CurrentNeighborhood Health Plan of Rhode IslandPolicy 2137-A

Epclusa (sofosbuvir-velpatasvir) coverage

Defines coverage criteria, prescriber requirements, duration limits, special populations, and continuity rules for Epclusa (sofosbuvir-velpatasvir) for treatment of chronic hepatitis C virus (HCV) genotypes 1-6 for members aged ≥3 years when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEpclusa (sofosbuvir-velpatasvir) coverage

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 genotype testing when indicated) to support the requested duration.

POLICY UPDATE CHANGES

No material clinical/coverage changes

6Covered HCV genotypes

3Minimum member age (years)

12-24Authorized treatment duration (weeks)

Coverage Summary

Coverage Summary: Epclusa (sofosbuvir-velpatasvir) is covered for the treatment of chronic hepatitis C virus (HCV) infection genotypes 1–6 for adults and pediatric patients aged >= 3 years when approval criteria are met. For patients with decompensated cirrhosis (Child Turcotte Pugh class B or C), Epclusa is indicated for use in combination with ribavirin; some decompensated scenarios may require extended durations (see criteria). All other indications are considered experimental/investigational and not medically necessary. (Policy: 2137-A; Scope: defines coverage criteria, prescriber requirements, duration limits, special populations, and continuity rules.)

General covered indications and baseline requirements

Epclusa is covered for FDA-approved indications and compendial uses when ALL of the following are met:

ALL of the following

General baseline requirements
- Diagnosis of chronic hepatitis C virus (HCV) infection genotype 1, 2, 3, 4, 5, or 6
- Age: Member age 3 years or older>= 3 years
- Prescriber: Prescribed by or in consultation with a provider experienced in management of HCV

Notes: All other indications are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria — Treatment duration & scenarios

Treatment duration and specific scenarios

Authorization durations may be granted per clinical scenario as follows:

ANY of the following

Genotype 1-6, no cirrhosis or compensated cirrhosis: Treatment-naïve OR prior failure with peginterferon alfa + ribavirin with or without an HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir); Authorization up to 12 weeks total12 weeks
Pediatrics (<18) without cirrhosis or with compensated cirrhosis: Either: failed prior interferon-based regimen with or without RBV and has NOT received an NS3/4A protease inhibitor or NS5A inhibitor; OR failed prior sofosbuvir-based regimen and has NOT received an NS3/4A protease inhibitor or NS5A inhibitor; Authorization up to 12 weeks total12 weeks
Unknown/undetermined genotype without cirrhosis: Member is treatment-naïve and does NOT have any of: HBsAG positive; current pregnancy; known or suspected hepatocellular carcinoma; prior liver transplantation; Authorization up to 12 weeks total12 weeks
Genotype testing is required for members with any of the listed characteristics
Decompensated cirrhosis (CTP class B or C) - initial authorization: HCV genotype 1-6 with decompensated cirrhosis; Authorization up to 12 weeks total12 weeks
Decompensated cirrhosis (CTP class B or C) - extended duration: HCV genotype 1-6 with decompensated cirrhosis AND documented anemia (baseline hemoglobin below 10 g/dL) OR ribavirin (RBV) ineligibility; Authorization up to 24 weeks total24 weeks
Baseline hemoglobin < 10 g/dL or RBV ineligibility
Recurrent HCV post liver transplantation without decompensated cirrhosis: Recurrent HCV genotype 1-6 post liver transplant without cirrhosis or with compensated cirrhosis; Authorization up to 12 weeks total12 weeks
Recurrent HCV post liver transplantation with decompensated cirrhosis: Treatment-naïve members with recurrent HCV genotype 1-6 post liver transplant and decompensated cirrhosis; Authorization up to 12 weeks total12 weeks
Recurrent HCV post liver transplantation with decompensated cirrhosis - treatment experienced: Treatment-experienced members with recurrent HCV genotype 1-6 post liver transplant and decompensated cirrhosis; Authorization up to 24 weeks total24 weeks
Kidney transplant recipients: Members with HCV genotype 1-6 infection without cirrhosis or with compensated cirrhosis who are treatment-naïve or who have NOT failed prior treatment with a direct-acting antiviral; Authorization up to 12 weeks total12 weeks
Organ recipient from HCV-viremic donor: Members who received a liver or non-liver organ transplant from an HCV-viremic donor; Authorization up to 12 weeks total12 weeks
Genotype 3 with Y93H substitution: Treatment-naïve members with compensated cirrhosis who have the Y93H substitution associated with velpatasvir resistance; Authorization up to 12 weeks total12 weeks
Decompensated cirrhosis - prior DAA or NS5A failure: Members with decompensated cirrhosis who failed prior treatment with a sofosbuvir- or NS5A inhibitor-based regimen; Authorization up to 24 weeks total24 weeks
HCV and HIV coinfection: Members with HCV and HIV coinfection when the criteria for approval of the requested regimen in the coverage criteria above are met

Ribavirin (RBV) Ineligibility (Appendix / Exclusions)

RBV ineligibility definition (Appendix)

RBV ineligibility is defined by ONE OR MORE of the following:

Intolerance to RBV

Pregnancy: Pregnant female or male whose female partner is pregnant

Hemoglobinopathy

Didanosine interaction: Coadministration with didanosine

Cardiac disease: History of significant or unstable cardiac disease

Definitions: RBV ineligibility is defined as one or more of the following: intolerance to RBV; pregnant female or male whose female partner is pregnant; hemoglobinopathy; coadministration with didanosine; or history of significant or unstable cardiac disease. Decompensated cirrhosis is defined as Child Turcotte Pugh (CTP) class B or C.

Provider Actions

Prior Authorization

Prior authorization required with duration limits

Prior authorization is required. Authorization durations vary by clinical scenario — typically up to 12 weeks for most indications (e.g., members without cirrhosis or with compensated cirrhosis, many post-transplant and transplant-donor scenarios, genotype 3 with Y93H, certain pediatric cases) and up to 24 weeks in specified situations (e.g., decompensated cirrhosis with documented anemia or RBV ineligibility, decompensated members who failed prior DAA/NS5A therapy, certain treatment-experienced post-transplant cases). Durations granted depend on the specific clinical scenario as detailed in the Treatment duration section.

Documentation Required

Prescriber expertise and supporting information

Medication must be prescribed by or in consultation with a provider experienced in the management of hepatitis C virus infection. Supporting documentation that may be requested includes treatment status (treatment-naïve or retreatment), confirmation of member readiness (for initial treatment), for retreatment the reason for retreatment and confirmation of readiness and ability to adhere to the plan, hepatitis B virus screening results, and Metavir/Fibrosis score.

Treatment status (treatment-naïve or retreatment)
Confirmation of member readiness (initial treatment)
Reason for retreatment and confirmation of readiness/adherence (retreatment)
Hepatitis B virus screening results
Metavir/Fibrosis score

Documentation Required

Genotype testing requirement for certain members

Genotype testing is required for members with any of the characteristics listed under the unknown/undetermined genotype section: hepatitis B surface antigen (HBsAG) positive, current pregnancy, known or suspected hepatocellular carcinoma, or prior liver transplantation.

HBsAG positive
Current pregnancy
Known or suspected hepatocellular carcinoma (HCC)
Prior liver transplantation

Clinical Evidence & Background

Primary references: FDA package inserts for Epclusa and generic sofosbuvir-velpatasvir (April 2022) and relevant ribavirin package inserts; guideline reference: AASLD/IDSA/IAS‑USA recommendations for testing, managing, and treating hepatitis C.

Clinical background: Epclusa (sofosbuvir-velpatasvir) is a pan-genotypic HCV direct-acting antiviral indicated for chronic HCV genotypes 1–6 in adults and pediatric patients aged >= 3 years. It is approved for patients without cirrhosis or with compensated cirrhosis; for patients with decompensated cirrhosis (CTP class B or C) Epclusa is used in combination with ribavirin per labeling and policy guidance, with some decompensated or prior‑failure situations eligible for extended authorization (up to 24 weeks). Use for indications outside the FDA‑approved or compendial uses is considered experimental/investigational and not medically necessary. Prescriptions must be written by or in consultation with a provider experienced in HCV management.

Policy: 2137-A	Internal policy reference number
Qsets: 5920-A, 6284-A	Clinical question set references

OpenPayer

Epclusa (sofosbuvir-velpatasvir) coverage

Coverage Summary

Initial Therapy Criteria — Treatment duration & scenarios

Continuation Therapy Criteria

Ribavirin (RBV) Ineligibility (Appendix / Exclusions)

Provider Actions

Applicable Codes & Policy Identifiers

Clinical Evidence & Background

Key Thresholds

Revision History