Zepatier (elbasvir/grazoprevir) — Blue Cross Blue Shield of Montana

Preferred products

• Mavyret (glecaprevir/pibrentasvir)
• Epclusa (sofosbuvir/velpatasvir)

Initial criteria

• Screening for HBV was positive for current or prior HBV infection, and prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment with the requested agent
• If the patient has an FDA labeled indication, then ONE of the following: (A) Patient age is within FDA labeling for the requested indication and agent OR (B) Support for use for patient’s age and indication
• If client has preferred agent(s) for patient’s specific factors (e.g., age, genotype, cirrhosis, treatment-naive vs experienced, previous treatment), then ONE of the following: (A) Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) Requested agent is a preferred agent for patient’s specific factors OR (C) Patient has been treated with requested non-preferred agent in the past 30 days OR (D) Patient currently stable on requested non-preferred agent [chart notes required] OR (E) Patient has tried and had inadequate response to ALL preferred agents [chart notes required] OR (F) ALL preferred agents discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR (G) Patient has intolerance or hypersensitivity to ALL preferred agents [chart notes required] OR (H) Patient has FDA labeled contraindication to ALL preferred agents OR (I) ALL preferred agents expected to be ineffective or cause barrier to adherence or worsen comorbid condition or cause adverse reaction [chart notes required] OR (J) ALL preferred agents not in best interest of patient based on medical necessity [chart notes required] OR (K) Patient tried another drug in same pharmacologic class or mechanism as all preferred agents and discontinued due to lack of efficacy or adverse event [chart notes required] OR (L) Support for use of requested non-preferred agent over preferred agents
• ONE of the following: (A) Prescriber is a specialist in area of diagnosis (gastroenterology, hepatology, infectious disease) OR (B) ALL of the following: (1) Patient is treatment-naïve AND (2) Patient does not have cirrhosis or has compensated cirrhosis AND (3) Requested agent supported in AASLD guidelines for simplified treatment AND (4) Patient meets all qualifications for simplified HCV treatment
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Patient meets all requirements and will use requested agent in a regimen noted in Table 3 (FDA labeling) or Table 4 (AASLD/IDSA guidelines for decompensated cirrhosis)
• Requested length of therapy does NOT exceed duration per Table 3 or Table 4

Approval duration

6 months (BCBSIL and BCBSMT); others up to duration of treatment in Table 3 or 4