Harvoni — CareFirst (Caremark)

Initial criteria

• Prescribed by or in consultation with a provider experienced in the management of hepatitis C virus infection
• Member age ≥ 3 years
• For genotype 1 infection (without ribavirin):
• - Authorization of up to 12 weeks total may be granted for treatment‑naïve members with compensated cirrhosis
• - Authorization of up to 12 weeks total may be granted for treatment‑naïve members without cirrhosis when any of the following are met: member age < 18 years OR HIV co‑infection OR pre‑treatment HCV RNA ≥ 6 million IU/mL
• - Authorization of up to 8 weeks total may be granted for treatment‑naïve members without cirrhosis who have pre‑treatment HCV RNA < 6 million IU/mL and do not have HIV co‑infection
• - Authorization of up to 12 weeks total may be granted for members without cirrhosis who failed prior treatment with PEG‑IFN ± ribavirin ± HCV protease inhibitor
• - Authorization of up to 24 weeks total may be granted for members with compensated cirrhosis who failed prior treatment with PEG‑IFN ± ribavirin ± HCV protease inhibitor
• For genotype 4 or 5 infection: Authorization of up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis who are treatment‑naïve or who failed prior treatment with PEG‑IFN ± ribavirin ± HCV protease inhibitor
• For genotype 6 infection: Authorization of up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis when member is treatment‑naïve and does not have genotype 6e subtype OR has failed prior PEG‑IFN ± ribavirin ± HCV protease inhibitor
• For decompensated cirrhosis (CTP class B or C): Authorization of up to 24 weeks total may be granted for members with genotype 1, 4, 5, or 6 infection and documented anemia (baseline hemoglobin <10 g/dL) or ribavirin ineligibility
• For recurrent HCV infection post liver transplantation: Authorization of up to 12 weeks total may be granted for members with recurrent genotype 1, 4, 5, or 6 infection post‑transplant without cirrhosis or with compensated cirrhosis
• For kidney transplant recipients: Authorization of up to 12 weeks total may be granted for members with genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis who are treatment‑naïve or have not failed prior direct‑acting antiviral therapy
• For combination with ribavirin: see below
• For genotype 1 infection with compensated cirrhosis who failed prior PEG‑IFN ± ribavirin ± HCV protease inhibitor, authorization up to 12 weeks
• For decompensated cirrhosis (CTP class B or C): authorization up to 12 weeks for members with genotype 1, 4, 5, or 6 infection; up to 24 weeks for those who failed prior sofosbuvir‑based regimen
• For recurrent infection post‑liver transplant: authorization up to 12 weeks for treatment‑naïve members with recurrent genotype 1, 4, 5, or 6 infection and decompensated cirrhosis; up to 24 weeks for treatment‑experienced members; up to 12 weeks for genotype 1 or 4 infection post‑transplant without cirrhosis or with compensated cirrhosis who are treatment‑naïve or failed prior PEG‑IFN ± ribavirin ± HCV protease inhibitor
• For HCV and HIV coinfection: Authorization when all criteria for the requested regimen above are met

Reauthorization criteria

• Continuation of therapy may be authorized when all initial coverage criteria are still met

Approval duration

Up to 8, 12, or 24 weeks total depending on genotype, treatment status, and cirrhosis status