sofosbuvir and ledipasvir (Harvoni®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of chronic hepatitis C, genotype 1, 4, 5, 6 - with or without Ribavirin per FDA approved dosing.

All of the following must be met as a condition for coverage:

  • Patient must have compensated liver disease by fibroscan ultrasound or biopsy, documenting stage 2, 3 or stage 4.  Acitest-Fibrotest is not accepted as documentation.
  • Resistance testing must be included with the prior authorization request for genotype 1.
    • Treatment failure associated with HCV resistance to newly developed direct-acting antiviral agents is not an uncommon occurrence and poses a substantial problem to clinicians trying to re-treat patients who have failed available interferon-free treatments.

This Medication is Not Approvable for the following condition(s):

  • Patients with Stage 0 or Stage 1 fibrosis
  • Patients who have failed/relapsed on sofosbuvir plus simeprevir or ribavirin
  • Any condition not listed above as an approved indication

Duration of Therapy:

Fibrosis

  • Stage 1 none or mild peri-portal fibrosis – not approvable
  • Stage 2 peri-portal fibrosis with/without extension and portal-portal bridging – approvable
  • Stage 3 portal-central bridges but no nodular formation - approvable
  • Stage 4 definite cirrhosis – approvable
  • Treatment naïve stage 3, viral load less than 6 M IU   8 weeks
  • Treatment naïve stage 3, viral load greater than 6 M IU or stage 4  12 weeks
  • Treatment failure* stage 3   12 weeks
  • Treatment failure* stage 4  24 weeks

Dosing:

  • Genotype 1, treatment-naive without cirrhosis or with compensated cirrhosis (Child-Pugh class A) - Harvoni (90 mg/400 mg)  daily for 12 weeks.
  • Genotype 1, treatment-experienced without cirrhosis - Harvoni (90 mg/400 mg) daily for 12 weeks.
  • Genotype 1, treatment-experienced with compensated cirrhosis (Child-Pugh class A) - Harvoni (90 mg/400 mg) daily for 24 weeks.
  • Genotype 1, treatment-experienced with decompensated cirrhosis (Child-Pugh class B or C) - Harvoni (90 mg/400 mg) once daily for 12 weeks in combination with ribavirin.
  • Genotype 1 or 4 - treatment-naive and treatment-experienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh class A) - Harvoni (90 mg/400 mg) once daily for 12 weeks in combination with ribavirin.
  • Genotype 4, 5, or 6 - treatment-naive and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh class A) - Harvoni (90 mg/400 mg) once daily for 12 weeks.
  • *Treatment failure/relapse with non-sofosbuvir drug regimens

 

Last review date: September 4, 2018