ModifiedHealth NetPolicy CP CPA.290

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Coverage Criteria

Criteria and coverage policy for Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for treatment of chronic hepatitis C virus (HCV) infection in adults, including initial and continuation therapy requirements for commercial line of business.

Policy Summary

PayerHealth Net

PolicySofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Coverage Criteria

Policy CodePolicy CP CPA.290

Change TypeAdded guidancerevised continuation criteria

Effective Date07.26.17

Next Review Date

Key ActionSubmit prior authorization with documentation of detectable HCV RNA within 6 months and prior treatment history consistent with FDA or AASLD-IDSA recommendations.

SourceLink

POLICY UPDATE CHANGES

Added Appendix G for guidance on incomplete adherence and AASLD-IDSA recommended management of treatment interruptions.

For continued therapy criteria, revised option for treatment duration minimum from 60 days to 28 days and removed requirement for specific confirmed genotype with treatment status.

For continued therapy criteria, added 'Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen' for continued therapy.

Eliminated adherence program participation criterion for initiation since member is managed by an HCV-trained specialist.

24 weeksmaximum approval duration

Detectable HCV RNArequired diagnostic evidence

Adultsage group

HBV boxed warning

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Appendix Gnew guidance

Coverage Criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Initial Therapy

Covered when ALL of the following are met

Initial Approval: 1) Diagnosis of HCV infection evidenced by detectable serum HCV RNA by quantitative assay within the last 6 months; 2) Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or provider with certified HCV treatment training (see Appendix F); 3) Age >= 18 years; 4) Member meets ONE of the following (a, b, or c): a) Prior regimen contained an NS5A inhibitor (daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, or velpatasvir); OR b) Genotype 1a or 3 and previously treated with a sofosbuvir-containing regimen (with or without peginterferon/ribavirin or an NS3/4A protease inhibitor); OR c) Treatment-naive with compensated cirrhosis and baseline NS5A RAS Y93H (genotype 3); 5) If cirrhosis present, confirmation of Child-Pugh A; 6) Life expectancy >= 12 months with HCV treatment; 7) Dose does not exceed sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg once daily (1 tablet/day); 8) Prescribed regimen is consistent with an FDA or AASLD‑IDSA recommended regimen; 9) For treatment-experienced members, prior receipt of >= 8 weeks of the referenced DAA regimen unless virologic failure was determined earlier.

Chart note and lab copies required

Continuation Therapy

Covered when ALL of the following are met for continued therapy

Continuation Approval: 1) Member is currently receiving Vosevi or has previously met initial approval criteria (including applicable continuity-of-care provisions where state/product rules apply); 2) Member is responding positively to therapy; 3) Documentation supports the member has completed at least 28 days of treatment with Vosevi when requesting continuation; 4) Prescribed regimen and dose remain consistent with FDA or AASLD‑IDSA recommendations (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg once daily).

Approval duration up to a total of 24 weeks

Initial and retreatment coverage criteria

Treatment-experienced and select treatment-naive scenarios covered when regimen, genotype, and prior DAA exposure match AASLD‑IDSA or FDA‑approved indications

Genotype 1-6 with prior NS5A inhibitor exposure: Treatment-experienced with prior NS5A inhibitor exposure (with or without compensated cirrhosis): Vosevi one tablet PO once daily for 12 weeks (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg).

Reference: FDA labeling and AASLD‑IDSA; see Appendix D for NS5A inhibitors list.

Genotype 1a or 3 with prior sofosbuvir-containing regimen without NS5A inhibitor: Treatment-experienced who previously received a sofosbuvir-containing regimen without an NS5A inhibitor (with or without compensated cirrhosis): Vosevi one tablet PO once daily for 12 weeks (same maximum dose).

Reference: FDA labeling.

Treatment-experienced after Mavyret: Genotype 1-6 treatment-experienced after Mavyret failure: Vosevi one tablet PO once daily for 12 weeks if without cirrhosis; specific pathways for compensated cirrhosis per dosing guidance (see policy).

Reference: AASLD‑IDSA (updated December 2023).

Treatment interruption and adherence management

Management of missed doses and interruptions per AASLD‑IDSA (applicable to treatment‑naive patients without cirrhosis or with compensated cirrhosis receiving Mavyret or Epclusa; other regimens/populations require expert consultation).

Short interruption (<7 days): If missed <7 days: restart DAA immediately and complete originally planned duration (e.g., 8 or 12 weeks).

Applies generally per Appendix G.

Interruption >7 days within first 28 days: If missed >7 days during the first 28 days: restart DAA immediately and obtain HCV RNA as soon as possible; if HCV RNA is negative, complete the originally planned course (consider extending by 4 weeks for genotype 3 and/or cirrhosis); if HCV RNA is positive or not obtained, extend DAA treatment by an additional 4 weeks.

Appendix G recommendations.

Interruption after >=28 days: If missed 8–20 consecutive days after >=28 days of therapy: restart DAA immediately and obtain HCV RNA; if HCV RNA negative, complete planned course (consider extension for genotype 3 and/or cirrhosis); if HCV RNA positive or not obtained, stop and retreat per AASLD‑IDSA retreatment recommendations. If missed >=21 consecutive days, assess for SVR12 and if SVR12 not achieved, retreat per AASLD‑IDSA guidance.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.CPA.09 or the member’s evidence of coverage. Requests for off‑label use should include clinical rationale and supporting literature or coverage determinations to demonstrate that the indication meets the plan’s off‑label criteria.

Co‑administration of Vosevi with rifampin is a contraindication and is not permitted due to clinically significant drug interactions. Prescribers must avoid concurrent use and document alternative treatment approaches when rifampin exposure is necessary.

Hepatitis B virus (HBV) co‑infection requires active monitoring and management. HBV reactivation during or after direct‑acting antiviral therapy for HCV is a boxed warning; cases of fulminant hepatitis, hepatic failure, and death have been reported. Patients co‑infected with HBV should be monitored for reactivation and receive treatment for HBV as clinically indicated prior to, during, and after HCV therapy.

Requests for indications that are not FDA‑approved and that lack sufficient documentation of efficacy and safety per the off‑label use policy may be considered not medically necessary. Providers should refer to CP.CPA.09 and supply supporting clinical evidence when seeking coverage for off‑label indications.

The policy previously specified treatment for “chronic” HCV; this qualifier has been removed to align with AASLD‑IDSA recommendations to treat both acute and chronic HCV. Providers should follow current AASLD‑IDSA guidance when assessing eligibility.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate a current diagnosis of chronic HCV and include detectable serum HCV RNA by a quantitative assay within the prior 6 months. Prescriptions must be written by or in consultation with an HCV-trained specialist (gastroenterologist, hepatologist, infectious disease specialist, or a provider with certified HCV training). Therapy must be consistent with FDA labeling or AASLD‑IDSA recommended regimens.

Detectable HCV RNA within 6 months
Prescription by or consultation with an HCV-trained specialist
Regimen consistent with FDA or AASLD‑IDSA guidance

Documentation Required

Provider must submit documentation (office chart notes, lab results, and other clinical information) that the member meets all approval criteria. Required documentation includes genotype, recent quantitative HCV RNA, documentation of cirrhosis status (including Child‑Pugh A confirmation if cirrhosis present), life expectancy information when relevant, and copies of prior DAA treatment records.

Definitions and Abbreviations

RAS — Resistance-associated substitution (RAS)

DefinitionResistance-associated substitution (RAS): viral substitutions that confer reduced susceptibility to NS5A inhibitors; specific baseline RAS (e.g., Y93H) may be required to guide therapy.

Examples referenced in policyBaseline NS5A RAS Y93H called out for genotype 3 with compensated cirrhosis as a consideration for therapy selection.

PurposeUsed to identify viral variants that may reduce effectiveness of NS5A-containing regimens and to guide selection of Vosevi or alternative regimens.

DocumentationProviders should document presence or absence of baseline NS5A RAS when it influences regimen choice per AASLD-IDSA and policy dosing pathways.

Child-Pugh class

Definition

Background

Vosevi is a fixed‑dose oral tablet that combines the nucleotide analog NS5B polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor voxilaprevir. It is formulated as a single tablet (sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg) and is indicated for adult patients without cirrhosis or with compensated cirrhosis (Child‑Pugh A) for specified retreatment and treatment‑experienced scenarios per FDA labeling and AASLD‑IDSA guidance.

Policy Summary

PayerHealth Net

PolicySofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Coverage Criteria

Policy CodePolicy CP CPA.290

Change TypeAdded guidancerevised continuation criteria

Effective Date07.26.17

Next Review Date

Key ActionSubmit prior authorization with documentation of detectable HCV RNA within 6 months and prior treatment history consistent with FDA or AASLD-IDSA recommendations.

SourceLink

On This Page

Vosevi with ribavirin for complex scenarios: For certain treatment‑experienced scenarios (per dosing tables), Vosevi one tablet PO once daily combined with weight‑based ribavirin for 12 or 24 weeks depending on prior regimen and cirrhosis status; follow dosing tables in the document.

See dosing tables and AASLD‑IDSA references.

Genotype 3 treatment‑naive with RAS Y93H: Treatment‑naive genotype 3 with compensated cirrhosis and baseline NS5A RAS Y93H: Vosevi one tablet PO once daily for 12 weeks (AASLD‑IDSA referenced).

Reference: AASLD‑IDSA (updated December 2023).

Appendix G; consult expert for other populations.

Chart notes and lab results supporting detectable HCV RNA
Documentation of genotype and cirrhosis (Child‑Pugh score if applicable)
Life expectancy when applicable
Copies of prior DAA regimens with dates and outcomes

Documentation Required

Document Prior DAA Regimen and Genotype

Prescribers must document prior DAA treatment history and HCV genotype. Clearly identify prior regimens (drug names, dates, duration, reason for discontinuation or virologic failure) and any prior exposure to NS5A inhibitors (daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir). If applicable, provide baseline NS5A resistance-associated substitution (RAS) testing (e.g., Y93H) and results.

List prior DAA agents, treatment dates, duration, and response
Specify prior NS5A inhibitor exposure (agent name)
Include baseline NS5A RAS testing and results when relevant (e.g., Y93H)

Step Therapy

Select Treatment by Prior Regimen and History

Treatment selection must follow the patient’s prior treatment history. Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is indicated and dosed per genotype and prior DAA exposure: for patients with prior NS5A inhibitor experience, Vosevi one tablet PO daily for 12 weeks is the standard; for genotype 1a or 3 previously treated with sofosbuvir without an NS5A inhibitor, follow FDA‑labeling guidance; other scenarios (prior Mavyret or Zepatier failure, compensated cirrhosis) have specific AASLD‑IDSA–referenced pathways and durations (including consideration of weight‑based ribavirin and extended duration in select cases). Ensure prescribed regimen and duration match the listed dosing guidance.

Follow genotype- and prior-regimen–specific dosing (see Dosage and Administration)
For prior NS5A exposure: Vosevi 1 tablet PO QD for 12 weeks (per labeling)
For prior sofosbuvir without NS5A in genotypes 1a or 3: follow FDA labeling and AASLD‑IDSA guidance
Consider RBV or extended duration when AASLD‑IDSA recommends based on prior regimen and cirrhosis status

Note

Non‑FDA Indications

Non–FDA approved indications not specifically addressed by this policy require submission under the off‑label use policy (CP.CPA.09) with sufficient documentation of efficacy and safety. Include peer‑reviewed evidence or guideline support and rationale for use when requesting coverage for off‑label indications.

Requests for indications outside FDA labeling must follow CP.CPA.09
Provide supporting evidence (published studies, guideline recommendations) and rationale

Denial Risk

HBV Reactivation Risk — Boxed Warning

HBV reactivation is a boxed warning for all HCV direct‑acting antivirals. Screen patients for hepatitis B (HBsAg, anti‑HBc, anti‑HBs) before initiating therapy. Monitor patients co‑infected with HBV during and after DAA treatment for signs of reactivation and treat HBV per clinical guidelines as indicated. Failure to monitor may result in fulminant hepatitis, hepatic failure, or death.

Screen for HBV (HBsAg, anti‑HBc, anti‑HBs) prior to DAA initiation
Monitor co‑infected patients during and after therapy for HBV reactivation
Provide or refer for HBV treatment if reactivation occurs

Child-Pugh class: a scoring system to classify liver disease severity based on bilirubin, albumin, INR, ascites, and encephalopathy.

Class A5–6 points (Child-Pugh A).

Class B7–9 points (Child-Pugh B).

Class C10–15 points (Child-Pugh C).

Scoring componentsBilirubin, Albumin, INR, Ascites, Encephalopathy — each scored 1–3 points to reach total.