Pharmacy Policy Updates-Medicare Advantage The following recommendations included on this update have been approved by the Pharmacy and Therapeutics Committee. Please note: For Medicare Advantage plans most Part D eligible drugs and drug policies are not considered in force and administered until CMS approval is obtained. Please refer to the most current approved formulary document which is available at https://www.premera.com/medicareadvantage/pharmacy-services/ Pharmacy policies are updated and available on the secure provider Medicare Advantage web page at https://www.premera.com/wa/provider/medicareadvantage/ and click on the policies link on the right side. New Drugs: Invokana (canagliflozin oral tablet) Indication: as an adjunct to diet and exercise to improve glycemic control in adults with diabetes mellitus Type 2 with PA A documented trial, failure, or contraindication to metformin therapy, up to a maximum effective dose of 2000 mg/day AND Documented trial and failure of a sulfonylurea or pioglitazone therapy; OR contraindications exist to both of these therapies that precludes trial of a sulfonylurea (e.g., known hypersensitivity reactions to components of product) or pioglitazone (e.g., Class III or IV heart failure). AND A documented HbA1c, obtained within the last six months, which is greater than or equal to 7% and less than or equal to 10%. Gilotrif (afatinib dimaleate oral tablet) Indication: First-line treatment of patients with metastatic non-small cell lung Page 1 Premera Medicare Advantage 029960 (11-2013)
cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. with PA Verification of EGFR mutation status on exon 19 and exon 21 identified by an FDA approved test such as Qiagen s Therascreen EGFR RGQ PCR kit. Suclear (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride reconstituted solution) Indication: cleansing of the colon in preparation for colonoscopy in adults. Formulary Alternatives: TriLyte, Moviprep, Suprep, generic PEG 3350 Vituz (hydrocodone bitartrate / chlorpheniramine maleate oral solution) Indication: Cough, Associated with upper respiratory allergies or a common cold Health Plan: Benefit Exclusion (cough & cold meds are not covered) Diclegis (doxylamine / pyridoxine oral tablet) Indication: Treatment of nausea and vomiting in pregnant women who do not respond to conservative management [pending meeting Part D coverage eligibility] Simbrinza (brinzolamide / brimonidine eye drop) Indication: Ocular hypertension; Open-angle glaucoma Formulary alternatives: Azopt, dorzolamide, brimonidine, dorzolamide/timolol Page 2 Premera Medicare Advantage 029960 (11-2013)
Inversine (mecamylamine oral tablet) Indication: Moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension Formulary alternatives: multiple formulary options Cystaran (cysteamine HCL eye drop) Indication: Treatment of corneal cysteine crystal accumulation in patients with cystinosis for ophthalmic use only. with PA, quantity limit Meeting the FDA approved indication Procysbi (cysteamine bitartrate oral capsule / delayed release) Indication: Treatment of corneal cysteine crystal accumulation in patients with cystinosis with PA Documentation of trial and failure, contraindication or intolerance to Cystagon tablets Sirturo (bedaquiline fumarate oral tablet) Indication: Multidrug resistant tuberculosis, In combination with at least 3 other agents Liptruzet (atorvastatin / ezetimibe oral tablet) Page 3 Premera Medicare Advantage 029960 (11-2013)
Indication: Hyperlipidemia Formulary alternatives: simvastatin, pravastatin, atorvastatin Dutoprol (metoprolol succinate / hydrochlorothiazide oral tablet extended release) Indication: Hypertension (not for initial therapy) Formulary alternatives: multiple formulary options including the ingredients taken as individual agents Tivicay (dolutegravir sodium oral tablet) Indication: for use in combination with other antiretroviral agents for the treatment of HIV New Strengths/Formulations: Prolensa (bromfenac sodium 0.07% eye drop) Indication: In cataract surgery for postoperative inflammation and ocular pain Formulary alternatives: bromfenac 0.09% ophthalmic drops Topicort Spray (desoximetasone topical spray) Indication: treatment of plaque psoriasis Formulary alternatives: desoximetasone 0.25% cream, gel or ointment Page 4 Premera Medicare Advantage 029960 (11-2013)
TOBI podhaler (tobramycin) Indication: Management of cystic fibrosis patients with Pseudomonas aeruginosa Afinitor Disperz (everolimus - oral tablet for suspension) Indication: To treat subependymal giant cell astrocytoma Namenda XR (memantine oral capsule extended release) Indication: Moderate to severe dementia of the Alzheimer's type. Formulary Alternatives: Namenda IR, donepezil, rivastigmine, Exelon patch with PA Diagnosis of AD as defined by DSM-IV criteria and MMSE OR SLUMS exam. Have moderate to severe AD as defined by a Mini-Mental State Exam (MMSE) or Saint-Louis University Mental Status (SLUMS) Exam of less than 20. Must be able to perform with minor assistance at least one self-care activity of daily living as defined by toileting, feeding, grooming, ambulation, bathing, or dressing. New Indications: Ilaris (canakinumab) New FDA-approved indication: Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Health Plan Action: Clinical criteria for use updated with the new indication Page 5 Premera Medicare Advantage 029960 (11-2013)
Xgeva (denosumab ) New FDA-approved indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity Health Plan Action: Clinical criteria for use updated with the new indication Other P&T Actions: Moviprep and Suprep Bowel prep agents Added to formulary with no criteria for use New Generic Medications First time generics to market Acitretin (Soriatane ) Repaglinide (Prandin ) o Non-formulary Butalbital/Acetaminophen/Caffeine (Orbivan ) o Non-formulary Donepezil HCL (Aricept 23mg ) o Formulary with PA Lomustine (Ceenu ) Teniposide (Vumon ) Page 6 Premera Medicare Advantage 029960 (11-2013)
o Medical benefit Amiodarone HCL (Pacerone ) Morphine Sulfate (Kadian ) o Non-formulary Acamprosate Calcium (Campral ) o Formulary with PA Temozolomide (Temodar ) o Medical benefit with PA Hydrocort Butyrate/Emoll ( Locoid Lipocream ) o Non-formulary Adefovir Dipivoxil (Hepsera ) Methen/M-Blue/Sal/NA Phose/Hyos (Uretron D-S ) o Benefit Exclusion (non-fda approved) Cycloserine (Seromycin ) Health Plan Clinical Policy Updates: Policy Name Ilaris Xgeva Promacta Tracleer; Ventavis; Tyvaso; Letairis Amitiza, Linzess Trilipix Zytiga Criteria Changes Addition of new indication to policy Addition of new indication to policy New black box warning and criteria for new indication were added Some additions to the Position Statement and FDA approved indications New indication; age restriction; quantity limit no longer necessary Retiring this policy - generic is now available Took out docetaxel requirement, as this was missed previously. Page 7 Premera Medicare Advantage 029960 (11-2013)
Campath Benzodiazepines - MAPD Penlac Retiring this policy - drug is obsolete Removed the rectal formulation from clinical policy - formulation usually used for seizure - low HRM utilization risk Retiring this policy An Independent Licensee of the Blue Cross Blue Shield Association Page 8 Premera Medicare Advantage 029960 (11-2013)