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. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist or other physicians experienced with treating hepatitis C; AND
  2. Laboratory confirmed hepatitis C genotype 2 or 32; AND
  3. Laboratory confirmed quantitative HCV RNA test must be done within the last 12 months3; AND
  4. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug (with the exception of daclatasvir for genotype 3); AND
  5. Fibrosis stage of  F2 or greater (Metavir scale or equivalent)4; OR

     Fibrosis stage less than F2 (Metavir scale or equivalent)4 AND at least one of the following:

  • Co-infection with HIV or hepatitis B virus
  • Post organ transplant (liver and/or non-liver organ transplant)
  • Extra-hepatic manifestations5
  • Chronic kidney disease stage 3, 4 or 5 as defined by National Kidney Foundation Kidney Disease outcomes Quality Initiative6
  • Co-existent liver disease with diagnosis evidence for fatty liver disease (e.g., non-alcoholic steatohepatitis )7
  • Diabetes receiving treatment with anti-diabetic drugs
  • Women who are planning pregnancy within the next 12 months

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 cirrhosis8

12 weeks with RBV

OR

 

Genotype 3:

  • Treatment-naïve  and treatment-experienced1 with no cirrhosis or with compensated cirrhosis8

24 weeks with RBV

NOTES:

  1. “Treatment-experienced” is defined as patients who have been previously treated with a PegIFN/RBV regimenand who have not experienced adequate response.
  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. 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 (such as AST-to-Platelet Ratio Index (APRI) or Fibrosis-4 (FIB-4) score) either alone or in combination.  Supporting documentation must be submitted.
  5. “Extra-hepatic manifestation” includes but is not limited to: symptomatic vasculitis associated with HCV-related mixed cryoglobulinemia, HCV immune complex-related nephropathy and non-Hodgkin B cell lymphoma, porphyria cutanea tarda, and glomerulonephritis. Supporting documentation must be submitted .
  6. “Chronic kidney disease” stage 3, 4 or 5 will include patients with glomerular filtration rate (GFR) <60 mL/min/1.73m2 for >3 months.
  7. Special Authority requests for patients with fibrosis stage less than F2 and fatty liver disease must include a confirmation that ultrasound imaging has been done with diagnosis of fatty liver disease. Additional diagnostic reports or documents may be requested.
  8.  “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 following direct-acting antiviral (DAA) treatment failures will be considered on exceptional case-by-case basis. “Direct-acting antiviral treatment failure” is defined as a patient who has been previously treated with any combination of DAAs—including regimens containing  NS3/4A protease inhibitors, NS5A inhibitors and NS5B inhibitors—who have not experienced adequate response. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases.

Additional Information

Special Authority Request Form(s)