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Limited coverage drugs – sofosbuvir-velpatasvir-voxilaprevir

Last updated on August 21, 2024

 

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Generic name

 sofosbuvir-velpatasvir-voxilaprevir

Strength & form

 400 mg/100 mg/100 mg tablet
 

Special Authority criteria

For the treatment of direct acting antivirals (DAA) experienced including: 

  • NS5A inhibitor treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1, 2, 3, 4 , 5 or 6 infection, or
  • Non-NS5A inhibitor sofosbuvir-containing regimen treatment-experienced2 adult patients with CHC genotype 1, 2, 3, or 4 infection

Who meet ALL the following criteria:

  • Fibrosis stage of F0 or greater (Metavir scale or equivalent)
    • Special Authority requests for patients must include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (AST-to-Platelet Ratio Index [APRI] or fibrosis-4 [FIB-4]) either alone or in combination. Supporting documentation must be submitted

AND

  • Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other prescriber experienced with treating hepatitis C

AND

  • Laboratory-confirmed hepatitis C genotype3 1, 2, 3, 4, 5 or 6

AND

  • Laboratory-confirmed quantitative HCV RNA or dried blood spot test test must be done within the previous 12 months4 at SVR 12 or SVR24

AND

  • Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug
 

Treatment regimens for genotype 1, 2, 3, 4, 5 or 6 DAA experienced adult patients with:

Approval period

NS5A inhibitor treatment-experienced1 with no cirrhosis or with compensated cirrhosis5

 12 weeks

Treatment regimens for genotype 1, 2, 3 or 4 DAA experienced adult patients with:

  

Non-NS5A inhibitor, sofosbuvir-containing regimen treatment-experienced2 with no cirrhosis or with compensated cirrhosis5

 12 weeks

Practitioner exemptions

  • None

Special notes

  • 1NS5A inhibitor treatment-experienced is defined as patients who have been previously treated with NS5A inhibitor regimen and who have relapsed or not responded. In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir
  • 2Non-NS5A inhibitor, sofosbuvir-containing regimen treatment-experienced is defined as patients who have been previously treated with sofosbuvir without an NS5A inhibitor regimen, and who have relapsed or not responded. In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir)
  • 3Special Authority requests must include the genotype report from the latest post-treatment course
  • 4Special Authority requests must include the most recent HCV RNA test performed in the last 12 months. HCV RNA should be confirmed to be detectable at SVR12 or SVR24
  • 5Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6)
  • Special Authority requests for re-treatment for sofosbuvir-velpatasvir-voxilaprevir treatment failures will be considered on an exceptional case-by-case basis. Sofosbuvir-velpatasvir-voxilaprevir treatment failure is defined as patients who have been previously treated with sofosbuvir-velpatasvir-voxilaprevir and who have relapsed or not responded. PharmaCare's Hepatitis Drug Benefit Adjudication Advisory Committee (HEPDBAAC) reviews all requests for coverage of exceptional cases
  • Additional coverage requests for ribavirin may be considered on an exceptional case-by-case basis. Please provide rationale and supporting document(s) to support a request

Additional information

Special Authority requests