Skip to content
The Policy VaultThe Policy Vault

Harvoni (ledipasvir/sofosbuvir) — Blue Cross Blue Shield of Oklahoma

hepatitis C genotype 4

Preferred products

  • Harvoni (ledipasvir/sofosbuvir)
  • Ledipasvir/Sofosbuvir

Initial criteria

  • The patient has a diagnosis of hepatitis C genotype 1, 2, 3, 4, 5, or 6 AND
  • ONE of the following: (A) The patient is treatment naive OR (B) The patient was previously treated with ONLY peginterferon and ribavirin with or without an HCV protease inhibitor OR (C) The patient has decompensated cirrhosis AND
  • If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication OR (B) There is support for the use of the requested agent for the patient’s age [medical records required] AND
  • The prescriber has screened the patient for current or prior hepatitis B viral (HBV) infection AND
  • If the screening for HBV was positive, the prescriber will monitor the patient for HBV flare-up or reactivation during and after treatment AND
  • If the client has preferred agent(s) for the patient’s specific factors, then ONE of the following applies: request type, prior use, intolerance, hypersensitivity, contraindication, ineffectiveness, adherence barrier, comorbid worsening, or medical necessity must be met [chart notes required] AND
  • ONE of the following: (A) The prescriber is a specialist (gastroenterologist, hepatologist, infectious disease) or has consulted with one OR (B) Treatment naive, no or compensated cirrhosis, requested agent supported in AASLD guidelines for simplified treatment, and patient meets all simplified treatment qualifications AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • The patient meets all requirements and will use the requested agent in a treatment regimen noted in Table 1 (FDA labeling) or Table 2 (AASLD/IDSA guidelines for decompensated cirrhosis) AND
  • The requested length of therapy does NOT exceed that in Table 1 or 2 for the patient’s treatment regimen

Approval duration

6 months (BCBSIL/MT) or up to treatment duration per Tables 1–2 (≥12 weeks for BCBSNM)