New pharmacy policies
Effective February 1, 2025
Gene Therapies for Rare Diseases, 5.01.644 PBC | Premera HMO
New policy
- In accordance with Alaska law (HB 226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Briumvi, Lemtrada, Ocrevus, Ocrevus Zunovo, Tyruko, and Tysabri moved from Pharmacotherapy of Multiple Sclerosis, 5.01.565 to 5.01.644
- Clarified that the medications listed in this policy are subject to the product’s FDA dosage and administration prescribing information
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Revised pharmacy policies
Effective February 1, 2025
Drugs for Weight Management, 5.01.621 PBC | Premera HMO
Medical necessity criteria added/updated
- Adult weight-related comorbid condition criteria updated to include asthma, cardiovascular disease, COPD, coronary artery disease, dyslipidemia, hypertension, knee osteoarthritis, metabolic-dysfunction associated steatotic liver disease/non-alcoholic fatty liver disease, obstructive sleep apnea, polycystic ovarian syndrome, and type 2 diabetes mellitus
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Dupixent (dupilumab), 5.01.575 PBC | Premera HMO
Medical necessity criteria added/updated
- Dupixent (dupilumab) asthma criteria updated eosinophil count from 300 cells/mcL within the last 12 months to 150 cells/mcL within the last 12 months
- Criteria added for new indication, treatment of chronic obstructive pulmonary disease (COPD) certain individuals when criteria are met
- Age requirement updated from 18 years and older to 12 years and older for the treatment of chronic rhinosinusitis with nasal polyps
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
IL-5 Inhibitors, 5.01.559 PBC | Premera HMO
Medical necessity criteria added/updated
- In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Receiving treatment for CRS exception added to site-of-service requirements
- Nucala (mepolizumab), Fasenra (benralizumab), and Cinqair (reslizumab) asthma criteria updated eosinophil count from 300 cells/mcL within the last 12 months to 150 cells/mcL within the last 12 months
- Fasenra (benralizumab) criteria updated to include the treatment of certain individuals with eosinophilic granulomatosis with polyangiitis
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Immune Checkpoint Inhibitors, 5.01.591 PBC | Premera HMO
Medical necessity criteria updated
- In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Imfinzi (durvalumab) for the treatment of adults with limited-stage small cell lung cancer (SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy and Imfinzi is used as a single agent.
- Keytruda (pembrolizumab) for the treatment of unresectable advanced or metastatic malignant pleural mesothelioma as first-line treatment in adults when used in combination with pemetrexed and platinum chemotherapy
- Opdivo (nivolumab) for the treatment of resectable non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements in the neoadjuvant setting, in combination with platinum-doublet chemotherapy, followed by single-agent nivolumab as adjuvant treatment after surgery
- Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy for the first-line treatment of microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer
- Tevimbra (tislelizumab-jsgr) for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1) when used in combination with platinum and fluoropyrimidine-based chemotherapy
Drug/medical necessity criteria added
- Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which is a SC dosage form of Tecentriq (atezolizumab), to policy for the treatment of NSCLC, SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Medical Necessity Criteria for Pharmacy Edits, 5.01.605 PBC | Premera HMO
Drug/medical necessity criteria added
- Cobenfy (xanomeline and trospium chloride) and Opipza (aripiprazole oral film) added to Antipsychotics, Second Generation
- Arikayce (amikacin liposome) for the treatment of Mycobacterium avium complex lung disease
- Akynzeo (netupitant and palonosetron), Emend (aprepitant), Sancuso (granisetron transdermal system), and Varubi (rolapitant) added to new section titled ‘Cancer Related Antiemetics’
- Zelapar (selegiline) added to Parkinson’s Disease Agents
- TobraDex ST (tobramycin and dexamethasone ophthalmic suspension) added to Brand Ophthalmic Corticosteroids
- Kyzatrex (testosterone capsules) and Undecatrex (testosterone capsules) added to Testosterone Replacement Products
Drug/medical necessity criteria removed
- Gout drugs brand colchicine, Gloperba (colchicine), Mitigare (colchicine), Uloric (febuxostat), and Zyloprim (allopurinol) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Gout, 5.01.616
- Rezdiffra (resmetirom) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases, 5.01.615
Drug/medical necessity criteria updated
- Apokyn (apomorphine) criteria updated to require a trial and inadequate response to generic apomorphine first
- Xadago (safinamide) updated to include selegiline as a qualifying prerequisite drug
- Re-authorization criteria for Xdemvy (lotilaner) updated to allow for retreatment of Demodex blepharitis after greater than or equal to 1 year since completing a prior treatment course
- Testosterone Replacement Products updated to limit use to individuals assigned male at birth or individuals assigned female at birth for the treatment of gender dysphoria-
- Zemplar (paricalcitol) criteria updated to require a trial and inadequate response to generic paricalcitol first
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases, 5.01.615 PBC | Premera HMO
Medical necessity criteria added
- Livdelzi (seladelpar) for the treatment of primary biliary cholangitis when criteria are met
- Rezdiffra (resmetirom) moved from Medical Necessity Criteria for Pharmacy Edits 5.01.605 to Policy 5.01.615 Pharmacologic Treatment of Chronic Non-Infectious Liver Diseases
Medical necessity criteria updated
- Iqirvo and Ocaliva criteria updated to exclude combination use with Livdelzi
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacologic Treatment of Gout, 5.01.616 PBC | Premera HMO
Medical necessity criteria added
- Gout drugs brand colchicine, Gloperba (colchicine), Mitigare (colchicine), Uloric (febuxostat), and Zyloprim (allopurinol) moved from Medical Necessity Criteria for Pharmacy Edits, 5.01.605 to Pharmacologic Treatment of Gout, 5.01.616
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacologic Treatment of Transthyretin-Mediated Amyloidosis, 5.01.593 PBC | Premera HMO
Medical necessity criteria updated
- Vyndamax (tafamidis) and Vyndaqel (tafamidis meglumine) criteria updated for the diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), removed New York Heart Association class IV heart failure as exclusion, updated the assessment of cardiac involvement and history of heart failure, added inclusion of a 6MWT requirement and added quantity limits
Medical necessity criteria added
- Attruby (acoramidis) for the treatment of ATTR-CM when criteria are met
Medical necessity criteria removed
- Tegesdi (inotersen) removed as the product was withdrawn from the market by the manufacturer
Investigational criteria added
- Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacotherapy of Arthropathies, 5.01.550 PBC | Premera HMO
Medical necessity criteria added/updated
- In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Receiving treatment for cytokine release syndrome (CRS) exception added to site-of-service requirements
- Age requirements per prescribing information added to all criteria throughout policy
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563 PBC | Premera HMO
Medical necessity criteria added/updated
- In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Site of service requirements removed from Stelara (ustekinumab) IV and Skyrizi (risankizumab-rzaa) IV
- Receiving treatment for CRS exception added to site-of-service requirements
- Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564 PBC | Premera HMO
Medical necessity criteria added/updated
- In accordance with Alaska law (HB226), site of service is not applicable to fully-insured members in Alaska; instead refer to the infusion drug medical necessity criteria only
- Receiving treatment for CRS exception added to site-of-service requirements
- Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated
- Actemra (tocilizumab) IV, Tofidence (tocilizumab-bavi) IV, and Tyenne (tocilizumab-aazg) IV CRS criteria to indicate that coverage is medically necessary if CRS is treatment-induced (not limited to CAR-T products) and grade 3 or 4
- Kineret (anakinra) criteria updated to include treatment of CRS in certain individuals
- Niktimvo (axatilimab-csfr) added for the treatment of chronic graft versus host disease after failure of at least two prior lines of systemic therapy when criteria are met
- Fabhalta (iptacopan) added to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgaN) at risk of rapid disease progression when criteria are met
- Clarified the Filspari (sparsentan) is for slowing kidney function decline in adults with primary IgAN who are at risk for disease progression
- Tarpeyo (budesonide) urine protein-to-creatinine ratio updated from ≥1.5 g/g to ≥0.8 g/g or proteinuria ≥1 g/day
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacotherapy of Multiple Sclerosis, 5.01.565 PBC | Premera HMO
Drug removed
- Extavia (interferon-beta 1b) removed throughout policy as it has been withdrawn from the market
Medical necessity criteria added/updated
- Prescriber requirements added to all products throughout policy
- Age requirements per prescribing information added to all criteria throughout policy where age criteria are not already explicitly stated
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months
Pharmacotherapy of Type I and Type II Diabetes Mellitus, 5.01.569 PBC | Premera HMO
Medical necessity criteria updated
- Removed Bydureon as product has been discontinued (Bydureon BCise is still available)
- Sitagliptin added as a non-preferred Dipeptidyl Peptidase IV (DPP-4) Inhibitors
- Sitagliptin-metformin and Zituvimet XR (sitagliptin-metformin extended-release) added as non-preferred DPP-4 and biguanide combinations
Length of approval criteria added
- Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months