CurrentCignaPolicy IP0735

Harvoni Prior Authorization Policy

Cigna drug coverage policy describing prior authorization requirements, clinical criteria for medical necessity, approved indications and durations, exclusions, prescriber requirements, and completion-of-therapy approvals for ledipasvir/sofosbuvir (Harvoni and authorized generic) across pediatric (≥3 years) and adult populations.

Policy Summary

PayerCigna

PolicyHarvoni Prior Authorization Policy

Policy CodePolicy IP0735

Change TypeNew; Early Annual Revision (no criteria changes)

Effective DateNov 15, 2025

Next Review Date

Key ActionPrior authorization is required for benefit coverage of ledipasvir/sofosbuvir products; approvals are provided for the duration noted in the clinical criteria.

SourceLink

POLICY UPDATE CHANGES

New policy created with effective date 07/01/2025 and later early annual revision noting no criteria changes on 11/15/2025.

6Approved Indications Listed

3Pediatric age thresholds (≥3, <3 excluded)

1Required specialty prescriber

Coverage Summary & Coverage Stance

Coverage stance: covered_with_criteria. Policy IP0735 (Harvoni prior authorization) is a Cigna drug coverage policy that requires prior authorization and specifies clinical criteria, approved indications and treatment durations, prescriber specialty/consult requirements, exclusions, and approvals to complete an ongoing course of therapy for ledipasvir/sofosbuvir (Harvoni and authorized generic) across pediatric (≥3 years) and adult populations. Status: CURRENT. Effective date: 2025-11-15.

Not Medically Necessary / Exclusions

Ledipasvir/sofosbuvir products for any other use are considered not medically necessary, including but not limited to:

Combination with other DAAs: Combination with Any Other Direct-Acting Antivirals (DAAs) Not Including Ribavirin: ledipasvir/sofosbuvir should not be used with other products containing sofosbuvir or other DAAs (except ribavirin)
Pediatric age exclusion: Pediatric Patient (Age < 3 years): the safety and efficacy of ledipasvir/sofosbuvir have not been established in pediatric patients < 3 years of age
Retreatment with ledipasvir/sofosbuvir in patients who have previously received ledipasvir/sofosbuvir (e.g., prior null responders, partial responders, relapsers, or patients who did not complete a course due to adverse reaction or other reasons)

Prior Authorization, Prescriber Requirements, and Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of ledipasvir/sofosbuvir products. All approvals are provided for the duration noted in the clinical criteria (e.g., 8, 12, or 24 weeks as specified per indication and patient factors).

Documentation Required

Prescriber specialty/consult requirement

Ledipasvir/sofosbuvir must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician. For transplant-related indications the prescriber options are expanded to include transplant-affiliated clinicians (e.g., for post‑liver transplant: prescribers affiliated with a transplant center such as a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; for kidney transplant recipients: gastroenterologist, hepatologist, infectious diseases physician, nephrologist, liver transplant physician, or renal transplant physician).

Billing Rule

Preferred products requirement

Use of preferred products is required before approval of the requested ledipasvir/sofosbuvir product per the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM025). See PSM025 for preferred product criteria requirements and exceptions.

Prior Authorization

Completion of therapy approvals

If a patient has already been started on ledipasvir/sofosbuvir for an approved indication, approve the remaining duration necessary to complete the prescribed course of therapy (for example, if 3 of 12 weeks have been received, approve the remaining 9 weeks).

Clinical Evidence & References

Primary sources: Harvoni prescribing information (Gilead, March 2020) and AASLD/IDSA HCV guidance (updated Dec 19, 2023).

Optional quick facts

Age indicationApproved in patients ≥ 3 years of age

Typical approved durationsCommon durations: 8 weeks, 12 weeks, or 24 weeks (regimen-specific per genotype, prior treatment, and cirrhosis status)

8-week criteria8 weeks may be considered for treatment-naïve patients without cirrhosis with baseline HCV RNA < 6 million IU/mL

12-week criteria12 weeks is standard for many genotypes and scenarios (including genotypes 4–6, transplant recipients, and treatment-naïve or experienced patients without cirrhosis)

24-week criteria24 weeks for some treatment-experienced patients with compensated cirrhosis or specific decompensated/ribavirin-ineligible scenarios

Background & Definitions

Ledipasvir/sofosbuvir is a fixed-dose combination antiviral indicated for chronic HCV in patients ≥ 3 years for genotypes 1, 4, 5, and 6 (with or without compensated cirrhosis), genotype 1 with decompensated cirrhosis in combination with ribavirin, and genotype 1 or 4 in liver transplant recipients with ribavirin. Dosing: adults take one tablet once daily; pediatric dosing and oral pellets are weight-based for patients ≥ 3 years. Recommended durations vary by genotype, prior treatment status, cirrhosis status, and ribavirin eligibility (e.g., 8 weeks for selected treatment-naïve, noncirrhotic adults with baseline HCV RNA < 6 million IU/mL; 12 or 24 weeks in other scenarios; ribavirin dosing is weight-based per labeling). AASLD/IDSA guidance (Dec 19, 2023) provides simplified, regimen-specific recommendations and continues to recommend ledipasvir/sofosbuvir in specified situations.

Ribavirin eligible: patient can tolerate and be prescribed ribavirin per prescriber assessment; the labeling provides weight-based dosing (e.g., 1,000 mg for patients <75 kg and 1,200 mg for those ≥75 kg, with modified starting and titration guidance in decompensated cirrhosis).

Child-Pugh: classification of liver cirrhosis severity used in the criteria — compensated (Child‑Pugh A) versus decompensated (Child‑Pugh B or C), which informs recommended treatment regimens and durations.