CurrentNeighborhood Health Plan of Rhode IslandPolicy 2176-A

Vosevi (sofosbuvir-velpatasvir-voxilaprevir)

Coverage policy for Vosevi for treatment of chronic hepatitis C virus (HCV) infection in adults across genotypes 1-6, including special populations (post-liver transplant, kidney transplant, HCV/HIV coinfection), with genotype- and prior-treatment–based authorization durations and exclusions for decompensated cirrhosis.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVosevi (sofosbuvir-velpatasvir-voxilaprevir)

Policy CodePolicy 2176-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior DAA treatment history to support the requested duration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

6Covered genotypes (1-6)

12wTypical max authorization

24wAuthorization after prior Vosevi failure

adultAge restriction (adult only)

Coverage Summary & Scope

Coverage: Vosevi (sofosbuvir-velpatasvir-voxilaprevir) is covered with criteria for treatment of chronic hepatitis C virus (HCV) infection in adults across genotypes 1–6. Authorization is genotype- and prior-treatment–dependent with typical maximum durations of up to 12 weeks for most covered indications and up to 24 weeks for prior Vosevi failure. Use is restricted to adults and excludes members with decompensated cirrhosis/moderate or severe hepatic impairment (Child-Turcotte-Pugh class B or C).

Key policy thresholds

Policy number2176-A

SubjectVosevi (sofosbuvir-velpatasvir-voxilaprevir)

Authorization duration (most covered indications)Up to 12 weeks total

Authorization duration after prior Vosevi failureUp to 24 weeks total

Patient ageAdult only

Initial Therapy Criteria

General Coverage Criteria

Vosevi is covered when ALL of the following are met:

ALL of the following

Patient age: Patient is an adultadult only
See policy: medication approved for use in adult members only
Prescriber specialty: Prescribed by or in consultation with a provider experienced in management of HCV infection
Documentation of prescriber specialty/consultation may be requested
FDA indication: Indication is one of the FDA-approved indications listed below
See FDA-Approved Indications and Authorization Durations group
Hepatic function exclusion: Member does not have decompensated cirrhosis/moderate or severe hepatic impairment (Child-Turcotte-Pugh class B or C)CTP class B or C excluded
Use in members with decompensated cirrhosis/CTP B or C is excluded

FDA-Approved Indications and Authorization Durations

Authorization MAY be granted per the specific genotype and prior-treatment history as detailed:

Covered Indications (genotype- & prior-treatment–specific)

Genotype 1, 2, 4, 5, or 6 infection (prior DAA failure): Member failed prior treatment with any direct-acting antiviral regimen (e.g., NS5A- or sofosbuvir-containing regimen except glecaprevir/pibrentasvir [Mavyret])Authorization of up to 12 weeks total may be granted
Genotype 1 or 3 infection previously treated with sofosbuvir without an NS5A inhibitor: Genotype 1a or 3 infection previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitorAuthorization of up to 12 weeks total may be granted
Additional benefit not shown for some subgroups per policy
Genotype 1, 2, 4, 5, or 6 who failed Mavyret (without cirrhosis):

Continuation of Therapy

Continuation requirement: All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria

Continuation requests must meet same coverage criteria

Unproven / Not Medically Necessary

Decompensated cirrhosis: defined in this policy as moderate or severe hepatic impairment (Child-Turcotte-Pugh class B or C); use is excluded for these members.

Direct-acting antiviral (DAA): HCV antiviral regimens including NS5A- or sofosbuvir-containing regimens (examples cited in the policy include glecaprevir/pibrentasvir [Mavyret]).

This policy’s definitions and coverage align with FDA indications for Vosevi and require prescribing by or in consultation with a provider experienced in HCV management.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required with documentation of prior DAA treatment history

Obtain prior authorization and document prior direct-acting antiviral (DAA) treatment history to support the requested duration. Include specifics such as prior NS5A- or sofosbuvir-containing regimens and whether the member previously received glecaprevir/pibrentasvir (Mavyret); durations granted are genotype- and prior-treatment–dependent (typically up to 12 weeks, with up to 24 weeks for prior Vosevi failure).

Document prior NS5A- or sofosbuvir-containing regimens
Document prior glecaprevir/pibrentasvir (Mavyret) exposure or failure
Support requested authorization duration with genotype- and prior-treatment history (e.g., up to 12 weeks or up to 24 weeks for prior Vosevi failure)

Documentation Required

Specialty prescriber requirement

Vosevi must be prescribed by, or in consultation with, a provider experienced in management of HCV infection. You may be asked to document the prescriber’s specialty or evidence of consultation with an experienced HCV provider.

Documentation Required

Exclusion documentation

Do not prescribe this medication for members with decompensated cirrhosis (Child-Turcotte-Pugh class B or C). Documentation of hepatic function (Child-Turcotte-Pugh status) may be requested to confirm this exclusion.

Documentation Required

Supportive information that may be requested

The plan may request supportive information to satisfy regulatory requirements. Provide the items below when requested to help substantiate the authorization.

Treatment status (treatment‑naïve vs retreatment)
For initial treatment: confirmation of member readiness
For retreatment: reason for retreatment (e.g., prior treatment failure, reinfection), confirmation of readiness, and ability to adhere
Hepatitis B virus screening results
Metavir/Fibrosis score

Applicable Codes

Drug (NDC)NDC

No codes listed

Background & Clinical Context

Vosevi (sofosbuvir-velpatasvir-voxilaprevir) is an FDA-approved regimen for certain adults with chronic HCV infection, especially for patients who have previously failed NS5A- or sofosbuvir-containing regimens. The policy aligns coverage to FDA indications (genotypes 1–6 with specific prior-treatment scenarios) and restricts use in members with decompensated cirrhosis (Child-Pugh B or C).

Clinical Evidence

Evidence: For efficacy and safety data, refer to the FDA labeling and clinical trials cited in the product references (e.g., Vosevi package insert) and relevant clinical guidelines. This policy summary does not reproduce trial-level evidence.

Definitions

Decompensated cirrhosis: Moderate or severe hepatic impairment (Child-Turcotte-Pugh class B or C) — use excluded.

Direct-acting antiviral (DAA): HCV antiviral regimens including NS5A- or sofosbuvir-containing regimens; examples cited include glecaprevir/pibrentasvir (Mavyret).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVosevi (sofosbuvir-velpatasvir-voxilaprevir)

Policy CodePolicy 2176-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior DAA treatment history to support the requested duration.

SourceLink

On This Page

Member without cirrhosis who failed prior treatment with glecaprevir/pibrentasvir (Mavyret)

Authorization of up to 12 weeks total may be granted

Genotype 3 infection without cirrhosis (prior DAA failure): Member without cirrhosis who failed prior treatment with any direct-acting antiviral regimen (e.g., NS5A- or sofosbuvir-containing regimen, including glecaprevir/pibrentasvir [Mavyret])Authorization of up to 12 weeks total may be granted

Genotype 3 with compensated cirrhosis (Y93H) - treatment-naïve: Treatment-naïve members with compensated cirrhosis who have the Y93H substitution associated with velpatasvir resistanceAuthorization of up to 12 weeks total may be granted

Prior Vosevi (sofosbuvir/velpatasvir/voxilaprevir) failure: Members with or without compensated cirrhosis who failed prior treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi)Authorization of up to 24 weeks total may be granted

Longer duration allowed after prior Vosevi failure

Recurrent HCV post liver transplant: Recurrent HCV genotype 1, 2, 3, 4, 5, or 6 infection post liver transplant who failed prior treatment with any direct-acting antiviral regimen (e.g., NS5A- or sofosbuvir-containing regimen)Authorization of up to 12 weeks total may be granted

Kidney transplant recipients with HCV genotype 1, 2, 3, 4, 5, or 6 infection who failed prior treatment with any direct-acting antiviral regimen (e.g., NS5A- or sofosbuvir-containing regimen)Authorization of up to 12 weeks total may be granted

HCV and HIV coinfection: Members with HCV/HIV coinfection when the criteria for approval of the requested regimen in the coverage criteria above are metAuthorization of up to 12 weeks total may be granted when criteria met

OpenPayer

Vosevi (sofosbuvir-velpatasvir-voxilaprevir)

Coverage Summary & Scope

Initial Therapy Criteria

Continuation of Therapy

Unproven / Not Medically Necessary

Provider Actions & Documentation Requirements

Applicable Codes

Background & Clinical Context

Clinical Evidence

Definitions

Revision History