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Limited coverage criteria – sofosbuvir-velpatasvir

Last updated on March 24, 2025

 

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Generic name

 sofosbuvir-velpatasvir (for use with or without ribavirin [RBV])

Strength & form

 400 mg/100 mg tablet

Special Authority criteria

Approval period

For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1, 2, 3, 4, 5, 6 or mixed genotype infection who meet ALL of the following criteria:

  • Fibrosis stage of F0 or greater (Metavir scale or equivalent)
    • Special Authority requests for patients must include a fibrosis score test performed in the past 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

  • Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or another prescriber experienced with treating hepatitis C

AND

  • Laboratory-confirmed quantitative HCV RNA  or dried blood spot test must be done within the previous 12 months3

AND

  • Laboratory-confirmed2 hepatitis C genotype 1, 2, 3, 4, 5 or 6 for treatment-experienced1 patients only

AND

  • Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug

 

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

12 weeks
Treatment-naïve and treatment-experienced1 with decompensated cirrhosis5

12 weeks with RBV

OR

24 weeks

Practitioner exemptions

  • None

Special notes

  • 1Treatment-experienced is defined as patients who have been previously treated with PegIFN/RBV regimen, including regimens containing HCV protease inhibitors (for genotype 1) and who have relapsed or not responded
  • 2Special Authority requests must include the genotype report from the latest HCV post-treatment course
  • 3Special Authority requests must include the most recent HCV RNA test performed in the last 12 months
  • 4Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6)
  • Decompensated cirrhosis is defined as cirrhosis with a CPS = B or C (7 or above). Special Authority requests for patients with decompensated cirrhosis must include a clinical history or ultrasound imaging diagnosis, laboratory test reports, and fibrosis score test performed in the past 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (AST-to-platelet ratio index [APRI] or fibrosis-4 [FIB-4]) either alone or in combination. Supporting documentation must be submitted

Additional information

Special Authority request form(s)