Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) coverage
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Defines prior authorization, coverage criteria, and treatment conditions for Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Delaware First Health Medicaid members. Applies to initial and continued therapy, listing required documentation, alternative therapies, and contraindications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
Initial Therapy
Covered when ALL of the following are met for Initial Approval (Hepatitis C Infection):
Chart note documentation and copies of lab results are required.
Continued Therapy
Covered when ALL of the following are met for Continued Therapy:
Approved duration should be consistent with a regimen in Section V Dosage and Administration; see state addendums for continuity of care exceptions.
Other/Off-label
Other indications and exclusions:
Refer to off‑label and formulary policies cited in Section III and policy text for routing of recent label changes or unlisted uses.
Initial and genotype/prior-treatment-based coverage
Covered when regimen and patient history align with FDA labeling or AASLD-IDSA recommendations, including treatment-experienced scenarios:
Per Section V Dosage and Administration (FDA labeling).
See Section V dosing rows for genotype/prior-treatment specifics.
Policy references AASLD-IDSA Dec 2023 updates for genotype- and prior‑treatment–specific dosing and possible RBV addition.
Incomplete adherence and treatment interruption management
Management of interrupted therapy per AASLD-IDSA recommendations:
Applies generally to treatment‑naïve patients without decompensated cirrhosis receiving Mavyret or Epclusa; guidance referenced for other DAAs.
Recommendations vary by timing, genotype, and cirrhosis; consult AASLD‑IDSA retreatment guidance.
These recommendations primarily apply to treatment‑naïve, non‑decompensated patients receiving Mavyret or Epclusa; consult experts for complex cases.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request is supported by sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 (for Medicaid) or other applicable evidence of coverage documents.
Requests that involve coadministration with rifampin are explicitly contraindicated and will be denied; rifampin coadministration is listed as a contraindication in the policy Appendix C.
Initial Therapy
Initial Therapy
Initial coverage criteria for Vosevi:
Vosevi standard 12‑week course for many treatment‑experienced scenarios per labeling.
Initial therapy dosing
Initial therapy dosing excerpts from labeling and guidelines:
Per FDA‑approved labeling and AASLD‑IDSA recommendations referenced in Section V.
Policy references AASLD‑IDSA Dec 2023 updates for RBV inclusion and extended durations.
Continuation / Continued Therapy
Continued Therapy
Continuation criteria for members already on Vosevi:
See policy for continuity of care exceptions by state; continued therapy additions to be consistent with FDA/AASLD‑IDSA regimens as noted in review updates.
Continued therapy notes
Continued therapy criteria updated in review notes
References reviewed and updated; see policy change log in Appendix F references.
Provider Actions and Documentation Requirements
Prior authorization required with supporting HCV clinical data
Prior authorization is required. Requests must include documentation that the member has detectable serum HCV RNA by quantitative assay within the last 6 months, HCV genotype, documentation of prior DAA exposure or RAS testing when applicable, confirmation that member is ≥ 18 years of age, and that the prescribed dosing is consistent with FDA or AASLD-IDSA recommendations. Chart note documentation and copies of lab results are required to support these elements.
- Detectable serum HCV RNA by quantitative assay within last 6 months
- HCV genotype documentation
- Prior DAA regimen history or RAS testing as applicable
- Age ≥ 18 years
- Regimen/dose consistent with FDA or AASLD-IDSA recommendations
- Chart notes and copies of lab results must be submitted
Prior authorization governed by prior DAA regimen history
Prior authorization determinations for Vosevi are governed by the policy's clinical criteria, which require clarification of prior DAA regimen history (treatment-experienced with NS5A inhibitor or specific sofosbuvir-containing regimens) and alignment with FDA or AASLD-IDSA recommended regimens for approval.
- Treatment-experienced status and prior regimen details are required for decision-making
- Policy references FDA labeling and AASLD-IDSA guidance for genotype- and prior-treatment–specific pathways
Step/therapeutic substitution: trial of preferred DAAs required
Members in specified prior-treatment scenarios must have documented trial of Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) as required by the criteria before Vosevi will be authorized, unless the agent is contraindicated or there is documented clinically significant adverse effect or intolerance.
- Required trial of Mavyret or sofosbuvir/velpatasvir when criteria (genotype/prior regimen) specify
- Exception when contraindicated or clinically significant adverse effects/intolerance documented
Preferred-agent redirection to Mavyret or Epclusa in specified scenarios
The policy contains redirection pathways to preferred agents — for certain treatment-naïve genotype 3 scenarios and other policy-specified situations the member must be tried on (or redirected to) Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) prior to Vosevi unless contraindicated or prior failure is documented.
- Redirection to Mavyret or Epclusa AG is required in specified genotype 3 treatment-naïve with compensated cirrhosis + baseline NS5A RAS Y93H scenario
- Attempts or documentation of prior failure of preferred agent required per policy
Required documentation: chart notes and lab results
Providers must submit chart note documentation and copies of laboratory results to support the diagnosis, HCV RNA, genotype, prior treatments, cirrhosis status (including Child-Pugh A if present), and RAS testing when applicable; these documents are required with the prior authorization request.
- Office chart notes supporting diagnosis and prior treatment history
- Lab results including quantitative HCV RNA and genotype
- Documentation of cirrhosis status and Child-Pugh A confirmation if cirrhosis present
- RAS testing results (e.g., Y93H) when required by criteria
Supporting documentation: reference prescribing information and AASLD‑IDSA guidance
Prescribers should reference and may need to document adherence to primary references — Vosevi prescribing information and AASLD‑IDSA HCV guidance — for dosing, recommended regimens, prior‑treatment pathways, and management of interruptions.
- Vosevi Prescribing Information (Gilead) cited in references
- AASLD‑IDSA HCV guidance (updated December 2023) cited for regimen recommendations and interruption management
Denial risk for missing supporting documentation
Failure to submit the required supporting documentation (for example, chart notes and lab results demonstrating the member meets all approval criteria) may result in denial of the prior authorization request.
- Incomplete or missing chart notes/lab results can lead to denial
Contraindication-triggered denial for rifampin coadministration
Requests involving coadministration with rifampin are contraindicated; coverage for such requests would be denied per the policy's contraindications.
- Coadministration with rifampin is listed as an explicit contraindication
Step Therapy and Preferred-Agent Requirements
| Prior-treatment scenario | Required step prior to Vosevi |
|---|---|
| Genotype 1 with prior treatment containing an NS5A inhibitor without an NS3/4A protease inhibitor (e.g., Daklinza, Epclusa, Harvoni) | |
| Member must use Mavyret as the preferred agent before Vosevi unless contraindicated or intolerant | |
| Genotype 1a or 3 with prior treatment containing sofosbuvir (with or without peginterferon/ribavirin or an NS3/4A protease inhibitor) | |
| Member must use Mavyret as the preferred agent before Vosevi unless contraindicated or intolerant | |
| Genotype 1–6 with prior treatment with either Vosevi or Mavyret | |
| Member must use Mavyret in combination with Sovaldi and ribavirin (per policy) prior to alternative pathways | |
| Genotype 3, treatment‑naive with compensated cirrhosis and documented baseline NS5A RAS Y93H for velpatasvir | |
| Member must use Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) in combination with ribavirin prior to Vosevi unless contraindicated |
| Clinical scenario | Preferred redirection or attempt before Vosevi |
|---|---|
| Treatment‑naive genotype 3 with compensated cirrhosis and documented baseline NS5A RAS Y93H | |
| Redirect or attempt therapy with Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) combined with ribavirin per AASLD‑IDSA pathway before Vosevi, unless contraindicated | |
| Other policy‑preferred scenarios where AASLD guidance favors alternative regimens (e.g., Mavyret or Epclusa) before protease‑containing regimens | |
| Policy requires attempt or redirection to preferred regimens (Mavyret or Epclusa AG) prior to Vosevi unless contraindication or documented prior failure of the preferred agent |
Coding and Clinical Classifications
Quantity Limits
Background
Vosevi is a fixed‑dose, oral combination product containing sofosbuvir (NS5B inhibitor), velpatasvir (NS5A inhibitor), and voxilaprevir (NS3/4A protease inhibitor). It is indicated for adults with chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis in specified prior‑treatment contexts and the policy aligns use with FDA labeling and AASLD‑IDSA recommendations.
Definitions and Abbreviations
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