Limited coverage drugs – sofosbuvir

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

400 mg

tablet

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:

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 prescriber experienced with treating hepatitis C

AND

3. Laboratory-confirmed hepatitis C genotype 2 or 3²

AND

4. Laboratory-confirmed quantitative HCV RNA test done within the previous 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)

For genotype 2 patients:

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

For genotype 3 patients:

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