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 Secure Tools and Resourcesbutton 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. Class Reviews Pharmacy & Therapeutics Effective April 1, 2016 (Unless noted otherwise below) Effective dates are pending CMS approval Actinic Keratosis Treatment The following medications were reviewed: imiquimod 5% (Aldara ), fluorouracil 2%, 5% (Efudex ), diclofenac 3% (Solaraze ), fluorouracil 0.5% (Carac ), imiquimod 2.5%, 3.75% (Zyclara ), and ingenol (Picato ). More than 85% of claims (between July 1 and Dec. 31, 2015) were for the generic imiquimod 5% and fluorouracil 2%, 5% products, and the cost per member per treatment was less than $300. Page 1 An Independent Licensee of the Blue Cross Blue Shield Association 029960 (04-2016)
Cost of other products was significantly higher ($700 $3,300 per member per treatment). Although these represented a minority of claims, there is little to no utilization management of these products currently. Given the relatively similar efficacy, we recommend that this class of medications be managed through a prior authorization process requiring trial and failure of the generic topical medications. We recommend that the tier status of fluorouracil 0.5% (Carac ), be changed to non-preferred brand for Medicare in 2017. Generic fluorouracil 2%, 5%, and imiquimod 5%: No changes (formulary, non-preferred generic tier when applicable) Diclofenac 3% (Solaraze ), Imiquimod 2.5%, 3.75% (Zyclara ): Update prior authorization criteria; no changes to formulary status: non-formulary Fluorouracil 0.5% (Carac ), ingenol (Picato ): Formulary, Tier 4 (non-preferred brand), prior authorization, to be implemented jan. 1, 2017 New Drugs and Combinations Fillgrastim-sndz (Zarzio ) subcutaneous injection Reduce the duration of neutropenia and neutropenia-related clinical sequelae e.g. febrile neutropenia, in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis Reduce the incidence and duration of sequelae of severe neutropenia (e.g. fever infections oropharyngeal ulcers) in symptomatic patients with congenital neutropenia cyclic neutropenia or idiopathic neutropenia Cobimetinib (Cotellic ) tablet Indication: Malignant melanoma, Unresectable or metastatic with a BRAF V600E or V600K mutation, in combination with vemurafenib Formulary alternatives: dabrafenib (PA), trametinib (PA), vemurafenib (PA), Formulary, tier 6 (specialty), prior authorization, quantity limit of 63 per 28 days Sulfur hexafluoride microsphere (Lumason ) vial Indication: Suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Part B benefit Ferric pyrophosphate citrate (Triferic ) injection Indication: Ferric pyrophosphate citrate is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). Part B benefit Irinotecan Liposomal (Onivyde ) vial Indication: A topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Talimogene laherparepvec (Imlygic ) suspension for injection Indication: A genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Trabectedin (Yondelis ) vial Indication: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen. Tagrisso (Osimertinib Mesylate) oral tablets Indication: For the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. The indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Formulary, tier 6 (specialty), prior authorization Daratumumab (Darzalex ) vial Indication: Treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are doublerefractory to a PI and an immunomodulatory agent. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Ixazomib Citrate (Ninlaro ) capsule Indication: Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Formulary, tier 6 (specialty), prior authorization Alectinib Hydrochloride (Alecensa ) capsule Indication: A kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Formulary alternative: Zykadia (ceritinib) Formulary, tier 6 (specialty), prior authorization New Strengths and Formulations Gefitinib (Iressa ) tablet Indication: A tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by and FDA-approved test.
Limitation of Use: Safety and efficacy of Iressa have not been established in patients whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations. Formulary, tier 6 (specialty), prior authorization, QL (30/30) Sumatriptan succinate (Zecuity ) patch Indication: A serotonin (5HT) 1b/1d receptor agonist (triptan) in an iontophoretic transdermal system, indicated for the acute treatment of migraine with or without aura in adults. Formulary alternatives: sumatriptan nasal spray, sumatriptan subcutaneous injection, sumatriptan tablets, rizatriptan tablets and orally disintegrating tablets, zolmitriptan nasal spray (formulary for commercial members), zolmitriptan tablets and orally disintegrating tablets Non-formulary Dichlorphenamide (Keveyis ) tablet Indication: The treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. Non-formulary Aspirin (Durlaza ER) capsule Indication: A nonsteroidal anti-inflammatory drug indicated to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina and to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack. Formulary Alternatives: Plavix, Brilinta OTC Alternatives: aspirin, enteric-coated aspirin Non-formulary New Indications Ambrisentan (Letairis ) Expanded FDA-approved indication: Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Decision: Update policy with new indication Simprevir (Olysio ) Expanded FDA-approved indication: Olysiois a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 or 4 infection as a component of a combination antiviral treatment regimen. Decision: Policies were updated with new indication. Nivolumab (Opdivo ) Expanded FDA-approved indication: Opdivo is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of: Unresectable or metastatic melanoma:
As a single agent in patients with disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. In combination with ipilimumab in patients with BRAF V600 wild-type melanoma. These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials. Metastatic non-small cell lung cancer in patients with 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 OPDIVO Decision: Update policy with new indication Ledipasvir/sofosbuvir (Harvoni ) Expanded FDA-approved indication: Harvoni is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection. Decision: Policies were updated with new indication. Pegfilgrastim (Neulasta ) Expanded FDA-approved indication: Neulasta is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Decision: No currently active policy, therefore, no action is needed. Rosuvastatin (Crestor ) Expanded FDA-approved indication: CRESTOR is an HMG Co-A reductase inhibitor indicated for: Patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-c, LDL-C, apob, nonhdl-c, and TG levels and to increase HDL-C Pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (hefh) to reduce elevated total-c, LDL-C and apob after failing an adequate trial of diet therapy Patients with hypertriglyceridemia as an adjunct to diet Patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet Patients with homozygous familial hypercholesterolemia (hofh) to reduce LDL-C, total-c, and apob Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-c and LDL-C as an adjunct to diet Risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors Decision: No currently active policy, therefore, no updates are needed. Ibuprofen (Caldolor ) Expanded FDA-approved indication: Caldolor is a non-steroidal anti-inflammatory drug indicated in adults and pediatric patients six months and older for the: Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
Reduction of fever Decision: No currently active policy, therefore no updates are needed. Dabigatran (Pradaxa ) Expanded FDA-approved indication: Pradaxa is a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days To reduce the risk of recurrence of DVT and PE in patients who have been previously treated Pradaxa 110 mg capsules: For the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery Decision: No currently active policy, therefore no action is needed. Drug Safety Monitoring Drug Name Change Summary Dutasteride (Avodart ) capsule Add to formulary, non-preferred generic (tier 2) Praluent (alirocumab) Add to formulary, specialty tier with prior authorization Repatha (evolucumab) Add to formulary, specialty tier with prior authorization Clinical Policy Changes Policy Name PCSK9 Bosulif Arranon Faslodex Folotyn Herceptin Hycamtin Ixempra Xalkori Change Summary Both PCSK9 agents are being added to the formulary to capture savings in costpositioning contracts. Criteria were updated to include more practical diagnoses parameters for familial hypercholeterolemia. Removed "Other Criteria" from policy. Cancer Network (NCCN). Added reauthorization criteria requiring documented response to therapy. "Other criteria" removed and requests would be reviewed based on FDA indication and the chemotherapy operational policy as is already stated in the policy. Duration of approval changed from "3 months up to 6 months" to 6 months. More recent guidelines were referenced. "Other Criteria" removed as these requests would be reviewed based on NCCN recommendations, per operational policy. Duration of approval changed from "up to 6 months" to 6 months. Position statement updated to include a reference to NCCN Compendium recommendations. Cancer Network (NCCN). Added reauthorization criteria requiring documented response to therapy. "Other Criteria" removed as these requests would be reviewed based on NCCN recommendations, per operational policy. Duration of approval changed from 3 months to 6 months. Cancer Network (NCCN). Removed "Other Criteria" from this policy.
Criteria for immune thrombocytopenia (ITP) and arteritis were added as requests for these off-label uses have become more frequent. This criteria will apply only Rituxan to commercial, Medicaid, and Health Insurance Marketplace lines of business. Criteria will be submitted to CMS and will be effective once approved. Pomalyst Cancer Network (NCCN). Submit to CMS. Yervoy Removed "Other Criteria" from this policy. Gilotrif Cancer Network (NCCN). Submit to CMS. "Other criteria" removed and requests would be reviewed based on FDA indication and the chemotherapy operational policy as is already stated in the Zydelig policy. Duration of approval changed from "3 months up to 6 months" to 6 months. Submit to CMS. Abraxane Prior Authorization policy reactivated New FDA approved indications added: Opdivo 1) in combination with ipilumumab with BRAF V600 wild-type melanoma 2) renal cell carcinoma The following policies was retired: Taxol First Generics to Market Drug/Policy Name Action Taken Tobramycin (Kitabis ) Pak Line extension. Not a true generic, will process as brand non-formulary Nevirapine ER (Viramune XR ) Line extension formulary, non-preferred generic (tier 2) tablet Molindone HCL (Moban ) Line extension non-formulary tablet Repaglinide-metformin Line extension non-formulary for all lines of business (Prandimet ) tablet Linezolid (Zyvox ) suspension Line extension formulary, specialty (tier 6), pending CMS approval Dutasteride-tamsulosin (Jalyn ) Line extension non-formulary capsule Olopatadine (Patanol ) drops Add to formulary, effective April 1 Linezolid (Zyvox ) tablets Now meets generic definition, will process as generic formulary, specialty (tier 6)