ModifiedCentenePolicy HIMPA.SP3

Ledipasvir/Sofosbuvir (Harvoni) coverage criteria

Clinical coverage and prior authorization criteria for use of ledipasvir/sofosbuvir (Harvoni) for treatment of chronic hepatitis C virus (HCV) infection across Centene-affiliated health plans; specifies diagnostic, prescriber, step-therapy, and dosing requirements that affect prescribers and payers.

Policy Summary

PayerCentene

PolicyLedipasvir/Sofosbuvir (Harvoni) coverage criteria

Policy CodePolicy HIMPA.SP3

Change TypeMaterial revisions: step therapy, 8-week option clarified, appendices added

Effective DateAug 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of quantitative HCV RNA within 6 months, genotype, cirrhosis status, and treatment history.

SourceLink

POLICY UPDATE CHANGES

Member must use sofosbuvir-velpatasvir (Epclusa authorized generic), unless contraindicated or clinically significant adverse effects are experienced.

For treatment-naive adult members without cirrhosis with baseline viral load <6 million IU/mL, Harvoni may be approved for 8 weeks.

Revised policy/criteria section to also include generic ledipasvir/sofosbuvir and removed qualifier of "chronic" from HCV criteria per AASLD-IDSA guidance.

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

Applied Epclusa authorized generic redirection to all requests per SDC and clarified brand-preferred status of Epclusa in most cases.

1,4,5,6FDA genotypes

Age ≥3

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Coverage and Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Hepatitis C infection criteria: 1) Diagnosis of HCV infection as evidenced by detectable serum HCV RNA by quantitative assay within the last 6 months; 2) Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease specialist, or a provider with certified HCV training (see Appendix F); 3) Confirmed HCV genotype 1, 4, 5, or 6; 4) Age ≥ 3 years; 5) Documentation of treatment status (treatment-naive or treatment-experienced); 6) Documentation of cirrhosis status (no cirrhosis, compensated cirrhosis, or decompensated cirrhosis); 7) Life expectancy ≥ 12 months with HCV treatment; 8) Prescribed regimen consistent with FDA or AASLD-IDSA recommended regimen (see Dosage and Administration); 9) Dose does not exceed ledipasvir 90 mg/sofosbuvir 400 mg per day and 1 tablet per day; 10) Member must use sofosbuvir-velpatasvir (Epclusa authorized generic) unless contraindicated or clinically significant adverse effects are experienced (Illinois exception to step therapy applies as of 1/1/2026 per IL HB 5395).

Includes 8-week option for treatment-naive, noncirrhotic adults with baseline HCV RNA < 6 million IU/mL

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving Harvoni via the Centene benefit or has previously met initial approval criteria (or is enrolled in a state/product continuity-of-care program when applicable); 2) Member is responding positively to therapy; 3) Documentation the member has completed at least 28 days of Harvoni therapy; 4) Prescribed regimen consistent with FDA or AASLD-IDSA recommendations; 5) Dose does not exceed ledipasvir 90 mg/sofosbuvir 400 mg per day and 1 tablet per day.

Approval duration up to a total of 24 weeks

Initial and specialized treatment regimens — Covered when regimen, duration, and patient characteristics match FDA labeling or AASLD-IDSA recommendations

Covered when regimen, duration, and patient characteristics match FDA labeling or AASLD-IDSA recommendations

Genotype 1 treatment-naive without cirrhosis 8-week option: Treatment-naive, without cirrhosis, HIV-uninfected, AND baseline HCV RNA < 6 million IU/mL: Harvoni one tablet PO QD for 8 weeks.HCV RNA < 6 million IU/mL

Per FDA labeling and AASLD-IDSA; referenced in Dosage and Administration

Genotype 1 other scenarios: Treatment-naive without cirrhosis not meeting 8-week criteria or with compensated cirrhosis: Harvoni one tablet PO QD for 12 weeks; treatment-experienced without cirrhosis: 12 weeks; treatment-experienced with compensated cirrhosis: Harvoni plus weight-based ribavirin for 12 weeks (or alternative per guidance).

Per Dosage and Administration section

Decompensated cirrhosis: Genotype 1, 4, 5, or 6 with decompensated cirrhosis: Harvoni one tablet PO QD plus low initial dose ribavirin (600 mg, increased as tolerated) for 12 weeks (or 24 weeks if ribavirin-intolerant); prior sofosbuvir- or NS5A-failure may require 24 weeks with ribavirin.

Treatment interruption management — Management of treatment interruptions per AASLD-IDSA recommendations

Management of treatment interruptions per AASLD-IDSA recommendations (applies to Mavyret and Epclusa; guidance referenced for interruptions of Harvoni where applicable)

Short interruption <7 days: If missed <7 days, restart DAA therapy immediately and complete the originally planned duration (8 or 12 weeks); interruptions <7 days are unlikely to impact SVR12.<7 days

General statement: interruptions <7 days unlikely to affect SVR12

Interruption 8-28 days: If missed ≥8 days and <28 days, restart DAA therapy immediately and obtain HCV RNA as soon as possible; if HCV RNA is negative, complete planned course; consider extending by 4 weeks for genotype 3 and/or cirrhosis; if HCV RNA is positive or not obtained, extend 4 weeks or stop and retreat per AASLD-IDSA retreatment guidance.8-28 days

From Appendix G

Interruptions ≥21–28+ days:

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the off‑label use policy HIM.PA.154 or other applicable evidence of coverage documents.

Coadministration of Epclusa with proton pump inhibitors requires specific handling per the product labeling. The policy clarifies that coadministration with omeprazole up to 20 mg is not considered acceptable medical justification for inability to use Epclusa; if coadministration is deemed medically necessary, Epclusa should be given with food and taken 4 hours before omeprazole 20 mg as directed in the Epclusa prescribing information.

Use of Harvoni (ledipasvir/sofosbuvir) for indications that are not FDA‑approved and not specifically covered by this policy is not authorized unless the prescriber supplies sufficient supporting documentation consistent with the off‑label use policy HIM.PA.154 or applicable evidence of coverage provisions.

Requests that attempt to justify avoidance of Epclusa on the basis of coadministration with omeprazole ≤ 20 mg will not be accepted as an appropriate medical reason to bypass the preferred agent. Such requests may be denied as not medically necessary when the only rationale is omeprazole coadministration at this dose.

Policy Identifiers, Product Codes, and Key Values

Policy identifiermixed

HIMPA.SP3

Policy reference number (internal)

Product strengths availablemixed

90 mg/400 mg	Ledipasvir 90 mg and sofosbuvir 400 mg tablet
45 mg/200 mg	Ledipasvir 45 mg and sofosbuvir 200 mg tablet
33.75 mg/150 mg	Ledipasvir 33.75 mg and sofosbuvir 150 mg oral pellets

Baseline HCV RNA — threshold used in regimen consideration

Baseline HCV RNA threshold< 6 million IU/mL

Evidence source for thresholdION‑3 trial and Dosage & Administration support 8‑week consideration for baseline HCV RNA < 6 million IU/mL

Required timing of testDetectable quantitative serum HCV RNA within the last 6 months required for PA

Maximum approval duration — policy limit

Maximum approval durationUp to a total of 24 weeks

Consistency requirementApproved duration should be consistent with a regimen in Dosage and Administration

Prior Authorization, Documentation, and Step-Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for ledipasvir/sofosbuvir (Harvoni) requests. Providers must submit clinical documentation demonstrating that the member meets all approval criteria, including diagnosis and recent laboratory confirmation. Requests without required documentation may be denied or returned for additional information.

PA required with documentation of diagnosis and quantitative HCV RNA within last 6 months
Prescriber requirements: gastroenterologist, hepatologist, infectious disease specialist, or provider with HCV training (some plan exceptions apply)

Step Therapy

Preferred Product Redirection and Step-Therapy

The policy includes preferred product redirections and step-therapy expectations. Members must use sofosbuvir-velpatasvir (Epclusa authorized generic) as the preferred agent first unless there is a documented contraindication or clinically significant adverse effect. Some plan- and state-specific exceptions (for example Illinois HIM per IL HB 5395, HIM Georgia prescriber exception, and Florida redirection history) apply — verify line-of-business rules.

Drug Background and Scope

Harvoni is a fixed‑dose combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, indicated for treatment of HCV genotypes 1, 4, 5, and 6 in adults and pediatric patients aged ≥3 years. Per the dosing guidance and clinical trial evidence cited in the policy, treatment‑naive adults without cirrhosis and with baseline HCV RNA < 6 million IU/mL may be treated with Harvoni one tablet PO once daily for 8 weeks (the ION‑3 trial demonstrated high SVR12 rates in this population). For other genotype‑ and clinical‑scenario combinations, Harvoni dosing and duration should follow FDA labeling and AASLD‑IDSA recommendations.

Definitions and Clinical Scoring

SVR12 — definition and role

DefinitionSustained virologic response at 12 weeks (SVR12)

Use in policySVR12 is the efficacy endpoint referenced for treatment success in clinical trial and regimen guidance

Appendix referenceListed in Appendix A abbreviations as SVR12

DAA — direct‑acting antiviral

DefinitionDirect‑acting antiviral (DAA)

ContextDAAs are listed in Appendix D as the class of agents for HCV treatment and carry HBV reactivation boxed warning when treating HCV/HBV coinfection

Policy Changes and Revision Timeline

2023-09-21step_therapy_update

Per SDC, removed stepwise redirection and applied Epclusa authorized generic redirection to all requests (redirection adjustments documented).

2024-05-30policy_revision

Revised policy to include generic ledipasvir/sofosbuvir, removed 'chronic' qualifier from HCV criteria per AASLD‑IDSA, added prescriber exception for HIM Georgia, and added Appendix G for guidance on incomplete adherence and treatment interruptions.

2024-12-23operational_clarification

Per SDC, applied Epclusa authorized generic redirection broadly (approval noted 12/23/2023) and clarified brand-preferred status in most plans; Florida redirection adjusted to Epclusa authorized generic only.

Policy Summary

PayerCentene

PolicyLedipasvir/Sofosbuvir (Harvoni) coverage criteria

Policy CodePolicy HIMPA.SP3

Change TypeMaterial revisions: step therapy, 8-week option clarified, appendices added

Effective DateAug 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of quantitative HCV RNA within 6 months, genotype, cirrhosis status, and treatment history.

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Providers must submit required clinical documentation with the PA request. Incomplete requests lacking required records (see list below) increase the risk of denial or delay.

Office chart notes documenting history and indication
Quantitative HCV RNA result within the last 6 months (detectable)
Confirmed HCV genotype (1, 4, 5, or 6 when applicable per criteria)
Documentation of treatment status (treatment-naive or treatment-experienced)
Documentation of cirrhosis status (no cirrhosis, compensated, or decompensated)
Prescriber specialty/consultation note or documentation of HCV training where applicable
Any prior HCV treatment records and rationale for deviation from preferred agent

Denial Risk

Documentation-based Denials and Redirection Risk

Requests missing required documentation or not following preferred redirection may be denied or redirected. Examples include no recent quantitative HCV RNA, no genotype confirmation when required, or failure to trial the Epclusa authorized generic without documented contraindication.

Denial risk if quantitative HCV RNA within 6 months is not provided
Denial or redirection if no documentation of genotype when required
Denial or redirection if preferred agent (Epclusa authorized generic) not tried and no contraindication documented

Note

Step-Therapy History and Current Redirection

Historical and current redirection/step-therapy guidance: the policy history shows iterative redirections toward Epclusa (authorized generic or brand-preferred depending on state/business). Providers should expect operational redirection to the preferred product per the member's plan unless a documented clinical exception applies.

Epclusa authorized generic redirection applied broadly (verify plan-specific language)
Past redirections to Vosevi were removed where no overlapping indications exist
Plan-level operational expectations: prior authorization systems may redirect or require step documentation