CurrentCignaPolicy N/A

Oncology - Inrebic Prior Authorization Policy

Defines prior authorization criteria for coverage of Inrebic (fedratinib capsules) for FDA-approved indication (myelofibrosis) and select other uses with supportive evidence (accelerated/blast phase myeloproliferative neoplasm; myeloid or lymphoid neoplasms with eosinophilia and JAK2 rearrangement). Approvals are for 1 year when criteria are met.

Policy Summary

PayerCigna

PolicyOncology - Inrebic Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revisions and additions

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Inrebic; approvals are provided for 1 year when criteria are met and documentation of a trial of Jakafi is required for myeloid/lymphoid neoplasms with JAK2 rearrangement.

SourceLink

POLICY UPDATE CHANGES

Myelofibrosis criterion changed from 'intermediate-2 or high-risk disease' to 'higher-risk disease.'

Accelerated or Blast Phase Myeloproliferative Neoplasm condition of approval and criteria were added.

For myeloid or lymphoid neoplasms, requirement that the patient has tried Jakafi (ruxolitinib) was added.

Annual revisions on 10/11/2023 and 06/26/2024 noted 'No criteria changes.'

3Covered Indications Listed

1 yrApproval Duration

RequiredPrior Authorization

Coverage Summary

Defines prior authorization criteria for coverage of Inrebic (fedratinib capsules) for FDA-approved indication and select other uses with supportive evidence. Coverage stance: covered_with_criteria. Approvals are for 1 year when criteria are met. Indicated and supported uses include: FDA-approved myelofibrosis (higher-risk primary or secondary myelofibrosis in adults), accelerated or blast phase myeloproliferative neoplasm (supportive evidence for symptom palliation), and myeloid or lymphoid neoplasms with eosinophilia and JAK2 rearrangement (with required trial of Jakafi where specified).

Key facts

Covered Indications Listed3

Approval Duration1 year

Prior Authorization RequirementPrior Authorization recommended; approvals provided for 1 year when criteria are met

Last Review Date2023-10-11

Has Material ChangeYes (policy records material changes in 2025 and 2026)

Initial Therapy Criteria

FDA-Approved Indication - Myelofibrosis

Approve for 1 year if the patient meets BOTH of the following (A and B):

Other Uses with Supportive Evidence - Accelerated or Blast Phase Myeloproliferative Neoplasm

Approve for 1 year if the patient meets BOTH of the following (A and B):

Other Uses with Supportive Evidence - Myeloid or Lymphoid Neoplasms

Approve for 1 year if the patient meets ALL of the following (A, B, C and D):

Unproven / Not Covered Conditions

Conditions Not Covered

Experimental, investigational or unproven uses

ANY of the following

Inrebic (fedratinib capsules) is considered experimental, investigational or unproven for ANY other use(s)

Provider Actions

Prior Authorization

Prior authorization requirement

Prior authorization is recommended for prescription benefit coverage of Inrebic. Approvals are provided for 1 year when criteria are met.

Approval duration: 1 year
Prior authorization required

Documentation Required

Document trial of Jakafi for myeloid or lymphoid neoplasms

For myeloid or lymphoid neoplasms with eosinophilia and a JAK2 rearrangement, documentation that the patient has tried Jakafi (ruxolitinib tablets) is required.

Affected condition: Myeloid or lymphoid neoplasms with eosinophilia and JAK2 rearrangement
Required agent: Jakafi (ruxolitinib)

Background

Background: Inrebic (fedratinib) is a JAK2-selective kinase inhibitor indicated for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis in adults. NCCN guideline contexts include recommendations for use in higher-risk myelofibrosis (patients with symptomatic splenomegaly and/or constitutional symptoms who are not transplant candidates or when transplant is not feasible), consideration for accelerated or blast phase myeloproliferative neoplasms for palliation of splenomegaly or other disease-related symptoms, and consideration for myeloid/lymphoid neoplasms with JAK2 rearrangement particularly when Jakafi (ruxolitinib) is unavailable or not tolerated.

Definitions

Higher-risk diseaseTerm used to describe disease severity for myelofibrosis (replaces 'intermediate-2 or high-risk disease'); specific staging definition not provided in policy.

Disease-related symptomsExamples include fatigue, fever, night sweats, weight loss, abdominal discomfort, splenomegaly, thrombocytosis, or leukocytosis.

Revision History

02/19/2025Early Annual Revision

Myelofibrosis criterion changed from 'intermediate-2 or high-risk disease' to 'higher-risk disease.' (material change)

02/19/2025Early Annual Revision

Accelerated or Blast Phase Myeloproliferative Neoplasm condition of approval and criteria were added under Other Uses with Supportive Evidence. (material change)

02/11/2026Annual RevisionLatest

For myeloid or lymphoid neoplasms, requirement that the patient has tried Jakafi (ruxolitinib) was added. (material change)

10/11/2023Annual Revision

No criteria changes.

06/26/2024Annual Revision