sofosbuvir-velpatasvir — CareFirst (Caremark)

Initial criteria

• Member must be 3 years of age or older
• Medication must be prescribed by or in consultation with a provider experienced in the management of hepatitis C virus infection
• For HCV infection without ribavirin — genotype 1, 2, 3, 4, 5, or 6: Authorization up to 12 weeks for members 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 without cirrhosis or with compensated cirrhosis: Authorization up to 12 weeks if failed prior interferon-based regimen with or without ribavirin and no prior NS3/4A protease inhibitor or NS5A inhibitor, OR failed prior sofosbuvir-based regimen and have not received a protease or NS5A inhibitor
• For unknown or undetermined genotype without cirrhosis: Authorization up to 12 weeks if treatment-naïve and member is not hepatitis B surface antigen positive, not pregnant, no known or suspected hepatocellular carcinoma, and no prior liver transplantation (genotype testing required if any characteristics present)
• For decompensated cirrhosis (CTP class B or C): Authorization up to 24 weeks if documented anemia (Hgb <10 g/dL) or ribavirin ineligibility
• For recurrent HCV infection post-liver transplantation: Authorization up to 12 weeks if genotype 1–6 without cirrhosis or with compensated cirrhosis
• For kidney transplant recipients: Authorization up to 12 weeks for genotype 1–6 infection without cirrhosis or with compensated cirrhosis who are treatment-naïve or have not failed prior DAA
• For organ recipients from HCV-viremic donors: Authorization up to 12 weeks following liver or non-liver organ transplant
• For HCV infection in combination with ribavirin — genotype 3 with Y93H substitution and compensated cirrhosis: Authorization up to 12 weeks for treatment-naïve
• For decompensated cirrhosis (CTP class B or C) with HCV genotype 1–6 infection: Authorization up to 12 weeks if treatment-naïve; authorization up to 24 weeks if failed prior treatment with sofosbuvir- or NS5A inhibitor–based regimen
• For recurrent HCV infection post-liver transplantation and decompensated cirrhosis: Authorization up to 12 weeks for treatment-naïve; authorization up to 24 weeks if treatment experienced
• For HCV/HIV coinfection: Authorization may be granted when criteria above are met

Reauthorization criteria

• All members requesting continuation of therapy must continue to meet initial coverage criteria

Approval duration

Up to 12 or 24 weeks total depending on indication as specified