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Harvoni (ledipasvir/sofosbuvir tablets and oral pellets)Cigna

Recurrent Hepatitis C Virus (HCV) Post-Liver Transplantation, Genotypes 1, 4, 5, or 6

Initial criteria

  • For Chronic HCV, Genotype 1: Patient is ≥ 3 years of age AND meets one of the genotype-specific treatment conditions described (with or without cirrhosis, prior treatment experience, and ribavirin eligibility) AND the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.
  • For Chronic HCV, Genotypes 4, 5, or 6: Patient is ≥ 3 years of age AND the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.
  • For Recurrent HCV Post-Liver Transplantation, Genotypes 1 or 4: Patient is ≥ 3 years of age AND has recurrent HCV after a liver transplantation AND the medication will be prescribed in combination with ribavirin AND the prescriber is affiliated with a transplant center and is a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.
  • For Recurrent HCV Post-Liver Transplantation, Genotypes 5 or 6: Patient is ≥ 18 years of age AND has recurrent HCV after a liver transplantation AND the medication will be prescribed in combination with ribavirin AND the prescriber is affiliated with a transplant center and is a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.
  • For HCV in Kidney Transplant Recipients, Genotypes 1 or 4: Patient is ≥ 18 years of age AND is a kidney transplant recipient with HCV AND the prescriber is affiliated with a transplant center and is a gastroenterologist, hepatologist, infectious diseases physician, nephrologist, liver transplant physician, or renal transplant physician.
  • For patients already started on ledipasvir/sofosbuvir: Patient has been started on therapy for an indication listed above AND approve for remainder of course to complete prescribed duration.

Approval duration

12 or 24 weeks (as indicated by clinical scenario); continuation approvals for remaining course