGUANIDE CMB May-08 RetroDUR 1,484 1,142 X C4T ANTIHYPERGLYCM,INSUL-RESP.ENHANCER & BIGUANIDE CMB May-08 RetroDUR 1,484 1,142 X C5B PROTEIN REPLACEMENT 17 7 C5F DIETARY SUPPLEMENT, MISCELLANEOUS 1 1 C5J IV SOLUTIONS: DEXTROSE-WATER C5K IV SOLUTIONS: DEXTROSE-SALINE C5M IV SOLUTIONS: DEXTROSE AND LACTATED RINGERS C5O DILUENT SOLUTIONS C6A VITAMIN A PREPARATIONS 5 5 C6B VITAMIN B PREPARATIONS C6C VITAMIN C PREPARATIONS C6D VITAMIN D PREPARATIONS C6E VITAMIN E PREPARATIONS C6F PRENATAL VITAMIN PREPARATIONS C6G GERIATRIC VITAMIN PREPARATIONS C6H PEDIATRIC VITAMIN PREPARATIONS C6I ANTIOXIDANT MULTIVITAMIN COMBINATIONS C6K VITAMIN K PREPARATIONS C6L VITAMIN B12 PREPARATIONS C6M FOLIC ACID PREPARATIONS C6N NIACIN PREPARATIONS C6Q VITAMIN B6 PREPARATIONS C6R VITAMIN B2 PREPARATIONS C6T VITAMIN B1 PREPARATIONS C6Z MULTIVITAMIN PREPARATIONS C7A HYPERURICEMIA TX - PURINE INHIBITORS C7B DECARBOXYLASE INHIBITORS C7D METABOLIC DEFICIENCY AGENTS C7F APPETITE STIM. FOR ANOREXIA,CACHEXIA,WASTING SYND C8A METALLIC POISON,AGENTS TO TREAT C9C PARENTERAL AMINO ACID SOLUTIONS AND COMBINATIONS D1A PERIODONTAL COLLAGENASE INHIBITORS D1D DENTAL AIDS AND PREPARATIONS D2A FLUORIDE PREPARATIONS D4B ANTACIDS D4E ANTI-ULCER PREPARATIONS D4F ANTI-ULCER-H.PYLORI AGENTS D4G GASTRIC ENZYMES D4H ORAL MUCOSITIS/STOMATITIS AGENTS 1 1 D4J PROTON-PUMP INHIBITORS D4N ANTIFLATULENTS D5P INTESTINAL ADSORBENTS AND PROTECTIVES 5 4 D6A DRUGS TO TX CHRONIC INFLAMM. DISEASE OF COLON D6C IRRITABLE BOWEL SYND. AGENT,5HT-3 ANTAGONIST-TYPE D6D ANTIDIARRHEALS D6F DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT TA DO The preparation of this document was financed under an agreement with Indiana OMPP. Page 76

77 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month Program Type # PT Screened # PT Targeted CA or PDL ED OU TA DO D6S LAXATIVES AND CATHARTICS D7A BILE SALTS D7D DRUGS TO TREAT HEREDITARY TYROSINEMIA D7L BILE SALT SEQUESTRANTS D8A PANCREATIC ENZYMES D9A AMMONIA INHIBITORS F1A ANDROGENIC AGENTS F2A DRUGS TO TREAT IMPOTENCY G1A ESTROGENIC AGENTS G1B ESTROGEN/ANDROGEN COMBINATIONS G1D ESTROGEN & PROGESTIN WITH ANTIMINERALOCORTICOID CB 4 4 G2A PROGESTATIONAL AGENTS G3A OXYTOCICS G8A CONTRACEPTIVES,ORAL G8B CONTRACEPTIVES,IMPLANTABLE 6 6 G8C CONTRACEPTIVES,INJECTABLE G8F CONTRACEPTIVES,TRANSDERMAL G9B CONTRACEPTIVES, INTRAVAGINAL, SYSTEMIC H0A LOCAL ANESTHETICS H0E AGENTS TO TREAT MULTIPLE SCLEROSIS H1A ALZHEIMER'S THERAPY, NMDA RECEPTOR ANTAGONISTS H2C GENERAL ANESTHETICS,INJECTABLE H2D BARBITURATES H2E SEDATIVE-HYPNOTICS,NON-BARBITURATE H2F ANTI-ANXIETY DRUGS H2G ANTI-PSYCHOTICS,PHENOTHIAZINES H2H MONOAMINE OXIDASE(MAO) INHIBITORS H2M BIPOLAR DISORDER DRUGS H2S SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRIS) H2T ALCOHOL,SYSTEMIC USE 20 9 H2U TRICYCLIC ANTIDEPRESSANTS & REL. NON-SEL. RU-INHIB H2V TX FOR ATTENTION DEFICIT-HYPERACT(ADHD)/NARCOLEPSY H2W TRICYCLIC ANTIDEPRESSANT/PHENOTHIAZINE COMBINATNS H2X TRICYCLIC ANTIDEPRESSANT/BENZODIAZEPINE COMBINATNS H3A ANALGESICS, NARCOTICS H3C ANALGESICS, NON-NARCOTICS 6 3 H3D ANALGESIC/ANTIPYRETICS, SALICYLATES H3E ANALGESIC/ANTIPYRETICS,NON-SALICYLATE H3F ANTIMIGRAINE PREPARATIONS H3K ANALGESIC, NON-SALICYLATE & BARBITURATE COMB H3L ANALGESIC,NON-SALICYLATE,BARBITURATE,&XANTHINE CMB H3M NARC.& NON-SAL.ANALGESIC,BARBITURATE &XANTHINE CMB H3N ANALGESICS, NARCOTIC AGONIST AND NSAID COMBINATION H3O ANALGESIC, SALICYLATE, BARBITURATE,& XANTHINE CMB H3R NARCOTIC & SALICYLATE ANALGESICS, BARB.& XANTHINE H3T NARCOTIC ANTAGONISTS H3U NARCOTIC ANALGESIC & NON-SALICYLATE ANALGESIC COMB H3X NARCOTIC AND SALICYLATE ANALGESIC COMBINATION H3Y MU-OPIOID RECEPTOR ANTAGONISTS,PERIPHERALLY-ACTING 2 2 H4B ANTICONVULSANTS H6A ANTIPARKINSONISM DRUGS,OTHER H6B ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC H6C ANTITUSSIVES,NON-NARCOTIC H6E EMETICS H6H SKELETAL MUSCLE RELAXANTS H6I AMYOTROPHIC LATERAL SCLEROSIS AGENTS 14 9 H6J ANTIEMETIC/ANTIVERTIGO AGENTS H7B ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS The preparation of this document was financed under an agreement with Indiana OMPP. Page 77

78 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month H7D NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIB (NDRIS) H7E SEROTONIN-2 ANTAGONIST/REUPTAKE INHIBITORS (SARIS) H7J MAOIS - NON-SELECTIVE & IRREVERSIBLE H7N SMOKING DETERRENTS, OTHER H7O ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS,BUTYROPHENONES H7P ANTIPSYCHOTICS,DOPAMINE ANTAGONISTS, THIOXANTHENES H7R ANTIPSYCH,DOPAMINE ANTAG.,DIPHENYLBUTYLPIPERIDINES H7S ANTIPSYCHOTICS,DOPAMINE ANTAGONST,DIHYDROINDOLONES H7T ANTIPSYCHOTICS,ATYPICAL,DOPAMINE,& SEROTONIN ANTAG H7U ANTIPSYCHOTICS, DOPAMINE & SEROTONIN ANTAGONISTS H7W ANTI-NARCOLEPSY & ANTI-CATAPLEXY,SEDATIVE-TYPE AGT H7X ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED H7Y TX FOR ATTENTION DEFICIT-HYPERACT.(ADHD), NRI-TYPE H7Z SSRI &ANTIPSYCH,ATYP,DOPAMINE&SEROTONIN ANTAG COMB H8B HYPNOTICS, MELATONIN MT1/MT2 RECEPTOR AGONISTS J1A PARASYMPATHETIC AGENTS J1B CHOLINESTERASE INHIBITORS J2A BELLADONNA ALKALOIDS J2B ANTICHOLINERGICS,QUATERNARY AMMONIUM J2D ANTICHOLINERGICS/ANTISPASMODICS J3A SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS) J3C SMOKING DETERRENT-NICOTINIC RECEPT.PARTIAL AGONIST J5A ADRENERGIC AGENTS,CATECHOLAMINES J5B ADRENERGICS, AROMATIC, NON-CATECHOLAMINE J5D BETA-ADRENERGIC AGENTS J5E SYMPATHOMIMETIC AGENTS J5F ANAPHYLAXIS THERAPY AGENTS J5G BETA-ADRENERGIC AND GLUCOCORTICOID COMBINATIONS J5H ADRENERGIC VASOPRESSOR AGENTS J5J BETA-ADRENERGIC AND ANTICHOLINERGIC COMBINATIONS J7A ALPHA/BETA-ADRENERGIC BLOCKING AGENTS J7B ALPHA-ADRENERGIC BLOCKING AGENTS J7C BETA-ADRENERGIC BLOCKING AGENTS J9A INTESTINAL MOTILITY STIMULANTS J9B ANTISPASMODIC AGENTS 2 2 L0B TOPICAL/MUCOUS MEMBR./SUBCUT. ENZYMES L0C DIABETIC ULCER PREPARATIONS,TOPICAL L1A ANTIPSORIATIC AGENTS,SYSTEMIC L1B ACNE AGENTS,SYSTEMIC L2A EMOLLIENTS L3A PROTECTIVES L3P ANTIPRURITICS,TOPICAL L4A ASTRINGENTS 3 3 L5A KERATOLYTICS L5B SUNSCREENS 1 1 L5E ANTISEBORRHEIC AGENTS L5F ANTIPSORIATICS AGENTS L5G ROSACEA AGENTS, TOPICAL L5H ACNE AGENTS,TOPICAL L6A IRRITANTS/COUNTER-IRRITANTS L8B ANTIPERSPIRANTS L9A TOPICAL AGENTS,MISCELLANEOUS L9B VITAMIN A DERIVATIVES L9C HYPOPIGMENTATION AGENTS M0E ANTIHEMOPHILIC FACTORS M0F FACTOR IX PREPARATIONS M4B IV FAT EMULSIONS Program Type # PT Screened # PT Targeted CA or PDL ED OU M4D ANTIHYPERLIPIDEMIC - HMG COA REDUCTASE INHIBITORS May-08 RetroDUR 1,744 1,111 X M4E LIPOTROPICS May-08 RetroDUR 1,744 1,111 X M4G HYPERGLYCEMICS May-08 RetroDUR 1,484 1,142 X TA DO The preparation of this document was financed under an agreement with Indiana OMPP. Page 78

79 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month M4I ANTIHYPERLIP - HMG-COA&CALCIUM CHANNEL BLOCKER CB Program Type # PT Screened # PT Targeted CA or PDL ED OU M4L ANTIHYPERLIPIDEMIC-HMG COA REDUCTASE INHIB.&NIACIN May-08 RetroDUR 1,744 1,111 X M4M ANTIHYPERLIP.HMG COA REDUCT INHIB&CHOLEST.AB.INHIB May-08 RetroDUR 1,744 1,111 X M9A TOPICAL HEMOSTATICS 1 1 M9D ANTIFIBRINOLYTIC AGENTS M9F THROMBOLYTIC ENZYMES N1D PLATELET REDUCING AGENTS N1E PLATELET PROLIFERATION STIMULANTS 2 1 P0B FOLLICLE STIM./LUTEINIZING HORMONES 2 2 P1A GROWTH HORMONES P1B SOMATOSTATIC AGENTS P1E ADRENOCORTICOTROPHIC HORMONES 2 2 P1F PITUITARY SUPPRESSIVE AGENTS P1M LHRH(GNRH) AGONIST ANALOG PITUITARY SUPPRESSANTS P1P LHRH(GNRH)AGNST PIT.SUP-CENTRAL PRECOCIOUS PUBERTY P2B ANTIDIURETIC AND VASOPRESSOR HORMONES P3A THYROID HORMONES P3B THYROID FUNCTION DIAGNOSTIC AGENTS 2 2 P3L ANTITHYROID PREPARATIONS P4B BONE FORMATION STIM. AGENTS - PARATHYROID HORMONE P4D HYPERPARATHYROID TX AGENTS - VITAMIN D ANALOG-TYPE P4L BONE RESORPTION INHIBITORS P4M CALCIMIMETIC,PARATHYROID CALCIUM ENHANCER P4N BONE RESORPTION INHIBITOR & VITAMIN D COMBINATIONS P4O BONE RESORPTION INHIBITOR & CALCIUM COMBINATIONS 3 3 P5A GLUCOCORTICOIDS P5S MINERALOCORTICOIDS Q2C OPHTHALMIC ANTI-INFLAMMATORY IMMUNOMODULATOR-TYPE Q3A RECTAL PREPARATIONS Q3B RECTAL/LOWER BOWEL PREP.,GLUCOCORT. (NON-HEMORR) Q3D HEMORRHOIDAL PREPARATIONS Q3E CHRONIC INFLAM. COLON DX, 5-A-SALICYLAT,RECTAL TX Q3H HEMORRHOIDALS, LOCAL RECTAL ANESTHETICS Q3I HEMORRHOIDAL PREP, ANTI-INFAM STEROID/LOCAL ANESTH Q3S LAXATIVES, LOCAL/RECTAL Q4F VAGINAL ANTIFUNGALS Q4K VAGINAL ESTROGEN PREPARATIONS Q4S VAGINAL SULFONAMIDES 1 1 Q4W VAGINAL ANTIBIOTICS Q5A TOPICAL PREPARATIONS,MISCELLANEOUS Q5B TOPICAL PREPARATIONS,ANTIBACTERIALS Q5E TOPICAL ANTI-INFLAMMATORY, NSAIDS Q5F TOPICAL ANTIFUNGALS Q5H TOPICAL LOCAL ANESTHETICS Q5K TOPICAL IMMUNOSUPPRESSIVE AGENTS Q5N TOPICAL ANTINEOPLASTIC & PREMALIGNANT LESION AGNTS Q5P TOPICAL ANTI-INFLAMMATORY STEROIDAL Q5R TOPICAL ANTIPARASITICS Q5S TOPICAL SULFONAMIDES Q5V TOPICAL ANTIVIRALS Q5W TOPICAL ANTIBIOTICS Q5X TOPICAL ANTIBIOTICS/ANTIINFLAMMATORY,STEROIDAL Q6A OPHTHALMIC PREPARATIONS, MISCELLANEOUS 1 1 Q6C EYE VASOCONSTRICTORS (RX ONLY) Q6D EYE VASOCONSTRICTORS (OTC ONLY) Q6G MIOTICS/OTHER INTRAOC. PRESSURE REDUCERS Q6H EYE LOCAL ANESTHETICS 8 8 Q8C OTIC,ANTIINFECTIVE-LOCAL ANESTHETIC COMBINATIONS Q8F OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS Q8H EAR PREPARATIONS,LOCAL ANESTHETICS Q8P EAR PREPARATIONS ANTI-INFLAMMATORY TA DO The preparation of this document was financed under an agreement with Indiana OMPP. Page 79

80 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month Program Type # PT Screened # PT Targeted CA or PDL ED OU TA DO Q8R EAR PREPARATIONS,EAR WAX REMOVERS Q8W EAR PREPARATIONS,ANTIBIOTICS Q9B BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS R1A URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT R1B OSMOTIC DIURETICS 1 1 R1E CARBONIC ANHYDRASE INHIBITORS R1F THIAZIDE AND RELATED DIURETICS R1H POTASSIUM SPARING DIURETICS R1I URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG R1L POTASSIUM SPARING DIURETICS IN COMBINATION R1M LOOP DIURETICS R1R URICOSURIC AGENTS R1S URINARY PH MODIFIERS R4A KIDNEY STONE AGENTS 2 1 R5A URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE) R5B URINARY TRACT ANALGESIC AGENTS S2A COLCHICINE S2B NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE S2C GOLD SALTS 2 2 S2H ANTI-INFLAMMATORY/ANTIARTHRITICS AGENTS, MISC S2I ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR S2J ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR S2K ANTI-ARTHRITIC AND CHELATING AGENTS S2M ANTI-FLAM. INTERLEUKIN-1 RECEPTOR ANTAGONIST S2T NSAIDS (COX NON-SPECIFIC INHIB)& PROSTAGLANDIN CMB S7A NEUROMUSCULAR BLOCKING AGENTS T0A TOPICAL VIT D ANALOG/ANTIINFLAMMATORY, STEROIDAL T0B TOPICAL PLEUROMUTILIN DERIVATIVES T0C TOPICAL GENITAL WART-HPV TREATMENT AGENTS 1 1 U6A PHARMACEUTICAL ADJUVANTS, TABLETING 5 5 U6E OINTMENT/CREAM BASES U6F HYDROPHILIC CREAM/OINTMENT BASES U6H SOLVENTS U6N VEHICLES U6W BULK CHEMICALS U7A SUSPENDING AGENTS U7K FLAVORING AGENTS U7N SWEETENERS V1A ALKYLATING AGENTS V1B ANTIMETABOLITES V1C VINCA ALKALOIDS 5 3 V1E STEROID ANTINEOPLASTICS V1F ANTINEOPLASTICS,MISCELLANEOUS V1I CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS V1J ANTIANDROGENIC AGENTS V1M ANTINEOPLASTIC IMMUNOMODULATOR AGENTS V1N SELECTIVE RETINOID X RECEPTOR AGONISTS (RXR) 3 3 V1O ANTINEOPLASTIC LHRH(GNRH) AGONIST,PITUITARY SUPPR V1Q ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS V1T SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) V1X ANTINEOPLAST HUM VEGF INHIBITOR RECOMB MC ANTIBODY 4 4 V3A ANTINEOPLASTIC,HISTONE DEACETYLASE INHIBITORS,HDIS 3 3 V3E ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS 4 4 V3F ANTINEOPLASTIC - AROMATASE INHIBITORS W1A PENICILLINS W1C TETRACYCLINES W1D MACROLIDES W1E CHLORAMPHENICOL AND DERIVATIVES 2 1 The preparation of this document was financed under an agreement with Indiana OMPP. Page 80

81 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month Program Type # PT Screened # PT Targeted CA or PDL ED OU TA DO Q8R EAR PREPARATIONS,EAR WAX REMOVERS Q8W EAR PREPARATIONS,ANTIBIOTICS Q9B BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS R1A URINARY TRACT ANTISPASMODIC/ANTIINCONTINENCE AGENT R1B OSMOTIC DIURETICS 1 1 R1E CARBONIC ANHYDRASE INHIBITORS R1F THIAZIDE AND RELATED DIURETICS R1H POTASSIUM SPARING DIURETICS R1I URINARY TRACT ANTISPASMODIC, M(3) SELECTIVE ANTAG R1L POTASSIUM SPARING DIURETICS IN COMBINATION R1M LOOP DIURETICS R1R URICOSURIC AGENTS R1S URINARY PH MODIFIERS R4A KIDNEY STONE AGENTS 2 1 R5A URINARY TRACT ANESTHETIC/ANALGESIC AGNT (AZO-DYE) R5B URINARY TRACT ANALGESIC AGENTS S2A COLCHICINE S2B NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE S2C GOLD SALTS 2 2 S2H ANTI-INFLAMMATORY/ANTIARTHRITICS AGENTS, MISC S2I ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR S2J ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR S2K ANTI-ARTHRITIC AND CHELATING AGENTS S2M ANTI-FLAM. INTERLEUKIN-1 RECEPTOR ANTAGONIST S2T NSAIDS (COX NON-SPECIFIC INHIB)& PROSTAGLANDIN CMB S7A NEUROMUSCULAR BLOCKING AGENTS T0A TOPICAL VIT D ANALOG/ANTIINFLAMMATORY, STEROIDAL T0B TOPICAL PLEUROMUTILIN DERIVATIVES T0C TOPICAL GENITAL WART-HPV TREATMENT AGENTS 1 1 U6A PHARMACEUTICAL ADJUVANTS, TABLETING 5 5 U6E OINTMENT/CREAM BASES U6F HYDROPHILIC CREAM/OINTMENT BASES U6H SOLVENTS U6N VEHICLES U6W BULK CHEMICALS U7A SUSPENDING AGENTS U7K FLAVORING AGENTS U7N SWEETENERS V1A ALKYLATING AGENTS V1B ANTIMETABOLITES V1C VINCA ALKALOIDS 5 3 V1E STEROID ANTINEOPLASTICS V1F ANTINEOPLASTICS,MISCELLANEOUS V1I CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS V1J ANTIANDROGENIC AGENTS V1M ANTINEOPLASTIC IMMUNOMODULATOR AGENTS V1N SELECTIVE RETINOID X RECEPTOR AGONISTS (RXR) 3 3 V1O ANTINEOPLASTIC LHRH(GNRH) AGONIST,PITUITARY SUPPR V1Q ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS V1T SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERM) V1X ANTINEOPLAST HUM VEGF INHIBITOR RECOMB MC ANTIBODY 4 4 V3A ANTINEOPLASTIC,HISTONE DEACETYLASE INHIBITORS,HDIS 3 3 V3E ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS 4 4 V3F ANTINEOPLASTIC - AROMATASE INHIBITORS W1A PENICILLINS W1C TETRACYCLINES W1D MACROLIDES W1E CHLORAMPHENICOL AND DERIVATIVES 2 1 The preparation of this document was financed under an agreement with Indiana OMPP. Page 81

82 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month Program Type # PT Screened # PT Targeted CA or PDL ED OU TA DO W1F AMINOGLYCOSIDES W1G ANTITUBERCULAR ANTIBIOTICS W1J VANCOMYCIN AND DERIVATIVES W1K LINCOSAMIDES W1M STREPTOGRAMINS 3 1 W1N POLYMYXIN AND DERIVATIVES W1O OXAZOLIDINONES W1P BETALACTAMS W1Q QUINOLONES W1S CARBAPENEMS (THIENAMYCINS) W1W CEPHALOSPORINS - 1ST GENERATION W1X CEPHALOSPORINS - 2ND GENERATION W1Y CEPHALOSPORINS - 3RD GENERATION W1Z CEPHALOSPORINS - 4TH GENERATION W2A ABSORBABLE SULFONAMIDES W2E ANTI-MYCOBACTERIUM AGENTS W2F NITROFURAN DERIVATIVES W2G CHEMOTHERAPEUTICS, ANTIBACTERIAL, MISC W3A ANTIFUNGAL ANTIBIOTICS W3B ANTIFUNGAL AGENTS W4A ANTIMALARIAL DRUGS W4C AMEBACIDES 2 2 W4E ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL AGENTS W4G 2ND GEN. ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL W4K ANTIPROTOZOAL DRUGS,MISCELLANEOUS W4L ANTHELMINTICS W4M ANTIPARASITICS W4P ANTILEPROTICS W5A ANTIVIRALS, GENERAL W5C ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS W5D ANTIVIRAL MONOCLONAL ANTIBODIES W5F HEPATITIS B TREATMENT AGENTS W5G HEPATITIS C TREATMENT AGENTS W5I ANTIVIRALS, HIV-SPECIFIC, NUCLEOTIDE ANALOG, RTI W5J ANTIVIRALS, HIV-SPECIFIC, NUCLEOSIDE ANALOG, RTI W5K ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI W5L ANTIVIRALS, HIV-SPEC., NUCLEOSIDE ANALOG, RTI COMB W5M ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITOR COMB W5N ANTIVIRALS, HIV-SPECIFIC, FUSION INHIBITORS W5O ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG W5P ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB W5Q ARTV CMB NUCLEOSIDE,NUCLEOTIDE,&NON-NUCLEOSIDE RTI W5T ANTIVIRALS, HIV-SPECIFIC, CCR5 CO-RECEPTOR ANTAG. 7 7 W5U ANTIVIRALS,HIV-1 INTEGRASE STRAND TRANSFER INHIBTR W7B VIRAL/TUMORIGENIC VACCINES W7C INFLUENZA VIRUS VACCINES W7H ENTERIC VIRUS VACCINES W7K ANTISERA W7L GRAM POSITIVE COCCI VACCINES W7N TOXIN-PRODUCING BACILLI VACCINES/TOXOIDS W7Q GRAM NEGATIVE COCCI VACCINES 5 5 W7T ANTIGENIC SKIN TESTS W7Z VACCINE/TOXOID PREPARATIONS,COMBINATIONS W8D OXIDIZING AGENTS W8E ANTISEPTICS,GENERAL 8 8 The preparation of this document was financed under an agreement with Indiana OMPP. Page 82

83 ATTACHMENT 3.4. RETRODUR EXCEPTIONS & INTERVENTIONS (continued) Retrospective DUR Criteria Indiana Medicaid RetroDUR Program Thera Class Code Thera Class Code Spec Description # Claims # Utilizers Month Z2E IMMUNOSUPPRESSIVES Z2F MAST CELL STABILIZERS Z2G IMMUNOMODULATORS Z2H SYSTEMIC ENZYME INHIBITORS Z2L MONOCLONAL ANTIBODIES TO IMMUNOGLOBULIN E(IGE) Z2N 1ST GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS Z2O 2ND GEN ANTIHISTAMINE & DECONGESTANT COMBINATIONS Z2P ANTIHISTAMINES - 1ST GENERATION Z2Q ANTIHISTAMINES - 2ND GENERATION Z4B LEUKOTRIENE RECEPTOR ANTAGONISTS Z4E 5-LIPOXYGENASE INHIBITORS Program Type # PT Screened # PT Targeted CA or PDL ED OU TA DO NOTE: The patient targeted values includes the number of patient reviewed in treatment of the specific disease state. RetroDUR Program Code Key Program Code Code Description DO Dose Optimization OU Over Utilization TA Therapeutic Appropriate The preparation of this document was financed under an agreement with Indiana OMPP. Page 83

84 ATTACHMENT 3.5. RETRODUR INTERVENTIONS PERFORMED DESCRIPTION The following information is a year-end summary description of RetroDUR activities that were approved by the DUR Board and performed by ACS through the following RetroDUR program types: standard RetroDUR programs and IBM (targeted phone calls to prescribers). TAI (therapeutic academic interventions or face-to-face physician visits) was discontinued in FFY 2005 after negotiation of a new contract. (Note: Not all RetroDUR criteria and initiatives include pharmacy cost savings. Quality of care initiatives may actually increase pharmacy costs, while reducing the use of other resources, such as medical expenditures. The overall goal of quality of care initiatives is to improve the quality of life of the participant.) INDIANA MEDICAID -- FFY 2008 Month Intervention Name IBM Retro DUR Intervention Description Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Mar-08 Apr-08 May-08 Jun-08 Jul-08 Aug-08 Sep-08 No Intervention Approved No Intervention Approved No Intervention Approved No Intervention Approved No Intervention Approved No Intervention Approved No Intervention Approved No Intervention Approved Medication Adherence- Antidiabetic Therapy Medication Adherence- Antilipotropics Therapy Medication Adherence- Antihypertensive Therapy No Intervention Approved No Intervention Approved No Intervention Approved X X X Patients included in this review were patients who received less than 60 days of Antidiabetic Therapy during a 90 day period of claims activitiy. A table entitled Improving Medication Adherence was provided to prescribers to support good adherence to drug therapy leads to positive health outcomes. Patients included in this review were patients who received less than 60 days of Antilipotropics Therapy during a 90 day period of claims activitiy. A table entitled Improving Medication Adherence was provided to prescribers to support good adherence to drug therapy leads to positive health outcomes. Patients included in this review were patients who received less than 60 days of AntiHypertensive Therapy during a 90 day period of claims activitiy. A table entitled Improving Medication Adherence was provided to prescribers to support good adherence to drug therapy leads to positive health outcomes. The preparation of this document was financed under an agreement with Indiana OMPP. Page 84

85 ATTACHMENT 4 SUMMARY OF DUR BOARD ACTIVITIES FFY 2008 The preparation of this document was financed under an agreement with Indiana OMPP. Page 85

86 VIII. ATTACHMENT 4. SUMMARY OF DUR BOARD ACTIVITIES A. Indicate the number of DUR Board meetings held. DUR Board meetings are held monthly. Twelve meetings were held during FFY B. List additions/deletions to DUR Board approved criteria. 1. For prospective DUR, list problem type/drug combinations added or deleted. See Attachment 4.1 for modifications [additions & deletions] to DUR Boardapproved ProDUR criteria. For prospective DUR, the DUR Board worked on two major initiatives: (1) Mental Health Quality Edits-The DUR Board approved criteria requiring prior authorization (hard edit) where duplication of antipsychotic, antidepressant, and sedative hypnotic medicationsoccurred. The DUR Board also approved criteria requiring prior authorization (hard edit) for daily dosages of 25mg and 50mg quetiapine. (2) Mental Health Quantity Limits The DUR Board continues to approve quantity limits on the mental health medications. This effort is to enhance quality and appropriateness in mental health prescribing practices. Claims that exceed the established limit will require a prior authorization. 2. For retrospective DUR, list therapeutic categories added or deleted. See Attachment 4.2 for additions and deletions of DUR Board-approved RetroDUR criteria. C. Describe Board policies that establish whether and how results of prospective DUR screenings are used to adjust retrospective DUR screens. Also, describe policies that establish whether and how results of retrospective DUR screenings are used to adjust prospective DUR screens. Analyses of both ProDUR and RetroDUR edits and criteria have always been used by the OMPP (through its contractors and the DUR Board) to help establish new costcontainment initiatives and to monitor rational drug use and prescribing. It has been standard practice by the OMPP and DUR Board to expect that the contractor would develop and present innovative ideas on cost containment & therapeutic appropriateness through DUR program efforts. The DUR Board advises on the Preferred Drug List (PDL), ProDUR & PA programs, RetroDUR programs, and newsletters (through the contractor) that address educational issues that relate to the prescribing and utilization of prescription drugs in the most costeffective manner. The preparation of this document was financed under an agreement with Indiana OMPP. Page 86

87 ATTACHMENT 4. (continued) In FFY 2006, while OMPP switched to EDS as the contractor for claims processing, ACS continued to be the clinical programs contractor. As the clinical programs contractor for OMPP, ACS reviewed drug trends for ideas on cost containment, therapeutic appropriateness, & overuse under the oversight of OMPP and the DUR Board. For FFY 2008, these ideas were implemented in the form of medication adherence in the form of letter interventions on therapeutic appropriateness. Up to a certain threshold, the more RetroDUR screenings & interventions that are performed, the higher the RetroDUR savings. The DUR Board approved even less interventions for FFY08 than in any of the prior years of FFY05, FFY06, and FFY07. The DUR Board approved and ACS conducted less RetroDUR interventions every year. Less interventions subsequently results in less savings from RetroDUR programs. For example: FFY08 RetroDUR Savings = $219,458 FFY07 RetroDUR Savings = $165, FFY06 RetroDUR Savings = $59,201 FFY05 RetroDUR Savings = $1.61 million FFY04 RetroDUR Savings = $2.3 million. D. Describe any policies used to encourage the use of therapeutically equivalent generic drugs. Include relevant documentation, if available, as ATTACHMENT 5. See Attachment 5 for specific descriptions & relevant documentation. The State of Indiana has a mandatory generic substitution statute. Indiana regulation was also added to require Prior Authorization for prescriptions written as Brand Medically Necessary when generic substitution is possible. Drugs exempted from this statute include all mental health/cross indicated drugs per 405 IAC , Coumadin, Provera, Synthroid, Tegretol, Lanoxin, Premarin, Dilantin, and claims with 06 override for BMN, and days supply of 4 or less. E. Describe DUR Board involvement in the DUR education program (e.g., newsletters, continuing education, etc). Also, describe policies adopted to determine mix of patient or provider specific intervention types (e.g., letters, face to face visits, increased monitoring). Provider bulletins and DUR Board Newsletters, that notify and educate prescribers and pharmacists on specific topics associated with the ProDUR and RetroDUR programs, are reviewed and approved by OMPP and the DUR Board. There are no written policies to determine mix of patient or provider specific intervention types. However, ACS monitors claims, presents RetroDUR criteria on cost containment, and performs at least 3,600 RetroDUR interventions to prescribers about specific patients drug therapy problems or cost containment issues during the year. RetroDUR interventions were performed either by IBM (calls and to prescribers) or RetroDUR (mail letters to prescribers). There were no face-to-face visits. The preparation of this document was financed under an agreement with Indiana OMPP. Page 87

88 ATTACHMENT 4. (continued) F. Describe DUR Board involvement in the DUR education program (e.g., newsletters, continuing education, etc). Also, describe policies adopted to determine mix of patient or provider specific intervention types (e.g., letters, face to face visits, increased monitoring). IBM (calls and faxed letters) and Regular RetroDUR (mailed letters) educational interventions were also reviewed and approved by the DUR Board. Attachment 4.3 contains meeting minutes highlighting DUR Board involvement in DUR education. Attachment 4.4 contains DUR Board Newsletters & relevant Provider Bulletins. The preparation of this document was financed under an agreement with Indiana OMPP. Page 88

89 ATTACHMENT 4.1. PROSPECTIVE DUR CRITERIA CHANGES The DUR Board Has Adopted ProDUR Criteria Changes Listed Below by Problem Type INAPPROPRIATE DOSE (HIGH DOSE) THERAPEUTIC DUPLICATION DRUG ALLERGY INTERACTION 1. ^^ All Drugs containing acetaminophen, except < 3grams/day for <10 days*(july 2006) - (Changed to hard non-overridable edit except by PA only) 1. Thera.Dup. See Table 1.B for Drug List *(7/22/03) - Changed to soft overridable edit in June 2004) Thera.Dup. Certain Mental Health Drugs where > 2 Rxs require PA. *(1/17/2007) SSRI/SNRI Antidepressants-Two or more; Sedative Hypnotic-Two or more (March 2008) INAPPROPRIATE DURATION DRUG/ DRUG INTERACTIONS DRUG DISEASE CONTRAINDICATION 1. Early Refill * (7/1/02) 1. DD Severity Level 1 * (1/15/03) Day Supply for Non-Maintenance *(7/1/02) UNDERUTILIZATION OTHER OTHER (specify) DOSE OPTIMIZATION (specify) GENERIC APPROPRIATENESS (specify) 1. Xanthines, ACE Inhibitors, Oral Hypoglycemics, Anti-Convulsants*(before 1999) 1. ^^ Certain Mental Health Drugs where quantity limits are reviewed. *(June 2007) 2. Seroquel, Low Dose Use (March 2008) ^^CHANGES WERE FROM OVERRIDES TO PRIOR AUTHORIZATION (PA) REQUIRED *Implementation Dates Pro-DUR Criteria Requiring PA 1. Brand Medically Necessary Indication *(8/20/01) The preparation of this document was financed under an agreement with Indiana OMPP. Page 89

90 ATTACHMENT 4.2. RETRO-DUR CRITERIA CHANGES (& ADDITIONS) INAPPROPRIATE DOSE (HIGH DOSE) THERAPEUTIC DUPLICATION OVERUTILIZATION 1. NONE 1. NONE 1. NONE _ _ _ _ _ INAPPROPRIATE DURATION DRUG / DRUG INTERACTION DRUG / DISEASE CONTRAINDICATION 1. NONE 1. NONE 1. NONE _ _ _ OTHER: DOSE OPTIMIZATION OTHER: THERAPEUTIC APPROPRIATENESS OTHER: GENERIC APPROPRIATENESS SPECIFY SPECIFY SPECIFY 1. NONE 1. Medication Adherence-Antidiabetic _ 2. Medication Adherence-Antilipotropic Medication Adherence-Antihypertensive _ 6. FOR EACH PROBLEM TYPE, LIST (DRUGS / DRUG CATEGORY / DISEASE COMBINATIONS) FOR WHICH DUR BOARD CONDUCTED IN-DEPTH REVIEWS. PLEASE INDICATE WITH AN ASTERICK THOSE FOR WHICH CRITERIA WERE ADOPTED. The preparation of this document was financed under an agreement with Indiana OMPP. Page 90

91 ATTACHMENT 4.3. INDIANA DUR BOARD CONDENSED MEETING MINUTES October 2007 December DUR Board Members Marko A. Mychaskiw, R.Ph., Ph.D. Chairperson Philip N. Eskew, Jr., M.D. Vice Chairperson Terry Lindstrom, Ph.D. Brian W. Musial, R.Ph. Vicki F. Perry Thomas A. Smith, P.D., M.S., FASCP Patricia A. Treadwell, M.D. John J. Wernert, M.D. G. Thomas Wilson, R.Ph.,J.D. *********************************************************************** October 19, 2007 In Attendance: Philip Eskew, Jr., M.D., Chair John Wernert, M.D. Brian Musial, RPh. Terry D. Lindstrom, Ph.D. Patricia Treadwell, M.D. Rhonda Eldridge, RPh. Jeff Brown, RPh., MS, BCPS Kent Summers, RPh., Ph.D. Also Present: Marc Shirley, R.Ph. OMPP Michael Sharp, R.Ph. Pharmacy Director OMPP Chris Johnson, Pharm.D. Pharmacy Director MDWise Jeannine M. Murray, R.Ph. Pharmacy Director Anthem Carol Ott, Pharm.D., BCPP - MHQAC Katasha Butler, Pharm.D. MHS Pinkesh Patel, Pharm.D. ACS MEETING CALLED TO ORDER: Dr. Phillip Eskew, Acting Chairman, called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. He asked all the members to introduce themselves as there were three new members elected to the Board. The preparation of this document was financed under an agreement with Indiana OMPP. Page 91

92 APPROVAL OF MINUTES: Dr. Phillip Eskew asked for approval of the minutes from the August and September meetings. His request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: None. OPENING COMMENTS: Mr. Marc Shirley welcomed the new members. He informed the new Board members regarding parking issues and to contact Karen Clifton if they have any concerns related to parking. PROPOSED LEVEL ONE EDITS FROM MHQAC: Dr. Carol Ott reminded the Board regarding the edits currently in place related to polypharmacy and appropriate use edits. MHQAC has approved several additional edits, but there are limited resources to implement these proposed changes. Therefore, she requested to receive an approval of the three edits, two or more SSRI and/or SNRI antidepressants, excluding bupropion and mirtazapine, use of low dose atypical antipsychotics specifically quetiapine (less than 300mg), and a 15-day trial fill for new atypical prescriptions. Dr. Ott also presented the proposed changes and addition to the mental health medication utilization edits. The proposed changes in these medications were as follows: increase Abilify 5mg to 1.5/day, limit Exelon patch, Methylin 2.5mg chewable, Risperdal consta 12.5mg/ml to 2 syringes/28 days, trifluoperazine 10mg 4/day, Seroquel XR 200mg, Seroquel XR 300mg, Seroquel XR 400mg 4/day and Vyvanase 30mg, 50mg, 70mg. Board Discussion: Dr. Lindstrom inquired on whether the MHQAC will have further discussion on the use of low dose quetiapine and a 15-day trial of atypical prescriptions. Dr. Ott informed that MHQAC has approved all of these edits, but decided to roll these in phases as we have limited resources. Dr. Wernert requested further clarification on rollout phase for low dose atypical antipsychotics. Dr. Patricia Treadwell advised that all the changes should appear on same communication with the rollout dates in order for prescribers to make informed decisions. Mr. Sharp responded that they would be very cautious as they move forward in implementing these changes. He also mentioned that he would keep the Board informed of the future rollouts of these utilization edits. Board Action: After the discussion, Dr. Eskew requested a motion to approve all of the new MHQAC edits and leave the implementation of the edit dates open, depending on resources, for the State. The motion was moved, seconded and passed with a unanimous vote. Dr. Eskew requested a motion to approve the proposed changes to the mental health medication utilization edits. It was moved, seconded and approved with a unanimous vote. ACS UPDATE: Dr. Patel presented the prior authorization (PA) statistics for the month of August and September Dr. Patel also presented the Board with the existing Indiana Medicaid policy on maintenance medication. Currently, the state allows the pharmacy/patients to dispense/receive maintenance medication for up to 365 days supply. The preparation of this document was financed under an agreement with Indiana OMPP. Page 92

93 He proposed to change maintenance medications be limited in quantity to no more than a 100 (one hundred) days supply per dispensing. Board Discussion: Mr. Musial inquired whether EDS claims processing system allows a 365 days on maintenance drugs. Mr. Sharp informed that there has never been any limitation on maintenance drugs except addressed thru preferred drug list. He also mentioned that the State is trying to bring the program in line with other programs. Board Action: Dr. Eskew requested a motion to accept the requested changes and the motion was moved and seconded. The motion passed unanimously. MANAGED CARE ORGANIZATION UPDATE: Proposed PDL Changes MDWise: Chris Johnson summarized the changes for the month of September for MDWise PDL that was sent to the Board. He requested to add Zaditor OTC and Alaway OTC to PDL without clinical edits. He requested Rhinocort Aqua be added to PDL with trial of generic flunisolide and generic fluticasone, and add Pataday to PDL with trial of Zaditor OTC, Aalaway OTC and Patanol. He also requested to remove Nasonex, Optivar and Elestat from PDL. Mr. Johnson presented the changes for the month of October. He requested to add Asmanex, Amitiza, Levemir, Selzentry, Seroquel XR, and Emend without any clinical edits. He mentioned Aranesp, pegasys and generic ribavirin would be added to PDL with prior authorization criteria. He requested to add Januvia, Janumet, Exforge with step edit, trial of ACE inhibitors, and Megace with quantity limits and Lupron with a prior authorization. He also requested that the following products be moved to non-preferred status: Bactroban cream, Procrit, Peg-Intron, quinine, rebetol, and ribavirin capsules. Dr. Eskew requested a motion to accept the requested changes and it was moved and seconded. The motion passed unanimously. Proposed PDL Changed Managed Health Services: Dr. Katasha Butler, a clinical pharmacist from Managed Health Services, summarized the changes for Managed Health Services that were sent to the Board. She requested adding Alocril ophthalmic, Betapace, Betapace AF, Betoptic ophthalmic, Byetta, Cipro HC, cortisporin ophthalmic suspension, Duragesic patches, Econopred plus, Glucophage XR, Fioricet with codeine, Fiorinal with codeine, Lofibra, Lopressor HCTZ, Polytrim ophthalmic, Protosol HC cream, Tamiflu, Tazorac cream and gel, Tazita XT, Zofran 24mg without any clinical edits. Lastly, she requested the quantity limits on Acular, Adalat CC, Alphagan P, glimiperide, Androderm, APAP with codeine, APAP with hydrocodone, APAP with oxycodone, aspirin with oxycodone, Asacol, The preparation of this document was financed under an agreement with Indiana OMPP. Page 93

94 Atripla, Atrovent, Atrovent NS, Betagan, Betimol, Betoptic S, Blephamide, Brimonidine, Cardene SR, carisoprodol, cefdinir capsules, cefprozil, ceftin suspension, cephalexin, Cerumenex, ciprofloxacin ophthalmic, clarithromycin, Combivir, Cosopt, cromolyn ophthalmic, cyclobenzaprine, Dilacor XR, Diltia XT, diltiazem SR capsules 12hr and 24hr, electrolyte soln/peg, estrodiol patches, Evista, fluorometholone drops, FML, FML S.O.P. ointment, gentamicin ophthalmic, glucose meters, Imdur, Inderal LA, inflamase forte, Inflamase mild eye drops, Kaletra oral solution, Kaletra softgel and tablets, Lexiva, Mevacor, ondansetron solution, Reyataz, sulfacetamide sodium 10%, sulfacetamide prednisolone, Timolol gel, Tobradex, tobramycin drops, Trizivir, Trusopt, Truvada, verapamil ER, Viroptic, and Voltaren ophthalmic. Dr. Eskew asked the Board members if the members had any questions related to the proposed edits. Dr. Eskew requested a motion to accept the proposed changes and it was seconded. The motion passed 7 to 1. NEW DRUGS: None LIAISONS WITH OTHER BOARD: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED. The preparation of this document was financed under an agreement with Indiana OMPP. Page 94

95 ATTACHMENT 4.3. (continued) In Attendance: John Wernert, M.D., Acting Chair Brian Musial, R.Ph. Terry D. Lindstrom, Ph.D. Rhonda Eldridge, R.Ph. Jeff Brown, R.Ph., MS, BCPS Kent Summers, R.Ph., Ph.D. Steven Bodenberg, R.Ph. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Chris Johnson, Pharm.D.--MDWise Jeannine M. Murray, R.Ph.--Anthem Katasha Butler, Pharm. D.--MHS Pinkesh Patel, Pharm.D.--ACS November 16, 2007 MEETING CALLED TO ORDER: Dr. John Wernert, Acting Chairman, called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Wernert asked for approval of the minutes from the October meeting. His request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: Dr. Wernert stated that the DUR Board accepts the recommendations of thetherapeutics Committee with the understanding that all applicable agreements will be executed within the time frame defined by ACS and OMPP. If the manufacturer does not submit the signed agreement to ACS within the time frame, then their medications that would have been deemed preferred in accordance with the agreement will be moved to non-preferred status. OPENING COMMENTS: Mr. Marc Shirley advised the Board members that there should be no discussion of supplemental rebates during today s open session. THERAPEUTICS COMMITTEE LIAISON REPORT: Dr. Pinkesh Patel presented the Therapeutics Committee s recommendations from the November 2nd meeting. He stated that (as always) the three primary drivers behind those recommendations were clinical implications, drug costs, and total program costs. The T-Committee reviewed seven therapeutic classes and offered the recommendations listed below. The Board discussed and acted on each class individually. The preparation of this document was financed under an agreement with Indiana OMPP. Page 95

96 1. CNS Agents Anti-emetic Agents o Maintain ondansetron as preferred but add the following quantity limits: 10 orally disintegrating tablets per fill; 1 bottle of oral liquid per fill o Move Zofran to non-preferred status with quantity limit of 10 orally disintegrating tablets per fill; 1 bottle of oral liquid per fill Narcotics o Move Panlor DC, Panlor SS, and Zerlor to non-preferred status o Move Dihydrocodeine/APAP/Caffeine to non-preferred status Cyclooxygenase 2 Inhibitors No changes recommended Narcotic Antitussive/1st generation Antihistamine Combinations o Add Tussionex to preferred status with quantity limit of 4 oz. per prescription o Add promethazine with codeine to preferred status with the quantity limit of 6 oz per prescription Prevacid NapraPAC No changes recommended Skeletal Muscle Relaxants o Move Amrix to non-preferred status o Move Soma 250 mg to non-preferred status Smoking Deterrent Agents o Move Nicotrol inhaler and nasal spray to non-preferred status Public Comment: None Board Discussion: Mr. Musial informed the Board that there was considerable discussion on quantity limits on the narcotic antitussive class. Dr. Wernert inquired if there were any discussions on the smoking deterrent class, specifically Nicotrol nasal spray. Board Action: It was moved and seconded that the recommendations for the CNS agents be approved. The motion passed unanimously. 2. Dermatologic Agents Agents to Treat Acne o Add Duac to preferred status with age restriction of _ 25 years of age o Maintain non-preferred status of Duac for patients > 25 years of age Antipsoriatics No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for dermatological agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 96

97 3. Endocrine Agents Antidiabetic Agents: o Add Janumet to preferred status o Move Exubera to non-preferred status o Add Duetact to preferred status with a step edit must fail a sulfonylurea or a TZD o Add Avandaryl 8/2 mg and 8/4 mg tablets to preferred status Bone Resorption Suppression Agents/Selective Estrogen Receptor Modulator Agents: o Maintain Fosamax tablets and Fosamax Plus D tablets as preferred with a step edit prior trial of Actonel within the past 90 days or previous use of Fosamax within the past 180days ; maintain current status of the other agents. Bone Formation Stimulating Agents (Forteo) No changes recommended Thiazolidinediones No changes recommended. Injectable Hypoglycemics: o Add Humulin and Humalog pens and cartridges, including mixtures to preferred status o Move Lantus SoloStar to non-preferred status o Add Levemir vials to the preferred status Growth Hormones: Add Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-Tropin, Zorbtive to preferred status with prior authorization criteria. Public Comment: None Board Discussion: Dr. Wernert asked if the growth hormone criteria were new or preexisting criteria. He also asked if the criteria were similar to those of other managed care organizations. Mr. Musial advised the Board of the discussions surrounding the growth hormone class. Mr. Musial mentioned there was a pediatric endocrinologist present at the Committee meeting who assisted the Committee members in developing the prior authorization criteria. The T-Committee wished to continue to provide practitioners the flexibility to use the agent they felt was appropriate and not restrict a practitioner to a particular diagnosis. Dr. Wernert expressed concern with having four different growth hormone prior authorization criteria sets for four different plans. Mr. Musial stated that the criteria when compared to those of other managed care organizations would be similar. There was a motion on the floor to carve out the prior authorization criteria and approve the medications within this class. Mr. Shirley said that if the criteria are clinically appropriate and reasonable then the Board could adopt the Committee s recommendations. Dr. Wernert requested a comparison of the growth hormone criteria sets across all plans, and Mr. Shirley stated that OMPP with the MCOs in providing that information. The preparation of this document was financed under an agreement with Indiana OMPP. Page 97

98 Board Action: There was a motion to accept the recommendations as presented. It was moved and seconded that the recommendations for endocrine agents be approved, along with growth hormone criteria. The motion passed 6 to Gastrointestinal Agents Chronic Constipation Agents o Add Amitiza to preferred status with step edit requires previous therapy with lactulose or sorbitol or polyethylene glycol within the past 90 days Antiulcer H.pylori Agents o Move Pylera to non-preferred status H2 Receptor Antagonists o Add cimetidine and Zantac syrup to preferred status o Move ranitidine syrup, Axid and Pepcid oral solutions to non-preferred status Ulcerative Colitis Agents o Add Colazal, Asacol, Canasa, Pentasa and Dipentum sulfasalazine and mesalamine to preferred status o Move Lialda, Rowasa Azulfidine, Azulfidine En-Tabs and Sulfazine EC to non-preferred status. Proton Pump Inhibitors (PPIs) o Add omeprazole to preferred status o Move Prilosec OTC to non-preferred status o Maintain Nexium and Protonix to preferred status but change edit to must fail Omeprazole or Prilosec OTC within past 90 days o Add Prevacid Solutabs to preferred status with age restriction 12 years of age and quantity limit of 1 tab/day o Maintain Prevacid solutabs as non-preferred for greater than 12 years of age and quantity limit of 1 tab/day o Move Prevacid suspension to non-preferred status o Change the step edit for all non-preferred agents including Prevacid, Aciphex, Prilosec and Zegerid (all dosage forms and strengths) to must fail omeprazole or Prilosec OTC and then another preferred PPI Public Comment: None Board Discussion: Mr. Brown inquired if there was any discussion surrounding cimetidine and its potential risk of drug-drug interactions. Mr. Musial informed the Board of extensive discussions related to proton pump inhibitors during the executive session. Mr. Musial also stated that Prilosec OTC claims would be denied, based on the T-Committee recommendations, and proposed a motion to change Prilosec OTC to preferred status. Dr. Wernert inquired about Nexium, asking if it was covered by the other managed care organizations. The preparation of this document was financed under an agreement with Indiana OMPP. Page 98

99 Board Action: Dr. Wernert requested a motion to approve all gastrointestinal agents except the PPI class. It was moved and seconded that the recommendations for gastrointestinal agents be approved. The motion passed unanimously. Dr. Wernert moved to add legend omeprazole to preferred status, maintain Prilosec OTC as preferred, maintain Protonix as preferred, but change the step to a trial of omeprazole or Prilosec OTC within past 90 days, add Prevacid solutabs to preferred status with age restriction 12 years of age and limit of 1 tab/day, move Prevacid suspension to non-preferred status, and move Nexium to non-preferred status with the following step: must fail omeprazole or Prilosec OTC and then a preferred PPI, maintain the non-preferred status of Prevacid, Aciphex, Prilosec and Zegerid (all dosage forms and strengths) but change the step edit to must fail omperazole or Prilosec OTC and then a preferred PPI. Mr. Musial seconded the motion. The motion passed unanimously. 5. Genitourinary Agents Agents to Treat Benign Prostatic Hyperplasia (BPH) o Move UroXatral to non-preferred status Urinary Tract Antispasmodics o Add Detrol to preferred status with the step edit must fail oxybutynin IR o Move Sanctura to non-preferred status and maintain step edit must fail oxybutynin IR Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for genitourinary agents be approved. The motion passed unanimously. 6. Hematologic Agents Hematinics No changes recommended Heparin and Related products No changes recommended Leukocyte Stimulants No changes recommended Platelet Aggregation Inhibitors No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for hematologic agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 99

100 7. Topical Agents Eye Antihistamines/Mast Cell Stabilizers o Add Pataday to preferred status Antiglaucoma Agents (Miotics/other intraocular pressure reducers) No changes recommended Topical Estrogen Agents No changes recommended Topical Immunomodulators o Add Elidel to preferred status o Move Protopic to non-preferred status Wound Care Products No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for topical agents be approved. The motion passed unanimously. 7th PDL REPORT: Dr. Michelle Laster-Bradley presented the evaluation of the Indiana Medicaid Preferred Drug List (PDL) program. A report is presented to the Board biannually and this iteration is the 7th report since PDL implementation in It was stated that copies of prior reports can be retrieved from the Indiana Medicaid website. The objectives of these reports are to determine if there have been any increases in Medicaid physician, lab or hospital costs, and also evaluate the impact of the PDL program upon Medicaid patients ability to obtain their prescription medications. The latest report begins by highlighting the key findings over the past four and half years of evaluation. It also specifies estimated savings over the past four and half years, which Dr. Laster-Bradley reported as being $51.47 million dollars. This figure includes $29.15 million savings from the federal rebate portion of the PDL program and $27.73 million from the supplemental rebates portion of the PDL program. After deducting of administrative costs, the State has saved an estimated $51.47 million over four and a half years. Dr. Laster-Bradley noted that the PDL program has not created any statistically significant access barriers to medically necessary medications. In addition, there were no statistical differences in any of the medical costs as a total, or individual physician visits, laboratory costs, or hospital costs between patients who were affected by the PDL program versus patients who were not affected by the PDL program. She mentioned that there continues to be noteworthy behavioral health drug expenditures. Dr. Laster- Bradley highlighted an analysis of the period spanning October 1, 2006 to March 31, The savings from the PDL during this six-month period was approximately $5.81 million, after deducting administrative costs. She also noted that once patients switch to preferred agents, they tend to remain on preferred agents. Regarding recommendations to the DUR Board, she mentioned prior authorization criteria be developed to determine where such criteria could and should be made more rigorous in ensuring clinically and fiscally responsible drug therapy. Dr. Laster-Bradley s other recommendation was to The preparation of this document was financed under an agreement with Indiana OMPP. Page 100

101 continue to analyze for new medications and monitoring for new therapeutic classes in order to determine if a PDL review is necessary. Board Discussion: Dr. Wernert questioned how savings has been estimated for this analysis period. Dr. Summers questioned if the supplemental savings were incremental or total program savings. Dr. Lindstrom commented that it appeared that savings were largely from supplemental rebates. He also stated that the Board would need to take further proactive steps further in order to realize further savings. From page 8, Mr. Musial requested modification of the word rigorous to appropriate. Dr. Summers inquired if PDL study excluded copays, coinsurance, and rebates at the hospital level. Mr. Brown asked if the PDL study evaluated compliance. Dr. Lindstrom inquired about the administrative cost of prior authorization. Dr. Wernert questioned how the impact of the MHQAC edits could be measured. Board Action: It was moved and seconded to approve the 7th PDL Report with changes as noted. The motion passed unanimously. ACS UPDATE: Dr. Patel presented the prior authorization (PA) statistics for the month of October Dr. Patel informed the Board that he did not have a RetroDUR topic to present at the time, but would present one next month. Board Discussion: None MANAGED CARE ORGANIZATION UPDATE: Proposed PDL Changes Anthem: Ms. Murray summarized the changes for the month of November that were sent to the Board. She requested to add Pulmozyme to the PDL products. She also requested that Prevpac and Prevacid Naprapac be moved to non-preferred status. Dr. Wernert mentioned a motion to accept the requested changes and it was moved and seconded. The motion passed unanimously. NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: Dr. Freedland, Director of Medical Affairs for EMD Sereno, addressed the Board on Serostim. He stated that Serostim is the only growth hormone that has a sophisticated secure distribution program. He further asked that only qualified pharmacies are contracted to distribute the drug or dispense the drug. Dr. Jerry Wright, a pain management specialist, requested the Board to consider adding Avinza to the preferred status. He mentioned that Avinza is dosed once a day and has a better compliance rates compared to a twice-a-day dosing drug regimen. Furthermore, because of the technology of Avinza, it is extremely difficult to extract the drug, which in turn decreases diversion. Dr. Ibrahim, a pain management specialist, requested the Board to consider adding Avinza to preferred status. The preparation of this document was financed under an agreement with Indiana OMPP. Page 101

102 OLD BUSINESS: None NEW BUSINESS: Dr. Wernert accepted the nomination for the officers for the next calendar year. Dr. Wernert nominated Dr. Patricia Treadwell as Chair and Mr. Brian Musial as Vice-Chair. The Board decided to vote during the next month s meeting. MEETING ADJOURNED. ************************************************************************ December 14, 2007 In Attendance: Philip Eskew, Jr. M.D., Acting Chairman Brian Musial, R.Ph. Terry D. Lindstrom, Ph.D. Rhonda Eldridge, R.Ph. Jeff Brown, R.Ph., MS, BCPS Kent Summers, R.Ph., Ph.D. Steven Bodenberg, R.Ph. Patricia Treadwell, M.D. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Kelly Henderson, Pharm.D.--MDWise Jeannine M. Murray, R.Ph.--Anthem Dan Baker, R.Ph.--MHS Pinkesh Patel, Pharm.D.--ACS MEETING CALLED TO ORDER: Dr. Philip Eskew, Acting Chairman, called the meeting of the IndianaMedicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Eskew asked for approval of the minutes from the November meeting. His request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: Dr. Eskew thanked the board members for their service. He also thanked Marc Shirley for keeping the Board well informed and provided with essential information to make decisions. The preparation of this document was financed under an agreement with Indiana OMPP. Page 102

103 OPENING COMMENTS: Mr. Shirley informed the Board of upcoming dates for upcoming major deliverables such as the 8 th and 9 th PDL reports, the CMS DUR Annual Report, the managed care annual formulary review, and the annual OTC Drug Formulary review. ACS UPDATE: Dr. Pinkesh Patel presented the prior authorization (PA) statistics for the month of November He also presented a proposed newsletter entitled The Value of Generics. Finally, a retro-dur topic, non-adherence to antihypertensives, antidiabetics, and lipotropics was explained. BOARD DISCUSSION: Mr. Musial commented on the price comparison table from the newsletter. Regarding discussion on the retro-dur topic, Dr. Summers requested an illustration of what a patient profile would look like. Dr. Patel informed the Board that during the January meeting he would present an example of a patient profile which will be mailed along with the retro-dur letters. BOARD ACTION: Mr. Musial placed a motion to approve the newsletter. Dr. Summers seconded the motion, and it was approved unanimously. MANAGED CARE ORGANIZATION UPDATE: Proposed PDL Changes MHS: Mr. Dan Baker summarized the changes that were provided to the Board in advance. He requested that Pulmicort Flexhaler be added to the PDL. He also requested that Benicar, Benicar HCT, and Freestyle Glucose be moved to non-preferred status. Dr. Eskew accepted a motion for approval. It was moved, seconded, and passed unanimously. Dr. Eskew asked if the Board needed a discussion on the growth hormone criteria from the different managed care organizations. Mr. Musial stated that the growth hormone criteria, which were approved by the Board last month for fee-for-service, are very similar to other managed care organizations criteria. NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: Mr. Joe Loftus from GlaxoSmithKline (GSK) provided the Board with informationon Avandia. He mentioned that the FDA has concluded that there is insufficient evidence to indicate that the risk of heart attack or death is different between Avandia and other oral type 2 diabetes agents. He also mentioned that the FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia compared to an active control agent. He informed the Board that GSK is developing a medication guide for patients to provide additional information about the benefits and risks and the safe use of Avandia. The preparation of this document was financed under an agreement with Indiana OMPP. Page 103

104 OLD BUSINESS: None NEW BUSINESS: Based on the previous month s nominations, the Board voted Dr. Patricia Treadwell as Board Chair and Brian Musial as Board Vice Chair for calendar year MEETING ADJOURNED ************************************************************************ January 2008 September DUR Board Members Patricia A. Treadwell, M.D. Chairperson Brian W. Musial, R.Ph. Vice Chairperson Philip N. Eskew, Jr., M.D. Steve Bodenberg, R.Ph. William J. Brown, M.S., R.Ph. Rhonda Eldridge, R.Ph. Terry Lindstrom, Ph.D. Kent Summers, R.Ph., Ph.D. John J. Wernert, M.D. In Attendance: Patricia Treadwell. M.D., Chairman Terry D. Lindstrom, Ph.D. Rhonda Eldridge, R.Ph. Kent Summers, R.Ph., Ph.D. Steven Bodenberg, R.Ph. John Wernert, M.D. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Chris Johnson, Pharm.D.--MDwise Jeannine M. Murray, R.Ph.--Anthem Dan Baker, R.Ph.--MHS Pinkesh Patel, Pharm.D.--ACS January 18, 2008 MEETING CALLED TO ORDER: Dr. Patricia Treadwell called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. The preparation of this document was financed under an agreement with Indiana OMPP. Page 104

105 APPROVAL OF MINUTES: Dr. Treadwell asked for approval of the minutes from the November meeting. Her request was moved, seconded and carried with a unanimous vote. REMARKS FROM THE CHAIR: None OPENING COMMENTS: None ACS UPDATE: Dr. Pinkesh Patel presented the prior authorization (PA) statistics for the month of December MHQAC Edits - Edits Statistics and Cost Impact Fee-for-Service: Dr. Patel presented the expenditure impact of the MHQAC edits for the fee-for-service Medicaid program. He stated that this report does not evaluate any health outcomes such as whether the edits changed expenditures for hospitalization/institutional stays, ER visits, or physician office visits. In addition, the report does not incorporate costs related to claims processing system modifications or additional costs pertaining to prior authorization administration. The MHQAC implemented two types of edits that were approved by the DUR Board. On January 1, 2007, the category 1 Medical Necessity Quality Edits, often referred to as polypharmacy edits, were implemented. On June 19, 2007, utilization edits were implemented that addressed opportunities to optimize dosing. The June utilization edits set a limit on the quantity of medication allowed per day. The polypharmacy and utilization edits were implemented consistently in both the traditional and managed care Medicaid pharmacy programs. Specific prior authorization criteria were developed to allow for overrides in specific circumstances that were warranted based on the prescribing situation. Dr. Patel explained that, for purposes of this report, ACS focused on specific mental health drugs that were targeted for polypharmacy or utilization edits, including atypical antipsychotics, typical antipsychotics, benzodiazepines (anti-anxiety drugs), sedativehypnotics, antidepressants, and agents used to treat ADHD. According to the comparison of paid claims between 2006 and 2007 using regression analysis, it was noted that no cost savings were generated from two or more tricyclic antidepressants, from three or more atypical antipsychotics, nor from three or more of any antipsychotics. Dr. Patel mentioned that expenditures for atypical antipsychotics continued to increase by $5.61 PUPM (per utilizer per month) from January through May There were no category one edits in place regarding sedative-hypnotics and ADHD medications, and the expenditures for these medications continued to increase at a rate of $2.28 PUPM and $.02 PUPM from January through May 2007, respectively. Dr. Patel informed the Board of the savings generated from the utilization edits that were implemented in June The impact of the edits on expenditures was measured from The preparation of this document was financed under an agreement with Indiana OMPP. Page 105

106 June through December He stated that the savings from the edit placed on the antidepressant class of medications was calculated to be $1,970,973, while an additional savings of $305,142 was generated from the State Maximum Allowable Cost (SMAC) program. Savings for atypical antipsychotics was calculated to be $2,889,863. Despite the amount paid per member per month remaining steady, the amount paid per utilizer per month constantly increased for the atypical antipsychotic class of medications. This may be due to increases in the manufacturer s wholesale acquisition cost. The savings for typical antipsychotic medications and benzodiazepines was calculated to be $2,634 and $73,758, respectively. The savings for the sedative-hypnotic class of medications was calculated to be $632,972. Due to the availability of generic zolpidem and the SMAC program, there was an additional savings of $552,686. The total savings for the ADHD medications amounted to $437,411. Board Discussion: Dr. Summers requested clarification of the meaning of modified regression analysis. He commented that in order to better understand this savings analysis, he would like to know the number of people that met the requirements, pre- and post-edits. Dr. Lindstrom asked if ACS intends to further analyze the data to determine if hospital expenditures increased or if care for the recipients was compromised. He also emphasized that the Mental Health Quality Advisory Committee (MHQAC) would like to know the impact of MHQAC s decisions on quality of health before evaluating drug savings. Mr. Michael Sharp, representing OMPP, informed the Board that this report was requested by MHQAC and, subsequently, by the Board in order to perform a simple cost savings analysis. The intent was not to evaluate any cost shifting. He further reminded the Board that the original intent of the MHQAC was not to save money, but instead to place several edits in place to promote educational initiatives. Mr. Sharp stated that he would take the Board s concerns to MHQAC before they consider additional edits. Dr. Wernert questioned whether to pursue other polypharmacy edits since (according to the analysis) these edits did not accomplish what the Board had anticipated. Mr. Sharp responded that the two edits approved by the Board in November are appropriate. He then stated that due to the price increases for atypical antipsychotics, the savings are blunted for the three or more antipsychotics edit. Based on a separate analysis, the State has noted that the price for single brand name drugs increased from 25% to 55% over the past three years. If the price continues to increase at that rate, the State will not be able to show any savings on these types of edits. Dr. Summers commented that before evaluating cost the Board should consider whether the edits had an impact on quality of care. MDwise: Chris Johnson, Director of Pharmacy, presented the analysis for MDwise. He noted that this report evaluates pharmacy claims from Dr. Johnson stated that MDwise evaluated the impact of the MHQAC edits on the overall program. He noted that for the first three quarters of 2006, the amount paid per member per month ($PMPM) trended downward, but during the fourth quarter, the $PMPM increased due to changes in the preferred drug list and the removal of restrictions on behavioral health medications. The $PMPM related to atypical antipsychotic agents is shown to have increased by approximately 13% between 2006 and The average paid amount per claim The preparation of this document was financed under an agreement with Indiana OMPP. Page 106

107 throughout all delivery systems in the MDwise plan for atypical antipsychotic medications increased from $ in January 2007 to $ in November The $PMPM for SSRI agents decreased by approximately $.33, or $1.1million annually throughout the MDwise plan. The $PMPM for SNRI agents increased by approximately $.10, or $330,000 annually. The $PMPM for benzodiazepines decreased by $.025, or $80,000 annually. The hypnotic agents claims PMPM and $PMPM remained relatively flat for the first three quarters of After the removal of restrictions in the fourth quarter of 2006, there was a gradual increase in claims numbers PMPM and $PMPM. He noted that the implementation of polypharamcy edits were not as significant as utilization edits. Board Discussion: Dr. Summers questioned the analysis as to why MDwise chose to use PMPM as a denominator as opposed to PUPM. He stated that the evaluation of savings is not meaningful unless the data is evaluated for cost shifting. He acknowledged the difficulty of interpreting this data. Dr. Lindstrom stated that since MCOs are a fully capitated system as opposed to the fee-for-service program, the negative impact of the edits on MCO members would be the responsibility of the MCOs. Anthem: Jeannine Murray presented the analysis of the MHQAC polypharmacy and utilization edits. She mentioned that Anthem is the smallest plan of the three managed care organizations. Anthem did not have 2006 pharmacy claims data for comparative analysis. She stated that the majority of recipient claims were rejected due to one of the following edits: three or more antidepressants, three or more benzodiazepines, or three or more atypical antipsychotics. The savings from the polypharmacy edits was calculated to be $38, She elaborated that the savings from the utilization edits was more significant compared to polypharmacy edits. Ms. Murray mentioned that the PUPM for the antipsychotics was among the highest, which was primarily driven by the cost of these agents. Risperdal was the most prescribed medication in the Anthem plan. Since the availability of the generic SSRI options, the count of prescriptions for Cymbalta and Lexapro has increased as has the total cost of the antidepressants. Board Discussion: None Managed Health Services (MHS): Dan Baker presented the MHQAC polypharmacy and utilization edits analysis. He mentioned that the polypharmacy edits were implemented late due to changes in staffing at Managed Health Services. After the implementation of the edits in September, there was a decrease of 75 unique members for the six categories of the polypharmacy edits. The three or more antidepressant category edit had the greatest number of unique recipients as well as the greatest decline due to the edits in the fourth quarter of The estimated savings for the six polypharmacy edits for fourth quarter 2007 was over $793,000. The antidepressant class of medications generated the most savings. Mr. Baker stated that the savings for the utilization edits was calculated to be $1.5 million for the period spanning June through December. The preparation of this document was financed under an agreement with Indiana OMPP. Page 107

108 Board Discussion: Dr. Summers commented that MHS was looking at cost avoidance. It was not clear if a conclusion could be drawn based on the analysis presented. Dr. Wernert asked the Board if it wanted to draw any conclusions for the MHQAC. Dr. Lindstrom asked if polypharmacy and utilization edits had any negative or positive impact on the quality of care. Dr. Wernert mentioned that if MHQAC were to proceed with future edits, he would prefer that MHQAC evaluate potential savings of interventions. Dr. Summers reiterated his point about whether there was enough information available to understand the impact of these edits on quality of care. He asked if there was a way to know the number of utilizers before and after the edits were implemented. Mr. Sharp informed the Board that OMPP is currently developing a report that will show the number of utilizers before and after edits are implemented. Mr. Sharp also mentioned that the MHQAC is also having difficulty determining how to measure quality of care. Mr. Sharp requested input from the board as related to the definition of quality and how to measure it. MANAGED CARE ORGANIZATION UPDATE: None NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED. ************************************************************************ In Attendance: Patricia Treadwell. M.D., Chairman Philip Eskew, Jr., M.D. Kent Summers, R.Ph., Ph.D. Steven Bodenberg, R.Ph. Brian Musial, R.Ph. William J. Brown, MS, RPh., BCPS Also Present: Marc Shirley, R.Ph.--OMPP Kristin Johnson -- OMPP February 22, 2008 The preparation of this document was financed under an agreement with Indiana OMPP. Page 108

109 Chris Johnson, Pharm.D.--MDwise Jeannine M. Murray, R.Ph.--Anthem Dan Baker, R.Ph.--MHS Pinkesh Patel, Pharm.D.--ACS MEETING CALLED TO ORDER: Dr. Patricia Treadwell called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Treadwell asked for approval of the minutes from the February meeting. Her request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: None OPENING COMMENTS: Mr. Marc Shirley informed the Board that due to weather conditions the T-Committee meeting was rescheduled, and hence, the recommendations from the T-Committee would be presented during the March meeting. The Office is also working on the DUR Board meeting schedule for the 2009 calendar. The schedule will be posted on the website soon. Mr. Shirley thanked Karen Clifton for her efforts in supporting the Board. Dr. Treadwell also thanked Ms. Clifton for her efforts in providing garage parking for the Board members. ACS UPDATE: Dr. Pinkesh Patel presented the prior authorization (PA) statistics for the month of January He mentioned that four new therapeutic classes were added on January 1, 2008, namely ulcerative colitis agents, chronic constipation agents, narcotic antitussives and antihistamine combinations, and topical immunomodulators. He also informed the Board of the recall of Duragesic 25μg. Since brand Duragesic is preferred, prior authorization requirements were lifted on generic fentanyl 25 μg until further notice. MANAGED CARE ORGANIZATIONS UPDATE: Proposed PDL Changes MDwise: Chris Johnson, Director of Pharmacy, summarized the changes for the month of February for the MDwise PDL that was previously sent to the Board. He requested that Actoplus met, Symbicort, Isentress, and Abreva be added to the PDL with no clinical edits. He also proposed to add the following agents to the PDL with clinical edits: Zomig and Zomig-ZMT with quantity limits of 9 tablets per month; Zomig Nasal Spray with a quantity limit of 6 nasal sprays per month; Azor requiring a trial of an ACEI in the past 60 days; Nicotine lozenges not allowed with Chantix; Rebif and Copaxone moved to preferred status; Suboxone added to preferred status for the treatment of opiate dependence/addiction for three months and can be approved for an additional three months; Subutex added to preferred status for the treatment of opiate dependence/addiction for four weeks. He also proposed changes or the addition of clinical edits to the following agents: Accutane with removal of a step edit; Singulair requires concurrent therapy with an inhaled corticosteroid for age 11 and under, for children age 12 it requires concurrent therapy of both an inhaled The preparation of this document was financed under an agreement with Indiana OMPP. Page 109

110 corticosteroid and a long-acting beta adrenergic agent; Accolate requires concurrent therapy with an inhaled corticosteroid for age 11 and under, for children age 12 and above it requires concurrent therapy of both an inhaled corticosteroid and a long-acting beta adrenergic agent; Relpax has a quantity limit of nine tablets per month; Nicotine Gum and Patches will not allow concurrent therapy with Chantix; Prevacid Solutabs require step therapy of 21 days of therapy with a first line agent in the last 30 days; ondansetron oral solution with a quantity limit of 150mls per month; acyclovir cream with a step edit, requires trial of Abreva for herpes labialis; acyclovir ointment with a step therapy requires a trial of oral acyclovir or Valtrex for genital herpes; Chantix with a quantity limit of 24 weeks and no concurrent therapy with nicotine replacement products. He also requested that Avonex and Intron A be removed from the preferred drug list (PDL). Board Discussion: Dr. Summers asked why MDwise proposed all of these changes to the preferred drug list. He also questioned if the changes were comparable to those of the other MCOs. Mr. Shirley noted that during the April meeting the Board will have the opportunity to compare the preferred drug lists of all MCOs. Dr. Treadwell requested a motion to accept the changes, and it was moved and seconded. The motion passed unanimously. Proposed PDL Changes Anthem: Jeannine Murray summarized the changes for the month of February for the Anthem PDL that was previously sent to the Board. She requested that clinical edits be added to the existing preferred drug list product, Procrit. She stated that approval of Procrit will require a hemoglobin level not to exceed 12g/dL and that the patient has adequate iron stores (including transferring saturation and ferritin). She also requested to change Loestrin 24 Fe, Ortho Tri-Cylen Lo, Myfortic and all cough and cold preparations containing methscopolamine and pyrilamine products such as AH Chew, Dehistine, Drishit, Duradryl, Duratann, Extendryl, Histatab, Histavent, K-tan, Pryilafen, Redur PCM and Ry-t-12 to non-preferred status. Dr. Treadwell requested a motion to accept the requested changes, and it was moved and seconded. The motion passed unanimously. NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED. The preparation of this document was financed under an agreement with Indiana OMPP. Page 110

111 March 14, 2008 In Attendance: Patricia Treadwell, M.D., Chairman Brian Musial, R.Ph., Vice Chair Philip Eskew, Jr., M.D. Terry D. Lindstrom, Ph.D. Rhonda Eldridge, R.Ph. Jeff Brown, R.Ph., MS, BCPS Kent Summers, R.Ph., Ph.D. Steven Bodenberg, R.Ph. John Wernert, M.D. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Jeannine M. Murray, R.Ph. Anthem Katasha Butler, Pharm.D. MHS Pinkesh Patel, Pharm.D. ACS MEETING CALLED TO ORDER: Dr. Patricia Treadwell called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Treadwell asked for approval of the minutes from the February meeting. Her request was moved, seconded and carried with a unanimous vote. REMARKS FROM THE CHAIR: None OPENING COMMENTS: Mr. Marc Shirley reminded the Board members that there should be no discussion in today s session of confidential or proprietary information having to do with supplemental rebate offers. THERAPEUTICS COMMITTEE LIAISON REPORT: Dr. Pinkesh Patel presented the Therapeutics Committee s recommendation from the February 29 th meeting. He stated that as always the three primary drivers behind those recommendations were clinical implications, drug costs, and total program costs. The T-Committee reviewed seven therapeutic classes and offered the recommendations listed below. The preparation of this document was financed under an agreement with Indiana OMPP. Page 111

112 1. Respiratory Agents Beta-Agonists o Move Perforomist inhalation solution to non-preferred status Leukotriene Inhibitors o Maintain the status of Zyflo CR as non-preferred Nasal Preparations No changes recommended Oral Inhaled Corticosteroids No changes recommended Non-sedating Antihistamines o Move all federal legend Zyrtec products, Clarinex and Clarinex-D products, and Xyzal tablets to non-preferred status o Remove step edits, age restrictions, and quantity limits for all products o Add OTC cetirizine and OTC Zyrtec regular tablets and syrup to preferred status Beta Adrenergics and Corticosteroids No changes recommended COPD Agents Move ipratropium/albuterol solution to non-preferred status Public Comment: None Board Discussion: Dr. John Wernert inquired about the number of patients that would be affected by the Zyrtec OTC switch. Dr. Kent Summers asked if the Zyrtec OTC switch was consistent with what the Managed Care Organizations (MCOs) were doing. Board Action: It was moved and seconded that the recommendations for the respiratory agents be approved. The motion passed unanimously. 2. Anti-infective Agents Anti-herpetic Agents o Move famciclovir tablets to non-preferred status Anti-influenza Agents o Maintain the status of Tamiflu 30 mg and 45 mg capsules as non-preferred First Generation Cephalosporins No changes recommended Third Generation Cephalosporins No changes recommended Fluoroquinolones No changes recommended Hepatitis C Agents No changes recommended Macrolides o Maintain the status of clarithromycin oral suspension as preferred Ketolides No changes recommended Otic Antibiotics o Maintain the status of ofloxacin otic solution as preferred Ophthalmic Antibiotics o Move Azasite to non-preferred Systemic Antifungals o Maintain the status of terbinafine tablets as preferred The preparation of this document was financed under an agreement with Indiana OMPP. Page 112

113 Vaginal Antimicrobials No changes recommended Topical Antifungals o Maintain the status of ciclopirox topical solution as preferred o Move Extina topical foam to non-preferred status Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for the antiinfective agents be approved. The motion passed unanimously. 3. Cardiovascular Agents ACE Inhibitors o Maintain the status of Altace tablets as non-preferred ACE Inhibitors with CCBs No changes recommended ACE Inhibitors with Diuretics No changes recommended Angiotensin Receptor Blockers (ARBs) No changes recommended ARBs with CCBs o Move Azor and Exforge to non-preferred status ARBs with Diuretics o Maintain the status of Hyzaar as preferred, but add the step edit prior use of ACE-I. Patients currently on Hyzaar will be grandfathered if they have a paid claim within the past 180 days Beta Blockers o Maintain the status of carvedilol tablets as preferred Calcium Channel Blockers (CCBs) o Maintain the status of verapamil ER PM capsules as preferred o Move Verelan PM capsules to non-preferred status CCB with Statin No changes recommended Direct Renin Inhibitors o Move Tekturna to non-preferred status. Selective Aldosterone Receptor Antagonists No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for the cardiovascular agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 113

114 4. Lipotropics Bile Acid Sequestrants No changes recommended Fibric Acid Derivatives o Move Lipofen to non-preferred status HMG CoA Reductase Inhibitors o Maintain the status of pravastatin 80mg tablets as preferred Other Lipotropics No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for the lipotropics agents be approved. The motion passed unanimously. 5. Triptans No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for the triptans agents be approved. The motion passed unanimously. 6. Electrolyte Depleters o Move Calphron to non-preferred status Public Comment: None Board Discussion: None Board Action: I t was moved and seconded that the recommendations for the electrolyte depleters agents be approved. The motion passed unanimously. 7. Multiple Sclerosis Agents No changes recommended Public Comment: None Board Discussion: None The preparation of this document was financed under an agreement with Indiana OMPP. Page 114

115 Board Action: It was moved and seconded that the recommendations for the multiple sclerosis agents be approved. The motion passed unanimously. ACS UPDATE: Dr. Patel presented the prior authorization (PA) statistics for the month of February Board Action: It was moved and seconded that the recommendations for the cardiovascular agents be approved. The motion passed unanimously. Dr. Patel also presented a newsletter that was sent to the Board members in advance. Dr. Patel informed the Board that he did not have a RetroDUR topic to present at this time but would present one next month. Board Discussion: None MANAGED CARE ORGANIZATION UPDATE: None NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: Mr. John Valenta from Novartis Pharmaceuticals addressed the Board on Exforge and Tekturna. He stated that Exforge is a combination of Diovan and Norvasc. He requested to have a step edit of a generic ACE or of a formulary ARB be placed on Exforge. He requested that Exforge be added to the preferred drug list. He also informed the Board about Tekturna, a first in its class of direct renin inhibitors. He requested a step edit for Tekturna and that Tekturna be added to the preferred drug list. OLD BUSINESS: None NEW BUSINESS: Mr. Steven Bodenberg was appointed as a liaison to the Board of Pharmacy. MEETING ADJOURNED ************************************************************************ The preparation of this document was financed under an agreement with Indiana OMPP. Page 115

116 In Attendance: Patricia Treadwell, M.D., Chair Philip Eskew, Jr., M.D. Terry D. Lindstrom, Ph.D. Jeff Brown, R.Ph., MS, BCPS Steven Bodenberg, R.Ph. John Wernert, M.D. April 18, 2008 Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Jeannine M. Murray, R.Ph. Anthem Chris Johnson, Pharm.D. MDwise Pinkesh Patel, Pharm.D. ACS MEETING CALLED TO ORDER: Dr. Patricia Treadwell called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Treadwell asked for approval of the minutes from the March meeting. Her request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: Dr. Treadwell announced that Board member Rhonda Eldridge had resigned. Next, she requested that Board members be present during the April Board meeting if at all possible, in order to ensure a quorum. OPENING COMMENTS: Mr. Marc Shirley reminded Board members that ACS will present the FFY 2007 DUR Annual Report at the May meeting. ACS UPDATE: Dr. Pinkesh Patel presented the prior authorization (PA) statistics for the month of March He informed the Board of three new mental health edits implemented on March 3. T hey include two or more SSRIs / SNRIs, two or more hypnotics, and low dose Seroquel. Board Discussion: None The preparation of this document was financed under an agreement with Indiana OMPP. Page 116

117 MANAGED CARE ORGANIZATION UPDATE: Annual Review of MCOs Prescription Drug Programs: Mike Sharp of the Office of Medicaid Policy and Planning stated that the Board members had all received an electronic copy of annual report, which is required by Senate Enrolled Act 228. He noted that members of the managed care organizations were available to answer questions related to the report. Board Discussion: Dr. Terry Lindstrom inquired as to the status of Crestor and Lipitor was on the MCOs formularies. Ms. Jeannine Murray from Anthem responded that either Crestor or Lipitor were available after therapeutic failure of simvastatin. Dr. Eskew inquired whether cefdinir was on the preferred drug list for any of the MCOs plans. Mr. Chris Johnson, from MDwise, mentioned that cefdinir requires step therapy to amoxicillin or any other forms of penicillin. Board Action: Dr. Eskew moved for approval of the report. The motion was seconded and was approved unanimously. Proposed PDL Changes MDwise: Chris Johnson, Director of Pharmacy, summarized the changes for the month of March for the MDwise PDL that had previously been sent to the Board. He requested that the cetirizine (tablets, liquid and chewables), Mirapex, terbinafine, Elmiron, Estrace vaginal cream, Vagifem vaginal tablets, and Intelence be added to the PDL with no clinical edits. He also proposed to add the following agents to the PDL with clinical edits: Pulmicort Respules with an age restriction of four years of age and under and a quantity limit of 0.25mg once per day or 0.5mg and 1mg ampules twice per day; fexofendaine products (except ODT) with a step edit two weeks trial of both loratadine and cetirizine products; fluconazole products with quantity limits added on 50mg and 100 mg tablets one per day, 200mg tablet 2 per day, 150mg tablet two per month, 10mg/ml and 40mg/ml suspension 35ml per month. Proposed PDL Changes--- Anthem: Jeannine Murray summarized the changes for the month of March for the Anthem PDL. She requested that clinical edits be added to alendronate and Byetta. She also requested that Actonel, Actonel Plus D, Fosamax, and Fosamax D, Nasonex, Canasa, and Remicade be switched to non-preferred status. NEW DRUGS: None LIAISONS WITH OTHER BOARDS: None PUBLIC COMMENT: None OLD BUSINESS: The Board voted on the re-appointment of five of the T-Committee members, including Dr. Harry Clifton Knight Jr., Dr. James T. Poulos, Dr. Michael C. Sha, Dr. C. Andrew Class, and Dr. Bill Malloy. It was moved, seconded, and carried with an unanimous vote. The preparation of this document was financed under an agreement with Indiana OMPP. Page 117

118 NEW BUSINESS: None MEETING ADJOURNED. ************************************************************************ May 23, 2008 In Attendance: Brain Musial, R.Ph., Vice Chair Philip Eskew, Jr., M.D. Terry D. Lindstrom, Ph.D. Jeff Brown, R.Ph., MS, BCPS Steven Bodenberg, R.Ph. John Wernert, M.D Kent Summers, R.Ph., Ph.D. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Medina Lee, R.Ph.--OMPP Katasha Butler, Pharm.D.--MHS Jeannine M. Murray, R.Ph.--Anthem Chris Johnson, R.Ph.--MDwise Pinkesh Patel, Pharm.D.--ACS Randall Renshaw, Pharm.D.--ACS MEETING CALLED TO ORDER: Brian Musial called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone APPROVAL OF MINUTES: Mr. Musial asked for approval of the minutes from the April 18 th meeting. It was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: None OPENING COMMENTS: None THERAPEUTICS COMMITTEE LIAISON REPORT: Dr Patel presented the Therapeutic Committee s recommendation from their May 2 nd meeting. He stated that, as always, the three primary drivers behind those recommendations were clinical implications, drug costs and total program costs. The committee reviewed seven therapeutic classes and offered the recommendations listed below. The Board discussed and acted on each class individually. The preparation of this document was financed under an agreement with Indiana OMPP. Page 118

119 1. CNS & Others Antiemetics o Move Emend 115mg vial to non-preferred status o Move granisetron 1mg tablets and 1mg/mL and 4mg/4mL injections to nonpreferred status o Move Granisol 10mg/2mL oral solution to non-preferred status Brand Name Narcotics o Maintain Fentora 300mcg buccal tablets as non-preferred with current PA criteria o Maintain Oxycontin 15mg, 30mg, and 60 mg tablets as preferred with the following quantity limits: 120 tablets per 25 days for the 15mg and 30mg tablets, and 60 tablets per 25 days for the 60mg tablets o Move oxycodone/ibuprofen 5/400mg to non-preferred status o Maintain all strengths of Opana ER as non-preferred Narcotic Antitussive/1st generation Antihistamine Combinations o Move Tussicaps 5mg/4mg and 10mg/8mg extended-release capsules to nonpreferred status with the quantity limit 2 caps per day and the age limit 6 years and older o Maintain Tussionex as preferred with quantity limit 4oz per prescription, add the age limit 6 years and older COX-2 Inhibitors No changes were recommended NSAID/PPI Combination No changes were recommended Skeletal Muscle Relaxants No Changes were recommended Smoking Deterrent Agents Remove Nicorette DS from the PDL document Public Comment: None Board Discussion: Dr. Wernert commented on the significance of the 25-day limit for Oxycontin. Board Action: It was moved and seconded that the recommendations for CNS & Others be approved. The motion passed unanimously. 2. Dermatologic Agents Acne Agents o Move Atralin 0.05% gel to non-preferred status o Maintain Duac CS convenience kit as preferred for patients 25 years of age and under o Maintain Duac CS convenience kit as non-preferred for patients over 25 years of age Antipsoriatics o Move Humira and Remicade to PDL neutral reviewed status Public Comment: None The preparation of this document was financed under an agreement with Indiana OMPP. Page 119

120 Board Discussion: None Board Action: It was moved and seconded that the recommendations for Dermatologic Agents be approved. The motion passed unanimously. 3. Endocrine Agents Antidiabetic Agents o Remove Exubera from the PDL document Bone Resporption Suppression Agents No changes were recommended Glitazones No changes were recommended Forteo No changes were recommended Bone Resorption Suppression Agents o Maintain the preferred status of alendronate o Remove the step edits for Fosamax and Fosamax Plus D and move Fosamax and Fosamax Plus D to non-preferred status o Maintain the current status of Boniva tablets, but remove the step edit patients must have been on Actonel or Fosamax within the past 180 days Insulin and the injectable Hypoglycemics o Maintain Symlin pens as preferred, but modify the step edit for Symlin vials and pens to the following must currently be on mealtime insulin (Apidra, Humalog, Humulin R, Novolin R, Novolog or Relion R) Growth Hormones o Maintain Nutropin AQ 20mg/2mL and Omnitrope 5mg/1.5mL cartridges as preferred with current PA criteria Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for Endocrine Agents be approved. There was one abstention. 4. Gastrointestinal Agents Proton Pump Inhibitor o Add OTC omeprazole 20 mg tablets to the OTC formulary and to preferred status o Change the language at the beginning of the Proton Pump Inhibitors section of the PDL to the following: New patients must first try omeprazole (Rx or OTC) or Prilosec OTC within 90 days before receiving Protonix. In addition, a new patient must first try omeprazole (Rx or OTC) or Prilosec OTC, and then a preferred PPI for a total length of therapy of four weeks, unless patient is intolerant to these agents, before receiving a non-preferred The preparation of this document was financed under an agreement with Indiana OMPP. Page 120

121 PPI. All patients with an existing PPI prior authorization are not subject to the step edit. o Change the step edit for all non-preferred agents to the following: "must fail omeprazole (Rx or OTC) or Prilosec OTC, and then a preferred PPI for a total length of therapy of four weeks unless patient is intolerant to these agents o Move pantoprazole tablets to non-preferred status with the step edit must fail omeprazole (Rx or OTC) or Prilosec OTC, then a preferred PPI for a total length of therapy of four weeks, unless patient is intolerant to these agents o Move Protonix Delayed Release oral suspension to non-preferred status with the step edit must fail omeprazole (Rx or OTC) or Prilosec OTC, then a preferred PPI for a total length of therapy of four weeks, unless patient is intolerant to these agents o Maintain Protonix (tablets and vials) as preferred with the step edit must fail omeprazole (Rx or OTC) or Prilosec OTC, within past 90 days and the quantity limit 1 tab/day H2 Blockers No changes were recommended H. pylori Agents No changes were recommended Ulcerative Colitis Agents o Move balsalazide to non-preferred status o Maintain the current status of the other agents Public Comment: None Board Discussion: Dr. Eskew noted that he liked the language for the PPIs the trial of four weeks, unless patient is intolerant. Board Action: It was moved and seconded that the recommendations for Gastrointestinal Agents be approved. The motion passed unanimously. 5. Genitourinary Agents Agents to treat BPH - No changes were recommended Urinary Tract Antispasmodics (UTAs) o Maintain Sanctura XR as non-preferred o Maintain Enablex as preferred but modify the step edit to must fail oxybutynin IR or prior trial of any cholinesterase inhibitor or memantine (Namenda ) within the past 180 days Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for Genitourinary Agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 121

122 6. Hematologic Agents Hematinics No changes were recommended Heparin and related products No changes were recommended Leukocyte Stimulants No changes were recommended Platelet Aggregation Inhibitors o Maintain Plavix 300mg as preferred, add a quantity limit of 1 tablet per prescription Public Comment: None Board Discussion: Dr. Wernert asked why the quantity limit for Plavix was 300mg. Mr. Musial said the T-Committee made the decision for safety reasons. Dr. Wernert also asked whether all leukocyte stimulants were non-preferred. Also, Dr. Eskew requested that the information regarding Plavix be added to the upcoming newsletter. Board Action: It was moved and seconded that the recommendations for Hematologic Agents be approved. The motion passed unanimously. 7. Ophthalmic Agents Eye Antihistamines, Mast Cell stabilizers No changes recommended Glaucoma Agents o Move Combigan Ophthalmic solution to non-preferred status Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for Topical Agents be approved. The motion passed unanimously. 8. Topical Agents Topical Estrogen Agents No changes recommended Wound Care Products No changes recommended Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for Topical Agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 122

123 DUR ANNUAL REPORT: Randall Renshaw of ACS presented the draft FFY 2007 DUR Annual Report. Dr. Renshaw briefly addressed several attachments and tables included in the report, noting the following: Attachment 2 contains ProDUR prior authorization activity; Attachment 3 contains RetroDUR activity; Attachment 4 contains the DUR Board activities for the entire federal fiscal year; Attachment 5 contains information regarding the States generic substitution policy; and Attachment 6 is a combination of ProDUR and RetroDUR edits and associated savings from those edits. Dr. Renshaw then referred the Board to page 153 of the report, which listed the estimated savings $16.9 million. He added that the return on investment was $2.11 for every dollar spent on the DUR programs, a figure that encompasses both ProDUR and RetroDUR. Dr. Summers asked whether posting therapeutic duplication message for lipotropics was providing any efficiency or was, rather, a burden for the pharmacist. Mr. Musial requested to see a list of therapeutic duplication edits and the number of patients taking two or more statins in a given month. Dr. Wernert asked whether there was a difference in cost for regular prior authorization vs. miscellaneous prior authorization cost. Dr. Wernert also questioned the methodology for determining, and the validity of the DUR savings listed on page 157. Dr. Eskew requested that an executive summary be placed at the beginning of the document. Discussion evolved into the thought of a more comprehensive report that could potentially be provided to the legislature on behalf of the Board. Mr. Sharp informed the Board that he would provide a comprehensive update report in July that would list overall program activities and several key indicators used to measure the ability to manage the traditional medicaid pharmacy benefit efficiently. Mr. Sharp encouraged the board members to provide him input with respect to specific parameters that they would like to see included in the report. After substantial discussion regarding the cost savings and cost to administer aspects of the DUR program savings analysis, a motion was made to amend the draft DUR Annual Report with the corrections discussed at the meeting. The motion was seconded and passed. It was stated that the Board would need to see the revised report prior to the report being issued to CMS, so the revised draft will be mailed to the Board members prior to the June meeting and discussed at the meeting. ACS UPDATE: Dr. Patel presented the Prior Authorization (PA) statistics for the month of April The preparation of this document was financed under an agreement with Indiana OMPP. Page 123

124 MANAGED CARE ORGANIZATION UPDATE: Katasha Butler, Pharm. D. of MHS presented proposed PDL changes as described by the MHS document in the Board members packet. The proposed changes were moved, seconded, and approved. NEW DRUGS: None. LIAISONS WITH OTHER BOARD: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED ************************************************************************ In Attendance: Patricia Treadwell, M.D. Chair Terry D. Lindstrom, Ph.D. Steven Bodenberg, R.Ph. John Wernert, M.D Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Medina Lee, R.Ph.--OMPP Kristin L. Johnson--OMPP June 20, 2008 MEETING CALLED TO ORDER: Dr. Treadwell called the meeting to order, and noted that since there was not a quorum present, all matters before the Board that require a quorum would be postponed until the July meeting. REMARKS FROM THE CHAIR: As noted above. OPENING COMMENTS: None NEW DRUGS: None LIAISONS WITH OTHER BOARD: None PUBLIC COMMENT: None The preparation of this document was financed under an agreement with Indiana OMPP. Page 124

125 OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED ************************************************************************ July 18, 2008 In Attendance: Brain Musial, R.Ph., Vice Chair Philip Eskew, Jr., M.D. Terry D. Lindstrom, Ph.D. Jeff Brown, R.Ph., MS, BCPS Steven Bodenberg, R.Ph. Kent Summers, R.Ph., Ph.D. Also Present: Michael Sharp, R.Ph.--OMPP Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Medina Lee, R.Ph.--OMPP James Santella, RPh. --MHS Jeannine M. Murray, R.Ph.--Anthem Chris Johnson, R.Ph.--MDwise Pinkesh Patel, Pharm.D.--ACS Randall Renshaw, Pharm.D.--ACS MEETING CALLED TO ORDER: Brian Musial called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Mr. Musial asked for approval of the minutes from the May 23 rd and June 20 th meetings. It was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: None The preparation of this document was financed under an agreement with Indiana OMPP. Page 125

126 OPENING COMMENTS: Mike Sharp, Pharmacy Director for Indiana Medicaid, addressed the Board regarding the Mental Health Quality Advisory Committee (MHQAC) recommendations to add quantity limits on several newer medications. The MHQAC also recommended requiring prior authorization for the concomitant use of oral Risperdal and Invega. Mr. Sharp also informed the Board that the MHQAC will pursue an educational intervention for prescribers who have patients taking two or more atypical antipsychotics. This effort will be coordinated between the MCOs and FFS. DUR ANNUAL REPORT: Dr. Randall Renshaw of ACS presented the revised draft FFY 2007 DUR Annual Report. Dr. Renshaw addressed all the questions from the May meeting. Since there were no additional questions from the Board, Dr. Eskew moved for approval. The draft report was moved, seconded, and approved unanimously. 8th PDL REPORT: Dr. Renshaw presented the evaluation of the Indiana Medicaid Preferred Drug List (PDL) program. A report is presented to the Board biannually and this iteration is the eighth report since PDL implementation in It was stated that copies of prior reports can be retrieved from the Indiana Medicaid website. The objectives of these reports are to determine if there have been any increases in Medicaid physician, lab or hospital costs, and also evaluate the impact of the PDL program upon Medicaid patients ability to obtain their prescription medications. The latest report begins by highlighting the key findings over the past five years of evaluation. It also specifies estimated savings over the past five years, which Dr. Renshaw reported as being $61.35 million dollars. This figure includes $29.81 million savings from the federal rebate portion of the PDL program and $31.54 million from the supplemental rebate portion of the PDL program. After deduction of administrative costs, the State has saved an estimated $55.26 million over four-and-a-half years. Dr. Renshaw noted the report s observation that as has been the case with all prior reports the PDL program has not created any significant access barriers to medically necessary medications. In addition, there were no statistical differences in any of the medical costs as a total, or individual physician visits, laboratory costs, or hospital costs between patients who were affected by the PDL program versus patients who were not affected by the PDL program. He noted the continuing significant behavioral health drug expenditures. Dr. Renshaw highlighted an analysis of the period spanning October 1, 2006 to March 31, The savings from the PDL during this six-month period was approximately $5.81 million, after deducting administrative costs. He also noted that once patients switched to preferred agents, they tended to remain on preferred agents. Dr. Renshaw noted the report recommendations that (1.) as updated clinical information becomes available, criteria used in making prior authorization determinations will be reviewed to determine whether or not changes need to be made that would ensure clinically and fiscally reasonable drug therapy, and (2.) there would be continuing monitoring and analysis of new medications and therapeutic classes in order to determine whether or not PDL review is necessary. The preparation of this document was financed under an agreement with Indiana OMPP. Page 126

127 Board Action: It was moved and seconded to approve the eighth PDL Report, with changes as noted. The motion passed unanimously. ACS UPDATE: Dr. Pinkesh Patel of ACS presented the Prior Authorization (PA) statistics for the month of May and June He also presented a newsletter which was provided to the Board in advance. The proposed newsletter was moved, seconded, and approved unanimously. MANAGED CARE ORGANIZATION UPDATE: Proposed PDL Changed Managed Health Services: James J. Santella Jr. presented proposed PDL changes as described by the MHS document in the Board members packet. The proposed changes were moved, seconded, and approved. Proposed PDL Changes MDWise: Chris Johnson presented proposed PDL changes as described by the MDwise document in the Board members packet. The proposed changes were moved, seconded, and approved. Proposed PDL Changes Anthem: Jeannine Murray presented proposed PDL changes as described by the Anthem document in the Board members packet. The proposed changes were moved, seconded, and approved. DRUG INTERACTION SOFTWARE: Val Berger, pharmacist with EDS, provided information requested by the Board at their May meeting, regarding drug-drug interactions. He explained the different severity levels of drug interactions. He also informed that the severity levels are updated as new clinical information becomes available. NEW DRUGS: None LIAISONS WITH OTHER BOARD: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED The preparation of this document was financed under an agreement with Indiana OMPP. Page 127

128 In Attendance: Patricia Treadwell, M.D. Chair Brain Musial, R.Ph. Vice Chair Terry D. Lindstrom, Ph.D. Jeff Brown, R.Ph., MS, BCPS Kent Summers, R.Ph., Ph.D. John Wernert, M.D. Also Present: Marc Shirley, R.Ph.--OMPP Kristin L. Johnson--OMPP Medina Lee, R.Ph.--OMPP Jeannine M. Murray, R.Ph.--Anthem Katasha Butler, R.Ph.--MHS Chris Johnson, R.Ph.--MDwise Pinkesh Patel, Pharm.D.--ACS August 22, 2008 MEETING CALLED TO ORDER: Dr. Patricia Treadwell called the meeting of the Indiana Medicaid DUR Board to order and welcomed everyone. APPROVAL OF MINUTES: Dr. Treadwell asked for approval of the minutes from the July meetings. Her request was moved, seconded, and carried with a unanimous vote. REMARKS FROM THE CHAIR: None OPENING COMMENTS: Mr. Marc Shirley reminded the Board members to please notify the Board chair via , with a cc: to himself and Board secretary Karen Clifton, as soon as possible if the member determines that he or she will not be able to attend a scheduled Board meeting. THERAPEUTICS COMMITTEE MEETINGS/PDL REVIEW: Dr. Pinkesh Patel of ACS presented the Therapeutics Committee s recommendation from their August 1 meetings. He stated that as always the three primary drivers behind those recommendations were clinical implications, drug costs, and total program costs. The Therapeutics Committee reviewed seven therapeutic classes and the FFS Indiana Medicaid OTC Drug Formulary and offered the recommendations listed below. The Board discussed and acted on each class individually. The preparation of this document was financed under an agreement with Indiana OMPP. Page 128

129 1. Respiratory Agents β-agonist o Move Foradil to preferred status Leukotriene Inhibitors o Maintain the preferred status of Singulair, but change step edit to adults 12 years of age and older must have had one of the following medications within the past six months: methylxanthine, beta agonist and/or oral inhaled corticosteroid Nasal Preparation o Add Patanase to preferred status o Add Omnaris to non-preferred status o Move Allegra suspension to non-preferred status; maintain the non-preferred status of both Allegra orally disintegrating tablets and Xyzal oral solution; add the following step edit for all non-preferred agents: New patients must first try cetirizine and loratadine within 90 days prior to receiving a nonpreferred agent ; add the quantity limit 10 mls/day for all oral liquids Beta Adrenergic and Corticosteroid Combinations No changes recommended Oral Corticosteroids o Move Pulmicort Flexhaler to non-preferred status for all patients o Maintain current status and age limits for Pulmicort Respules, but add the following quantity limits for the vials: 240 mls/month (0.25 mg/2 ml vial); 120 mls/month (0.5 mg/2 ml vial); 60 mls/month (1 mg/2 ml vial) Agents to Treat COPD o Maintain the preferred status of Combivent, but add the quantity limit 2 inhalers/month Public Comment: Dr. Chris Arsever of Merck provided information regarding Singulair as being an alternative to inhaled corticosteroid for mild persistent asthma. Board Discussion: Dr. Kent Summers requested all three MCOs to inform how Singulair is being handled in their respective plans. The pharmacy directors presented their respective policies regarding Singulair. Board Action: It was moved and seconded that the recommendations for respiratory agents be approved. The motion passed unanimously. 2. Anti-Infective Agents Antiviral (Anti-Herpetic) Agents No changes recommended Antiviral (Anti-Influenza Agents) No changes recommended Cephalosporin (1st and 3rd generations) o Move cefdinir to non-preferred status o Move Omnicef to preferred status The preparation of this document was financed under an agreement with Indiana OMPP. Page 129

130 Macrolides No changes recommended Fluoroquinolones No changes recommended Ketolides No changes recommended Topical Antifungals o Maintain the preferred status of ciclopirox 0.77% topical gel Systemic Antifungals o Maintain the non-preferred status of Lamisil 125- and mg oral granules Ophthalmic Antibiotics o Move Zymar to preferred status with the age limit 30 years of age or older ; add the following step edit for both Vigamox and Zymar : patients under 30 years of age must first have a trial on at least one preferred agent within the past 30 days Otic Antibiotics o Move ofloxacin otic solution to non-preferred status Vaginal Anti-Microbial o Move Metrogel to non-preferred status Hepatitis C Agents o Maintain new ribavirin 400- and 600-mg strength tablets as preferred Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for anti-infective agents be approved. The motion passed unanimously. 3. Cardiovascular Agents ACE Inhibitors o Maintain ramipril capsules as preferred ACE / Calcium Channel Blockers o Move amlodipine/benazepril and Tarka to non-preferred status; all patients who have received amlodipine/benazepril or Tarka within the past 90 days will be grandfathered; maintain the quantity limit 30 capsules/month for both brand and generic Lotrel ACE Inhibitors with diuretics No changes recommended Angiotensin II Receptor Blockers (ARBs) No changes recommended ARBs with diuretics No changes recommended ARBs with CCBs o Move Exforge to preferred status α - β blockers, β-blockers o Add Bystolic to non-preferred status o Move Coreg IR, Coreg CR, and Toprol XL to non-preferred status; The preparation of this document was financed under an agreement with Indiana OMPP. Page 130

131 maintain current quantity limits for Coreg IR and Coreg CR, but change the step edit for both agents from must be on an ACE or ARB to must have prior trial on carvedilol; must be on an ACE or ARB Calcium Channel Blockers (CCBs) o Maintain the non-preferred status of the following new strengths of Sular : 8.5-, 17-, 25.5-, and 34-mg tablets CCBs with HMG COA reductase inhibitors No changes recommended Aldosterone Receptor Blockers No changes recommended Direct Renin Inhibitor o Move Tekurna to preferred status with the step edit trial of an ACE or ARB within the past 90 days Direct Renin Inhibitor and Diuretic Combination o Add Tekurna HCT to preferred status with the step edit trial of an ACE or ARB within the past 90 days Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for cardiovascular agents be approved. The motion passed unanimously. 4. Lipotropics Agents Bile acid sequestrants No changes recommended Fibric acid derivatives No changes recommended HMG CoA reductase inhibitors o Move Crestor to non-preferred status; all patients who have received Crestor within the past 90 days will be grandfathered Other Lipotropics o Add Simcor to preferred status Public Comment: Mr. Tom McMullen of Astra Zeneca informed the Board of Crestor s unique properties, compared to other lipid lowering agents. In head-to-head comparisons, Crestor lowered LDL cholesterol more than any single compared agent with more patients achieving their in-step target goals. Board Discussion: Dr. Wernert inquired again regarding whether or not there were any brand name lipid lowering products that were preferred on the MCOs PDLs. Board Action: It was moved and seconded that the recommendations for lipotropics agents be approved. The motion passed unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 131

132 5. Triptans Triptans o Add Treximet to preferred status with the quantity limit 1 box of 9 tabs per month Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for triptans be approved. The motion passed unanimously. 6. Electrolyte depleter Agents Electrolyte Depleter Agents o Move Renvela to PDL neutral reviewed status Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for electrolyte depleter agents be approved. The motion passed unanimously. 7. Multiple Sclerosis Agents Multiple Sclerosis Agents o Maintain Copaxone as preferred, but add quantity limit 1 kit per month o Maintain Avonex as preferred, but add quantity limit 4 vials or syringes per month Public Comment: None Board Discussion: None Board Action: It was moved and seconded that the recommendations for multiple sclerosis agents be approved. The motion passed unanimously. Dr. Lindstrom requested that the future T-Committee recommendations have a rationale listed for the changes to the PDL, similar to MCO requests for PDL changes. Dr. Wernert echoed a similar message, stating that it would make it easier to review the T- Committee s recommendations. Dr. Wernert made a motion to request the Therapeutics Committee to provide the rationale for their decisions. Dr. Lindstrom seconded the motion and it was approved unanimously. The preparation of this document was financed under an agreement with Indiana OMPP. Page 132

133 8. OTC Drug Formulary ANNUAL REVIEW OTC Medications o Remove Vitamin E 400 IU liquid/capsules from the OTC Drug Formulary; maintain Vitamin E 100 IU and 200 IU capsules on OTC formulary, but add the quantity limit 30 caps/month for both strengths Public Comment: None Board Discussion: After discussion, Dr. Wernert commented that there are cardiovascular benefits for Vitamin E 400 IU and as such it should not be removed from the OTC Drug Formulary. The Board amended the T-Committee s recommendation regarding Vitamin E 400 IU and decided to keep it on the OTC Drug Formulary, with the following quantity limit: 30 caps/month or liquid max 400 IU/day with 30 day limit. Board Action: It was moved and seconded that the recommendations be approved. The motion passed 5 to 1. MHQAC Utilization Edits: Dr. Patel presented the MHQAC recommendations which were provided to the Board in advance. It was moved and seconded to approve the recommendations. The motion passed unanimously. ACS UPDATE: Dr. Patel presented the Prior Authorization (PA) statistics for the month of July There were a total of 3,970 PAs entered in July. Proposed RetroDUR interventions: Dr. Patel presented two RetroDUR interventions, non-compliance to antidepressant medications and anticonvulsants Drug Utilization Evaluation (DUE). Dr. Wernert requested editorial changes for the anticonvulsants proposal. Dr. Summers had a question related to off label use of anticonvulsants. Board Action: The Board approved the non-compliance to antidepressant medication intervention unanimously. The Board requested to make the changes as suggested to the anticonvulsant DUE proposal. Dr. Patel informed the Board that he would make suggested changes and provide more information at the next meeting. MANAGED CARE ORGANIZATION UPDATE: Proposed PDL Changes Anthem: Ms. Jeannine Murray, Pharmacy Director for Anthem, summarized the changes for Anthem s PDL that were sent to the Board. Dr. Wernert asked for approval of the requested changes. It was moved, seconded and carried with a unanimous vote. The preparation of this document was financed under an agreement with Indiana OMPP. Page 133

134 Proposed PDL Changes MDwise: Mr. Chris Johnson of MDwise summarized the changes that were sent to the Board. Dr. Wernert asked for approval of the PDL changes. It was moved and seconded. The motion was approved 5 to 1. NEW DRUGS: None LIAISONS WITH OTHER BOARD: None PUBLIC COMMENT: None OLD BUSINESS: None NEW BUSINESS: None MEETING ADJOURNED ************************************************************************** In Attendance: Brain Musial, R.Ph. Vice Chair John Wernert, M.D. Also Present: Marc Shirley, R.Ph.--OMPP Mike Sharp, R.Ph.--OMPP Kristin L. Johnson--OMPP Jeannine M. Murray, R.Ph.--Anthem Chris Johnson, R.Ph. Mdwise September 26, 2008 MEETING CALLED TO ORDER: In absence of the Chair, Vice Chair Brian Musial called the meeting to order. Mr. Musial stated that since there was not a quorum for the meeting, the meeting would be brief. He said that, regarding Remarks from the Chair, he would offer no comments given that the Chair was not present. He then deferred to OMPP for any opening comments. OPENING COMMENTS: Marc Shirley stated that all agenda items for today s meeting that required a quorum would be carried forth to the October meeting. MEETING ADJOURNED The preparation of this document was financed under an agreement with Indiana OMPP. Page 134

135 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS January 2008, April 2008 AND July 2008 January 2008 Newsletter The preparation of this document was financed under an agreement with Indiana OMPP. Page 135

136 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) The preparation of this document was financed under an agreement with Indiana OMPP. Page 136

137 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) The preparation of this document was financed under an agreement with Indiana OMPP. Page 137

138 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) The preparation of this document was financed under an agreement with Indiana OMPP. Page 138

139 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) April 2008 Newsletter The preparation of this document was financed under an agreement with Indiana OMPP. Page 139

140 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) The preparation of this document was financed under an agreement with Indiana OMPP. Page 140

141 ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) The preparation of this document was financed under an agreement with Indiana OMPP. Page 141

142 State of Indiana Medicaid Drug Utilization Review (DUR) Programs - FFY2008 Annual CMS Report ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) July 2008 Newsletter Prepared by ACS Government Healthcare Solutions, PBM 2009 Primary author: frs The preparation of this document was financed under an agreement with Indiana OMPP. 6/3/2009 Page 142

143 State of Indiana Medicaid Drug Utilization Review (DUR) Programs - FFY2008 Annual CMS Report ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) Prepared by ACS Government Healthcare Solutions, PBM 2009 Primary author: frs The preparation of this document was financed under an agreement with Indiana OMPP. 6/3/2009 Page 143

144 State of Indiana Medicaid Drug Utilization Review (DUR) Programs - FFY2008 Annual CMS Report ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) Prepared by ACS Government Healthcare Solutions, PBM 2009 Primary author: frs The preparation of this document was financed under an agreement with Indiana OMPP. 6/3/2009 Page 144

145 State of Indiana Medicaid Drug Utilization Review (DUR) Programs - FFY2008 Annual CMS Report ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) Prepared by ACS Government Healthcare Solutions, PBM 2009 Primary author: frs The preparation of this document was financed under an agreement with Indiana OMPP. 6/3/2009 Page 145

146 State of Indiana Medicaid Drug Utilization Review (DUR) Programs - FFY2008 Annual CMS Report ATTACHMENT 4.4. DUR BOARD NEWSLETTERS (continued) Prepared by ACS Government Healthcare Solutions, PBM 2009 Primary author: frs The preparation of this document was financed under an agreement with Indiana OMPP. 6/3/2009 Page 146

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