Vosevi - NC Standard

Restricted Product(s)

• Vosevi® (sofosbuvir/velpatasvir/voxilaprevir)

FDA Approved Use

• For the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: 
  • Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor 
  • Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor 
  • Additional benefit of Vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of chronic hepatitis C (CHC) infection with confirmed genotypes 1,2,3,4,5, or 6; AND 
2. Patients with genotypes 1,2,3,4,5, or 6 have been previously treated and failed on a regimen containing an NS5A inhibitor (daclatasvir, elbasavir, ledipasvir, ombitasvir, or velpatasvir) (medical record documentation required); OR 
3. Patients with genotypes 1a or 3 have been previously treated and failed on a regimen with sofosbuvir (Sovaldi) without an NS5A inhibitor (medical record documentation required); AND 
4. The patient has no cirrhosis or has compensated cirrhosis (Child Pugh A) (medical record documentation required); AND 
5. The patient has been genotyped after treatment failure (medical record documentation required); AND
6. HCV RNA levels demonstrate treatment failure after 12 or 24 weeks post-treatment (please submit medical record documentation of 2 HCV RNA values to support virologic treatment failure); AND 
7. Medical record documentation including genotype, fibrosis score, and HCV RNA (within the last 6 months), Child-Pugh score, and as specified within the criteria is provided; AND 
8. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., hematologist or infectious disease); AND 
9. Vosevi will not be used in combination with other direct acting antivirals (DAA) to treat CHC; AND 
10. The prescribed dosing does not exceed FDA labeling; AND 11. For formularies that exclude (non-formulary) the requested medication, satisfactory completion may of criteria above may warrant approval.

Duration of Approval: 12 weeks 

References

All information referenced is from FDA package insert unless otherwise noted below.

American Association for the Study of Liver Diseases and Infectious Disease Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. When and in Whom to Initiate HCV Therapy. 2016

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

August 2024: Criteria change: Removed failure to complete previous CHC regimen or non-adherence requirement that the same genotype must be ruled out for retreatment. Added P&T review statement.

November 2022: Criteria update: Formatting changes and review.

August 2021: Criteria update. Annual criteria review. No changes to policy.

July 2017: Original utilization management criteria issued