Mavyret (glecaprevir/pibrentasvir) — Blue Cross Blue Shield of Texas

Preferred products

• Harvoni (ledipasvir/sofosbuvir)
• Ledipasvir/Sofosbuvir

Initial criteria

• The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• ONE of the following: (A) The patient is treatment naive OR (B) The patient was previously treated with ONLY peginterferon and ribavirin with or without an HCV protease inhibitor OR (C) The patient has decompensated cirrhosis AND
• If the patient has an FDA labeled indication, ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication and agent OR (B) There is support for the use of the requested agent for the patient’s age [medical records required] AND
• The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• If HBV screening was positive, the prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment AND
• If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment naive vs experienced, previous treatment), then ONE of the following applies: (A) Member type exceptions OR (B) Requested agent is a preferred agent OR (C) Patient has been treated with requested non-preferred agent in the past 30 days OR (D) Patient is currently stable on the requested non-preferred agent [chart notes required] OR (E) Tried and had an inadequate response to ALL preferred agents [chart notes required] OR (F) ALL preferred agents discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR (G) Intolerance or hypersensitivity to ALL preferred agents [chart notes required] OR (H) FDA labeled contraindication to ALL preferred agents [chart notes required] OR (I) ALL preferred agents expected to be ineffective or cause adherence barrier, worsen comorbid condition, or harm [chart notes required] OR (J) ALL preferred agents not in best interest of patient based on medical necessity [chart notes required] OR (K) The patient has tried another drug in same class and discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR (L) There is clinical support for use of requested non-preferred agent over 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 patient is treatment naive AND The patient does not have cirrhosis or has compensated cirrhosis AND The requested agent is supported in AASLD guidelines for simplified treatment AND The patient meets all qualifications for AASLD simplified treatment per policy tables 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 1 (FDA labeling) or 2 (AASLD/IDSA guidelines for decompensated cirrhosis) AND
• The requested length of therapy does not exceed duration noted in Table 1 or 2 for the patient’s regimen

Approval duration

6 months (BCBSIL and BCBSMT) or up to duration of treatment (other plans; ≥12 weeks for BCBSNM)