CurrentNeighborhood Health Plan of Rhode IslandPolicy 2134-A

Ledipasvir‑sofosbuvir (Harvoni) — coverage criteria for chronic hepatitis C

Defines coverage and authorization criteria for Harvoni (ledipasvir‑sofosbuvir) for treatment of chronic hepatitis C virus (HCV) across genotypes 1, 4, 5, and 6 in adults and pediatric patients ≥3 years, including special populations such as cirrhosis, transplant, and coinfection.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLedipasvir‑sofosbuvir (Harvoni) — coverage criteria for chronic hepatitis C

Policy CodePolicy 2134-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; authorized duration depends on genotype, cirrhosis status, treatment history, transplant/HIV status, and viral load.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1,4,5,6HCV genotypes covered

3 yrsminimum age

8–24 wkstreatment duration range

≥6M IU/mLviral load threshold

<10 g/dLanemia threshold

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Coverage and Medical Necessity Criteria

Coverage criteria by genotype and clinical scenario

Covered when ALL of the following per scenario are met:

General eligibility: Patient is ≥3 years of age and requested regimen is for HCV genotype 1, 4, 5, or 6 as per FDA-approved indications; prescriber experienced in HCV management must prescribe or consult

Also applies to pediatric patients ≥3 years

Genotype 1 — treatment‑naïve without cirrhosis: Either (a) authorize up to 12 weeks for treatment‑naïve with compensated cirrhosis OR (b) authorize up to 12 weeks for treatment‑naïve without cirrhosis when member is <18 years, or has HIV coinfection, or has pre‑treatment HCV RNA ≥ 6 million IU/mL OR (c) authorize up to 8 weeks for treatment‑naïve without cirrhosis when pre‑treatment HCV RNA < 6 million IU/mL and no HIV coinfectionPre‑treatment HCV RNA 6 million IU/mL

Genotype 1 — prior PEG‑IFN ± RBV ± protease inhibitor failure: Authorize up to 12 weeks for members without cirrhosis who failed prior PEG‑IFN ± RBV ± protease inhibitor; authorize up to 24 weeks for members with compensated cirrhosis who failed prior PEG‑IFN ± RBV ± protease inhibitor

Prior treatment failure influences duration

Genotype 4 or 5: Authorize up to 12 weeks for members without cirrhosis or with compensated cirrhosis who are treatment‑naïve or who failed prior PEG‑IFN ± RBV ± protease inhibitor

Genotype 6: Authorize up to 12 weeks for members without cirrhosis or with compensated cirrhosis when (a) treatment‑naïve and not genotype 6e subtype OR (b) failed prior PEG‑IFN ± RBV ± protease inhibitor

Decompensated cirrhosis (CTP B or C): Authorization up to 24 weeks may be granted for genotypes 1,4,5,6 with decompensated cirrhosis when member has documented anemia (baseline Hgb < 10 g/dL) or is RBV‑ineligible; authorization up to 12 weeks may be considered in some decompensated scenarios and prior failure of a sofosbuvir‑based regimen may allow up to 24 weeksBaseline Hgb < 10 g/dL

RBV ineligibility defined in Appendix (e.g., pregnancy, intolerance, hemoglobinopathy, coadministration with didanosine, unstable cardiac disease)

Recurrent HCV post liver transplant: Authorize up to 12 weeks for treatment‑naïve recurrent HCV genotypes 1,4,5,6 post‑transplant without cirrhosis or with compensated cirrhosis; authorize up to 24 weeks for treatment‑experienced with decompensated cirrhosis

Kidney transplant recipients: Authorize up to 12 weeks for genotypes 1,4,5,6 without cirrhosis or with compensated cirrhosis who are treatment‑naïve or have not failed prior direct‑acting antiviral therapy

HCV/HIV coinfection: Authorization may be granted when the requested regimen meets the coverage criteria above; HIV coinfection does not alter core approval criteria but is specifically noted for some genotype‑specific decisions

Harvoni (ledipasvir‑sofosbuvir) is covered only for the FDA‑approved indications listed in this policy. Specifically, coverage is limited to treatment of chronic hepatitis C virus (HCV) infection in adults and pediatric patients 3 years of age and older for: HCV genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; genotype 1 with decompensated cirrhosis when used in combination with ribavirin; and genotype 1 or 4 in liver transplant recipients without cirrhosis or with compensated cirrhosis when used in combination with ribavirin.

Use of Harvoni for any indication other than the FDA‑approved indications or recognized compendial uses is considered experimental/investigational and is not medically necessary; such requests are not eligible for coverage under this policy.

Clinical Thresholds and Key Values

Pre-treatment HCV RNA threshold for 8‑week eligibility

Pre-treatment HCV RNA threshold>= 6 million IU/mL

Use for 8-week eligibilityMembers without cirrhosis and no HIV coinfection with pre-treatment HCV RNA < 6 million IU/mL may be authorized up to 8 weeks; >= 6 million IU/mL supports authorization of up to 12 weeks

Relevant populationApplies to treatment‑naïve members with HCV genotype 1 without cirrhosis

Baseline hemoglobin threshold

Baseline hemoglobin threshold< 10 g/dL

Context of useDocumented anemia (baseline Hgb below 10 g/dL) may support authorization of up to 24 weeks for members with decompensated cirrhosis (CTP B or C)

Prior Authorization, Documentation, and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required; treatment duration authorized depends on genotype, presence/absence of cirrhosis (compensated vs decompensated), prior treatment, and other clinical factors. Requests not meeting the listed indications or approval criteria may be denied.

Coverage limited to listed indications — requests for other indications or that do not meet approval criteria may be denied.
Authorization durations vary (examples): Genotype 1 — up to 8, 12, or 24 weeks depending on cirrhosis and prior treatment; Genotype 4/5/6 — commonly up to 12 weeks with specified exceptions; Decompensated cirrhosis — up to 12 or 24 weeks depending on prior regimen failure; Post-liver transplant and kidney transplant recipients have specified durations.
Prior treatment influences authorized duration — prior failure with PEG-IFN ± RBV ± protease inhibitor or failure of a sofosbuvir-based regimen may increase the authorized duration (e.g., up to 24 weeks in some scenarios).

Denial Risk

Prior Treatment Influences Duration

Key Definitions and Eligibility Notes

Ribavirin (RBV) ineligibility definition

RBV ineligibility — intoleranceIntolerance to ribavirin

RBV ineligibility — pregnancyPregnant female or male whose female partner is pregnant

RBV ineligibility — hemoglobinopathyPresence of a hemoglobinopathy

RBV ineligibility — drug interactionCoadministration with didanosine

RBV ineligibility — cardiac diseaseHistory of significant or unstable cardiac disease

Decompensated cirrhosis (CTP B or C) — definition and authorization guidance

Decompensated cirrhosis definition

Clinical Background

Harvoni is an oral fixed‑dose combination of the direct‑acting antivirals ledipasvir and sofosbuvir approved for treatment of chronic HCV infection. The FDA indications include use in adults and pediatric patients aged 3 years and older for genotypes 1, 4, 5, and 6 without cirrhosis or with compensated cirrhosis. Specific approvals also address use in genotype 1 with decompensated cirrhosis (in combination with ribavirin) and in liver transplant recipients with genotype 1 or 4 (in combination with ribavirin) as noted above.

Policy Revision History

2024-12reference updateLatest

Package insert for Harvoni (ledipasvir‑sofosbuvir) updated (Gilead Sciences; December 2024) and cited in policy references.

2024-07reference update

Ribavirin capsules/tablets package inserts updated (Aurobindo Pharma; July 2023 and May 2023) and cited in policy references.

2023-12-19guideline update