DRAFT Minutes Indiana Medicaid DUR Board Meeting of November 19, 2010 Meeting No. 167

Transcription

1 DRAFT Minutes Indiana Medicaid DUR Board Meeting of November 19, 2010 Meeting No. 167 In attendance: Terry Lindstrom, Ph.D. Vice Chairperson Petra Fippen, R.Ph. Carol Ott, PharmD, BCPP Rhea Ellen Miller-Boley, R.Ph. Patricia Treadwell, M.D. Philip Eskew, Jr., M.D. Jeff Brown, M.S., R.Ph., BCPS Brian Musial, R.Ph. Also present: Marc Shirley, R.Ph. OMPP Emily Hancock, PharmD, MPA OMPP Medina Lee, R.Ph. OMPP Kristin Baldock OMPP Troy Reese, PharmD ACS Carla Maxwell, PharmD ACS Dan Carpenter, R.Ph. HP MEETING CALLED TO ORDER: Brian Musial, Acting Chairperson, called the meeting of the Indiana Medicaid DUR Board to order. APPROVAL OF MINUTES: A motion to approve the draft minutes from the October meeting was seconded and carried with a unanimous vote. REMARKS FROM THE CHAIR: Brian Musial announced that Dr. Lindstrom is retiring from the Board after next month s meeting and thanked him for his service. OPENING COMMENTS: Marc Shirley acknowledged Dr. Lindstrom s retirement. PREFERRED DRUG LIST REVIEW/THERAPEUTICS COMMITTEE RECOMMENDATIONS: Dr. Troy Reese, ACS, presented the Therapeutics Committee s PDL recommendations from their November 5, 2010 meetings. Dr. Reese reminded the Board that recommendations are based on appropriate clinical therapy and cost of therapies with the intent to have quality healthcare at an affordable price. The Committee reviewed ten therapeutic groups, representing 43 therapeutic classes, and offered the recommendations listed below. The Board discussed and acted on each class individually. 1. CNS and Others Antiemetics o Add Zuplenz 4 mg and 8 mg soluble film to non-preferred with the quantity limit of 10 films/rx COX-II Inhibitors No changes recommended Narcotics o Add Exalgo 8 mg, 12 mg, and 16 mg extended-release tablets to non-preferred with a quantity limit of 30 tabs/25 days. Dr. Reese stated that the T-Committee added the quantity limit. However that may pose a problem if higher doses are required. Up to 64 mg were used during studies. With the current quantity limit, patients may not be able to obtain such dosing. Dr. Reese suggested the Board consider a quantity limit of 64 mg/day. o Add Primlev 5 mg-300 mg, 7.5 mg-300 mg, and 10 mg-300 mg tablets to nonpreferred 1

2 o Add Rybix ODT 50 mg tablets to non-preferred with a quantity limit of 400 mg/day o Maintain Suboxone 2 mg-0.5 mg and 8 mg-2 mg oral film as non-preferred with current PA criteria Narcotic Antitussive/1 st Generation Antihistamine Combinations No changes recommended NSAID/PPI Combination o Add Vimovo 375 mg-20 mg and 500 mg-20 mg tablets to non-preferred with current SmartPA criteria for brand NSAIDs NSAID and Prostaglandin Combination No changes recommended Skeletal Muscle Relaxants No changes recommended Smoking Deterrent Agents No changes recommended Board Discussion: Board member Philip Eskew stated that he thought the smoking deterrent agents would be discussed. Mr. Musial explained this class was included in the CNS and Others group. And that the T-Committee accepted the ACS recommendation and did not pull it out as a separate issue. Emily Hancock, with OMPP, added that the larger issue is having a rule amendment to allow a second twelve weeks of pharmacotherapy. Currenly, the State Budget Agency is not approving new initiatives or any changes with a positive fiscal. She added that the Medicaid Director has advised that the Agency is in agreement with the second twelve weeks of pharmacotherapy, and when the State s financial condition clears, they will re-consider it. Board member Carol Ott stated that Wishard has been evaluating patients on smoking cessation products. She noted that they sometimes are not able to get the prescription filled, either because the preferred product is not available or some other unknown reason. Dr. Ott recommended that the preferred list be re-evaluated for smoking deterrent agents and determine if it is necessary. Board member Terry Lindstrom stated that, It s a policy issue that these things are preferred or available. Carol finds they re not functionally available, but from a standpoint of policy, they are available. So it s a policy issue. Dr. Eskew replied, the statistics show that if you give them the second twelve weeks of Chantix, you have a bigger impact percentage-wise. So that s the policy. Dr. Lindstrom stated that some individuals can t even get necessarily a first one. Dr. Ott added that the pharmacy may be the actual barrier. Dr. Eskew suggested that this topic be included in the next newsletter or other Medicaid publication.. Mr. Musial reviewed the current PDL status for this class noting that most oral products are covered. Dr. Ott commented that that is not what s happening at the pharmacy. For whatever reason, one particular patch will be filled and another on will not. Mr. Musial stated that could be due to manufacturer rebate. He asked Medina Lee, with OMPP, if it was possible to get a list of labelers. She replied that it is possible. Mr. Musial stated that there was a motion and a discussion. Dr. Reese asked the Board if they wanted to discuss the Exalgo recommendation he made during his presentation. He advised that with the current quantity limit of 30 tabs/25 days, patients needing more than 16 mg/day may not be able to get it. So if the limit is changed to 64 mg/day, patients will be able to mix strengths to achieve those higher doses. Board member Petra Fippen asked, In the studies, was there a percentage of patients that needed more than the maximum 16 mg per day? Dr. Reese replied that he did not have that number. Mr. Musial stated with multiple strengths, the 64 mg limit is placed on the higher strength and the others remain as 1 tab/day. That way someone s not taking eight of the 8 mg tablets to get 64 mg. Board member Jeff Brown agreed to amend his motion to 1 tablet a day for the 8 and 12 mg strengths and 64 mg/day for the 16 mg strength. Dr. Reese asked for clarification, Is that 30 tablets for 30 days or 30 tablets for 25 days? Mr. Musial confirmed 30 tabs/ 25 days. Dan Carpenter, with HP, stated that, From a processing standpoint, the 30 for 25 is a little bit of a challenge. One per day is a lot easier from a processing standpoint. Mr. Musial replied the thought process behind that was to allow a bit of a window for patients to get a refill without having to wait exactly 30 days. Board Action: Mr. Brown motioned to amend the quantity limit on Exalgo to 1 tab/day for the 8 mg and 12 mg strengths and 64 mg/day for the 16 mg strength. The motion was seconded and unanimously passed. Then the Board motioned and seconded the approval of the CNS and others class recommendations with the approved amendment. The motion passed unanimously. 2

3 2. Dermatologic Agents Acne Agents o Add the following products to preferred for those 25 years old and under and to nonpreferred for those over 25 years old: acne gel (BP), BP creamy wash, BP gel, BP lotion, BP wash, BP wash kit, Clinac BPO gel, erythromycin-benzoyl gel, clindamycin gel, clindamycin lotion, clindamycin pledgets, clindamycin solution, erythromycin gel, and erythromycin solution o Add the following products to non-preferred: adapalene cream, adapalene gel, Benprox wash, Benzac AC gel, Benzac AC wash, Benzac W wash liquid, Benzefoam, Benziq wash, BP cleanser, BP cream, BP pads, BP 10-1 wash, Brevoxyl complete pack, Brevoxyl gel, Neobenz microwash, Nuox gel, Oscion cleanser, Triaz cleanser, Triaz foaming cloths, Triaz pads, Zaclir lotion, Ovace shampoo, RE wash, Seb-prev wash, sodium sulfacetamide med pads, sulfacetamide sod top susp, Avar cleanser, Clarifoam EF, Clenia CR, Clenia wash, Plexion cleanser, Plexion cleansing cloths, Plexion SCT cream, Prascion cleanser, Prascion FC cleanser, Prascion RA cream, Rosaderm cleanser, Rosula cleanser, sodium sulfacetamide-sulfur lotion, sodium-sulf sulfur cleanser, sulfacet-sulfur susp, Benzamycin Pak gel, Clindagel, clindamycin foam, Ery pads, Evoclin, Permoderm gel, Zoderm cleanser, Zoderm cream, Zoderm gel, Rosac cleanser, Rosula pads, Claris, Akne-mycin ointment, and Veltin o Move Klaron to preferred for patients 25 years old and under, and to non-preferred for patients over 25 years old o Move Duac CS and sulfacetamide sodium lotion to non-preferred for all recipients Antipsoriatic Agents o Add calcipotriene ointment to non-preferred o Remove Amevive, Enbrel, Humira, Remicade, and Stelara from the Antipsoriatic class (now reviewed with Targeted Immunomodulators) Board Discussion: Board member Dr. Treadwell inquired if calcipotriene cream was preferred. Board member Petra Fippen replied yes. Dr. Treadwell asked why the ointment is recommended as non-preferred. Mr. Musial answered that the discussion was mostly centered on the cosmetic, greasy vs. non-greasy formulation. Kristen Baldock, with OMPP, added that there was also a significant cost difference. Board Action: It was moved and seconded that the recommendations for the dermatologic agents be approved. The motion passed unanimously. 3. Endocrine Agents Antidiabetic Agents, Oral o Maintain Actoplus Met, Actos, Avandamet, Avandia, Avandaryl, Duetact, glipizide/metformin, glyburide/metformin, Janumet, Januvia, and Onglyza as preferred, but include the step edit must fail metformin within the past 180 days o Add Actoplus Met XR 15 mg-1,000 mg and 30 mg-1,000 mg tablets to preferred with the step edit must fail metformin within the past 180 days o Maintain Glucovance and Metaglip as non-preferred, but include the step edit must fail metformin within the past 180 days o Remove step edits currently in place for Avandaryl, Duetact, glipizide/metformin, glyburide/metformin, Glucovance, and Metaglip o Note: Patients with a paid claim within 100 days prior to effective date will be grandfathered Bone Resorption Agents o o Remove Actonel with Calcium from the PDL Add Prolia injection to non-preferred with the following criteria: must have a diagnosis of osteoporosis AND fail or be intolerant to previous osteoporosis therapy with a preferred bisphosphonate; OR must have a diagnosis of osteoporosis AND be determined to be a high risk patient as determined by the World Health Organization (WHO) Fracture Risk Assessment Model; OR if patient is unable to take oral medications, physician documentation required indicating the reason Reclast is not appropriate 3

4 Prescriber must also confirm patient is not hypocalcemic Forteo No changes recommended Growth Hormones No change recommended Injectable Hypoglycemics, Insulin o Remove Humulin 50/50 vials from the PDL Injectable Hypoglycemics, Non-insulin o Revise Byetta step edit to must have a trial of metformin within the past 180 days o Revise Victoza step edit to must have a trial of metformin within the past 180 days Board Discussion: Nina Bandali, with ACS, asked the Board to consider grandfathering for patients currently on Byetta and Victoza. Mr. Musial asked, so this is the trial of metformin so it s not a look-back on existing members? Dr. Bandali replied that is correct and that the T-Committee changed the trial but did not specify grandfathering. A motion for the amendment was made and seconded and passed unanimously. Board Action: Dr. Eskew motioned to amend grandfathering for patients currently on Byetta and Victoza. The motion was seconded and unanimously passed. Then the Board motioned and seconded the approval of the endocrine class recommendations with the approved amendment. The motion passed unanimously. 4. Gastrointestinal Agents Antiulcer Preparations No changes recommended Chronic Constipation Agents No changes recommended H. Pylori Agents No changes recommended H2 Receptor Antagonists o Move famotidine oral suspension to non-preferred Pancreatic Enzymes o Add Pancreaze to preferred Proton-Pump Inhibitors o Add omeprazole magnesium/sodium bicarbonate capsules to non-preferred with current step edit for non-preferred agents o Move Protonix tablets to non-preferred with the following step edit and quantity limit: patients using Protonix prior to effective date will be exempt from omeprazole trial; all other patients must fail omeprazole and then a preferred PPI for a total length of therapy of 4 weeks unless intolerant to these agents; limit 1 tab/day o Maintain Zegrid OTC capsules as not covered Ulcerative Colitis Agents o Move balsalazide 750 mg capsules to preferred o Move Colazal 750 mg capsules to non-preferred Board Discussion: Board member Jeff Brown spoke about the drug interaction between proton pump inhibitors and Protonix and if patients on clopidogrel can get Protonix. Mr. Musial replied that they will be able to get the brand or generic. Board member Carol Ott questioned the non-preferred status of Sanctura and Sanctura XR on the presentation slide. However, on the SmartPA rule, they are listed as preferred. Dr. Reese explained that the current SmartPA rules is based on the original proposal and that it will be updated based on any PDL recommendations approved by the Board. Board Action: It was moved and seconded that the recommendations for the gastrointestinal agents be approved. The motion passed unanimously. 5. Genitourinary Agents Agents to Treat BPH o Move Flomax 0.4 mg capsules to non-preferred o Add Jalyn 0.5 mg-0.4 mg capsules to non-preferred o Move tamsulosin 0.4 mg capsules to preferred 4

5 Urinary Tract Antispasmodics o Move Toviaz 4 mg and 8 mg tablets to preferred with SmartPA criteria o Move Sanctura 20 mg tablets to non-preferred with SmartPA criteria o Move Sanctura XR 60 mg capsules to non-preferred with SmartPA criteria o Add trospium 20 mg tablets to non-preferred with SmartPA criteria o Maintain the current status of all other agents, but add SmartPA criteria Board Discussion: Petra Fippen asked if this class would be discussed further under the SmartPA agenda. Mr. Musial replied that the Board would have a change to look at the whole criteria in terms of the SmartPA approved by the T-Committee and they could make a recommendation to approve or change. Board Action: It was moved and seconded that the recommendations for the genitourinary agents be approved. The motion passed unanimously. 6. Hematologic Agents Hematinics No changes recommended Heparin and Related Preparations o Move enoxaparin syringes to non-preferred Leukocyte (WBC) Stimulants No changes recommended Platelet Aggregation Inhibitors No changes recommended Board Discussion: None. Board Action: It was moved and seconded that the recommendations for the hematologic agents be approved. The motion passed unanimously. 7. Topical Agents Ear Preparations No changes recommended Eye Antihistamines/Mast Cell Stabilizers No changes recommended Eye Anti-inflammatory Agents No changes recommended Glaucoma Agents o Maintain Lumigan 0.01% drops as non-preferred Ophthalmic Anti-inflammatory, Immunomodulator-Type (Restasis) No changes recommended Topical Anti-inflammatory, NSAIDs o Add Pennsaid to non-preferred with step edit currently in place for Flector Patch and Voltaren Gel: MD documentation required indicating oral medications are unsuitable for patient use Topical Antiparasitics No changes recommended Topical Estrogen Agents No changes recommended Topical Immunodulators No changes recommended Topical Anti-herpetic Neuralgia Agent (Lidoderm) No changes recommended Wound Care Products No changes recommended Board Discussion: None. Board Action: It was moved and seconded that the recommendations for the topical agents be approved. The motion passed unanimously. 8. Oral Contraceptives Oral Contraceptives o Add Gianvi tablets to non-preferred o Add Natazia tablets to non-preferred 5

6 o Note: Effective January 1, 2011, the post and pay edit will be removed and a PA will be required for all non-preferred agents Board Discussion: None. Board Action: It was moved and seconded that the recommendations for the oral contraceptives be approved. The motion passed unanimously. 9. Prenatal Vitamins Prenatal Vitamins o Add Prenate softgels to non-preferred o Add PreQue tablets to non-preferred o Note: Effective January 1, 2011, the post and pay edit will be removed and a PA will be required for all non-preferred agents Board Discussion: None. Board Action: It was moved and seconded that the recommendations for the prenatal vitamins be approved. The motion passed unanimously. 10. Targeted Immunomodulators Targeted Immunomodulators o Add Amevive vials to non-preferred with SmartPA criteria; and must have tried at least 2 preferred agents o Add Cimzia kits to preferred with SmartPA criteria o Add Enbrel kits, sureclick, and syringes to preferred with SmartPA criteria o Add Humira pens, starter pack, and syringes to preferred with SmartPA criteria o Add Kineret syringes to non-preferred with SmartPA criteria; and must have tried at least 2 preferred agents o Add Remicade to non-preferred with the following criteria: physician documentation required indicating patient had tried and is intolerant to at least 1 preferred agent: or documentation required indicating preferred agents are unsuitable for patient use; or patient has diagnosis of fistulizing Crohn s disease o Add Simponi syringes to non-preferred with SmartPA criteria; and must have tried at least 2 preferred agents o Add Stelara syringes and vials to non-preferred with SmartPA criteria: and must have tried at least 2 preferred agents Board Discussion: Dr. Lindstrom asked if the Board would get to discuss the SmartPA rule separate from the PDL recommendations. Mr. Musial replied that they would. Board Action: It was moved and seconded that the recommendations for the targeted immunomodulators be approved. The motion passed unanimously. EVALUATION OF THE INDIANA MEDICAID PDL PROGRAM REPORT #13: Dr. Reese presented a summary overview of Report #13. He stated that Report #13 marks the eighth year since the inception of the PDL program and the sixth year of evaluating the clinical and fiscal impact of implementing the program for the State of Indiana. The evaluation period for this report is October 1, 2009 through March 31, He reminded the Board that OMPP took over the claims processing administration for the managed care and the Healthy Indiana Plan as of January 1, Therefore, part of the data reflects post pharmacy consolidation. Dr. Reese reviewed the objectives of the PDL report which are to evaluate the following: any increase in Medicaid physician, laboratory or hospital cost; the impact of the PDL on recipient s ability to receive medication; the number of times 6

7 prior authorization was requested and the number of times a prior authorization was approved or denied; and the cost of administering the PDL. Dr. Reese reviewed the key findings since the inception of the PDL in The estimated savings to Medicaid, after federal rebates are considered, are $32.72 million. The supplemental rebates from the seven years of operation were approximately $46.95 million. Adding these two figures, the total estimated savings are $79.67 million. The cost to administer the PDL over this time period was $9.45 million. Subtracting this from the total estimated savings results in total net estimated savings of $70.22 million to the Sate from the PDL program. Other key findings Dr. Reese presented were that once a patient was switched from a non-preferred to a preferred drug, the vast majority did not switch back to a non-preferred drug. He also noted that having a PDL did not negatively impact the recipient s ability to obtain their medication. The final key finding was that medical expenditures were not statistically significant different when comparing those that were affected by the PDL to those who were not impacted by the PDL. Dr. Reese presented an analysis of the current reporting period of October 1, 2009 to March 31, 2010, stating that the total estimated savings was $0.55 million. The associated supplemental rebates were approximately $2.80 million. Combining the two results in total estimated savings of $3.35 million. The cost to administer the PDL during the period was $675,000. Therefore, the net estimated PDL program savings for the reporting period are $2.68 million. Dr. Reese continued by stating the total drug expenditures for the fee-for-service program for the reporting period were approximately $237.6 million. He explained that the expenditures are broken down into three categories. The first is drugs that are not subjected to the PDL. This category represented 20.8% of expenditures or approximately $49.4 million. Behavioral health drugs represented 37.1% or approximately $88.1 million. Drugs subjected to the PDL, 85 classes, represented 42.1% of expenditures or $100.1 million. Dr. Reese concluded by presenting ACS recommendations for the PDL. Continue to review criteria used in prior authorization determinations to verify where such criteria could and should be made more appropriate in ensuring clinical and fiscal responsible drug therapy. Continue analysis of new medications and monitor for new therapeutic classes in order to determine whether or not PDL updating and or revisions are necessary. Continue quantity limits on drug therapy to ensure optimization of drug use. Continue step therapy to control costs shift market share and help ensure appropriate use of PDL medications. And, finally, continue to employ SmartPA rules to decrease administrative costs, improve provider relations and enhance call center efficiency. It was moved and seconded that PDL Report #13 be approved. The motion passed unanimously. SMART PA RULES PRESENTATION TARGETED IMMUNOMODULATORS: Dr. Reese stated the he was presenting the SmartPA proposal for targeted immunomodulators as approved by the T-Committee. The drugs covered under this rule are Amevive, Cimzia, Enbrel, Humira, Kineret, Simponi, and Stelara. Dr. Reese indicated that he will review each drug, giving the approved diagnoses and the approval criteria. He informed the Board that there will be a lot of repetitiveness with drugs with the same approval diagnosis. Therefore, he will go over it the first time, but will not keep repeating the same information each time. Dr. Reese went on to present the following information. Approval Diagnosis for Amevive Psoriasis (2 year historical review for submitted ICD-9) Approval Criteria for Amevive (must meet 1 of 2 criteria sets) Criteria 1 A total of 180 days or more of topical therapy in the past days with: -calcipotriene -corticosteroids, or -tazarotene AND A total of 180 days or more of systemic drug therapy in the past 210 days with: -cyclosporine, or -acitretin 7

8 Dr. Reese noted that the original proposal had an age limitation of 18 years old or older on this and all of the drugs covered under this rule. However, the T-Committee decided to eliminate this criteria. Dr. Reese also stated that he will present some information at the end of the presentation to consider adding the age restriction back in. Criteria 2 Paid drug claim for alefacept in the past days Approval Diagnoses for Cimzia Crohn s Disease/Regional Enteritis (2 year historical review for submitted ICD-9) Ulcerative Colitis (2 year historical review for submitted ICD-9) Rheumatoid Arthritis (2 year historical review for submitted ICD-9) Approval Criteria for Cimzia (must meet 1 of 4 criteria sets) Criteria 1 Diagnosis of Crohn s disease, regional enteritis, or ulcerative colitis in the past 2 years AND 90 days or more of one of the following regimens in the past 365 days: -concurrent systemic glucocorticoid AND mesalamine, -mercaptopurine, or -methotrexate Criteria 2 Diagnosis of Crohn s disease, regional enteritis, or ulcerative colitis in the past 2 years AND Paid drug claim for certolizumab in the past 45 days Criteria 3 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 4 Paid drug claim for certolizumab in the past 45 days Approval Diagnoses for Enbrel Psoriasis (2 year historical review for submitted ICD-9) Ankylosing Spondylitis (2 year historical review for submitted ICD-9) Psoriatic Arthropathy (2 year historical review for submitted ICD-9) Rheumatoid Arthritis (2 year historical review for submitted ICD-9) Juvenile Chronic Polyarthritis (2 year historical review for submitted ICD-9) Approval Criteria for Enbrel (must meet 1 of 8 criteria sets) Criteria 1 A total of 180 days or more of topical therapy in the past days with: -calcipotriene -corticosteroids, or -tazarotene AND A total of 180 days or more of systemic drug therapy in the past 210 days with: -cyclosporine, or -acitretin Criteria 2 8

9 Paid drug claim for etanercept in the past 45 days Criteria 3 Diagnosis of ankylosing spondylitits in the past 2 years Criteria 4 Diagnosis of psoriatic arthropathy in the past 2 years AND 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 5 Diagnosis of psoriatic arthropathy in the past 2 years AND Paid drug claim for etanercept in the past 45 days Criteria 6 Diagnosis of juvenile chronic polyarthritis in the past 2 years Dr. Reese reminded the Board that there was an age restriction of 2 years old or older with this criteria set, but was removed by the T-Committee. Criteria 7 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 8 Paid drug claim for etanercept in the past 45 days Approval Diagnoses for Humira Psoriasis (2 year historical review for submitted ICD-9) Ankylosing Spondylitis (2 year historical review for submitted ICD-9) Psoriatic Arthropathy (2 year historical review for submitted ICD-9) Rheumatoid Arthritis (2 year historical review for submitted ICD-9) Juvenile Chronic Polyarthritis (2 year historical review for submitted ICD-9) Crohn s Disease/Regional Enteritis (2 year historical review for submitted ICD-9) Ulcerative Colitis (2 year historical review for submitted ICD-9) Approval Criteria for Humira (must meet 1 of 10 criteria sets) Criteria 1 Diagnosis of psoriatic arthropathy in the past 2 years AND 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 2 Diagnosis of psoriatic arthropathy in the past 2 years AND 9

10 Paid drug claim for adalimumab in the past 45 days Criteria 3 Diagnosis of Crohn s disease, regional enteritis, or ulcerative colitis in the past 2 years AND 90 days or more of one of the following regimens in the past 365 days: -concurrent systemic glucocorticoid AND mesalamine, -mercaptopurine, or -methotrexate Criteria 4 Diagnosis of Crohn s disease, regional enteritis, or ulcerative colitis in the past 2 years AND Paid drug claim for adalimumab in the past 45 days or a paid drug claim for infliximab in the past 365 days Criteria 5 Diagnosis of ankylosing spondylitis in the past 2 years Criteria 6 A total of 180 days or more of topical therapy in the past days with: -calcipotriene -corticosteroids, or -tazarotene AND A total of 180 days or more of systemic drug therapy in the past 210 days with: -cyclosporine, or -acitretin Criteria 7 Paid drug claim for adalimumab in the past 45 days Criteria 8 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 9 Paid drug claim for adalimumab in the past 45 days Criteria 10 Diagnosis of juvenile chronic polyarthritis in the past 2 years Dr. Reese informed the Board that the age restriction of 4 years old or older was removed from this criteria set by the T-Committee. Approval Diagnosis for Kineret: Rheumatoid Arthritis (2 year historical review for submitted ICD-9) Approval Criteria for Kineret (must meet the following criteria) One of the following o 90 days or more of drug therapy in the past 365 days with any of the following: 10

11 o -leflunomide OR Paid drug claim for anakinra in the past 45 days Approval Diagnoses for Simponi Ankylosing Spondylitis (2 year historical review for submitted ICD-9) Psoriatic Arthropathy (2 year historical review for submitted ICD-9) Rheumatoid Arthritis (2 year historical review for submitted ICD-9) Approval Criteria for Simponi (must meet 1 of 5 criteria sets) Criteria 1 Diagnosis of ankylosing spondylitis in the past 2 years Criteria 2 Diagnosis of psoriatic arthropathy in the past 2 years AND 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 3 Diagnosis of psoriatic arthropathy in the past 2 years AND Paid drug claim for golimumab in the past 45 days Criteria 4 90 days or more of drug therapy in the past 365 days with any of the following: -leflunomide Criteria 5 Paid drug claim for golimumab in the past 45 days Approval Diagnosis for Stelara Psoriasis (2 year historical review for submitted ICD-9) Approval Criteria for Stelara (must meet 1 of 2 criteria sets) Criteria 1 A total of 180 days or more of topical therapy in the past days with: -calcipotriene -corticosteroids, or -tazarotene AND A total of 180 days or more of systemic drug therapy in the past 210 days with: -cyclosporine, or -acitretin Criteria 2 Paid drug claim for ustekinumab in the past 90 days 11

12 Denial Criteria History of a targeted immumomodulator other than the one on the incoming claim in the past 30 days Failure to meet approval criteria Dr. Reese concluded the presentation by reminding the Board that the age restrictions had been removed from the criteria sets and asked them to consider implementing them again. He also stated that some research had been done on claims from the past six months. Of the claims, there were 287 pharmacy claims for 67 members, age 17 and under, for drugs covered under this rule. Enbrel and Humira were filtered out since they have diagnosis for juvenile chronic polyarthritis. That left 19 claims, representing six members 17 and under, who received one of these medications. Dr. Reese stated that this shows having the age restriction would have little impact on providers. Board Discussion: Dr. Lindstrom wanted to discuss the psoriasis diagnosis and the prior requirement of both topical and systemic agents. He felt that it could be determined in three months if a patient is heading for a better state. Dr. Treadwell agreed and suggested changing the AND to an OR on all criteria for psoriasis. Petra Fippen added that she would also be willing to change that to a 90-day trial versus 180-day trial. Dr. Treadwell agreed. Mr. Musial began the discussion regarding the age restriction by stating the sense of the T-Committee was, that the pediatricians and the family practice and general medicine guys weren t going to touch these kids anyway. They were going to end up in a subspecialty at Riley or somewhere else. He stated that this is why the criteria was pulled. Dr. Treadwell agreed. Board Action: Dr. Lindstrom moved that for all the psoriasis criteria, the requirement for topical AND systemic therapy be changed to topical OR systemic therapy. The motion was seconded and passed unanimously. Petra Fippen moved that for all psoriasis criteria, the total days of therapy requirement for topical or system drug be changed from a 180-day trial to a 90-day trial. The motion was seconded and passed unanimously. Dr. Treadwell moved that the age restriction remain off of all criteria. The motion was seconded and passed unanimously. Then the Board motioned and seconded the approval of the targeted immunomodulator SmartPA proposal with the approved amendments. The motion passed unanimously. SMART PA RULES PRESENTATION URINARY TRACT ANTISPASMODICS: Dr. Reese stated the he was presenting the SmartPA proposal for urinary tract antispasmodics as approved by the T-Committee. He presented the following information. Approval Diagnosis Cognitive Impairment o Determined by submitted ICD-9 diagnosis (2 year historical review), or o Inferred by agents to treat dementia (180 day historical review) Preferred Drugs Detrol Enablex Flavoxate (generic) Oxybutynin IR (generic) Oxytrol Sanctura Sanctura XR Toviaz Oxybutynin IR No PA required Approval Criteria for Preferred Drugs (must meet one of the following criteria) Diagnosis of cognitive impairment in the past 2 years History of at least 30 days of therapy with a dementia agent in the past 180 days History of at least 28 days of therapy with preferred oxybutynin IR in the past 3 months Contraindication, allergy, or intolerance to oxybutynin IR (Call Center only) 12

13 Dr. Reese stated to the Board that the original criteria set had that a prescription written by a urologist would be an approval criteria. However, the T-Committee removed that criteria. Non-preferred Drugs Detrol LA Ditropan Ditropan XL Gelnique Oxybutynin ER Urispas Vesicare Approval Criteria for Non-preferred Drugs (must meet one of the following criteria sets) Criteria 1 Diagnosis of cognitive impairment in the past 2 years AND o At least 28 days of therapy with a preferred drug other than oxybutynin in the past 3 months OR o Contraindication, allergy or intolerance to preferred drugs (Call Center only) Criteria 2 History of at least 30 days of therapy with a dementia agent in the past 180 days AND o At least 28 days of therapy with a preferred drug other than oxybutynin in the past 3 months OR o Contraindication, allergy, or intolerance to preferred drugs (Call Center only) Criteria 3 History of at least 14 days of therapy with preferred oxybutynin IR in the past 3 months OR contraindication, allergy, or intolerance to oxybutynin IR (Call Center only) AND o At least 14 days of therapy with a preferred drug other than oxybutynin in the past 3 months OR o Contraindication, allergy, or intolerance to preferred drugs (Call Center only) Dr. Reese stated that there was a criteria allowing prescriptions for non-preferred drugs, written by a urologist, would be approved. However, this criteria was removed by the T-Committee. Denial Criteria Failure to meet approval criteria Board Discussion: Dr. Ott questioned the cognitive impairment diagnosis and asked if it is saying that only people with cognitive impairment can get urinary tract antispasmodics. Dr. Reese answered no, it is not limiting these drugs to only those with cognitive impairment. Mr. Musial reminded the Board that, the SmartPA is designed to eliminate the need for a prescriber to make a phone call or send a fax. He went on to explain that it allows patients with certain conditions to get these drugs without phone calls or faxes. There was a lot of discussion regarding oxybutynin and it s use in the cognitive impaired. It was explained that oxybutynin IR was only one of the preferred medications. If there is a contraindication with its use, the provider could use one of the other preferred drugs. Board Action: It was moved and seconded that the recommendations for the urinary tract antispasmodics SmartPA proposal be approved. The motion passed unanimously. ACS PA STATISTICS UPDATE: Dr. Troy Reese presented the prior authorization (PA) statistics for the month of October He stated that there were 9,677 PAs for the month. Of those, 9,099 were approved and 568 were denied. He noted that the increase in PAs was mostly due to Synagis PAs and the new Sedative Hypnotic/Benzodiazepine Duplicate SmartPA rule implemented on October 5. PDL CLASS NAME CHANGES: Dr. Reese informed the Board that as of January 1, 2011, there will be some name changes to some of the PDL therapeutic classes. He announced the following changes. Chronic Constipation Agents will now be Laxative and Cathartics. Triptans will now be Antimigraine Preparations. 13

14 Agents to Treat COPD will now be Bronchodilator Agents, Beta Adrenergic and Anticholinergic Combinations. Eye Antibiotic/Corticosteroid Combinations will now be Ophthalmic Antibiotic/Corticosteroid Combinations. Eye Antihistamines will now be Ophthalmic Antihistamines. Other Lipotropics will now be Lipotropics. Nasal Preparations will now be Nasal Antihistamines, Nasal Anti-inflammatory Steroids. Inspra will now be Potassium- Sparing Diuretics. Synagis will now be Antiviral Monoclonal Antibodies. Xolair will now be Monoclonal Antibodies to Immumoglobulin E. And Topical Estrogen Agents will now be Vaginal Estrogen Preparations. ACS RETRO-DUR INTERVENTION UPDATE: Emily Hancock, with OMPP, gave a status update of the upcoming intervention on utilization of stimulants. The Mental Health Quality Advisory Committee (MHQAC) proposes to refine the target indication as abuse potential and define the population as 14 years old and older in order to capture the abuse potential in both high school and college. She also stated that Dr. Ott, who is a member of the MHQAC, wanted a special focus on the abuse of Provigil and Nuvigil on college campuses. Dr. Hancock indicated that with this concept, the therapeutic used for children with ADD and ADHD would not be targeted. UTILIZATION EDITS QUARTERLY REVIEW / RECOMMENDATIONS: Dr. Reese presented the new utilization edits that were approved at the October meeting of the Mental Health Quality Advisory Committee. He announced the following edits. Name of Medication Aricept 23 mg (new strength) Focalin XR 20 mg Focalin XR 40 mg (new strength) Oleptro ER 150 mg Oleptro ER 300 mg Procentra 5 mg/5 ml Proposed Utilization Edit 1 tab/day Was 2 caps/day; changed to 1 cap/day 1 cap/day 1.5 tabs/day 1 tab/day 40 ml/day NEW DRUGS: None. LIAISONS WITH OTHER BOARDS: None. PUBLIC COMMENT: Nancy Smith with Terra Pharmaceuticals, spoke about calcipotriene ointment. She stated that the ointment had been off the market for about 4 or 5 years and was brought back in October. Therefore, they were not able to get all of the information to ACS before the submission deadline. She stated that is probably why it was placed on non-preferred. She also stated that the company also brought back a generic formulation. OLD BUSINESS: None. NEW BUSINESS: Dr. Eskew stated that after the December meeting is adjourned, the Board will be going across to the Marriott for breakfast or coffee in honor of Dr. Lindstrom s retirement from the Board. He announced that anyone in the audience is welcome to attend. Mr. Musial reminded the Board that officers are to be elected at the December meeting. MEETING ADJOURNED. 14