CurrentNeighborhood Health Plan of Rhode IslandPolicy 2137-A

Sofosbuvir‑velpatasvir (Epclusa) coverage

Criteria and authorization guidance for coverage of Epclusa (sofosbuvir-velpatasvir) for treatment of chronic hepatitis C virus (HCV) infection for members of Neighborhood Health Plan of Rhode Island, including pediatric and transplant populations when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySofosbuvir‑velpatasvir (Epclusa) coverage

Policy CodePolicy 2137-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of genotype, treatment history, cirrhosis status and supporting labs to request approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 yearsminimum patient age for treatment

12 weekstypical authorization duration

24 weeksextended authorization duration

1-6covered HCV genotypes

Coverage Criteria for Sofosbuvir‑Velpatasvir (Epclusa)

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General coverage criteria

Covered when ALL of the following are met

FDA indication: Patient is adult or pediatric >= 3 years with chronic HCV infection (genotype 1–6), either without cirrhosis or with compensated cirrhosis; use with ribavirin is indicated for decompensated cirrhosis per labelingage >= 3 years; genotypes 1-6

Includes treatment of adults and pediatric patients 3 years and older; decompensated cirrhosis use per labeling

Prescriber requirement: Medication prescribed by or in consultation with a provider experienced in management of HCV

Per policy prescriber specialty requirement

Approval criteria specific to genotype, prior treatment history, transplant status, and cirrhosis status are met per policy sections (e.g., authorization durations up to 12 weeks for most indications; up to 24 weeks for certain decompensated or retreatment scenarios)treatment durations per indication

See individual indication nodes for details

Unknown genotype

Covered when ALL of the following are met for unknown genotype

Unknown genotype: Member has unknown or undetermined HCV genotype, is without cirrhosis, is treatment‑naive, and does not have any of the following: HBsAG positive, known or suspected hepatocellular carcinoma, current pregnancy, or prior liver transplantation

Genotype testing is required for members with any of the listed characteristics

Decompensated cirrhosis

Covered when ANY of the following decompensated cirrhosis conditions are met

Decompensated cirrhosis - anemia or RBV ineligibility: Member with decompensated cirrhosis (CTP class B or C) and documented anemia (baseline hemoglobin < 10 g/dL) or documented ribavirin (RBV) ineligibility may be authorized for up to 24 weeksHgb < 10 g/dL

RBV ineligibility defined in appendix

Decompensated cirrhosis - standard: Member with decompensated cirrhosis (CTP class B or C) may be authorized for up to 12 weeks in some scenarios (duration varies by prior treatment history)

Prior treatment history may extend authorization to 24 weeks if prior failure on sofosbuvir- or NS5A-inhibitor regimens

Genotype 3 with resistance substitution

Covered when ALL of the following are met for genotype 3 with Y93H

Genotype 3 with Y93H: Treatment‑naive members with genotype 3 and compensated cirrhosis who have the Y93H substitution associated with velpatasvir resistance may be authorized for up to 12 weeks

Y93H is a velpatasvir-associated resistance-associated substitution relevant for genotype 3

Recurrent HCV post liver transplant

Covered when ALL of the following are met for post-transplant recurrent infection

Post-liver transplant recurrent HCV: Members with recurrent HCV post liver transplantation without cirrhosis or with compensated cirrhosis may be authorized for up to 12 weeks; treatment‑experienced members with recurrent HCV and decompensated cirrhosis may be authorized for up to 24 weeks

Authorization duration depends on treatment history and cirrhosis status

Transplant-related coverage

Covered when ALL of the following transplant-related conditions are met

Kidney transplant recipients: Authorization of up to 12 weeks may be granted for kidney transplant recipients without cirrhosis or with compensated cirrhosis who are treatment‑naive or who have not failed a direct‑acting antiviral

Applies to HCV genotypes 1–6

Organ recipient from HCV‑viremic donor: Authorization of up to 12 weeks may be granted for members who received a liver or non‑liver organ from an HCV‑viremic donor

Applies to liver and non‑liver organ recipients

Continuation of therapy

Continuation requirements: Members requesting continuation of therapy (including new members) must meet all coverage requirements in this policy

Applies to continuation requests and transfers of care

All indications for Epclusa (sofosbuvir-velpatasvir) that are not specifically listed as FDA‑approved indications or recognized compendial uses in this policy are considered experimental/investigational and not medically necessary.

Use of Epclusa for conditions or indications that are not described in this policy (non‑FDA or non‑compendial uses) is considered not medically necessary and will not be authorized.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Duration approvals vary by indication (typically up to 12 weeks; up to 24 weeks for certain decompensated or retreatment scenarios).

Authorization durations typically up to 12 weeks; up to 24 weeks for some decompensated or retreatment scenarios

Prior Authorization

Consideration of Prior HCV Treatments

Consider prior hepatitis C virus (HCV) treatment history when evaluating requests. Authorization decisions reference whether the member is treatment‑naive, prior treatment with interferon‑based regimens, peginterferon alfa + ribavirin, sofosbuvir‑based regimens, NS3/4A protease inhibitors, or other direct‑acting antivirals; some approvals and durations differ for retreatment or prior DAA failure.

Consideration of prior HCV treatments (treatment‑naive vs retreatment)
Prior specific therapies relevant: interferon‑based regimens, peginterferon alfa + RBV, sofosbuvir‑based regimens, NS3/4A protease inhibitors, other DAAs

Documentation Required

Supporting Documentation

Supporting documentation may be requested to meet regulatory and clinical requirements. Typical documentation includes treatment status (initial vs retreatment), for initial treatment — confirmation of member readiness and ability to adhere to therapy, and for retreatment — reason for retreatment (treatment failure, reinfection), confirmation of readiness and adherence. Additional requested information may include Metavir/fibrosis score and hepatitis B screening results.

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

Documentation Required

Prescriber Specialty Requirement

Medication must be prescribed by, or in consultation with, a provider experienced in management of hepatitis C virus infection.

Denial Risk

Non‑approved Indications Not Covered

Requests that do not meet the approval criteria or that are for indications other than the FDA‑approved and compendial uses are considered experimental/investigational and are not covered.

Definitions and Key Terms

Decompensated cirrhosis (CTP class B or C)

DefinitionPatients with Child-Turcotte-Pugh (CTP) class B or C cirrhosis

Authorization durationsMay be authorized up to 12 weeks in some decompensated scenarios; up to 24 weeks when documented anemia (baseline Hgb < 10 g/dL) or RBV ineligibility is present, or when prior SOF- or NS5A-inhibitor treatment failure occurred

Anemia thresholdBaseline hemoglobin (Hgb) below 10 g/dL supports extended authorization (up to 24 weeks)

Genotypes coveredApplies to HCV genotypes 1–6

Y93H substitution

DefinitionY93H is a velpatasvir-associated resistance-associated substitution relevant for genotype 3

PopulationTreatment-naive members with compensated cirrhosis and genotype 3 infection

Authorization impactPresence of Y93H may permit authorization of a 12-week sofosbuvir-velpatasvir regimen

ScopeSpecific to genotype 3 infections when Y93H is detected

Ribavirin (RBV) ineligibility

DefinitionRibavirin (RBV) ineligibility is defined as one or more of: intolerance to RBV; pregnant female or male with pregnant partner; coadministration with didanosine; hemoglobinopathy; history of significant or unstable cardiac disease

Clinical relevanceRBV ineligibility may support extended authorization (up to 24 weeks) for members with decompensated cirrhosis

DocumentationRBV ineligibility should be documented in the medical record per policy appendix

OpenPayer

Sofosbuvir‑velpatasvir (Epclusa) coverage

Coverage Criteria for Sofosbuvir‑Velpatasvir (Epclusa)

Billing and Product Codes

Provider Actions and Authorization Requirements

Background

Definitions and Key Terms