Kentucky Pharmacy and Therapeutics Advisory Committee meeting minutes Triton Park Blvd., Louisville, KY April 26, p.m.-3 p.m.
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1 Kentucky Pharmacy and Therapeutics Advisory Committee meeting minutes Triton Park Blvd., Louisville, KY April 26, p.m.-3 p.m. Attendees: Andrew Rudd Steven Broudy Setifah Jordan Keith Huff Dean Christy Decisions: 1. WARFARIN PRODUCTS Warfarin Products NTI Category review PRODUCTS INCLUDED IN THE REVIEW: COUMADIN TABLETS, JANTOVEN TABLETS, WARFARIN TABLETS CURRENT PREFERRED PRODUCTS: COUMADIN, JANTOVEN AND WARFARIN 2. BIPOLAR PRODUCTS Coumadin will move from Preferred to Non- Preferred (current utilizers will be grandfathered) Bipolar Disorder-NTI Category review PRODUCTS INCLUDED IN THE REVIEW: EQUETRO CAPSULE, LITHIUM CARBONATE CAP, LITHIUM CARBONATE ER TAB, LITHIUM 8 MEQ/5 ML SOLUTION, LITHOBID ER 300 MG TABLET CURRENT PREFERRED PRODUCTS: EQUETRO CAPSULE, LITHIUM CARBONATE CAP LITHIUM CARBONATE ER TAB Equetro will move from Preferred to Non-Preferred ( maintain Prior Authorization) Lithium 8 meq/5 ml will move from Non-Preferred to Preferred Anthem Blue Cross and Blue Shield Medicaid is the trade name of Anthem Kentucky Managed Care Plan, Inc., independent licensee of the Blue Cross and Blue Shield Association. ANTHEM is a registered trademark of Anthem Insurance Companies, Inc. The Blue Cross and Blue Shield names and symbols are registered marks of the Blue Cross and Blue Shield Association. WEBPAKY May 2017
2 3. THEOPHYLLINE PRODUCTS Anthem Blue Cross and Blue Shield Medicaid Page 2 of 14 Theophylline Products- NTI Category Review PRODUCTS INCLUDED IN THE REVIEW: ELIXOPHYLLIN 80 MG/15 ML ELIX, THEOPHYLLINE 80 MG/15 ML SOLN, THEOPHYLLINE ER 400 MG TABLET, THEOPHYLLINE ER 600 MG TABLET, THEOPHYLLINE ER 100 MG TABLET, THEOPHYLLINE ER 200 MG TABLET, THEOPHYLLINE ER 300 MG TAB, THEOPHYLLINE ER 450 MG TAB, THEO-24 ER 100 MG CAPSULE, THEO-24 ER 200 MG CAPSULE, THEO-24 ER 300 MG CAPSULE, THEO-24 ER 400 MG CAPSULE CURRENT PREFERRED PRODUCTS: ELIXOPHYLLIN 80 MG/15 ML ELIX, THEOPHYLLINE 80 MG/15 ML SOLN, THEOPHYLLINE ER 100 MG TABLET, THEOPHYLLINE ER 200 MG TABLET, THEOPHYLLINE ER 300 MG TAB, THEOPHYLLINE ER 450 MG TAB, THEO-24 ER 100 MG CAPSULE, THEO-24 ER 200 MG CAPSULE, THEO-24 ER 300 MG CAPSULE, THEO-24 ER 400 MG CAPSULE Elixophyllin 80 mg/15 ml elixir (Brand) will move from Preferred to Non-Preferred (current utilizers will be grandfathered) Theophylline 400 mg ER and 600 mg ER tablet will move from Non-Preferred to Preferred Theo-24 ER capsule (Brand) will move from Preferred to Non-Preferred (current utilizers will be grandfathered) 4. LAMA AND LAMA/LABA PRODUCTS LAMA and LAMA/LABA Products Category review PRODUCTS INCLUDED IN THE REVIEW: SEEBRI NEOHALER 15.6 MCG INHALER, SPIRIVA 18 MCG CP-HANDIHALER, SPIRIVA RESPIMAT 2.5 MCG INHALER, SPIRIVA RESPIMAT 1.25 MCG INHALER, TUDORZA PRESSAIR 400 MCG INHALER, INCRUSE ELLIPTA 62.5 MCG INHALER, ANORO ELLIPTA MCG INHALER, UTIBRON NEOHALER MCG, STIOLTO RESPIMAT INHAL SPRAY, BEVESPI AEROSPHERE INHALER CURRENT PREFERRED PRODUCTS: SPIRIVA 18 MCG CP-HANDIHALER, SPIRIVA RESPIMAT 2.5 MCG INH, SPIRIVA RESPIMAT 1.25 MCG INHALER, ANORO ELLIPTA MCG INHALER Spiriva 18 mcg Handihaler will move from Preferred to Non-Preferred with Step Edit
3 5. VAGINAL ESTROGENS Anthem Blue Cross and Blue Shield Medicaid Page 3 of 14 Vaginal Estrogens Category review PRODUCTS INCLUDED IN THE REVIEW: ESTRACE 0.01% CREAM, ESTRING 2 MG VAGINAL RING, VAGIFEM 10 MCG VAGINAL TAB, YUVAFEM 10 MCG VAGINAL INSERT, PREMARIN VAGINAL CREAM, FEMRING 0.05 MG VAGINAL RING, FEMRING 0.10 MG VAGINAL RING CURRENT PREFERRED PRODUCTS: PREMARIN VAGINAL CREAM Premarin vaginal cream will move from Preferred to Non-Preferred with Step Edit Yuvafem 10mcg vaginal insert (Generic Vagifem) will move from Non-Preferred to Preferred 6. PROGESTINS Progestins (Makena) Category review PRODUCTS INCLUDED IN THE REVIEW: HYDROXYPROGESTERONE 1.25 G/5ML, MAKENA 1;250 MG/5 ML VIAL, MAKENA 250 MG/ML VIAL CURRENT PREFERRED PRODUCTS: MAKENA 1;250 MG/5 ML VIAL and MAKENA 250 MG/ML VIAL Hydroxyprogesterone 1.25 g/5 ml will move from Non-Preferred To Preferred (with Prior Authorization) 7. NALOXONE PRODUCTS Naloxone Products Category review PRODUCTS INCLUDED IN THE REVIEW: NALOXONE 0.4 MG/ML SYRINGE, NALOXONE 2 MG/2 ML SYRINGE, NALOXONE 0.4 MG/ML VIAL, NALOXONE 4 MG/10 ML VIAL, NARCAN 4 MG NASAL SPRAY, EVZIO 0.4 MG AUTO-INJECTOR, EVZIO 2 MG AUTO-INJECTOR, BD LUER-LOK SYRINGE 1ML 20GX1'' CURRENT PREFERRED PRODUCTS: NALOXONE 0.4 MG/ML SYRINGE, NALOXONE 2 MG/2 ML SYRINGE, NARCAN 4 MG NASAL SPRAY Naloxone 0.4 mg/ml vial will move from Non-Preferred to Preferred Naloxone 4 mg/10 ml vial will move from Non-Preferred to Preferred
4 Page 4 of 14 BD Luer-lok syringe 1ml 20gx1'' will move from Non-Preferred to Preferred 8. TOPICAL METRONIDAZOLE Topical Metronidazole Category Review PRODUCTS INCLUDED IN THE REVIEW: METROCREAM 0.75% CREAM, METROGEL TOPICAL 1% GEL, METROGEL TOPICAL 1% PUMP, METROLOTION TOPICAL 0.75%, METRONIDAZOLE TOPICAL 0.75% GEL, METRONIDAZOLE TOPICAL 1% GEL, METRONIDAZOLE 0.75% CREAM, METRONIDAZOLE 0.75% LOTION, METRONIDAZOLE TOP 1% GEL PUMP, NORITATE 1% CREAM, ROSADAN 0.75% GEL, ROSADAN 0.75% CREAM CURRENT PREFERRED PRODUCTS: METRONIDAZOLE TOPICAL 0.75% GL, METRONIDAZOLE 0.75% CREAM, METRONIDAZOLE 0.75% LOTION, ROSADAN 0.75% GEL, ROSADAN 0.75% CREAM Metronidazole topical 1% gel will move from Non-Preferred to Preferred Metronidazole topical 1% gel pump will move from Non-Preferred to Preferred 9. ACNE- TOPICAL RETINOIDS Acne-Topical Retinoids New Product PRODUCTS INCLUDED IN THE REVIEW: OTC DIFFERIN 0.1% GEL CURRENT PREFERRED PRODUCTS: ADAPALENE GEL,ADAPALENE CREAM,TRETINOIN GEL, TRETINOIN CREAM, TRETINOIN MICRO GEL, TRETINOIN EMOLLIENT CREAM OTC Differin 0.1% Gel will move from Non-Preferred to Preferred 10. MISCELLANEOUS UTILIZATION MANAGEMENT EDITS Anthem Blue Cross and Blue Shield Medicaid (Anthem) Medicaid UM Alignment Topical Steroids Quantity Limit Alignment Reason for Review Some need to be revised with most recent P&T limits. Revise QL with most recent P&T -approved limits.
5 Page 5 of 14 Insulin Quantity Limit Alignment Reason for Review Some need to be revised with most recent P&T limits. Add/ revise QL with most recent P&T -approved limits. Topical Lidocaine Quantity Limit Alignment Reason for Review Some need to be revised with most recent P&T limits. Add/ revise QL with most recent P&T -approved limits. Cost of Care Opportunities Class Drug Recommended Edit Targeted Immune Modulators Pulmonary Arterial Hypertension Xeljanz XR I. Maintain PA and trial of preferred products. Revatio Oral Suspension I. Add criteria to verify individual is unable to swallow tablets. Revise PA criteria documents PA for appropriate use is currently active. ss N ew UM Edits on New Drugs Class Drug Recommended Edit Atopic Dermitis Nausea and Vomitting of Pregnancy Eucrisa Bonjesta Prior Authorization I IV. Individual is 2 years of age or older; AND Has a diagnosis of mild to moderate atopic dermatitis; AND V. Had a trial of and inadequate response or intolerance to one topical corticosteroid unless use is not acceptable. QL: 100gm per 30 days. Prior Authorization I. Female, 18 years of age or older; AND I IV. Nausea and vomiting of pregnancy; AND Trial of and inadequate response to conservative management; AND Trial of immediate-release doxylamine and pyridoxine. Not be approved for: Hyperemesis gravidarum. QL: 2 tablets per day.
6 Page 6 of 14 Class Drug Recommended Edit Cancer Rubraca Prior Authorization I. Diagnosis of advanced ovarian cancer; AND I A deleterious BRCA mutation (verified by diagnostic testing); AND Trial of and insufficient response, to at least two prior chemotherapy treatments. QL 200mg: 6 tablets per day. QL 300mg: 4 tablets per day. Immune Globulin Cuvitru Prior Authorization Step I. Clinically appropriate use defined by Anthem MPTAC. I. Trial of 1 preferred product unless preferred products are not FDA approved, or medically accepted, for the prescribed indication and Cuvitru is; OR Preferred products are not acceptable due to concomitant clinical condition. Antiplatelet Yosprala Prior Authorization I. Documentation of medical necessity for Yosprala (aspirin delayed-release/omeprazole) is provided to define the inadequate response to the agents when used separately AND the medical reason the combination agent is clinically necessary. QL: 1 tablet per day. Constipation Linzess 72mcg Relistor Tablet Trulance Prior Authorization I. Individual is 18 or older (Trulance, Linzess). I QL Appropriate diagnosis based on FDA approved indications. Trial of generic Miralax. Linzess 72mcg: 1 capsule per day. Relistor 150mg: 3 tablets per day. Trulance: 1 tablet per day. Rh Immune Globulins MicRhoGam MicRhoGam RhoGam QL: 2 fills per 365 days.
7 Page 7 of 14 Class Drug Recommended Edit RhoGam Plus Pancreatic Enzyme Replacement Therapies (PERT) Pancreaze 2,600 units Pertzye 4,000 units QL: 25 capsules per day. Contraceptives Taytulla QL: 1 capsule per day. Contraceptives Xulane QL: 3 patches per 28 days. Topical Antifungals Jublia (8mL) Kerydin (10mL) QL: 1 bottle per 30 days. Dry Eye Restasis (multidose) QL: 1 bottle per 28 days Asthma ArmonAir Respiclick Step edit: Trial of 2 preferred ICS. QL: 1 inhaler (60 doses) per 30 days. Asthma AirDuo Respiclick Step: I. Individual has a diagnosis of asthma and has had a trial and inadequate response to one oral inhaled corticosteroid (ICS) agent; OR Individual has a diagnosis of (COPD). QL: 1 inhaler (60 doses) per 30 days. SGLT-2 (Diabetes) Synjardy XR Step: I. Trial and inadequate response or intolerance to metformin; OR Has a contraindication to metformin; AND QL: 2 tablets per day Duchenne Muscular Dystrophy (DMD) Emflaza Prior Authorization I. Individual is 5 years of age or older; AND I IV. Diagnosis of DMD; AND Had a 6 month trial of oral prednisone; AND Documentation has been provided for excessive weight-gain with prednisone; AND V. Weight gain is likely to be a direct result of prednisone use. Requests for continuation: I. Criteria ensures individual has returned to, and
8 Page 8 of 14 Class Drug Recommended Edit maintained, baseline status on growth chart. Approval Duration: 6 months Add Prior authorization, Step Therapy and or quantity limits to new drugs Clinical Criteria to Non-Preferred Drug Current Status Reason for Review Non-preferred with default NP criteria. Drug specific criteria is preferred for 1 or more of the following reasons: No viable preferred products to offer as alternative. P&T approved criteria limit number of preferred products to 1 rather than trial of 2 products. Drug specific criteria more clearly defines preferred products. Alignment with Anthem use of PA criteria. Class Drug Drug Specific Edit Spinal Muscular Atrophy Dry Eye Post-herpetic Neuralgia Antidepressant Immune Globulin Tuberculosis Spinraza Lacrisert Gralise EMSAM GamaSTAN S/D Cycloserine Criteria aligned with Anthem Medical policy for clinically appropriate use. Approval Duration: 6 months Individual is using to treat moderate to severe dry eye syndromes or related conditions; AND Individual has had a trial and inadequate response to one artificial tear agent. Individual is 18 years of age or older; AND Has a diagnosis of post-herpetic neuralgia; AND Had a trial of immediate release gabapentin Individual is 18 years of age or older; AND Individual has a diagnosis of major depressive disorder (MDD). Clinically appropriate indication based on FDAapproved indications, medically accepted off-label use and relevant guidelines. Individual has a diagnosis of pulmonary or extrapulmonary tuberculosis; AND The causative organisms are susceptible to cycloserine; AND Primary medications have proven inadequate; AND Use is part of multi-drug regimen; OR Individual has a diagnosis of acute urinary tract infection; AND The causative agents are susceptible to cycloserine; AND
9 Page 9 of 14 Class Drug Drug Specific Edit Conventional therapy for causative organism has failed. Not approved if contraindicated or clinically inappropriate. Tuberculosis Ophthalmic Antibiotics Sirturo Blephamide Individual is 18 years of age or older; AND Individual has a diagnosis of pulmonary multi-drug resistant tuberculosis (MDR-TB); AND Individual is unable to use an effective regimen for treatment of MDR-TB; AND Use is part of multi-drug regimen. Not approved if contraindicated or clinically inappropriate. L-Anthem to apply NP default criteria. Apply drug specific criteria to NP brands and generics.
10 Page 10 of 14 Revisions to Existing UM Edits PA Criteria Revisions Drug Edit Revision Daklinza and Sovaldi Clarify override criteria for the use in dual treatment-experienced individuals includes those with Genotype 3, without cirrhosis, and a prior trial of Sovaldi and ribavirin. Clarify criteria and approval durations for use with or without ribavirin. Update duration of treatment table based on label and AASLD/IDSA guidance. Hepatitis C Technivie and Ombitasvir + Paritaprevir + Ritonavir + Dasabuvir Agents Update to include additional agents excluded for concomitant use based on labeled drug interactions. All Add note to include a black box warning for risk of hepatitis B reactivation in HCV-HBV co-infected individuals. Wording and formatting updates to clarify protocol, rationale, and override criteria sections. Cancer Farydak Add carfilzomib as an option for combination therapy. Antifungals Noxafil Onmel Sporanox Terbinex Vfend Update prior authorization criteria based on label, relevant compendia and guidelines. Antipsychotics Invega Sustenna Clarify use as either monotherapy or adjunctive therapy. Antiplatelet Zontivity Add exclusionary criteria when contraindicated or clinically inappropriate. COPD Daliresp Update criteria based on clinical recommendations Add exclusion for use with concomitant strong cytochrome P450 inducers as recommended per label.
11 Page 11 of 14 Drug Edit Revision Gout Colcrys Mitigare Update criteria with an approval for recurrent pericarditis per off-label policy. Zurampic Add requirement for trial and inadequate response (unable to achieve target serum uric acid levels) to allopurinol. Remove exclusionary criteria that is duplicative. Add exclusionary criteria for use while contraindicated. Cancer Imbruvica Add criteria for new FDA indication for Marginal Zone Lymphoma. Transmucosal Immediate Release Fentanyl Actiq Fentora, etc Add exclusionary criteria for using for acute or postoperative pain, migraine headache pain, or noncancer related breakthrough pain. Antidepressant Cymbalta Irenka Remove benzodiazepines from edit as a potential prerequisite therapy for generalized anxiety disorder. Fibromyalgia Cymbalta Savella Revise diagnosis requirements for fibromyalgia. For fibromyalgia, update prior trial requirement from one agent to 2 agents for consistency within the class. Add remaining SSRIs as potential prerequisite therapy for fibromyalgia. Minor wording updates; updates to referenced guidelines. Fibromyalgia Lyrica Revise diagnosis requirements for fibromyalgia. Add remaining SSRIs as potential prerequisite therapy for fibromyalgia. Minor wording updates; updates to referenced guidelines. Osteoporosis Forteo Limit therapy to 24 months. Pulmonary Arterial Hypertension Tracleer Tracleer Letairis Opsumit Include exclusion for use when baseline aminotransferase levels are elevated prior to initiating therapy per labeled recommendation. Exclude combination therapy use with another endothelin receptor antagonist (ERA) agent.
12 Page 12 of 14 Drug Edit Revision Orenitram Uptravi Adempas Exclude combination therapy use with another prostacyclin analog or prostacyclin receptor agonist. Include updated label contraindication for use in Pulmonary Hypertension associated with Idiopathic Interstitial Pneumonias (PH-IIP). Update PA criteria with the above revisions Step Therapy Criteria Revisions Class Drug Recommended Edit Methotrexate Auto-injector Otrexup, Rasuvo Revise and clarify requirements for trial of generic injectable methotrexate agent. Immune Globulins Carimune, Flebogamma, Gammagard, etc Remove general approval criteria allowing a nonpreferred agent when preferred agents have contraindications to use and not associated with the non-preferred agent. Insulin Afrezza Tresiba Humalog Addition of exception criteria for pregnancy category. Novolog, etc Topical Agents for Actinic Keratosis Efudex (brand), Fluoroplex, fluorouracil 0.5% cream, Tolak Revise override language for unique labeled/ offlabel indications Clarify and revise override language for concomitant clinical situations. Oral Atypical Antipsychotic Agents Abilify, Fanapt, Vraylar, etc Added specific language allowing for continuation of a non-preferred agent if individual is currently using the non-preferred agent Update criteria for Rexulti requiring diagnosis, use of antidepressant therapy and, a trial of aripiprazole. Antidepressants Fetzima Khedezla, etc Remove override criteria based on FDA-approved indication. Antidepressants Aplenzin Forfivo Added requirement for documentation regarding need for brand agent to be consistent with similar
13 Page 13 of 14 criteria Topical Antifungal for Nails Jublia, Kerydin, Penlac, etc Add requirement for trial of 1 preferred topical antifungal for the nails. Otic Antibiotic Cetraxal, Ciprodex, Cipro HC, Otovel Include age of the individual as an additional clinical scenario for agent approval when the preferred agent(s) are not indicated in that population. Symbicort Update to include override criteria allowing approval in individual s between the ages of 6 and 12 years based on recent FDA-expanded pediatric indication. Asmtha/ COPD Advair Symbicort Update wording and formatting to maintain Asthma-specific override criteria and applicable. Advair Symbicort Flovent Pulmicort Qvar ProAir Proventil Xopenex Allow approval of a dry powder inhaler (DPI) if only metered dose inhalers (MDIs) are preferred when the individual has a weak or ineffective inspiratory effort. Allow approval of a MDI if only DPIs are preferred when the individual has a lack of handbreath coordination. Inhaled Corticosteroid (ICS) Agents Asmanex, Pulmicort, Aerospan, Alvesco, etc Include override criteria allowing approval for a designated non-preferred pressurized metered dose inhaler when individual requires utilization of an external spacer or valved-holding chamber for medication administration. Update Step Therapy Criteria with above revisions Quantity Limit Revisions Class Drug Recommended Edit Antibiotic Zyvox Add limit for 1 fill per 30 days to current QL. 600mg tablet: 28 tablets per fill; 1 fill per 30 days 100 mg/5 ml: 900 ml per fill; 1 fill per 30 days Update Quantity Limit with above revisions
14 Page 14 of 14 Medical Policy and Clinical Guidelines Policy Number Policy Name Key Revisions DRUG DRUG DRUG DRUG DRUG CG-DRUG-14 CG-DRUG-16 CG-DRUG-28 CG-DRUG-29 Tumor Necrosis Factor Antagonists Bezlotoxumab (ZINPLAVA ) Vedolizumab (Entyvio ) Botulinum Toxin Hyaluronan Injections in Joints Other Than the Knee Dihydroergotamine Mesylate (DHE) Injection for the Treatment of Migraine or Cluster Headaches in Adults White Blood Cell Growth Factors Alglucosidase alfa (Lumizyme, Myozyme ) Hyaluronan Injections in the Knee Enbrel: decreased minimum age from 18 to 4 years-old for plaque psoriasis Consultant review added definitions of severe C. difficile Consultant review - removed latent TB testing Wording revision of Clinically Equivalent Cost Effective section New Clinically Equivalent Cost Effective section Minor criteria clarification Removed biosimiliar Filgrastim-sndz (Zarxio ) New Title. Myozyme removed from U.S. market Wording revision of Clinically Equivalent Cost Effective section
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