Mavyret (glecaprevir/pibrentasvir) — CareFirst (Caremark)

Initial criteria

• Member must be age ≥ 3 years
• For recurrent HCV genotype 3 infection post liver transplantation without cirrhosis or with compensated cirrhosis who have not received an NS3/4A protease inhibitor or NS5A inhibitor, either: (a) failed prior treatment with peginterferon alfa (PEG-IFN) and ribavirin, OR (b) failed prior treatment with sofosbuvir and ribavirin with or without PEG-IFN
• For kidney transplant recipients: (a) HCV genotype 1–6 infection without cirrhosis or with compensated cirrhosis who are treatment-naïve or who have not failed prior treatment with a direct-acting antiviral (authorization up to 12 weeks), OR (b) HCV genotype 1 infection without cirrhosis or with compensated cirrhosis who failed prior treatment with an NS5A inhibitor (excluding Mavyret) and who have not received an NS3/4A protease inhibitor (authorization up to 16 weeks), OR (c) HCV genotype 3 infection without cirrhosis or with compensated cirrhosis who have not received an NS3/4A protease inhibitor or NS5A inhibitor and either failed prior PEG-IFN plus RBV, or failed prior sofosbuvir plus RBV with or without PEG-IFN (authorization up to 16 weeks)
• For organ recipients from HCV-viremic donors: (a) liver transplant from HCV-viremic donor – authorization up to 12 weeks total, (b) non-liver organ transplant – authorization up to 8 weeks total if treatment initiated within first week after transplant, OR (c) authorization up to 12 weeks total if treatment initiated more than one week after transplant
• For HCV infection in combination with sofosbuvir and ribavirin: (a) authorization up to 16 weeks total for members with HCV genotype 1–6 infection without cirrhosis or with compensated cirrhosis AND either failure with Mavyret (authorization up to 24 weeks following failure with sofosbuvir + Mavyret) OR failure with sofosbuvir/velpatasvir/voxilaprevir (Vosevi) (authorization up to 24 weeks for extremely difficult cases such as genotype 3 with cirrhosis)
• For HCV and HIV coinfection: authorization may be granted when criteria for approval of the requested regimen above are met
• Hepatitis B virus screening is required
• Treatment readiness and fibrosis assessment documentation may be requested

Reauthorization criteria

• Continuation of therapy may be approved when member continues to meet all initial coverage criteria

Approval duration

8–24 weeks total, depending on genotype, transplant status, and prior treatment history