sofosbuvir-velpatasvir — CareFirst (Caremark)

Initial criteria

• Medication must be prescribed by or in consultation with a provider experienced in the management of hepatitis C virus infection
• Member must be age ≥ 3 years
• For treatment without ribavirin: Authorization up to 12 weeks may be granted for genotype 1-6 infection without cirrhosis or with compensated cirrhosis who are treatment-naïve or who failed prior treatment with peginterferon alfa and ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)
• For members < 18 years of age without cirrhosis or with compensated cirrhosis: must have failed prior interferon-based regimen with or without ribavirin and not received NS3/4A or NS5A inhibitor, OR failed prior sofosbuvir-based regimen and not received NS3/4A or NS5A inhibitor
• For members with unknown or undetermined genotype without cirrhosis: authorization up to 12 weeks may be granted if treatment-naïve and no HBsAg positivity, not pregnant, no known or suspected hepatocellular carcinoma, and no prior liver transplantation (genotype testing required if any of these characteristics present)
• For members with decompensated cirrhosis (Child Turcotte Pugh class B or C): authorization up to 24 weeks may be granted for genotype 1-6 infection with documented anemia (baseline hemoglobin <10 g/dL) or ribavirin ineligibility
• For recurrent HCV infection post liver transplantation without cirrhosis or with compensated cirrhosis: authorization up to 12 weeks may be granted for genotype 1-6 infection
• For kidney transplant recipients with genotype 1-6 infection without cirrhosis or with compensated cirrhosis who are treatment-naïve or not failed prior direct-acting antiviral: authorization up to 12 weeks may be granted
• For organ recipients from HCV-viremic donors: authorization up to 12 weeks may be granted for those who received a liver or non-liver organ
• For treatment with ribavirin: authorization up to 12 weeks may be granted for genotype 3 infection in treatment-naïve members with compensated cirrhosis and Y93H substitution associated with velpatasvir resistance
• For decompensated cirrhosis (CTP class B or C) with ribavirin combination: authorization up to 12 weeks may be granted for treatment-naïve genotype 1-6 infection, or up to 24 weeks for members who failed prior sofosbuvir- or NS5A inhibitor-based regimen
• For recurrent HCV infection post liver transplantation with decompensated cirrhosis: authorization up to 12 weeks for treatment-naïve members, or up to 24 weeks for treatment-experienced members

Reauthorization criteria

• All members requesting continuation of therapy must meet all requirements in the coverage criteria

Approval duration

Up to 12 or 24 weeks total depending on genotype, treatment experience, and clinical situation