CurrentUnitedHealthcarePolicy 1 = 2025 P 2133-9

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity requirements for Vosevi for treatment of chronic hepatitis C in adults, including specific prior-treatment and cirrhosis criteria.

Policy Summary

PayerUnitedHealthcare

PolicyVosevi (sofosbuvir/velpatasvir/voxilaprevir) prior authorization

Policy CodePolicy 1 = 2025 P 2133-9

Change TypeRevised (material and non-material edits)

Effective Date1/1/2026

Next Review Date

Key ActionObtain prior authorization; approvals issued for up to 12 months when all coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

Authorization duration updated to 12 months.

Pangenotypic treatment criteria simplified.

Provider attestation wording simplified to 'physician/provider' attestation.

12 monthsAuthorization duration

1-6Genotypes

NS5A-experiencedPrimary approval

2026-01-01Effective

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Coverage Criteria for Vosevi

Treatment-experienced with NS5A inhibitor

Covered when ALL of the following are met

NS5A-experienced approval: 1. Diagnosis of chronic hepatitis C infection; 2. Prior treatment with an HCV NS5A inhibitor (examples include daclatasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir); 3. One of the following: (a) patient is without cirrhosis; OR (b) patient has compensated cirrhosis (Child-Pugh A); 4. Vosevi is not being used in combination with another HCV direct-acting antiviral agent (examples include sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, glecaprevir/pibrentasvir, sofosbuvir, elbasvir/grazoprevir); 5. Provider attests that the patient demonstrates treatment readiness, including ability to adhere to the regimen.

Authorization will be issued for 12 months.

Treatment-experienced with sofosbuvir (no NS5A) — genotype 1a or 3

Covered when ALL of the following are met

Sofosbuvir-experienced (no NS5A) approval: 1. Diagnosis of chronic hepatitis C genotype 1a or 3 infection; 2. Prior treatment with a regimen containing sofosbuvir (Sovaldi) without an NS5A inhibitor; 3. One of the following: (a) patient is without cirrhosis; OR (b) patient has compensated cirrhosis (Child-Pugh A); 4. Vosevi is not being used in combination with another HCV direct-acting antiviral agent (examples include sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, glecaprevir/pibrentasvir, sofosbuvir, elbasvir/grazoprevir); 5. Provider attests that the patient demonstrates treatment readiness, including ability to adhere to the regimen.

Authorization will be issued for 12 months.

Use of Vosevi in patients with decompensated cirrhosis (beyond Child‑Pugh A) is not described as covered under this policy. Additionally, Vosevi must not be used in combination with another HCV direct‑acting antiviral (examples include Epclusa, Harvoni, Mavyret, Sovaldi, and Zepatier). These restrictions are required for coverage and are referenced in the regimen‑specific criteria for treatment‑experienced populations.

Requests for Vosevi will be considered not medically necessary when the patient does not meet the specified prior‑treatment requirements. Specifically, coverage requires prior exposure to an HCV NS5A inhibitor for the primary treatment‑experienced indication; alternatively, for genotype 1a or 3 the patient must have prior treatment with a sofosbuvir‑containing regimen without an NS5A inhibitor. Absent these prior‑treatment criteria, the use of Vosevi is not supported by this policy.

Initial Therapy Authorization Criteria

Initial therapy

Initial authorization criteria

Initial therapy general: Meet diagnosis and prior-treatment criteria as specified per indication; Vosevi must not be used in combination with another HCV direct-acting antiviral; provider attests to treatment readiness including ability to adhere to regimen.

Authorization up to 12 months.

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be issued for up to 12 months when all coverage criteria are met.

Authorization period: up to 12 months

Note

Additional Utilization Rules

Other utilization management programs or supply limits may apply. Automated approval may be granted based on claims or medication history and diagnosis when available.

Automated approval may use prior claims/medication history and diagnosis codes
Other UM programs or quantity limits may apply

Documentation Required

Required Documentation

Provider must document the diagnosis, prior treatment history (including prior NS5A inhibitor or sofosbuvir-containing regimens as applicable), cirrhosis status (compensated vs decompensated), and an attestation of treatment readiness and ability to adhere to therapy.

Document diagnosis and genotype where applicable
Document prior HCV treatment regimen(s) and dates (e.g., prior NS5A inhibitor or sofosbuvir-containing regimen)
Document cirrhosis status (Child-Pugh class)
Include provider attestation of treatment readiness and adherence capability

Denial Risk

Triggers for Denial

Requests may be denied if prior-treatment criteria are not met, if the member has decompensated cirrhosis (e.g., Child-Pugh B or C), or if Vosevi is requested in combination with another HCV direct-acting antiviral.

Denial triggers include: lack of required prior NS5A or sofosbuvir treatment history (per criteria)
Presence of decompensated cirrhosis (Child-Pugh B or C)
Concurrent use of Vosevi with another HCV direct-acting antiviral agent

Step Therapy and Utilization Controls

Step	Requirement
1	Other utilization management programs or supply limits may apply; automated approval based on prior claims/medication history and diagnosis codes may be used.

Definitions

Compensated cirrhosis (Child-Pugh A) — definition

DefinitionCompensated cirrhosis defined as Child-Pugh A

Policy scopeCovers patients without cirrhosis or with compensated cirrhosis (Child-Pugh A)

Exclusion noteUse in decompensated cirrhosis (beyond Child-Pugh A) is not described as covered

NS5A inhibitor — examples

DefinitionNS5A inhibitor includes agents such as daclatasvir, velpatasvir, ledipasvir, elbasvir, and others.

Examples listed in policyDaklinza (daclatasvir); Epclusa (sofosbuvir/velpatasvir); Harvoni (ledipasvir/sofosbuvir); Zepatier (elbasvir/grazoprevir)

Context of usePrior treatment with an HCV NS5A inhibitor is required for one covered indication (all genotypes 1–6)

Background

Vosevi is a fixed‑dose combination of sofosbuvir, velpatasvir, and voxilaprevir. It is indicated for adult patients with chronic hepatitis C without cirrhosis or with compensated cirrhosis (Child‑Pugh A) who are treatment‑experienced: (1) patients with genotypes 1–6 previously treated with an NS5A‑containing regimen; and (2) patients with genotype 1a or 3 previously treated with a sofosbuvir‑containing regimen without an NS5A inhibitor.

Site of Care

Note

Supply limits noted; no specific site-of-care rules

Supply limits may be in place for Vosevi; the policy does not specify site-of-care restrictions for infusion centers or other settings.

Revision History

2025-08annual_review

Annual review: removed liver disease staging criteria used for quality purposes and simplified provider attestation wording to 'physician/provider' attestation.

2025-10annual_review

Annual review noted in records (last_review date recorded).

2025-10-01revisionLatest

Policy wording simplified for pangenotypic treatment criteria and authorization period updated to 12 months.