Vosevi (sofosbuvir/velpatasvir/voxilaprevir) coverage
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Defines prior authorization, approval durations, and medical necessity criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for treatment of chronic hepatitis C in adults; applies to Amerigroup plans with pharmacy benefits (not Medicare).
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Approval Criteria
Covered when ALL of the following are met:
Reference: AASLD/IDSA 2017; CDC 2013
Use in decompensated cirrhosis (Child-Pugh B or C) is excluded.
Includes but is not limited to: NS5A treatment-experienced Genotype 1; sofosbuvir-experienced Genotype 1a after prior sofosbuvir-containing regimen without an NS5A inhibitor; NS5A treatment-experienced Genotype 2; DAA-experienced Genotype 3 without cirrhosis; non-NS5A treatment-experienced Genotype 3 with compensated cirrhosis; dual P/R treatment-experienced Genotype 3 with compensated cirrhosis; certain treatment-naïve or polymorphism (Y93H) Genotype 3 scenarios; and DAA-experienced Genotype 4, 5, or 6. Some Genotype 3 indications require combination with ribavirin.
Exceptions: currently completing a course of Vosevi; documented severe hypersensitivity to Mavyret; concurrent use of an agent that cannot be substituted or temporarily discontinued and is contraindicated with Mavyret; or prior failure (relapse or non-SVR) of a regimen containing an NS5A inhibitor. Medication samples/coupons/discount cards do not count as a trial.
Vosevi may not be approved for individuals with certain high-risk conditions or contraindicated concomitant therapies. Specific exclusions include: severe or end-stage chronic kidney disease (CKD) requiring dialysis; decompensated cirrhosis; concurrent use with contraindicated or not‑recommended agents (examples include amiodarone; HIV protease inhibitor regimens containing atazanavir or lopinavir; tipranavir/ritonavir; efavirenz, etravirine, nevirapine; certain statins such as rosuvastatin and pitavastatin; cyclosporine; P‑glycoprotein inducers and moderate or strong CYP3A4 inducers like phenytoin, St. John’s Wort, phenobarbital, rifampin, rifabutin, rifapentine, carbamazepine, oxcarbazepine; and BCRP substrates such as methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, sulfasalazine, topotecan); and use in combination with other NS5A, NS3/4A protease, or NS5B polymerase inhibitors (for example, dasabuvir or another nucleotide NS5B inhibitor).
Use of Vosevi in individuals with decompensated cirrhosis (Child‑Pugh Class B or C) is considered not appropriate under this policy and is specifically excluded from approval. Requests for therapy in the setting of decompensated liver disease should not be approved per the policy language.
Medication and Coding Information
| NDC | Vosevi (sofosbuvir/velpatasvir/voxilaprevir) product — quantity limit 1 tablet per day |
Prior Authorization, Documentation, and Step Therapy
Prior authorization required; quantity & approval duration
Prior authorization is required for Vosevi. The product has a quantity limit of 1 tablet per day. Approval durations vary by genotype, prior treatment experience, cirrhosis status, and presence of polymorphisms (commonly 12 weeks for many listed genotype/treatment scenarios).
- Quantity limit: 1 tablet per day.
- Approval duration determined by genotype, treatment history, cirrhosis status, and polymorphism (see genotype-specific durations; many scenarios = 12 weeks).
Prior trial of preferred agent (Mavyret) required unless exception
Approval generally requires a prior trial and inadequate response to the preferred regimen Mavyret, unless an exception applies. Exceptions include currently completing a course of Vosevi, documented hypersensitivity to Mavyret, concomitant use of an agent that cannot be substituted and is contraindicated with Mavyret, or prior failure of an NS5A-containing regimen.
- Medication samples, coupons, or discount cards do not count as a prior trial.
- Acceptable exceptions: current Vosevi therapy; severe hypersensitivity to Mavyret ingredients; contraindicated concomitant agent that cannot be changed; prior relapse or non-SVR after NS5A-containing regimen.
Documentation of chronic hepatitis C, genotype, RNA, and liver status
Provide documentation of chronic hepatitis C infection including genotype and a positive HCV RNA result. When applicable, document compensated liver disease (Child-Pugh Class A), life expectancy >12 months, and enrollment in a substance abuse program for individuals who abuse alcohol or IV drugs.
- Document: HCV genotype and positive HCV RNA.
- Document compensated liver disease (Child-Pugh Class A) and life expectancy >12 months when indicated.
- If patient abuses alcohol or IV drugs, document enrollment in a substance abuse program.
Denial risks: CKD, decompensated cirrhosis, contraindicated concomitant agents
Requests may be denied for individuals with severe or end-stage CKD (eGFR <30 mL/min or requiring dialysis), decompensated cirrhosis (Child-Pugh Class B or C), or when therapy is requested with contraindicated concomitant agents.
- Severe or end-stage CKD (requires dialysis) is an exclusion.
- Decompensated cirrhosis (Class B or C) is not appropriate per policy.
- Concurrent use with contraindicated agents (e.g., amiodarone, certain HIV protease inhibitors, strong CYP3A4 inducers, BCRP substrates) may result in denial.
Background and Clinical Context
Chronic hepatitis C treatment has evolved to primarily use oral direct‑acting antiviral (DAA) regimens selected by viral genotype and prior treatment history. Vosevi (sofosbuvir/velpatasvir/voxilaprevir) is a fixed‑dose DAA combination positioned for use in certain treatment‑experienced patients and in genotype‑specific scenarios (for example, certain NS5A‑experienced or sofosbuvir‑experienced patients, and select genotype 4/5/6 indications). Clinical guidance (AASLD/IDSA) and assessment of hepatic function using the Child‑Pugh classification (Class A = compensated; Class B or C = decompensated) are used to determine appropriateness of Vosevi therapy.
Definitions and Treatment-Exposure Terms
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