CurrentUnitedHealthcarePolicy 2025 P 3133-7

Inrebic® (fedratinib) - Step Therapy - UnitedHealthcare Commercial Plans

UnitedHealthcare step therapy program governing coverage criteria for Inrebic (fedratinib) for commercial plans, requiring prior trial of ruxolitinib (Jakafi) or documented contraindication/intolerance, with special handling for patients <19 and members currently on therapy.

Policy Summary

PayerUnitedHealthcare

PolicyInrebic® (fedratinib) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3133-7

Change TypeRevised (annual review updates)

Effective DateJul 1, 2025

Next Review Date

Key ActionNew-to-therapy members must have trial and failure, contraindication, or intolerance to Jakafi (ruxolitinib) prior to coverage of Inrebic; members currently on Inrebic as documented in claims history may be allowed to continue without meeting step requirement.

SourceLink

POLICY UPDATE CHANGES

Effective Date updated to 7/1/2025 and program entry for 2025 included in header.

Updated coverage criteria in 4/2024 to include diagnosis of accelerated/blast phase myeloproliferative neoplasm.

1Step therapy required agent (ruxolitinib)

12Authorization duration (months)

Age <19Pediatric exception

Coverage Summary

Coverage stance: covered_with_criteria. This is a UnitedHealthcare step therapy program (Policy Number 2025 P 3133-7, status CURRENT) that requires a trial of Jakafi (ruxolitinib) — or documentation of contraindication or intolerance to ruxolitinib — before coverage of Inrebic (fedratinib) for adults with intermediate-2 or high-risk primary or secondary myelofibrosis. The criteria were expanded to include accelerated/blast phase myeloproliferative neoplasm per the NCCN recommendations.

Members currently on Inrebic as documented in claims history may continue their therapy without meeting the step requirement. Authorization duration is 12 months. Effective date: 7/1/2025.

Provider Actions & Authorization Rules

Step Therapy

Step therapy prior authorization requirement

New-to-therapy members must have a trial and failure, contraindication, or intolerance to Jakafi (ruxolitinib) prior to coverage of Inrebic. Members currently on Inrebic as documented in claims history may be allowed to continue without meeting the step requirement.

Documentation Required

Documentation of manufacturer assistance or sample use

If the member was established on Inrebic via a manufacturer-supplied sample or assistance from the Celgene Patient Support program, the member must meet initial authorization criteria as if new to therapy and provide documentation of the sample or assistance.

Prior Authorization

Authorization duration

Authorizations will be issued for 12 months.

Denial Risk

Age-based automatic processing exception

Prescriptions for members under age 19 will automatically process without a coverage review. Document the member's age to prevent inappropriate review.

Definitions & Background Notes

Definitions:

• Continuation of therapy: Members currently on Inrebic therapy as documented in claims history will be allowed to continue on their current therapy. Patients established on therapy via manufacturer samples or Celgene assistance must meet initial authorization criteria as if new to therapy.

• Manufacturer assistance/sample: Manufacturer supplied sample at no cost in the prescriber’s office or assistance from the Celgene Patient Support program (e.g., sample card redeemable at a pharmacy).

Background: This step therapy program requires a trial of ruxolitinib (Jakafi) or documentation of contraindication/intolerance before coverage of Inrebic for the indicated myelofibrosis/myeloproliferative neoplasm diagnoses. The NCCN also recommends Inrebic or Jakafi for accelerated/blast phase myeloproliferative neoplasms. Continuation-of-therapy handling for manufacturer samples is specified: patients who were established on therapy via manufacturer samples or Celgene assistance must meet initial authorization criteria as if new to therapy.

Clinical Evidence & References

P&T approval dates: 1/2020, 4/2020, 4/2021, 4/2022, 4/2023, 4/2024, 4/2025.

References: Inrebic [package insert]. Summit, NJ: Celgene Corporation. July, 2024; Jakafi [package insert]. Wilmington, DE: Incyte Corporation; January 2023; The NCCN Drugs and Biologics Compendium (NCCN Compendium™). Available at https://www.nccn.org/professionals/drug_compendium/content/ Accessed March 6, 2025.

Revision History

2025-04-01non-material updateLatest

Annual review: removed superscripts for references; no changes to clinical criteria. Effective Date updated to 7/1/2025 and program entry for 2025 included in header.

2024-04-01material update

Annual review: background and references updated to include NCCN recommendations; coverage criteria updated to include diagnosis of accelerated/blast phase myeloproliferative neoplasm.