Limited Coverage Drugs – sofosbuvir-velpatasvir-voxilaprevir

Generic Name

sofosbuvir-velpatasvir-voxilaprevir

Strength

400 mg, 100 mg, 100 mg

Form

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 of the following criteria:
  1. 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)) either alone or in combination. Supporting documentation must be submitted.

    AND
  2. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other physician experienced with treating hepatitis C;

    AND
     
  3. Laboratory confirmed hepatitis C genotype 31, 2, 3, 4, 5 or 6;

    AND
     
  4. Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months4 at SVR 12 or SVR24;

    AND
     
  5. 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

NOTES:

  1. “NS5A 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.
     
  2. “Non-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).
     
  3. Special Authority requests for patients must include the genotype report from the latest post-treatment course.
     
  4. Special Authority requests for patients 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.
     
  5. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).

Practitioner Exemptions

  • None

Special Notes

  • Special Authority requests for re-treatment for sofosbuvir-velpatasvir-voxilaprevir treatment failures will be considered on exceptional case-by-case basis. “Sofosbuvir-velpatasvir-voxilaprevir treatment failures” is defined as a patient who has been previously treated with sofosbuvir-velpatasvir-voxilaprevir, and who have relapsed or not responded. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases
  • Additional coverage request for ribavirin may be considered on exceptional case-by-case basis. Please provide rationale and supporting document(s) to support request

Additional information

Special Authority Request Form(s)