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Limited coverage drugs – sofosbuvir

Last updated on May 16, 2025

 

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Generic name

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

Strength & form

400 mg tablet

Special Authority criteria

Approval period

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

Fibrosis stage of F0 or greater (Metavir scale or equivalent)2

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 genotype 2 or 33

AND

Laboratory-confirmed quantitative HCV RNA test done within the previous 12 months4

AND

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

Genotype 2 patients (treatment-naïve and treatment-experienced1 with no cirrhosis or with compensated cirrhosis5)

  • 12 weeks with RBV

Genotype 3 patients (treatment-naïve and treatment-experienced1 with no cirrhosis or with compensated cirrhosis5)

  • 24 weeks with RBV

Practitioner exemptions

  • None

Special notes

  • 1Treatment-experienced is defined as patients who have been previously treated with a PegIFN/RBV regimen and who have relapsed or not responded
  • 2Special 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
  • 3Special Authority requests must include the most recent genotyping test report
  • 4Special Authority requests must include the most recent HCV RNA test performed in the past 12 months
  • 5Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6)
  • When selecting therapeutic options for patients with genotype 2 or 3 infection, prescribers should consider the Common Drug Review recommendation regarding sofosbuvir/velpatasvir (Epclusa™)
  • For further details, consult Information for prescribers: PharmaCare Expanded Coverage for Adults with Chronic Hepatitis C Infection

Special Authority requests