Mavyret (glecaprevir/pibrentasvir) — Blue Cross Blue Shield of Montana
hepatitis C genotype 1, 2, 3, 4, 5, or 6
Initial criteria
- The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
- If genotype 1, the prescriber has provided the patient’s subtype AND
- The patient is NOT treatment naive AND
- The patient has NOT been previously treated with the requested agent AND
- If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for the use of the requested agent for the patient’s age for the requested indication AND
- The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
- If the screening for HBV was positive for current or prior HBV infection, the prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment with the requested agent AND
- If the client has preferred agent(s) for the patient’s specific factors, then ONE of the following: (A) The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR (B) The patient has been treated with the requested non-preferred agent in the past 30 days OR (C) The requested agent is a preferred agent for the patient’s specific factors OR (D) The patient is currently being treated with the requested non-preferred agent and is currently stable on it OR (E) The patient has tried and had an inadequate response to ALL of the preferred agent(s) for the patient’s specific factors OR (F) The preferred agents were discontinued due to lack of efficacy or adverse event OR (G) The patient has an intolerance or hypersensitivity to all preferred agents OR (H) The patient has an FDA labeled contraindication to all preferred agents OR (I) The preferred agents are expected to be ineffective, cause adherence barriers, worsen comorbidity, or cause harm OR (J) The preferred agents are not in the best interest of the patient based on medical necessity OR (K) The patient has tried another drug in the same class or mechanism with inadequate response or adverse event OR (L) There is support for the requested non‑preferred agent over the preferred agents AND
- ONE of the following: (A) The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, hepatologist, or infectious disease) or has consulted with one OR (B) ALL of the following: (1) The patient is treatment naive; AND (2) The patient does NOT have cirrhosis or has compensated cirrhosis; AND (3) The requested agent is supported in AASLD guidelines for simplified treatment; AND (4) The patient meets all qualifications for simplified treatment as noted (see Table). AND
- The patient does NOT have any FDA labeled contraindications to the requested agent AND
- The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 9 AND
- The requested length of therapy does NOT exceed the Table 9 duration per FDA labeling
Approval duration
6 months (BCBSIL and BCBSMT); duration per Table 9 for others