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Limited coverage drugs – sofosbuvir-velpatasvir

Last updated on January 26, 2023

Generic name

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

Strength

 400 mg/100 mg

Form

 tablet
 

Special Authority criteria

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:

1. 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

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

AND

3. Laboratory-confirmed hepatitis C genotype2 1, 2, 3, 4, 5 or 6

AND

4. Laboratory-confirmed quantitative HCV RNA test must be done within the previous 12 months3

AND

5. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug
 
Treatment regimens for genotype 1, 2, 3, 4, 5 or 6 CHC adult patients who are Approval period

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

 12 weeks

Treatment-naïve or treatment-experienced1 with decompensated cirrhosis5

12 weeks with RBV

OR

24 weeks

Notes

  1. Treatment-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.
  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 past 12 months.
  4. Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).
  5. 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]) either alone or in combination. Supporting documentation must be submitted.

Practitioner exemptions

  • None

Special notes

  • None

Additional information

Special Authority requests