Indications for Prior Authorization:
- Treatment of adult patients with Chronic Hepatitis C (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have:
- Genotype 1, 2, 3, 4, 5, or 6 infection previously treated with an HCV regimen containing an NS5A inhibitor, AND
- Genotype 1a or 3 infection who have been previously treated with an HCV regimen containing Sovaldi (sofosbuvir) without a NS5A inhibitor
All of the following must be met as a condition for coverage:
- Patients must have fibrosis stage 2, 3, or 4 by fibroscan ultrasound or biopsy. Actitest-Fibrotest is not accepted as documentation.
- Resistance testing must be included with the prior authorization request for genotype 1 and 3.
- 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):
- Hepatitis C Virus (HCV) [any genotype], combination with any other Direct-Acting Antivirals (DAAs)
- Pediatric patient (age <18 years)
- Patients with Stage 0 or Stage 1 fibrosis
- Any condition not listed above as an approved indication
- Sofobuvir 400 mg/Velpatasvir 100 mg/Voxilaprevir 100 mg (1 tablet) once daily
Duration of Therapy:
- 12 weeks
- 12 weeks
Last review date: September 4, 2018