Currentmedical mutual - ohioPolicy N/A

Inrebic (fedratinib)

Defines prior authorization recommendations, clinical criteria for coverage, approval durations, conditions not recommended for approval, and documentation requirements for Inrebic (fedratinib) for adults with intermediate-2 or high-risk primary or secondary myelofibrosis and certain NCCN-cited indications.

Policy Summary

Payermedical mutual - ohio

PolicyInrebic (fedratinib)

Policy CodePolicy N/A

Change TypeAnnual review — no material change

Effective Date

Next Review DateOct 16, 2025

Key ActionPrior authorization is recommended; initial approval requires prescription by or in consultation with a hematologist or oncologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this revision.

1Covered Indications (explicit)

1Not Recommended (cosmetic)

Coverage Summary

Coverage stance: covered_with_criteria for Inrebic (fedratinib) therapy for myelofibrosis. Scope summary: Defines prior authorization recommendations, clinical criteria for coverage, approval durations, conditions not recommended for approval, and documentation requirements for Inrebic for adults with intermediate-2 or high-risk primary or secondary myelofibrosis and certain NCCN-cited indications. Effective date: (not provided). Last review: 2025-10-16. Next review: 2025-10-16. Boxed warning: Inrebic carries a boxed warning for encephalopathy, including Wernicke's encephalopathy. Pediatric limitation: safety and efficacy have not been established in pediatric patients.

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Recommended Authorization Criteria

Coverage of Inrebic is recommended in those who meet the following criteria:

ALL of the following

Diagnosis of myelofibrosis (MF), intermediate-2 or high-risk, primary or secondary (post-polycythemia vera or post-essential thrombocythemia)
Approve if patient is 18 years of age or older

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Inrebic. Initial approval requires prescription by or in consultation with a hematologist or oncologist.

Billing Rule

Initial prescriber specialty requirement

Initial approval requires Inrebic be prescribed by or in consultation with a physician who specializes in the condition being treated. In order to be considered for coverage, Inrebic must be prescribed by or in consultation with a hematologist or oncologist.

Documentation Required

Documentation upon request

The Company may request additional documentation (patient records, test results, provider credentials) to support medical necessity; failure to provide requested documentation may result in denial.

Operational details: Initial and extended approval durations are each 1 year. The payer may request additional documentation such as patient records, test results, and provider credentials. Prior authorization is recommended and initial therapy must be prescribed by or in consultation with a hematologist or oncologist. Per criteria notes, the prescriber must provide the specific diagnosis when requesting coverage for NCCN-cited indications.

Clinical Evidence & Safety

Evidence entries: Prescribing information: Inrebic capsules, Celgene; May 2025. Key trial cited: JAKARTA-2 single-arm phase 2 study (Lancet Haematol 2017). Guideline source: NCCN Drugs and Biologics Compendium (2025).

Safety and background: Inrebic is a JAK2-selective inhibitor indicated for adults with intermediate-2 or high-risk primary or secondary myelofibrosis. It carries a boxed warning for encephalopathy including Wernicke's encephalopathy. The drug has activity against JAK2 and FLT3. Safety and efficacy have not been established in pediatric patients.

Background & Definitions

Inrebic (fedratinib) is indicated for adults with intermediate-2 or high-risk primary or secondary myelofibrosis and is a JAK2-selective kinase inhibitor with activity against JAK2 and FLT3.

Definitions: Intermediate-2 or high-risk myelofibrosis — clinical risk categories for myelofibrosis as used in the indication; specific scoring criteria are not provided in this policy.