Limited Coverage Drugs – Sofosbuvir-Velpatasvir

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:

A. Fibrosis stage of F0 or greater (Metavir scale or equivalent);

Special Authority requests for patients 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

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

AND

C. Laboratory confirmed hepatitis C genotype 12, 2, 3, 4, 5 or 6;

AND

D. Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months3;

AND

E. 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 with: Approval Period

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

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 for patients must include the most recent genotyping test report. 

3. Special Authority requests for patients must include the most recent HCV RNA test performed in the last 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 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.

Practitioner Exemptions

  • None

Special Notes

  • None

Additional Information

Special Authority Request Form