Limited Coverage Drugs - Sofosbuvir

Generic Name

sofosbuvir (for use in combination with ribavirin (RBV))

Strength

 400 mg

Form

 tablet

When selecting therapeutic options for patients with genotype 2 or 3 infection, prescribers should consider the Common Drug Review recommendation regarding sofosbuvir/velpatasvir (Epclusa™).

Special Authority Criteria

For the treatment of treatment naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 2 or 3 infection who meet ALL of the following criteria:

  1. Fibrosis stage of  F0 or greater (Metavir scale or equivalent);
    Special Authority requests 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 physicians experienced with treating hepatitis C;

    AND
     
  3. Laboratory confirmed hepatitis C genotype 2 or 32;

    AND
     
  4. Laboratory confirmed quantitative HCV RNA test must be done within the last 12 months3;

    AND
     
  5. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug (with the exception of daclatasvir for genotype 3).

Treatment regimens for genotype 2 or 3 CHC patients with:

Approval Period

Genotype 2:

Treatment-naïve and treatment-experienced1 with no cirrhosis or with compensated cirrhosis4

12 weeks with RBV

Genotype 3:

Treatment-naïve and treatment-experienced1 with no cirrhosis or with compensated cirrhosis4

24 weeks with RBV

NOTES:

  1. “Treatment-experienced” is defined as patients who have been previously treated with a PegIFN/RBV regimen and who have relapsed or not responded.
     
  2. Special Authority requests must include the most recent genotyping test report. 
     
  3. Special Authority requests must include the most recent HCV RNA test performed in the last 12 months.
     
  4. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).

Practitioner Exemptions

  • None

Special Notes

  • None

Additional Information

Special Authority Request Form(s)