Mavyret (glecaprevir/pibrentasvir) — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
• 2. If genotype 1, the prescriber has provided the patient’s subtype AND
• 3. The patient is NOT treatment naive AND
• 4. The patient has NOT been previously treated with the requested agent AND
• 5. 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
• 6. The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
• 7. 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
• 8. If the client has preferred agent(s) for the patient’s specific factors (e.g., age, genotype, cirrhosis status, treatment naive vs treatment experienced, previous treatment), 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 has been treated with the requested non-preferred agent in the past 30 days OR E. The patient is currently being treated with the requested non-preferred agent and the patient is currently stable on the requested non-preferred agent [chart notes required] OR F. The patient has tried and had an inadequate response to ALL of the preferred agent(s) for the patient’s specific factors [chart notes required] OR G. ALL of the preferred agent(s) for the patient’s specific factors was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR H. The patient has an intolerance or hypersensitivity to ALL of the preferred agent(s) for the patient’s specific factors [chart notes required] OR I. The patient has an FDA labeled contraindication to ALL of the preferred agent(s) for the patient’s specific factors [chart notes required] OR J. ALL of the preferred agent(s) for the patient’s specific factors are expected to be ineffective based on known clinical characteristics or cause adherence barrier/adverse reaction/functional harm [chart notes required] OR K. ALL of the preferred agent(s) for the patient’s specific factors are not in the best interest of the patient based on medical necessity [chart notes required] OR L. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as ALL of the preferred agent(s) for the patient’s specific factors and that prescription drug was discontinued due to lack of efficacy, effectiveness, diminished effect, or an adverse event [chart notes required] OR M. There is support for the use of the requested non-preferred agent over the preferred agent(s) AND
• 9. 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 a specialist in the area of the patient’s diagnosis 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 the qualifications for AASLD guidelines simplified treatment
• 10. The patient does NOT have any FDA labeled contraindications to the requested agent AND
• 11. The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 9 AND
• 12. The requested length of therapy does NOT exceed the length of therapy noted in Table 9 (FDA labeling)

Approval duration

6 months (BCBSIL and BCBSMT); ≥12 weeks (BCBSNM); up to duration in Table 9