Mavyret (glecaprevir-pibrentasvir) — CareFirst (Caremark)

Initial criteria

• Prescriber must be experienced in the management of hepatitis C virus infection
• Member must not have decompensated cirrhosis or moderate/severe hepatic impairment (Child-Pugh class B or C)
• For combination therapy regimens, exclusions for the other antiviral drugs also apply
• For genotype 1 infection:
• • Authorization up to 8 weeks for treatment-naive members without cirrhosis or with compensated cirrhosis
• • Authorization up to 12 weeks for members without or with compensated cirrhosis who failed prior NS3/4A protease inhibitor therapy and have not received an NS5A inhibitor
• • Authorization up to 8 weeks for members without cirrhosis who failed interferon-based regimen with or without ribavirin and have not received an NS3/4A protease inhibitor or NS5A inhibitor
• • Authorization up to 12 weeks for members with compensated cirrhosis who failed interferon-based regimen with or without ribavirin and have not received NS3/4A protease inhibitor or NS5A inhibitor
• • Authorization up to 16 weeks for members without or with compensated cirrhosis who failed prior NS5A inhibitor (excluding glecaprevir/pibrentasvir) and have not received an NS3/4A protease inhibitor OR who failed prior sofosbuvir-based regimen and have not had prior NS5A plus NS3/4A protease inhibitor exposure
• For genotype 3 infection:
• • Authorization up to 8 weeks for treatment-naive without cirrhosis or with compensated cirrhosis
• • Authorization up to 16 weeks for members <18 years without cirrhosis or with compensated cirrhosis who failed prior NS5A inhibitor (excluding glecaprevir/pibrentasvir) and have not received an NS3/4A protease inhibitor
• • Authorization up to 12 weeks for members <18 years without cirrhosis or with compensated cirrhosis who failed prior NS3/4A protease inhibitor and have not received NS5A inhibitor
• • Authorization up to 16 weeks for members without cirrhosis or with compensated cirrhosis who failed prior interferon-based regimen and have not received NS3/4A or NS5A inhibitor, or who failed prior sofosbuvir-based regimen without sofosbuvir/NS5A inhibitor experience or prior NS5A+NS3/4A exposure
• For genotype 4 infection:
• • Authorization up to 8 weeks for treatment-naive without cirrhosis or with compensated cirrhosis
• • Authorization up to 12 weeks for treatment-naive with compensated cirrhosis and HIV coinfection
• • Authorization up to 16 weeks for members <18 years who failed prior NS5A inhibitor (excluding glecaprevir/pibrentasvir) and have not received NS3/4A protease inhibitor
• • Authorization up to 12 weeks for members <18 years who failed prior NS3/4A protease inhibitor and have not received NS5A inhibitor
• • Authorization up to 8 weeks for members without cirrhosis who failed prior interferon-based therapy and have not received NS3/4A or NS5A inhibitor
• • Authorization up to 12 weeks for members with compensated cirrhosis who failed prior interferon-based regimen and have not received NS3/4A or NS5A inhibitor
• • Authorization up to 16 weeks for members without cirrhosis or with compensated cirrhosis who failed prior sofosbuvir-based regimen and have not had prior NS5A plus NS3/4A protease inhibitor exposure
• For genotype 2, 5, or 6 infection:
• • Authorization up to 8 weeks for treatment-naive without cirrhosis or with compensated cirrhosis
• • Authorization up to 16 weeks for members <18 years who failed prior NS5A inhibitor (excluding glecaprevir/pibrentasvir) and have not received NS3/4A protease inhibitor
• • Authorization up to 12 weeks for members <18 years who failed prior NS3/4A protease inhibitor and have not received NS5A inhibitor
• • Authorization up to 8 weeks for members without cirrhosis who failed prior interferon-based regimen and have not received NS3/4A or NS5A inhibitor
• • Authorization up to 12 weeks for members with compensated cirrhosis who failed prior interferon-based regimen and have not received NS3/4A or NS5A inhibitor
• • Authorization up to 16 weeks for members without cirrhosis or with compensated cirrhosis who failed prior sofosbuvir-based regimen and have not had NS5A plus NS3/4A exposure
• For unknown genotype:
• • Authorization up to 8 weeks for treatment-naive without cirrhosis or with compensated cirrhosis who do not have any of the following: compensated cirrhosis with end-stage renal disease (eGFR <30 mL/min), HBsAg positive, current pregnancy, known or suspected hepatocellular carcinoma, or prior liver transplantation
• • Genotype testing required if any of those characteristics are present
• For recurrent HCV infection post liver transplantation:
• • Authorization up to 12 weeks for genotype 1-6 without cirrhosis or with compensated cirrhosis
• • Authorization up to 16 weeks for genotype 1 who failed prior NS5A inhibitor (excluding glecaprevir/pibrentasvir) and have not received NS3/4A protease inhibitor

Approval duration

8 to 16 weeks depending on genotype and prior treatment history