CurrentNeighborhood Health Plan of Rhode IslandPolicy 2137-A

Epclusa (sofosbuvir-velpatasvir) coverage policy

Defines coverage and authorization criteria for Epclusa (sofosbuvir-velpatasvir) for treatment of chronic hepatitis C virus (HCV) genotypes 1-6 in adults and pediatric patients ≥3 years, including cirrhosis status, transplant scenarios, decompensated disease, coinfection, and RBV ineligibility considerations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpclusa (sofosbuvir-velpatasvir) coverage policy

Policy CodePolicy 2137-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prescriber expertise and required clinical information, including HBV screening and treatment history, per the policy; authorizations granted for up to 12 or 24 weeks depending on indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

6HCV genotypes covered

≥3Minimum age

12 wksTypical authorized duration

24 wksExtended duration

Coverage Summary

Epclusa (sofosbuvir-velpatasvir) is indicated for the treatment of chronic hepatitis C virus (HCV) infection of genotypes 1 through 6 in adults and pediatric patients aged 3 years and older. It is indicated for patients without cirrhosis, with compensated cirrhosis, and for use in combination with ribavirin in patients with decompensated cirrhosis. The medication may also be used in certain transplant-related scenarios (e.g., recurrent HCV post liver transplant, recipients of organs from HCV-viremic donors) per the coverage criteria. All other indications are considered experimental/investigational and not medically necessary.

Key policy stats

HCV genotypes covered1-6 (six genotypes)

Minimum age≥3 years

Typical authorized durationUp to 12 weeks

Extended authorized durationUp to 24 weeks (for decompensated cirrhosis/prior failure)

Threshold: Baseline hemoglobin< 10 g/dL (documented anemia for RBV consideration)

Initial Therapy Criteria

General covered indications

Covered when ALL of the following are met:

ALL of the following

Diagnosis of chronic hepatitis C virus (HCV) infection with genotype 1, 2, 3, 4, 5, or 6
Member is aged 3 years or older
Prescribed by or in consultation with a provider experienced in management of HCV

Genotype 1-6: without cirrhosis or with compensated cirrhosis

Authorization of up to 12 weeks may be granted when ALL of the following are met:

ALL of the following

Genotype 1, 2, 3, 4, 5, or 6
No cirrhosis or compensated cirrhosis
AND one of the following treatment history scenarios
- Treatment-naïve
- Failed prior treatment with peginterferon alfa (PEG-IFN) and ribavirin (RBV) with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir)

Provider Actions

Prior Authorization

Authorization required with duration limits

Prior authorization is required. Authorizations are granted for up to 12 weeks for most covered indications (e.g., without cirrhosis or with compensated cirrhosis, many post-transplant and transplant-donor scenarios, pediatric criteria, genotype 3 with Y93H, etc.). Authorizations of up to 24 weeks may be granted for specific indications such as decompensated cirrhosis with documented anemia (baseline hemoglobin < 10 g/dL), RBV ineligibility, or certain prior treatment failures as specified in the criteria.

PA required
Durations: up to 12 weeks for most scenarios; up to 24 weeks for decompensated cirrhosis with documented anemia (Hgb < 10 g/dL), RBV ineligibility, or prior DAA/NS5A failure

Documentation Required

Prescriber expertise and clinical documentation

Medication must be prescribed by or in consultation with a provider experienced in management of HCV. Clinical documentation that may be requested to support authorization includes treatment status (treatment‑naïve vs retreatment), confirmation of readiness for therapy, for retreatment the reason for retreatment (e.g., prior treatment failure or reinfection), hepatitis B virus screening results, and Metavir/fibrosis score.

Prescribed by or in consultation with an HCV‑experienced provider
Possible documentation: treatment status; confirmation of readiness; reason for retreatment; HBV screening results; Metavir/fibrosis score

Documentation Required

Ribavirin ineligibility documentation

When seeking a longer (RBV‑based) duration or 24‑week authorization related to RBV considerations, document RBV ineligibility. RBV ineligibility is defined as one or more of: intolerance to ribavirin; pregnant female or male whose female partner is pregnant; hemoglobinopathy; coadministration with didanosine; or history of significant or unstable cardiac disease. Also note the policy threshold for documented anemia as baseline hemoglobin below 10 g/dL when applicable.

RBV ineligibility definition: intolerance; pregnancy concerns (female or male whose partner is pregnant); hemoglobinopathy; coadministration with didanosine; significant/unstable cardiac disease
Baseline hemoglobin < 10 g/dL documents anemia for RBV consideration

Background

Background: Epclusa (sofosbuvir-velpatasvir) is a fixed-dose combination antiviral regimen approved for the treatment of chronic HCV genotype 1–6 infection in adults and pediatric patients aged 3 years and older. It is indicated for patients without cirrhosis and those with compensated cirrhosis, and it is indicated in combination with ribavirin for patients with decompensated cirrhosis. The drug is intended to be prescribed by or in consultation with a provider experienced in the management of HCV. The policy addresses use across clinical scenarios including treatment-naïve and certain treatment-experienced patients, unknown genotype when testing cannot be completed, transplant-related indications (recurrent HCV post liver transplant, kidney transplant recipients, and recipients of organs from HCV-viremic donors), genotype 3 with the Y93H resistance substitution, and HCV/HIV coinfection when regimen criteria are met.

Definitions

TermRBV ineligibility

DefinitionIntolerance to RBV; pregnant female or male whose female partner is pregnant; hemoglobinopathy; coadministration with didanosine; history of significant or unstable cardiac disease.