CurrentUnitedHealthcarePolicy 2025 P 1146-16

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Harvoni

UnitedHealthcare prior authorization policy for Harvoni (ledipasvir/sofosbuvir) detailing approved HCV genotypes, combination therapy restrictions, authorization duration, and ancillary program rules for members covered under applicable benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs - Harvoni

Policy CodePolicy 2025 P 1146-16

Change TypeAnnual updates / reorganized criteria

Effective DateJan 1, 2026

Next Review Date

Key ActionPrior authorization/notification required for Harvoni; approvals issued for 12 months and may be granted based on documentation, prior claim/medication history, diagnosis codes, and/or claim logic.

POLICY UPDATE CHANGES

Reorganized criteria so that chronic HCV infection for treatment-experienced patients and other specific populations are addressed in one section; simplified cirrhosis status criteria and updated authorization to 12 months.

Added cirrhosis criteria for treatment of chronic hepatitis C genotype 4, 5 or 6.

Added criteria for genotype 1 patients with decompensated cirrhosis and for post-liver transplant genotype 1 or 4 patients per updated FDA label.

1,4,5,6Covered genotypes

12 moAuthorization duration

Not allowedCombination therapy

Policy number 2025 P 1146-16 (status: CURRENT) covers Harvoni (ledipasvir/sofosbuvir) with criteria. Coverage stance: covered_with_criteria. Scope: UnitedHealthcare prior authorization policy for Harvoni detailing approved HCV genotypes, restrictions on combination therapy, authorization duration, and program rules for applicable benefit plans. Short description: Harvoni is a fixed-dose combination indicated for chronic hepatitis C virus infection for genotypes 1, 4, 5, or 6 in adults and pediatric patients 3 years of age or older, with regimen notes for compensated versus decompensated cirrhosis and for post-liver transplant per the label.

Key Coverage Details

Covered genotypesGenotypes 1, 4, 5, or 6

Additional genotype-specific usesGenotype 1 with decompensated cirrhosis (with ribavirin); post-liver transplant genotype 1 or 4 (with ribavirin)

Authorization duration12 months

Effective date2026-01-01

Last review date2025-10-01

Drug definitionFixed-dose combination of ledipasvir and sofosbuvir for chronic HCV treatment (Harvoni)

Initial Therapy Criteria

Initial Authorization - Harvoni

Harvoni will be approved based on both of the following criteria:

Diagnosis of chronic hepatitis C genotype 1, 4, 5 or 6 infection
Patient is not receiving Harvoni in combination with another HCV direct acting antiviral agent (e.g., Sovaldi (sofosbuvir))

Authorization / Continuation Criteria

Authorization Duration

Authorization terms

Authorization will be issued for 12 months

Program and Coverage Notes / Additional Clinical Rules

State mandates may apply; federal regulatory requirements and member specific benefit plan coverage may impact coverage criteria
UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic
Supply limits may be in place
Medical necessity may be in place

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Harvoni. Approvals will be issued for 12 months. Approvals may be granted based on documentation and/or prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Documentation Required

Document genotype and combination therapy status

Provider must document a diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6 and that Harvoni will not be used in combination with another HCV direct-acting antiviral agent (for example, sofosbuvir/Sovaldi).

Billing Rule

State and plan mandates

State mandates, federal regulatory requirements, and the member-specific benefit plan coverage may impact approval. Other policies and utilization management programs may also apply.

Clinical Evidence & References

Evidence: Prescribing information — Harvoni package insert, December 2024.

Evidence: Guideline reference — American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C (accessed 2025).

Background

Harvoni is a fixed-dose combination of ledipasvir and sofosbuvir indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age or older. Indications include infection with HCV genotypes 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis. For genotype 1 with decompensated cirrhosis, Harvoni is indicated in combination with ribavirin. For liver transplant recipients with genotype 1 or 4 without cirrhosis or with compensated cirrhosis, Harvoni is indicated in combination with ribavirin, per the label.

Definitions:

Harvoni — Fixed-dose combination of ledipasvir and sofosbuvir for chronic HCV treatment.

Revision History

10/2025revisedLatest

2/2024added

Added cirrhosis criteria for treatment of chronic hepatitis C genotype 4, 5 or 6.

12/2016added

Added criteria for genotype 1 patients with decompensated cirrhosis.

12/2017added

Updated genotype 1 treatment-experienced criteria to include compensated cirrhosis only and added criteria for post-liver transplant genotype 1 or 4 patients per updated FDA label.

2016-2017 (historical notes)historical

Historical updates through 2016–2017 included additions of decompensated cirrhosis criteria for genotype 1 and post-liver transplant criteria for genotype 1 or 4; subsequent annual reviews noted no change to coverage criteria while references were updated.