CurrentColorado Rocky Mountain Health PlansPolicy N/A

Harvoni (ledipasvir/sofosbuvir) prior authorization

Prior authorization and notification requirements for Harvoni (ledipasvir/sofosbuvir) for treatment of chronic hepatitis C in eligible members; applies to prescribers and pharmacists handling UnitedHealthcare pharmacy benefits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyHarvoni (ledipasvir/sofosbuvir) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateOct 20, 2025

Key ActionSubmit prior authorization showing diagnosis of chronic HCV genotype 1, 4, 5, or 6 and confirm Harvoni is not being used with another HCV direct-acting antiviral.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

1,4,5,6Genotypes covered

P&T 2014-2025Policy review history

2026-01-01Effective

Coverage Criteria for Harvoni (ledipasvir/sofosbuvir)

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Initial Therapy

Initial therapy

Initial therapy coverage conditions:

Initial therapy: Patient has chronic hepatitis C virus infection of genotype 1, 4, 5, or 6; Harvoni is not prescribed to be used in combination with another HCV direct-acting antiviral agent (e.g., sofosbuvir-containing agents).

See product labeling for special populations (decompensated cirrhosis, post-transplant) and for situations requiring addition of ribavirin.

Continuation and Re-authorization

Continuation therapy

Re-authorization and continuation

Continuation auth: UnitedHealthcare may approve continuing therapy based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Authorization may be issued for up to 12 months; supply limits and medical necessity determinations may apply.

Provider Actions, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required — approval will be granted only when BOTH criteria are met. Authorization will be issued for up to 12 months. State mandates, federal requirements, and the member's benefit plan may affect coverage; other policies and utilization management programs may also apply.

Approval requires: diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6
Authorization period: up to 12 months
Coverage may be affected by state/federal mandates and member benefit plan
Other policies and utilization management programs may apply

Prior Authorization

Combination Therapy Restriction

Harvoni must not be used concurrently with another HCV direct-acting antiviral agent. Requests for combination therapy (for example, Harvoni plus sofosbuvir/Sovaldi or other HCV DAAs) will not be approved.

Concurrent use with another HCV direct-acting antiviral agent is prohibited
Example: Do not combine Harvoni with Sovaldi (sofosbuvir)

Denial Risk

Grounds for Denial and Automated Review

Requests may be approved or denied based on whether required criteria are met. Automated review processes may use prior claim or medication history, diagnosis codes (ICD-10), and claim logic to approve initial requests or re-authorizations. Supply limits and medical necessity rules may apply.

Approval/denial may be based on meeting the documented criteria
Automated approvals/re-authorizations may use prior claim/medication history and ICD-10 diagnosis codes
Supply limits and medical necessity checks may be applied

Documentation Required

Supporting Documentation and Automated Review

Supporting documentation may be required. Approvals and re-authorizations may rely on automated checks of prior claims, medication history, and diagnosis coding. Be prepared to provide clinical documentation if requested.

Documentation sources: prior claims, medication history, ICD-10 diagnosis codes
Supply limits and medical necessity may be enforced
Clinical documentation may be requested for manual review

Definitions

Harvoni (ledipasvir/sofosbuvir) — definition

DrugHarvoni (ledipasvir/sofosbuvir)

CompositionFixed‑dose combination of ledipasvir (NS5A inhibitor) and sofosbuvir (NS5B nucleotide analog polymerase inhibitor)

Indicated populationsAdults and pediatric patients ≥3 years with chronic HCV

Covered HCV genotypes per labelGenotype 1, 4, 5, or 6 (with specific guidance for compensated/decompensated cirrhosis and post‑transplant use)

Special label usesGenotype 1 with decompensated cirrhosis (with ribavirin); genotype 1 or 4 post‑liver transplant (with ribavirin)

Background

Harvoni is a fixed-dose combination of ledipasvir (an HCV NS5A inhibitor) and sofosbuvir (an HCV NS5B polymerase inhibitor). It is indicated for the treatment of chronic hepatitis C virus infection in adults and pediatric patients aged ≥3 years for applicable genotypes, including genotype 1, 4, 5, and 6, with dosing and use per the product label and specific guidance for patients with compensated or decompensated cirrhosis and certain post-transplant situations.