Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi)

SELF ADMINISTRATION

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

Dosing:

  • Sofobuvir 400 mg/Velpatasvir 100 mg/Voxilaprevir 100 mg (1 tablet) once daily

Duration of Therapy:

  • 12 weeks

Approval:

  • 12 weeks

 

Last review date: September 4, 2018