CurrentCignaPolicy N/A

Hepatitis C - Vosevi Prior Authorization Policy

Criteria and prior authorization requirements for coverage of Vosevi for treatment of chronic hepatitis C in adults, applicable to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHepatitis C - Vosevi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateAug 6, 2025

Key ActionObtain prior authorization with specialist prescribing or consultation and document age, cirrhosis status, and prior treatment history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wkstypical approved treatment duration

≥18minimum patient age for approval

Child‑Pugh Aallowed cirrhosis status

Not allowedpediatric use

Annualreview cadence

Coverage Criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

inv-01: Initial therapy — FDA-approved genotype-specific criteria

Covered when ALL of the following are met for FDA-approved indications (approve for 12 weeks):

Genotype 1b, 2, 4, 5, or 6: A) Patient is >= 18 years of age; AND B) Patient meets ONE of the following: i) Patient does not have cirrhosis; OR ii) Patient has compensated cirrhosis (Child-Pugh A); AND C) Patient had a prior null response, prior partial response, or relapse after prior treatment with an HCV direct-acting antiviral regimen containing an NS5A inhibitor; AND D) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Approve for 12 weeks.

Genotype 1a or 3: A) Patient is >= 18 years of age; AND B) Patient meets ONE of the following: i) Patient does not have cirrhosis; OR ii) Patient has compensated cirrhosis (Child-Pugh A); AND C) Patient meets ONE of the following: i) Patient had a prior null response, prior partial response, or relapse after prior treatment with an HCV direct-acting antiviral regimen containing an NS5A inhibitor; OR ii) Patient had a prior null response, prior partial response, or relapse after prior treatment with Sovaldi (sofosbuvir) + a non-NS5A inhibitor; AND D) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Policy Summary

PayerCigna

PolicyHepatitis C - Vosevi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateAug 6, 2025

Key ActionObtain prior authorization with specialist prescribing or consultation and document age, cirrhosis status, and prior treatment history.

SourceLink

On This Page

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inv-02: Other uses with supportive evidence / treatment completion

Other supported uses (approve for 12 weeks where specified):

Sovaldi + non-NS5A prior treatment (Genotypes 1b, 2, 4, 5, or 6): A) Patient is >= 18 years of age; AND B) Patient meets ONE of the following: i) Patient does not have cirrhosis; OR ii) Patient has compensated cirrhosis (Child-Pugh A); AND C) Patient had a prior null response, prior partial response, or relapse after prior treatment with Sovaldi (sofosbuvir) + a non-NS5A inhibitor; AND D) The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Approve for 12 weeks.

Continuation to complete a started course: If a patient has been started on Vosevi for an indication addressed in the authorization criteria, approve remaining duration required to complete the prescribed course (e.g., if 3 of 12 weeks received, approve 9 weeks).

Prescriber Requirements and Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vosevi. Approvals are issued for the duration specified in the policy (e.g., 12 weeks or as needed to complete an ongoing course). Prescriptions must be by or in consultation with a specialist (gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician).

Prior authorization required for Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
Approvals provided for the duration noted in the policy (e.g., 12 weeks or remaining weeks to complete an initiated course).
Prescriber requirement: gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician, or documented consultation with one.

Step Therapy

Therapy Sequencing Considerations

Follow guideline-based sequencing and the policy's approved indications when selecting therapy. Vosevi is primarily recommended for patients who are DAA-experienced or in retreatment scenarios described by guidelines and the policy; use alternative approved regimens when consistent with guideline recommendations and the patient's prior treatment history.

Use Vosevi for retreatment of DAA-experienced patients per AASLD guidance (e.g., prior NS5A-containing regimen failure).
Specific recommended uses include prior sofosbuvir-based treatment failure, prior glecaprevir/pibrentasvir failure, prior elbasvir/grazoprevir failure, and certain post-transplant or recurrent HCV scenarios as outlined in the policy.
Vosevi is not advantageous over Epclusa for several genotypes in patients previously treated with sofosbuvir without an NS5A inhibitor; follow policy and guideline guidance when sequencing therapy.

Documentation Required

Required Prescriber and Clinical Documentation

Document clinical rationale and prior treatment history clearly. Approval requires specialist prescriber or documented specialist consultation and supporting clinical documentation of prior regimens, genotype, cirrhosis status, and treatment response.

Provide documentation of HCV genotype and cirrhosis status (e.g., compensated vs decompensated).
Document prior antiviral regimens, including whether prior therapy included an NS5A inhibitor or sofosbuvir, and the type of treatment failure (null, partial, or relapse).
If therapy was already started, document dates of therapy received and remaining duration needed to complete the approved course.

Denial Risk

Denial Triggers

Denials may occur if the request lacks a covered diagnosis, appropriate prior-treatment documentation, or if the requested use is not supported by the policy (including combinations with other DAAs or pediatric use). Vosevi is considered not medically necessary for uses listed in the policy's Conditions Not Covered.

Requests missing documentation of covered HCV genotype, prior treatment history (including NS5A exposure), or cirrhosis status may be denied.
Vosevi is not medically necessary for combination use with any other DAAs (policy excludes co-administration).
Vosevi is not covered for patients under 18 years of age.

Definitions

Compensated cirrhosis (Child-Pugh A) — policy definition and implications

DefinitionCompensated cirrhosis is defined as Child-Pugh A and is an allowed cirrhosis status for Vosevi treatment per policy.

Coverage implicationPatients with Child-Pugh A (compensated cirrhosis) meet the cirrhosis criterion for approval when other criteria are met (approve for 12 weeks).

Age requirementMust be an adult (≥ 18 years) to qualify; pediatric patients (<18) are not eligible.

Prescriber requirementMedication must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

NS5A inhibitor — definition and examples

Class definitionNS5A inhibitors are a class of HCV direct-acting antivirals referenced as prior therapy that impacts Vosevi approval (prior NS5A-containing regimen is a criterion).

Examples—explicitly listedDaklinza (daclatasvir), Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Mavyret (glecaprevir/pibrentasvir), Viekira Pak (ombitasvir-containing regimen), Zepatier (elbasvir/grazoprevir).

Policy relevancePrior null/partial response or relapse after an NS5A-containing regimen is a required criterion for many FDA‑approved Vosevi indications.

Regimen examples involving sofosbuvir without NS5ASovaldi (sofosbuvir) + a non-NS5A inhibitor (e.g., NS3 inhibitors like simeprevir) is called out separately for some genotype approvals.

OpenPayer

Hepatitis C - Vosevi Prior Authorization Policy

Coverage Criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Drug Coding

Prescriber Requirements and Provider Actions

Background

Definitions