CurrentmhnPolicy CP.CPA.290

Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) coverage

Defines clinical coverage, dosing, monitoring, and use criteria for sofosbuvir/velpatasvir/voxilaprevir (Vosevi) for treatment-experienced and select treatment-naïve HCV patients; intended for providers and prior authorization reviewers.

Policy Summary

Payermhn

PolicySofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) coverage

Policy CodePolicy CP.CPA.290

Change TypeMaterial updates to continued therapy duration and added guidance on interruptions

Effective DateJul 26, 2017

Next Review DateAug 25, 2025

Key ActionObtain prior authorization showing prescribed regimen and duration align with FDA or AASLD‑IDSA recommendations and document minimum prior exposure (≥28 days) when requesting continued therapy.

SourceLink

POLICY UPDATE CHANGES

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

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

Added a pathway to Vosevi approval for a specific treatment‑naïve genotype 3 scenario per AASLD guideline (baseline NS5A RAS Y93H with compensated cirrhosis).

Tabletproduct availability

12 wkscommon treatment duration

28min days for continued therapy

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Coverage Criteria for Vosevi

Initial and Continued Therapy Criteria

Covered when meeting specific treatment-experienced or defined treatment‑naïve criteria:

Primary covered scenarios: 1) Treatment-experienced with prior NS5A inhibitor exposure (genotypes 1-6) with or without compensated cirrhosis — Vosevi one tablet PO QD for 12 weeks.

Primary covered scenarios: 2) Treatment-experienced after a sofosbuvir-containing regimen without NS5A inhibitor (genotype 1a or 3) with or without compensated cirrhosis — Vosevi one tablet PO QD for 12 weeks.

Primary covered scenarios: 3) Treatment-experienced after Mavyret failure: without cirrhosis — Vosevi one tablet PO QD for 12 weeks; with compensated cirrhosis — Vosevi one tablet PO QD plus weight-based ribavirin (RBV) for 12 weeks.

Primary covered scenarios: 4) Selected retreatment with prior Vosevi exposure scenarios per AASLD-IDSA: Vosevi one tablet PO QD plus weight-based RBV for 24 weeks for certain treatment-experienced patients (AASLD-IDSA referenced).

Primary covered scenarios: 5) Treatment-naïve genotype 3 with compensated cirrhosis and baseline NS5A resistance-associated substitution Y93H — Vosevi one tablet PO QD for 12 weeks (AASLD-IDSA referenced).

Continued therapy: Prescribed regimen is consistent with an FDA or AASLD-IDSA recommended regimen and member has received a minimum prior treatment exposure to qualify for continued therapy approval.>=28 days prior therapy option

Policy updated to shorten minimum from 60 to 28 days.

Patients co-infected with hepatitis B virus (HBV) require active monitoring during and after direct-acting antiviral (DAA) therapy for hepatitis C because HBV reactivation is a recognized serious risk. The product labeling and Appendix E state that HBV reactivation is a Black Box warning for all DAAs and that reactivation has led to fulminant hepatitis, hepatic failure, and death in some cases; therefore, patients should be monitored for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up, and HBV infection should be treated as clinically indicated.

For prior authorization of continued therapy, the policy now allows a minimum prior treatment exposure option of ≥28 days (revised from 60 days). Continued approvals require that the prescribed regimen and duration remain consistent with FDA labeling or AASLD‑IDSA–recommended regimens (for example, the common Vosevi dosing pathways described under dosing and administration). When submitting requests for continued therapy, document the prior exposure duration and confirm the ongoing regimen aligns with the referenced FDA/AASLD‑IDSA guidance.

Coding and Scoring References

Referenced product codesNDC

NDC	Vosevi product prescribing information referenced (no explicit NDC provided in this section)

Child-Pugh scoring thresholds

Class A5-6 points

Class B7-9 points

Class C10-15 points

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prescriptions for sofosbuvir/velpatasvir/voxilaprevir (Vosevi) require prior authorization. Ensure the requested regimen and duration match FDA labeling or AASLD‑IDSA recommendations for the patient’s genotype, prior treatment history, and cirrhosis status. Include documentation of prior treatment history (e.g., prior NS5A or sofosbuvir-containing regimen and dates), baseline genotype and resistance testing if applicable (NS5A RAS Y93H for genotype 3), evidence of cirrhosis status (compensated vs decompensated; Child‑Pugh class if available), and planned treatment duration. Renewal/continuation requests must document treatment response and reason for extended therapy; minimum durations for continued therapy may be as short as 28 days when clinically justified per policy updates.

A copy of prior antiviral regimen and dates
Baseline HCV genotype and relevant RAS testing (if indicated)
Documentation of cirrhosis status (imaging, biopsy, or Child‑Pugh scoring)
Planned dose and duration consistent with FDA/AASLD‑IDSA guidance

Background

Direct-acting antivirals (DAAs) used to treat hepatitis C can precipitate hepatitis B virus (HBV) reactivation in co-infected patients. Appendix E emphasizes that HBV reactivation is a Black Box warning for all DAAs and that reactivation events have in some cases progressed to fulminant hepatitis, hepatic failure, and death. Because of this risk, clinicians and prior authorization reviewers should ensure HBV status is known and that appropriate monitoring and treatment plans for HBV are in place during and after DAA therapy. The Appendix also provides the Child-Pugh class thresholds (Class A = 5–6; B = 7–9; C = 10–15) to assess liver disease severity when evaluating treatment suitability.

Definitions

HBV reactivation — definition and clinical significance

DefinitionHBV reactivation is a Black Box Warning for all direct-acting antiviral drugs for HCV; reactivation has been reported in co-infected patients and can lead to fulminant hepatitis, hepatic failure, and death.

Clinical significancePatients should be monitored for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up; treat HBV infection as clinically indicated.

Policy implicationPresence of HBV co-infection requires monitoring and may affect safety and coverage decisions due to risk of severe hepatic outcomes.

Child-Pugh class — scoring components and class ranges

Scoring componentsUses bilirubin, albumin, INR, presence/severity of ascites, and presence/severity of hepatic encephalopathy to assign 1–3 points each.

Point breakdown examples

Policy Summary

Payermhn

PolicySofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) coverage

Policy CodePolicy CP.CPA.290

Change TypeMaterial updates to continued therapy duration and added guidance on interruptions

Effective DateJul 26, 2017

Next Review DateAug 25, 2025

SourceLink

On This Page

Documentation Required

Dosing Documentation — Prescribe per FDA/AASLD‑IDSA

Dosing and duration must be prescribed consistent with FDA‑approved labeling and AASLD‑IDSA guidance. Typical regimens include Vosevi one tablet PO once daily for 12 weeks for many treatment‑experienced scenarios; alternate regimens (e.g., Mavyret-based pathways) and adjustments for compensated cirrhosis or specific prior treatment failures are described in the dosing section. Maximum dose is one tablet (sofosbuvir 400 mg/ velpatasvir 100 mg/ voxilaprevir 100 mg) per day. For genotype 3 with baseline NS5A RAS Y93H or other specified scenarios, follow AASLD‑IDSA recommendations for regimen and duration.

Maximum dose: One tablet (sofosbuvir 400 mg/ velpatasvir 100 mg/ voxilaprevir 100 mg) per day
Common regimen: Vosevi one tablet PO QD for 12 weeks for many treatment‑experienced patients

Documentation Required

HBV Reactivation Monitoring

HBV Reactivation Monitoring Required: Direct‑acting antivirals for HCV carry a Black Box Warning for HBV reactivation. For patients with current or prior hepatitis B infection (HBsAg positive or anti‑HBc positive), obtain baseline HBV serologies prior to initiating therapy, monitor during and after treatment for signs of HBV reactivation or hepatitis flare, and manage or treat HBV infection according to clinical guidelines if reactivation occurs. Document baseline HBV testing and the monitoring plan in the prior authorization submission.

Obtain baseline HBsAg and anti‑HBc (± HBV DNA if indicated) before starting HCV DAA therapy
Monitor LFTs and HBV DNA during and after HCV treatment; treat HBV per standard of care if reactivation occurs
Include HBV testing results and monitoring plan with the authorization request

Bilirubin: 1 (<2 mg/dL), 2 (2–3 mg/dL), 3 (>3 mg/dL); Albumin: 1 (>3.5 g/dL), 2 (2.8–3.5 g/dL), 3 (<2.8 g/dL); INR: 1 (<1.7), 2 (1.7–2.2), 3 (>2.2).

Ascites and encephalopathy gradingAscites: 1 none, 2 mild/medically controlled, 3 moderate-severe/poorly controlled; Encephalopathy: 1 none, 2 mild/medically controlled (Grade I–II), 3 moderate-severe/poorly controlled (Grade III–IV).

Class rangesClass A = 5–6 points; Class B = 7–9 points; Class C = 10–15 points.