Sovaldi (sofosbuvir) — United Healthcare

Initial criteria

• Used in combination with ribavirin with or without peginterferon alfa
• Diagnosis of chronic hepatitis C genotype 1 or 4 infection AND used in combination with ribavirin AND one of the following: used in combination with peginterferon alfa OR (patient is ineligible for peginterferon alfa therapy AND patient has genotype 1 infection) AND patient has not experienced failure with a previous treatment regimen that includes Sovaldi AND patient is without decompensated liver disease (e.g., Child-Pugh B or C)
• Diagnosis of chronic hepatitis C genotype 2 or 3 infection AND used in combination with ribavirin AND patient has not experienced failure with a previous treatment regimen that includes Sovaldi
• Diagnosis of chronic hepatitis C genotype 1, 2, 3, or 4 infection AND one of the following: diagnosis of hepatocellular carcinoma OR patient has decompensated liver disease (e.g., Child-Pugh Class B or C) AND patient is an active candidate on the waiting list for a liver transplant AND used in combination with ribavirin AND patient has not experienced failure with a previous treatment regimen that includes Sovaldi

Approval duration

Genotype 1 or 4 with peginterferon alfa and ribavirin: 12 weeks; Genotype 1 with ribavirin and ineligible for peginterferon alfa: 24 weeks; Genotype 2 with ribavirin: 12 weeks; Genotype 3 with ribavirin: 24 weeks; Genotype 1, 2, 3, or 4 with ribavirin and hepatocellular carcinoma OR decompensated liver disease awaiting liver transplantation: 48 weeks