ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1232-8

Vosevi® (sofosbuvir, velpatasvir, and voxilaprevir) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization/notification coverage criteria for Vosevi for treatment of chronic hepatitis C in UnitedHealthcare Commercial Plans, specifying eligible genotypes, prior treatment experience, cirrhosis status, combination therapy exclusions, and authorization duration.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVosevi® (sofosbuvir, velpatasvir, and voxilaprevir) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1232-8

Change TypeModified (simplified criteria; auth duration updated)

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization; approvals will be issued for 12 months when coverage criteria are met and document prior treatment experience and cirrhosis status.

SourceLink

POLICY UPDATE CHANGES

Simplified pangenotypic treatment criteria and updated authorization to 12 months.

Added Mavyret as an example of HCV direct acting antiviral agent and removed examples of Sovaldi-containing regimens in prior update.

Program created and P&T approval history started in 9/2017.

12 monthsAuth Duration

1-6Indicated genotypes

1a & 3Covered (sofosbuvir-experienced w/o NS5A)

Coverage Summary & Criteria

Authorization duration: 12 months. Scope: Defines prior authorization/notification coverage criteria for Vosevi for treatment of chronic hepatitis C in UnitedHealthcare Commercial Plans, specifying eligible genotypes, prior treatment experience, cirrhosis status, combination therapy exclusions, and authorization duration. Coverage stance: covered_with_criteria. Background: Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is a fixed-dose combination antiviral indicated for treatment of chronic HCV in adults without cirrhosis or with compensated cirrhosis.

A. Treatment-experienced with NS5A inhibitor

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic hepatitis C infection
Patient has prior treatment experience with an HCV NS5A inhibitor (e.g., Daklinza (daclatasvir), Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Viekira (dasabuvir/ombitasvir/paritaprevir/ritonavir), Zepatier (elbasvir/grazoprevir))
Cirrhosis status
- Patient is without cirrhosis
- Patient has compensated cirrhosis (Child-Pugh A)
Patient is not receiving Vosevi in combination with another HCV direct acting antiviral agent (e.g., Epclusa, Harvoni, Mavyret (glecaprevir/pibrentasvir), Sovaldi (sofosbuvir), Zepatier)

B. Genotype 1a or 3 with prior sofosbuvir (no NS5A inhibitor)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic hepatitis C genotype 1a or 3 infection
Patient has prior treatment experience with a regimen containing Sovaldi (sofosbuvir) without an NS5A inhibitor
Cirrhosis status
- Patient is without cirrhosis
- Patient has compensated cirrhosis (Child-Pugh A)
Patient is not receiving Vosevi in combination with another HCV direct acting antiviral agent (e.g., Epclusa, Harvoni, Mavyret, Sovaldi, Zepatier)

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required

Vosevi requires prior authorization/notification; approval will be issued for 12 months when coverage criteria are met.

Documentation Required

Document prior treatment

Provider must document prior treatment experience with an NS5A inhibitor (for criterion A) or prior sofosbuvir-containing regimen without an NS5A inhibitor (for criterion B), and cirrhosis status (none or compensated Child-Pugh A).

Informational Drug Lists / Example Codes

Example prior NS5A inhibitors (informational drug list)NDC|mixed

daclatasvir	Daklinza (daclatasvir) - example NS5A inhibitor
sofosbuvir/velpatasvir	Epclusa - example NS5A-containing regimen
ledipasvir/sofosbuvir	Harvoni - example NS5A-containing regimen
dasabuvir/ombitasvir/paritaprevir/ritonavir	Viekira - example NS5A-containing regimen
elbasvir/grazoprevir	Zepatier - example NS5A-containing regimen

Example HCV direct acting antivirals to avoid concomitant use (informational)mixed

sofosbuvir/velpatasvir	Epclusa
ledipasvir/sofosbuvir	Harvoni
glecaprevir/pibrentasvir	Mavyret
sofosbuvir	Sovaldi
elbasvir/grazoprevir	Zepatier

Clinical Background & Definitions

Vosevi is a fixed-dose combination of sofosbuvir (NS5B polymerase inhibitor), velpatasvir (NS5A inhibitor), and voxilaprevir (NS3/4A protease inhibitor), indicated for treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). FDA-indicated uses include: patients with genotypes 1–6 who were previously treated with an NS5A-containing regimen; and patients with genotype 1a or 3 who were previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. Additional benefit over Epclusa was not shown for adults with genotype 1b, 2, 4, 5, or 6 previously treated with sofosbuvir without an NS5A inhibitor.

Compensated cirrhosis (Child-Pugh A) is defined as liver cirrhosis classified as Child-Pugh class A. Decompensated cirrhosis is not covered.

Evidence & References

Evidence items: Package insert — Vosevi [package insert], Foster City, CA: Gilead Sciences, Inc.; November 2019. Guideline — American Association for the Study of Liver Diseases and the Infectious Diseases Society of America: Recommendations for Testing, Managing, and Treating Hepatitis C (accessed September 8, 2025).

Policy Changes

10/2025material revisionLatest

Simplified pangenotypic treatment criteria; authorization duration updated to 12 months; updated references.

8/2022administrative update

Added Mavyret as an example of HCV direct acting antiviral agent and removed examples of Sovaldi-containing regimens; updated references.

9/2017initial program creation

Program created and P&T approval history started.