Premera Blue Cross Medicare Advantage Plans Pharmacy Policy Updates

Premera Blue Cross Medicare Advantage Plans Pharmacy Policy Updates Most Part D-eligible drugs and drug policies are not effective and administered un...
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Premera Blue Cross Medicare Advantage Plans Pharmacy Policy Updates Most Part D-eligible drugs and drug policies are not effective and administered until Centers for Medicare and Medicaid Services approval is obtained. Please refer to the most current approved formulary document at premera.com/medicare-advantage/pharmacy-services/. Pharmacy policies are updated and available on the secure provider Medicare Advantage website at premera.com/wa/provider/medicare-advantage/; simply click on the Get Started button in the right column. You can find the Premera Medicare Advantage (MA) Formulary (List of Covered Drugs) at premera.com/medicare-advantage/pharmacy-services/. You can also check the Premera MA Formulary using Epocrates.com:  

To download the formulary from epocrates.com onto your tablet or smartphone, log in to your Epocrates account, and select “Edit Formularies” Select “Washington” and “Medicare Part D—MA.” Add “Premera Medicare Advantage” to “Formularies on My Device” and select “Done”

Premera Medicare Advantage plans have a different formulary than non–Medicare Advantage plans. There may also be differences in prior authorization criteria for Premera Medicare Advantage members and Premera members on non–Medicare Advantage plans. If you have questions on specific criteria, formulary alternatives, or prior authorization/exception processes, please contact Pharmacy Services at 877-216-3644. Effective Aug. 1, 2015 (unless noted otherwise below) Effective dates are pending CMS approval Class Reviews: Testosterone Replacement Therapy (TRT) The following testosterone drugs were reviewed: testosterone cypionate injection, testosterone enanthate injection, testosterone gel and pump formulation (Androgel®), testosterone transdermal patch (Androderm®), testosterone topical solution (Axiron®), testosterone topical gel (Fortesta®), testosterone gel (Testim®), testosterone gel and pump (Vogelxo®), testosterone undecanoate IM (Aveed®), testosterone implant pellet (Testopel®), testosterone buccal system (Striant®).  TRT is indicated for adult males for conditions associated with a deficiency or absence of endogenous testosterone, commonly referred to as primary and hypogonadotropic hypogonadism.  No single product has been proven in reliable clinical studies to be more effective than another. All products appear to be similarly effective based on pharmacokinetic data.  The safety concern of increased risk of a cardiovascular event associated with TRT is Page | 1

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inconclusive at this time and the FDA has announced further studies are needed to establish a safety risk. Preferred Agents:  [Effective Sept. 1, 2015: Testosterone cypionate inj. and testosterone enanthate inj. o Formulary, Tier 2 (non-preferred generic)]  [Effective Jan. 1, 2016: Androgel, Androderm] o Formulary, Tier 3 (preferred brand), with Prior Authorization] Prior Authorization Criteria: o Diagnosis of primary or secondary hypogonadism (level drawn before 10 a.m.) -ORo Diagnosis of gender identity disorder with gender dysphoria by a licensed behavioral health practitioner Non-Preferred Agents:  [Effective Sept. 1, 2015: Axiron, Fortesta, Testim, Vogelxo, Striant,]  [Effective Oct. 1, 2015: Testopel, Aveed] o Medicare Part D: Non-Formulary o Medicare Part B: Non-Formulary, with Prior Authorization Prior Authorization Criteria: o Diagnosis of primary or secondary hypogonadism (level drawn before 10 a.m.) OR- diagnosis of gender identity disorder with gender dysphoria by a licensed behavioral health practitioner o Trial and failure, contraindication or intolerance to Androgel® AND Androderm®

Targeted Immunomodulators (TIMs) Class Review The drugs listed below were reviewed in a class review in treating three main disease categories: inflammatory bowel diseases (IBD), rheumatologic disorders, and dermatological disorders. TIMs agents are considered to be efficacious in their respective FDA indications compared to placebo. These agents are considered comparable in terms of efficacy and safety. Recommendations for formulary status are based on these designations and cost-positioning contracts available.  Category I (superior)- None  Category II (comparable) Choose at least one of the following TNF inhibitors: etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi® and Simponi Aria®)



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Choose at least one of the following with a different mechanism of action: abatacept (Orencia®), ustekinumab (Stelara®) Category IIB (new drug limited data): tocilizumab (Actemra®), tofacitinib (Xeljanz®), vedolizumab (Entyvio®), secukinumab (Cosentyx®), apremilast (Otezla®) An Independent Licensee of the Blue Cross Blue Shield Association

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Category III (inferior)-None

Preferred Agents: etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), golimumab (Simponi® and Simponi Aria®), and ustekinumab (Stelara®)  Formulary, available without prior authorization, quantity limitations will be in place when applicable to ensure appropriate utilization. Non-Preferred Agents: certolizumab (Cimzia®), abatacept (Orencia®), tocilizumab (Actemra®), tofacitinib (Xeljanz®), vedolizumab (Entyvio®), secukinumab (Cosentyx®), apremilast (Otezla®)  Non-Formulary The following medications were reviewed: secukinumab (Cosentyx®) Cosentyx is a new drug that was reviewed as part of the TIMs class review. Non-Formulary

Anticoagulant Class Review The following medications were reviewed: apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®), rivaroxaban (Xarelto®), warfarin (Coumadin®)  The objective of this review is to provide qualitative overview of the clinical effectiveness, safety, and impact on quality of life of these medications for non-valvular atrial fibrillation (NVAF) and the prevention and treatment of venous thromboembolism (VTE)  Target specific oral anticoagulants (TSOACs) are comparable to Warfarin for efficacy and safety. Given some safety concerns with dabigatran (Pradaxa), other agents should be considered as initial therapy. Diagnosis, individual patient characteristics and pharmacokinetics should guide choice of initial therapy. apixaban (Eliquis®) and rivaroxaban (Xarelto)  Formulary, Tier 3 (preferred brand) [Effective Jan. 1, 2016 dabigatran (Pradaxa)  Formulary Tier 4 (non-preferred brand)] edoxaban (Savaysa)  Formulary, Tier 4 (non-preferred brand) [Effective Jan. 1, 2016 warfarin (Coumadin)  Formulary, Tier 2 (non-preferred generic)]

Cephalosporin Combinations Class Review The following medications were reviewed: ceftolozane/tazobactam (Zerbaxa®), ceftazidime/avibactam (Avycaz®) This class review was limited to the two cephalosporin combinations approved by the FDA. Page | 3

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Zerbaxa® is the innovator agent in this new group, with Avycaz® being approved shortly after. The review is limited to these two drugs as they are similar in their structure (a cephalosporin combined with a beta-lactamase inhibitor). They are approved for complicated urinary tract infections and complicated intra-abdominal infections. ceftolozane/tazobactam (Zerbaxa)  Formulary, Tier 6 (specialty) ceftazidime/avibactam (Avycaz)  Formulary, Tier 6 (specialty) Insulin Update: Insulin glargine (Toujeo SoloStar®) 300 units/mL injection Indicated to help improve glycemic control in adults with diabetes mellitus (DM) Formulary, Tier 3 (preferred brand) Insulin human (Afrezza®) inhalation  

Indicated for the treatment of diabetes mellitus There is insufficient evidence to suggest that inhaled insulin is more efficacious than other available formulary insulin options. This product carries many risks associated with the inhalation administration, including a box warning for risk of acute broncho-spasm in patients with chronic lung disease.

Non-Formulary New Drugs and Combinations: Umeclidinium bromide (Incruse Ellipta®) blister strip for inhalation  

Indicated for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) Incruse Ellipta joins Spiriva® HandiHaler, Spirvia Respimat, and Tudorza® Pressair in the class of single agent long-acting, muscarinic antagonists

Formulary, Tier 3 (preferred brand) amphetamine sulfate (Evekeo®) tablets Indicated for Narcolepsy, ADHD, Exogenous Obesity Non-Formulary

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HPV Vaccine 9 (Gardasil 9®) injection Indicated for girls and women 9-26 years old and boys 9-15 years old to prevent various cancers, genital warts, and precancerous or dysplastic lesions caused by the HPV virus Formulary, Prior Authorization, Tier 5 (Injectable) tobramycin-nebulizer (Kitabis Kit®) inhalation Indicated for the management of cystic fibrosis in adults and children over six years of age with pseudomonas aeruginosa Non-Formulary guaifenesin-hydrocodone (Obredon®) oral solution Indicated for symptomatic relief of cough and to loosen mucus associated with the common cold Non-Formulary panobinostat lactate (Farydak®) capsules Indicated for multiple myeloma after relapse following two prior therapies, in combination with bortezomib and dexamethasone Formulary, Prior Authorization, Tier 6 (specialty) Quantity Limit (6 caps/21 days) albuterol sulfate (Proair Respiclick®) inhalation powder Indicated for the treatment and/or prevention of bronchospasm, and exercise-induced bronchospasm in patient’s 12 years and older. Formulary, Tier 2 (Generic), Quantity Limit (Two inhalers/30 days) fentanyl (Fentanyl®) 37.5 mcg/hr, 62.5 mcg/hr and 87.5 mcg/hr transdermal patch Indicated for the management of pain in opioid-tolerant patients, for round-the-clock pain management Non-Formulary methoxy polyethylene glycol-epoetin beta (Mircera®) injection Indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on/not on dialysis Non-Formulary

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blinatumomab (Blincyto®) vial Indicated for acute lymphoblastic leukemia (ALL) Non-Formulary for Part D, Prior Authorization for Part B New Strengths and Formulations: fluticasone furoate (Arnuity Ellipta®) inhalation powder Indicated as a once-daily maintenance treatment of asthma as prophylactic therapy in patients 12 years of age or older Formulary, Tier 3 (preferred brand) ivermectin (Soolantra®) cream Indicated for the treatment of inflammatory lesions of rosacea Non-Formulary hydrocodone bitartrate extended-release (Hysingla ER®) tablets Indicated for the management of pain severe enough of require daily, around-the-clock, long-term opioid treatment for which alternative treatments are inadequate Non-Formulary beclomethasone dipropionate (Qnasl Children®) nasal aerosol Indicated for treating nasal symptoms associated with seasonal and perennial allergic rhinitis in children four years of age and older. Non-Formulary morphine and naltrexone (Embeda®) capsules Indications: Morphine/naltrexone was developed as an analgesic that will have euphoric effects blocked, if capsules are crushed or dissolved, owning to its sequestered naltrexone component Non-Formulary carbidopa/levodopa extended release (Rytary ER®) capsules Indication: Parkinson’s Disease. New formulation of carbidopa/levodopa combination contains both extended and immediate release components to allow continuous release of the drugs in the GI tract Non-Formulary Page | 6

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ivacaftor (Kalydeco®) oral granules Indication: Cystic Fibrosis. New formulation to reach patient population of children 2-5 years of age Formulary, Tier 6 (specialty), Prior Authorization, Limited Access, Quantity Limit (60/30 days) immune globulin infusion 10 percent [human] with recombinant human hyaluronidase (Hyqvia®) intravenous solution Indication: Primary Immunodeficiency (PI) in adults (including but not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combine immunodeficiencies) Part B only, Prior Authorization colchicine (Mitigare®) capsules Indicated for prophylaxis of gout flares in adults. Non-Formulary New Indications: topiramate ER (Qudexy XR®) extended-release capsules Expanded FDA-approved indication:  Partial onset of seizures and primary generalized tonic-clonic seizures initial monotherapy in patients two years of age and older with partial onset or primary generalized tonic-clonic seizures  Lennox-Gastaut Syndrome (LGS)-adjunctive therapy in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome Action: Update policy with expanded indication ramucirumab (Cyramza®) vial New FDA-approved indication:  As a single agent or in combination with paclitaxel, for treatment of advanced gastric or gastroesophageal junction adenocarcinoma, with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy  In combination with docetaxel, for treatment of metastatic non-small cell lung cancer disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Cyramza.  In combination with FOLFIRI, for the treatment of metastatic colorectal cancer with Page | 7

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disease progression on or after prior therapy with bevacizumab, oxaliplatin, and fluoropyrimidine Action: Update policy with new indication nivolumab (Opdivo®) intravenous solution New FDA-approved indication:  Metastatic squamous non-cell lung cancer (NSCLC) with progression on or after platinum based chemotherapy Action: Update policy with new indication

Clinical Policy Changes Policy Name

Change Summary Retired prior authorization policy and changing to preferred brand tier due to availability of advantageous price positioning contracts

OxyContin

Added quantity limitations to align with CMS guidelines for 120 mg morphine equivalents per day dosing

Oxymorphone (Opana)

Added the new dose/formulation (granules packets) to the title Changed age limit to two and above No change in coverage criteria

Kalydeco

Asthma criteria updated to eliminate dosing oversight and benefit administration Xolair Reauthorization criteria simplified to read "objective documentation of response to therapy" for both asthma and chronic idiopathic urticaria The following policies were retired, effective Aug. 1, 2015: o Fusilev o Qutenza Other Formulary and Policy Changes: Drug Name golimumab (Simponi® and Simponi Aria®) syringe

Change Summary Add to formulary

dabigatran (Pradaxa®) capsule

Effective Jan. 1, 2016, this product will be changed from Tier 3 (preferred brand) to Tier 4 (non-preferred brand)

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MedWatch Safety Alerts March 1, 2015 – April 30, 2015 1. ISSUE: The FDA has concluded that Doribax® (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin®). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, the FDA approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia. BACKGROUND: In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either seven-day Doribax treatment or 10-day treatment with imipenem and cilastatin. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm. RECOMMENDATION: Healthcare professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intraabdominal infections and complicated urinary tract infections, including kidney infections (pyelonephritis).

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2. ISSUE: The FDA is clarifying its previous recommendation related to prescribing Revatio® (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is approved by the FDA only to treat PAH in adults, not in children. However, healthcare professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient. FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. The FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring. BACKGROUND: The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Revatio should never be used in children; however, some healthcare professionals have interpreted this information as a contraindication and have refused to prescribe or administer the drug. RECOMMENDATION: The evidence behind the FDA’s initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the Revatio drug label. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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