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Harvoni (ledipasvir/sofosbuvir) — United Healthcare

chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection

Preferred products

  • Epclusa

Initial criteria

  • For genotype 1 infection, treatment‑naive without cirrhosis and pre‑treatment HCV RNA < 6 million IU/mL:
  • • Diagnosis of chronic hepatitis C genotype 1 infection
  • • Patient is treatment‑naive (no previous failure with peginterferon + ribavirin ± an HCV protease inhibitor or Sovaldi)
  • • Laboratory report of pre‑treatment HCV RNA < 6 million IU/mL
  • • Provider attests patient demonstrates treatment readiness (adherence ability)
  • • Not used in combination with another HCV direct acting antiviral (e.g., Sovaldi)
  • Authorization will be issued for 8 weeks.
  • For genotype 1 infection, treatment‑naive without cirrhosis and HCV RNA ≥ 6 million IU/mL OR compensated cirrhosis (Child‑Pugh A):
  • • Diagnosis of chronic hepatitis C genotype 1 infection
  • • Treatment‑naive (as above)
  • • Either: (i) without cirrhosis and HCV RNA ≥ 6 million IU/mL OR (ii) with compensated cirrhosis (Child‑Pugh A)
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR currently on Harvoni therapy
  • Authorization will be issued for 12 weeks.
  • For genotype 1 infection, treatment‑naive or ‑experienced with decompensated cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 1 infection
  • • Either treatment‑naive or prior failure with peginterferon + ribavirin ± HCV protease inhibitor or Sovaldi
  • • Decompensated liver disease (Child‑Pugh B or C) AND used with ribavirin
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 12 weeks.
  • For genotype 1 infection, treatment‑experienced without cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 1 infection
  • • Prior treatment failure with peginterferon + ribavirin ± HCV protease inhibitor or Sovaldi
  • • Without cirrhosis
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 12 weeks.
  • For genotype 1 infection, treatment‑experienced with compensated cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 1 infection
  • • Prior treatment failure (as above)
  • • Compensated cirrhosis (Child‑Pugh A)
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 24 weeks.
  • For genotype 1 or 4 infection, liver transplant recipients (treatment‑naive or ‑experienced) without cirrhosis or compensated cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 1 or 4 infection
  • • Either treatment‑naive or prior failure with peginterferon + ribavirin ± HCV protease inhibitor or Sovaldi
  • • Liver transplant recipient AND used with ribavirin
  • • Without cirrhosis OR compensated cirrhosis (Child‑Pugh A)
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 12 weeks.
  • For genotype 4, 5, or 6 infection, treatment‑naive or ‑experienced without cirrhosis or with compensated cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 4, 5, or 6 infection
  • • Without cirrhosis OR compensated cirrhosis (Child‑Pugh A)
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 12 weeks.
  • For genotype 1, 4, 5, or 6 infection, kidney transplant recipients (treatment‑naive or non‑direct acting antiviral experienced) without cirrhosis or compensated cirrhosis:
  • • Diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6 infection
  • • Either treatment‑naive or not previously treated with a direct acting antiviral (e.g., Sovaldi)
  • • Kidney transplant recipient
  • • Without cirrhosis OR compensated cirrhosis (Child‑Pugh A)
  • • Provider attests treatment readiness
  • • Not used with another HCV direct acting antiviral
  • • History of intolerance/contraindication to Epclusa OR current Harvoni use
  • Authorization will be issued for 12 weeks.

Approval duration

8–24 weeks depending on genotype and cirrhosis/experience status