ModifiedHealth NetPolicy CP PHAR.279

Ledipasvir/sofosbuvir (Harvoni) coverage

Defines medical necessity and prior authorization criteria for ledipasvir/sofosbuvir (Harvoni) for Medicaid line of business, including indications, required documentation, step therapy preferences, dosing limits, and approval durations affecting providers who prescribe HCV antiviral therapy.

Policy Summary

PayerHealth Net

PolicyLedipasvir/sofosbuvir (Harvoni) coverage

Policy CodePolicy CP PHAR.279

Change TypeAnnual review — material updates and added Appendix F

Effective DateAug 24, 2024

Next Review Date

Key ActionSubmit prior authorization with supporting documentation including HCV RNA (within 6 months), genotype, cirrhosis status, and treatment history.

SourceLink

POLICY UPDATE CHANGES

Revised policy/criteria section to also include generic ledipasvir/sofosbuvir and removed qualifier of 'chronic' from HCV criteria.

Added Appendix F for guidance on incomplete adherence and AASLD-IDSA recommended management of treatment interruptions.

Treatment-naive without cirrhosis and HCV RNA <6 million IU/mL may be treated for 8 weeks per ION-3 data.

1,4,5,6Genotypes covered

>=3 yrsFDA min age

Up to 24 wksMax approval duration

90/400 mg

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Coverage Criteria for Ledipasvir/Sofosbuvir (Harvoni)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Hepatitis C Infection Requirements: 1) Diagnosis of HCV infection evidenced by detectable serum HCV RNA by quantitative assay within the last 6 months; 2) Age ≥ 3 years; 3) Documentation of treatment status (treatment‑naive or treatment‑experienced); 4) Confirmed HCV genotype 1, 4, 5, or 6; 5) Documentation of cirrhosis status (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis); 6) Member must have used preferred alternatives (Mavyret or sofosbuvir/velpatasvir [Epclusa authorized generic]) unless clinically significant adverse effects or contraindications exist; 7) Life expectancy ≥ 12 months with HCV treatment; 8) Prescribed regimen is consistent with FDA or AASLD‑IDSA recommended regimens; 9) Dose does not exceed ledipasvir 90 mg/sofosbuvir 400 mg once daily and 1 tablet per day.

Provider must submit documentation (e.g., office chart notes, lab results) to support criteria; step therapy and quantity/approval duration limits apply.

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continuation Therapy: 1) Member is currently receiving Harvoni and either is enrolled in a state/product with continuity of care regulations or previously met initial approval criteria; 2) Documentation supports current therapy and at least 28 days of recent treatment; 3) Member is responding positively to therapy; 4) Dose limits are maintained (ledipasvir 90 mg/sofosbuvir 400 mg, 1 tablet/day).

Approval duration should be consistent with dosing regimens in Section V (approval up to 24 weeks).

Initial Therapy / Regimen-specific criteria — Covered when the regimen and patient characteristics match FDA labeling and AASLD-IDSA guidance

Covered when the regimen and patient characteristics match FDA labeling and AASLD‑IDSA guidance:

Genotype 1 treatment‑naive without cirrhosis eligible for 8‑week regimen: Patient is treatment‑naive, without cirrhosis, HCV genotype 1, HIV‑uninfected, and pre‑treatment HCV RNA < 6 million IU/mL.HCV RNA <6 million IU/mL

Per ION‑3 data and AASLD‑IDSA/FDA guidance; maximum 8 weeks when criteria met.

Standard 12‑week regimen: Treatment‑naive (not meeting 8‑week criteria) or treatment‑experienced without cirrhosis, or with compensated cirrhosis: ledipasvir/sofosbuvir one tablet PO QD for 12 weeks.duration = 12 weeks

Per FDA labeling and AASLD‑IDSA; see Section V.

Decompensated cirrhosis or certain prior failures: Patients with decompensated cirrhosis: ledipasvir/sofosbuvir plus low initial dose ribavirin (e.g., 600 mg, increased as tolerated) for 12 weeks (or Harvoni for 24 weeks if RBV‑intolerant). Patients with prior sofosbuvir‑ or NSSA inhibitor‑based regimen failures may require extended courses (e.g., 24 weeks) with RBV.

Incomplete Adherence / Treatment Interruption Management — Management of missed doses and treatment interruptions per AASLD‑IDSA recommendations

Management of missed doses and treatment interruptions per AASLD‑IDSA recommendations:

Missed <7 days: If missed <7 days, restart DAA therapy immediately and complete the originally planned duration (e.g., 8 or 12 weeks).<7 days

Interruption unlikely to impact SVR12.

Interruptions during first 28 days: Restart DAA therapy immediately and obtain HCV RNA as soon as possible. If HCV RNA is negative, complete the originally planned course; if HCV RNA is positive or not obtained, extend therapy by 4 weeks for patients with genotype 3 and/or cirrhosis or consider retreatment per AASLD‑IDSA.interrupt <=28 days

Applicable to treatment‑naive patients without cirrhosis or with compensated cirrhosis; consult expert for other populations.

Interruptions after ≥28 days:

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP PMN.53.

Contraindications include the boxed warning for hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV; patients should be monitored for HBV reactivation and managed per clinical indication. When Harvoni is co‑administered with ribavirin, all contraindications to ribavirin (RBV) also apply to the combination regimen.

Requests for non‑FDA approved uses that lack sufficient clinical evidence or the required off‑label documentation per CP PMN.53 may be considered not medically necessary and are subject to denial.

The policy steers members toward authorized generics (for example, the Epclusa authorized generic) or other preferred agents; requests that do not provide acceptable medical justification for bypassing the authorized generic redirection may be considered not medically necessary and can be denied unless a clear clinical reason to avoid the preferred product is documented.

Coding and Product Information

Covered NDC CodesNDCCovered

0003-4224-11	Harvoni 90 mg/400 mg tablet (ledipasvir 90 mg / sofosbuvir 400 mg) 28-count
0003-4224-02	Harvoni 90 mg/400 mg tablet (ledipasvir 90 mg / sofosbuvir 400 mg) 7-count
0003-4225-11	Harvoni 45 mg/200 mg tablet (ledipasvir 45 mg / sofosbuvir 200 mg) 28-count
0003-4225-02	Harvoni 45 mg/200 mg tablet (ledipasvir 45 mg / sofosbuvir 200 mg) 7-count
0003-4226-11	Harvoni pellets 45 mg/200 mg (ledipasvir 45 mg / sofosbuvir 200 mg) packet
0003-4227-11	Harvoni pellets 33.75 mg/150 mg (ledipasvir 33.75 mg / sofosbuvir 150 mg) packet

Product Strengths and FormulationsmixedCovered

Tablet - 90 mg / 400 mg	Ledipasvir 90 mg + Sofosbuvir 400 mg (single tablet formulation)
Tablet - 45 mg / 200 mg	Ledipasvir 45 mg + Sofosbuvir 200 mg (tablet formulation for dose-adjusted use)
Oral pellets - 45 mg / 200 mg	Pellet formulation: Ledipasvir 45 mg + Sofosbuvir 200 mg per packet
Oral pellets - 33.75 mg / 150 mg	Pellet formulation: Ledipasvir 33.75 mg + Sofosbuvir 150 mg per packet

HCV RNA testing interval — detectable serum HCV RNA by quantitative assay within the last 6 months

HCV RNA testing intervalDetectable serum HCV RNA by quantitative assay within the last 6 months

HCV RNA threshold for 8-week regimen — < 6 million IU/mL

HCV RNA threshold for 8-week regimen< 6 million IU/mL

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., office chart notes, lab results, or other clinical information) showing HCV RNA quantitative levels (detectable) within the last 6 months, confirmed HCV genotype, cirrhosis status (no cirrhosis, compensated, or decompensated; include Child‑Pugh class when applicable), and prior HCV treatment history. Prescribed regimen must be consistent with FDA or AASLD‑IDSA guidance.

Required labs: quantitative HCV RNA within 6 months, genotype testing, baseline hepatic labs.
Document cirrhosis status and Child‑Pugh class when applicable.
Provide treatment history: treatment‑naive or treatment‑experienced, prior regimens and outcomes.

Denial Risk

Preferred Agent Redirection / Steerage Risk

Steerage to preferred agents is enforced. Requests that do not follow redirection to preferred agents (Mavyret or sofosbuvir/velpatasvir [Epclusa authorized generic]) or that seek non‑preferred agents must include clinical justification. Requests may be redirected to a preferred agent or denied if adequate justification is not provided.

Definitions and Scoring

Ledipasvir/sofosbuvir fixed-dose combination — Harvoni definition

Drug compositionFixed‑dose oral combination of ledipasvir (NS5A inhibitor) and sofosbuvir (nucleotide NS5B polymerase inhibitor)

Brand nameHarvoni

Typical adult tablet strengthLedipasvir 90 mg / Sofosbuvir 400 mg (one tablet PO QD for most adults)

Sustained virologic response at 12 weeks — SVR12 definition

DefinitionSustained virologic response at 12 weeks (SVR12) — undetectable HCV RNA 12 weeks after completion of therapy

Clinical significanceSVR12 is considered a virologic cure endpoint and is used to assess treatment success

Background

Harvoni is a fixed‑dose combination of ledipasvir (an NS5A inhibitor) and sofosbuvir (a nucleotide NS5B polymerase inhibitor) approved for treatment of HCV. The policy references FDA labeling and AASLD‑IDSA guidance for regimen selection, dosing, and monitoring, and notes the HBV reactivation boxed warning when treating HCV in patients coinfected with HBV.