Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) coverage
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Defines medical necessity and prior authorization criteria for Vosevi for treatment of chronic hepatitis C virus (HCV) infection for Medicaid members served by Peach State Health Plan.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial and Continued Therapy Criteria
Covered when ALL of the following are met for Hepatitis C infection (Initial Approval):
Chart note documentation and copies of lab results are required
Other Indications/Off-label Handling
Other diagnoses/indications (must meet all or specified):
Follow off‑label policy CP.PMN.53 for requests outside this policy
Initial Therapy — NS5A inhibitor treatment-experienced
Covered when ALL of the following are met for treatment-experienced patients:
Per FDA‑approved labeling and AASLD‑IDSA guidance
Initial Therapy — Prior sofosbuvir-containing regimen
Covered when ALL of the following are met for patients with prior sofosbuvir-containing regimen:
Per FDA labeling and Appendix F dosing table
Non‑FDA approved uses of Vosevi that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan’s off‑label use requirements. When requesting coverage for an off‑label indication, submit supporting clinical evidence per Peach State Health Plan’s Off‑Label Use Policy (CP.PMN.53) or applicable evidence‑of‑coverage documents to justify medical necessity.
Coadministration of Vosevi with rifampin is an explicit contraindication and will preclude authorization. Requests that document concurrent rifampin therapy will be denied unless rifampin has been discontinued and appropriate documentation is provided.
Requests for indications that are non‑FDA approved and lack adequate supporting documentation of benefit and safety are considered not medically necessary and will not be authorized. Providers should refer off‑label requests to the Off‑Label Use Policy (CP.PMN.53) and include the required clinical justification and evidence when seeking coverage for such uses.
Initial Therapy
Initial Therapy
Initial therapy criteria for HCV infection (must meet all):
Chart notes and lab documentation required for approval
Initial therapy — Vosevi dosing per FDA/AASLD labeling
Vosevi dosing per FDA and AASLD‑IDSA labeling:
Per FDA‑approved labeling and Appendix F AASLD‑IDSA references
Continuation Therapy
Continued Therapy
Criteria for continued therapy for HCV infection:
See Appendix F for guidance on incomplete adherence and treatment interruptions
Continued therapy — additional criteria and planned updates
Additional continuation criteria and planned updates:
Policy revisions noted in Appendix F/References
Provider Actions & Documentation
Prior authorization required — submit HCV RNA, age, genotype, treatment history
Prior authorization is required for Vosevi. Providers must submit documentation that the member has detectable serum HCV RNA by quantitative assay within the last 6 months, is age ≥ 18 years, and documentation of genotype and prior treatment history or baseline NS5A RAS Y93H (for treatment‑naïve genotype 3 with compensated cirrhosis) as applicable. If cirrhosis is present, confirm Child‑Pugh A; for treatment‑experienced members, document prior DAA regimen duration ≥ 8 weeks unless virologic failure occurred earlier. Prescribed regimen must be consistent with FDA or AASLD‑IDSA recommendations and dose limits (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg; 1 tablet/day).
- Detectable quantitative HCV RNA within the last 6 months required
- Age ≥ 18 years
- Genotype and prior treatment history or baseline NS5A RAS Y93H (when required) documented
- If cirrhosis: documentation of Child‑Pugh A status
- For treatment‑experienced: prior DAA regimen ≥ 8 weeks unless early virologic failure
- Regimen consistent with FDA or AASLD‑IDSA and dose limits not exceeded
Prior authorization for Vosevi — treatment‑experienced indications
Prior authorization is required when Vosevi is prescribed for treatment‑experienced HCV indications consistent with FDA labeling and AASLD‑IDSA guidance (commonly one tablet PO once daily for 12 weeks for NS5A‑experienced patients).
- Vosevi indicated for treatment‑experienced patients with prior NS5A exposure per FDA labeling
- Standard dosing: one tablet PO QD for 12 weeks for indicated treatment‑experienced scenarios
Step therapy preference — try Mavyret or sofosbuvir/velpatasvir first
Members must use Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) in specified scenarios prior to Vosevi unless contraindicated or clinically significant adverse effects occur.
- Genotype 1 with prior NS5A (without NS3/4A PI): member must use Mavyret
- Genotype 1a or 3 with prior sofosbuvir‑containing regimen: member must use Mavyret
- Genotype 3, treatment‑naïve with compensated cirrhosis and baseline NS5A RAS Y93H: member must use Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) with RBV
Preferred redirection — route members to Mavyret or Epclusa per guidance
Policy includes redirection to Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) for preferred treatment pathways in certain treatment‑naïve and other scenarios per AASLD guidance; exceptions apply when contraindications or clinically significant adverse effects exist or when criteria support Vosevi.
- Treatment‑naïve genotype 3 with compensated cirrhosis and baseline Y93H: redirect to Mavyret or Epclusa + RBV unless Vosevi criteria met
- Redirection pathways were added/clarified per prior reviews and AASLD‑IDSA guidance
Required supporting documentation — chart notes, labs, genotype, treatment history
Providers must submit supporting documentation with PA requests, including office chart notes and lab results showing that the member meets all approval criteria.
- Copies of quantitative HCV RNA results (within last 6 months)
- Chart notes confirming age, genotype, prior DAA treatment history, or baseline NS5A RAS testing as applicable
- Documentation of Child‑Pugh A if cirrhosis present and prior DAA duration when treatment‑experienced
HBV monitoring documentation — document reactivation monitoring for coinfected patients
Document monitoring for HBV reactivation in patients coinfected with HCV and HBV; include references to Vosevi prescribing information and AASLD‑IDSA guidance as supporting materials.
- Document a plan to monitor for HBV reactivation and hepatitis flare during and after HCV treatment
- Provide supporting references such as Vosevi Prescribing Information and AASLD‑IDSA guidance when available
Documentation‑driven denials — missing labs or treatment history will trigger denial
Requests lacking required documentation (e.g., no recent quantitative HCV RNA, missing chart notes or lab results) or that fail to meet genotype/prior treatment criteria may be denied.
- No quantitative HCV RNA in last 6 months is a common denial trigger
- Missing documentation of prior DAA regimen, genotype, or required baseline RAS testing may cause denial
Contraindication: rifampin — triggers denial
Coadministration with rifampin is a contraindication to Vosevi and will result in denial of therapy.
- Rifampin use is listed as a contraindication in Appendix C
Step Therapy / Preferred Alternatives
| Step | Requirement | Failure/Exception |
|---|---|---|
| Step 1 | ||
| Member must use Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) as indicated prior to Vosevi per policy scenarios: a) Genotype 1 with prior NS5A-only regimen → Mavyret; b) Genotype 1a or 3 with prior sofosbuvir-containing regimen → Mavyret; d) Genotype 3, treatment‑naive with compensated cirrhosis and baseline NS5A RAS Y93H → Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) in combination with ribavirin. | ||
| Exceptions: use of Vosevi without prior Mavyret/Epclusa is permitted only if Mavyret or sofosbuvir/velpatasvir is contraindicated or causes clinically significant adverse effects. |
| Step | Retreatment Requirement | Regimen / Notes |
|---|---|---|
| Step 2 | ||
| For members with prior Vosevi or prior Mavyret treatment, retreatment requires use of Mavyret in combination with Sovaldi (sofosbuvir) and ribavirin as specified by the policy. | ||
| AASLD‑IDSA–supported/appendix dosing: Sovaldi 400 mg + Mavyret (glecaprevir/pibrentasvir) + weight‑based RBV per genotype and cirrhosis status (off‑label but guideline‑supported); specific durations vary by scenario (see Appendix F). |
| Step | Preferred Redirection | When Vosevi Reserved |
|---|---|---|
| Step 1 | ||
| Policy redirects treatment‑naive members in specified scenarios to preferred alternatives (Mavyret or sofosbuvir/velpatasvir [Epclusa authorized generic]) before considering Vosevi per AASLD guidance and policy updates. | ||
| Vosevi is reserved for defined treatment‑experienced or guideline‑supported exceptions (e.g., NS5A‑experienced patients or other AASLD‑supported indications); prior preferred agent failure or contraindication may allow Vosevi use. |
Quantity Limits
Coding & Clinical Thresholds
Definitions
Site of Care
Oral outpatient (home) administration per prescribing information
Vosevi is an oral medication for outpatient use; administration is oral at home per the prescribing information and no site‑of‑care restriction is specified in this policy.
- One tablet PO once daily dosing described in Dosage and Administration
- No site restriction specified — oral outpatient (home) administration
Background
Vosevi is an oral fixed‑dose combination tablet containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg. The product combines a nucleotide NS5B polymerase inhibitor (sofosbuvir), an NS5A inhibitor (velpatasvir), and an NS3/4A protease inhibitor (voxilaprevir) to provide direct‑acting antiviral activity against hepatitis C virus. It is indicated for adult patients with chronic HCV in specific prior‑treatment contexts and is administered as one tablet once daily per FDA‑approved labeling and guideline‑based recommendations.
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