CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Harvoni (ledipasvir/sofosbuvir) — Coverage Criteria for Chronic Hepatitis C

Defines coverage criteria, prescriber requirements, durations, and special populations for Harvoni treatment of chronic hepatitis C virus (HCV) infection for members of the plan when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHarvoni (ledipasvir/sofosbuvir) — Coverage Criteria for Chronic Hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation (including hepatitis B screening and fibrosis score) — approval granted only if all approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weekscommon maximum authorization duration

24 weeksextended authorization duration

3 yrsminimum pediatric age

1,4,5,6covered genotypes

Coverage Criteria for Harvoni (ledipasvir/sofosbuvir)

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Initial therapy and special populations

Covered when ALL of the following are met according to genotype-specific and clinical scenario rules

General requirements: Member has an FDA‑approved or compendial indication for Harvoni, prescriber is a specialist or in consultation with a specialist in infectious disease, gastroenterology, hepatology, or transplant, and member has no exclusions to the prescribed therapy.

Genotype 1 (without ribavirin): Covered for adults and pediatric patients >= 3 years with genotype 1 infection without cirrhosis or with compensated cirrhosis. Authorization up to 12 weeks may be granted for treatment‑naive members with compensated cirrhosis; up to 12 weeks may be granted for treatment‑naive members without cirrhosis who are HIV‑coinfected, are <18 years of age, or have pre‑treatment HCV RNA >= 6 million IU/mL; up to 8 weeks may be granted for treatment‑naive members without cirrhosis who have pre‑treatment HCV RNA < 6 million IU/mL and are HIV‑uninfected; up to 12 weeks may be granted for members without cirrhosis who failed prior PEG‑IFN ± RBV ± HCV protease inhibitor; up to 24 weeks may be granted for members with compensated cirrhosis who failed prior PEG‑IFN ± RBV ± HCV protease inhibitor.

Genotype 4 or 5: Authorization of up to 12 weeks total may be granted for members without cirrhosis or with compensated cirrhosis who are treatment‑naive or who failed prior PEG‑IFN ± RBV ± HCV protease inhibitor.

Genotype 6: Covered for treatment‑naive members (excluding subtype 6e) without cirrhosis or with compensated cirrhosis for up to 12 weeks; coverage also for members who failed prior PEG‑IFN ± RBV ± HCV protease inhibitor.

Decompensated cirrhosis (CTP class B or C): For genotypes 1, 4, 5, or 6 with decompensated cirrhosis, authorization up to 24 weeks may be granted; use in combination with ribavirin for decompensated disease unless RBV ineligibility is documented (authorization criteria reference anemia or RBV ineligibility).

Recurrent HCV post–liver transplant: Authorization up to 12 weeks may be granted for members without cirrhosis or with compensated cirrhosis and recurrent genotype 1, 4, 5, or 6 infection post‑liver transplant; up to 24 weeks may be granted for treatment‑experienced members with decompensated cirrhosis post‑transplant.

Kidney transplant recipients: Authorization up to 12 weeks total may be granted for kidney transplant recipients without cirrhosis or with compensated cirrhosis who have genotype 1, 4, 5, or 6 infection and are treatment‑naive or have not failed prior direct‑acting antivirals.

Use with ribavirin: For certain indications (for example, decompensated cirrhosis or some treatment‑experienced scenarios) Harvoni is used in combination with ribavirin; documentation of RBV ineligibility permits omission of ribavirin.

HCV/HIV coinfection: Authorization may be granted for members with HCV and HIV coinfection when the criteria for the requested regimen in the genotype‑specific sections above are met.

Continuation Therapy

Covered when ALL of the following are met

Continuation requirements: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

All indications not listed in the EDA‑approved uses for Harvoni are considered experimental/investigational and not medically necessary. This includes any diagnosis or clinical scenario outside the specific genotypes and clinical situations enumerated in the approved indications.

Prior authorization is required and will only be granted when the request meets the approved indications and all other coverage criteria; requests for uses outside the EDA‑approved indications may be denied as experimental/investigational.

Indications that fall outside the FDA/compendial uses listed for Harvoni are considered not medically necessary. Coverage is limited to the specified genotypes and clinical scenarios approved by the EDA; requests for treatment outside those indications will not meet medical necessity criteria.

Providers should ensure the requested use corresponds to an EDA‑approved genotype/clinical scenario before submitting authorization requests, as uses not matching the approved list will be deemed not medically necessary.

Billing and Clinical Codes

Covered codes (not specified)mixed

none listed

No explicit CPT/HCPCS/ICD-10/NDC codes provided in document text

inv-06: HCV RNA — viral load thresholds used to determine treatment duration (8–12 weeks)

HCV RNA thresholdPre-treatment HCV RNA >= 6 million IU/mL versus < 6 million IU/mL is used to determine shorter (8 weeks) versus standard (12 weeks) authorization periods; members with HCV RNA >= 6 million IU/mL are eligible for up to 12 weeks, whereas treatment‑naive, HIV‑uninfected members with HCV RNA < 6 million IU/mL may be eligible for up to 8 weeks.

Typical short durationUp to 8 weeks total for treatment‑naive members without cirrhosis who are HIV‑uninfected and have pre‑treatment HCV RNA below 6 million IU/mL.

Typical standard durationUp to 12 weeks total for many treatment‑naive and previously treated scenarios, including those with pre‑treatment HCV RNA >= 6 million IU/mL, HIV co‑infection, or age <18 years.

Extended duration scenariosAuthorization up to 24 weeks may be granted in certain cases (e.g., compensated cirrhosis who failed prior PEG‑IFN–based therapy or decompensated cirrhosis), independent of HCV RNA threshold considerations.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required — requests will be approved only if all approval criteria are met. Common approval durations vary by genotype, prior treatment history, cirrhosis status, and other factors (examples below).

Authorization durations referenced in this policy (examples): up to 8, 12, or 24 weeks depending on regimen, prior treatment, and cirrhosis status.

Prior Authorization

Prior Treatment Influences Authorization

Prior treatment history influences regimen selection and authorization duration. Prior failure of peginterferon alfa (PEG-IFN) ± ribavirin (RBV) or prior failure of a sofosbuvir-based regimen may require longer treatment duration or different regimens. Examples: treatment-naive members without cirrhosis may be authorized up to 12 weeks in certain high-risk groups; members with compensated cirrhosis who failed prior PEG-IFN ± RBV may be authorized up to 24 weeks; members with genotype 1, 4, 5, or 6 and decompensated cirrhosis who failed a sofosbuvir-based regimen may be authorized up to 24 weeks.

Prior PEG-IFN ± RBV (with or without an HCV protease inhibitor) can lead to authorization up to 24 weeks for compensated cirrhosis.
Prior sofosbuvir-based regimen failure (e.g., sofosbuvir + RBV; sofosbuvir + PEG-IFN + RBV; sofosbuvir + simeprevir ± RBV) may lead to authorization up to 24 weeks for genotype 1, 4, 5, or 6 with decompensated cirrhosis.

Documentation Required

Supporting Documentation May Be Requested

Supporting documentation may be requested to verify clinical indications and regulatory requirements. For initial treatment this can include confirmation of member readiness and hepatitis B screening results; for retreatment this can include reason for retreatment (e.g., prior treatment failure or reinfection), confirmation of readiness, and ability to adhere to the proposed plan. Metavir/fibrosis scoring may also be requested.

Initial treatment: confirmation of member readiness; hepatitis B screening results.
Retreatment: reason for retreatment, confirmation of readiness, and adherence plan.
Fibrosis staging (Metavir/Fibrosis score) may be requested.

Documentation Required

Ribavirin Ineligibility Documentation Required

When ribavirin cannot be used, documentation of RBV ineligibility is required. RBV ineligibility is defined as one or more of the following conditions: intolerance to RBV; pregnancy in the female patient or a male patient with a pregnant female partner; coadministration with didanosine; hemoglobinopathy; or history of significant or unstable cardiac disease.

Required documentation must indicate which RBV ineligibility criterion applies.
Examples of RBV ineligibility: intolerance to RBV; pregnant female or male with pregnant partner; concomitant didanosine; hemoglobinopathy; significant or unstable cardiac disease.

Denial Risk

Failure to Meet Approval Criteria May Lead to Denial

Requests that do not meet all approval criteria or that involve exclusionary conditions may be denied. Ensure submitted documentation addresses prior treatment history, cirrhosis status, required lab/screening results, and RBV ineligibility (if claimed) to avoid denial risk.

Incomplete documentation of prior treatment failure, fibrosis/cirrhosis status, hepatitis B screening, or RBV ineligibility increases likelihood of denial.

Key Definitions

inv-13: RBV ineligibility — definitions (intolerance, pregnancy, coadministration, hemoglobinopathy, etc.)

Intolerance to ribavirinDocumented intolerance to RBV (e.g., adverse reactions preventing use).

Pregnancy-related contraindicationPregnant female or a male with a pregnant female partner (RBV contraindicated in pregnancy).

Coadministration with didanosineConcurrent use of didanosine that precludes safe coadministration with RBV.

HemoglobinopathyPresence of a hemoglobinopathy that increases risk with RBV therapy.

Significant or unstable cardiac diseaseHistory of significant or unstable cardiac disease making RBV unsafe to use.

inv-14: Decompensated cirrhosis — CTP class B or C; may require longer treatment and RBV considerations

DefinitionDecompensated cirrhosis is defined as Child‑Turcotte‑Pugh (CTP) class B or C cirrhosis.

Treatment duration implicationsAuthorization of up to 24 weeks total may be granted for members with decompensated cirrhosis (CTP B or C).

Ribavirin considerationsUse in combination with ribavirin is recommended for decompensated disease unless RBV ineligibility is documented; documented anemia (baseline Hgb <10 g/dL) or RBV ineligibility may affect use.

Prior treatment impactMembers with decompensated cirrhosis who failed prior sofosbuvir‑based regimens may be eligible for extended (up to 24 weeks) authorization.

OpenPayer

Harvoni (ledipasvir/sofosbuvir) — Coverage Criteria for Chronic Hepatitis C

Coverage Criteria for Harvoni (ledipasvir/sofosbuvir)

Billing and Clinical Codes

Provider Requirements and Prior Authorization

Key Definitions

Background on Harvoni