CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inrebic (fedratinib) — Coverage Criteria for Myelofibrosis

Defines authorization, inclusion, and exclusion criteria for coverage of Inrebic (fedratinib) for myelofibrosis and describes documentation and approval authority for Neighborhood Health Plan of Rhode Island medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInrebic (fedratinib) — Coverage Criteria for Myelofibrosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 8, 2024

Key ActionObtain prior authorization; UM Department review with final approval by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=50minimum platelet count required before treatment

400single dose maximum (mg)

120monthly quantity limit

MultipleUM committee reviews listed

Coverage Criteria for Inrebic (fedratinib)

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Myelofibrosis (initial coverage)

Covered when ALL of the following are met:

MF coverage criteria: Member has primary or secondary myelofibrosis (including post-polycythemia vera or post-essential thrombocythemia myelofibrosis); platelet count >= 50 x 10^9/L prior to start of treatment; member has splenomegaly.see platelet count threshold

Single-agent use of Inrebic (fedratinib) for MF

Continuation requests

Continuation therapy exemption

Continuation criteria: Requested medication was used within the last year; no disease progression and no intolerance to the requested medication; no additional medications are being added to the continuation request.

Exemption from this policy for continuation requests meeting all conditions

Coverage of Inrebic (fedratinib) is subject to specific constraints. Use is excluded if the request is for treatment after documented disease progression on the same regimen. There is a single-dose maximum of 400 mg, and dosing that exceeds this limit will not be approved. Additionally, therapy that would result in more than 120 (100 mg) capsules per month is excluded.

Investigational or off‑label uses of Inrebic (fedratinib) are not covered unless supported by sufficient evidence. Sufficient evidence must be generally accepted by the medical community and/or supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Acceptability is determined by factors including whether the patient and disease characteristics are adequately represented in the evidence, whether the regimen evaluated matches the requested regimen, whether reported outcomes are clinically meaningful, and whether study design and size provide reliable inference. Case reports and meeting abstracts without a full peer‑reviewed publication are generally inadequate to establish sufficient evidence.

Clinical Thresholds and Coding-related Limits

inv-05: Platelet count — minimum platelet count required before treatment

Minimum platelet count>= 50 x 10^9/L prior to start of treatment

Applies toMembers with primary or secondary myelofibrosis (including post-polycythemia vera MF and post-essential thrombocythemia MF)

Context for requirementPlatelet threshold required as part of initial coverage criteria for single-agent fedratinib

Initial Therapy Criteria

Initial therapy criteria

Initial MF therapy: Member has primary or secondary myelofibrosis; platelet count >= 50 x 10^9/L prior to start; presence of splenomegaly; fedratinib used as single agent.platelets >= 50 x 10^9/L

Coverage aligned to FDA labeling and referenced compendia/guidelines

Continuation Therapy Criteria

Continuation therapy

Continuation therapy exemption conditions

Continuation exemption: Requested medication used within last year; no disease progression and no intolerance; no additional medications added to request.

Exemption from this policy for continuation requests meeting all conditions

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization and approval path

Prior authorization is required for Inrebic (fedratinib) requests; initial review is performed by the Utilization Management Department and final approval is granted by the Utilization Management Committee.

Step Therapy

Continuation request exemption conditions

Continuation requests may be exempt from this policy when the requested medication was used within the last year, the member has not experienced disease progression or intolerance to the medication, and no additional medications are being added to the request.

Requested medication used within the last year
No disease progression and no intolerance to the requested medication
No additional medications are being added to the continuation request

Documentation Required

Supporting evidence required with requests

Provide supporting evidence with the request in the form of FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS criteria.

FDA-approved product labeling
CMS-approved compendia
NCCN or ASCO clinical guidelines
Peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Hard exclusion triggers (denial risk)

Requests will be excluded (denied) if dosing exceeds the single-dose limit of 400 mg, if treatment exceeds the maximum of 120 (100 mg) capsules per month, or if the drug is used after disease progression on the same regimen.

Dosing exceeds single dose limit of 400 mg
Treatment exceeds maximum limit of 120 (100 mg) capsules per month
Use after disease progression with the same regimen

Definitions

inv-11: Myelofibrosis (MF) — definition including primary or secondary MF and coverage prerequisites

DefinitionPrimary or secondary myelofibrosis, including post-polycythemia vera MF and post-essential thrombocythemia MF

Coverage prerequisitesMember has splenomegaly

Laboratory prerequisitePlatelet count >= 50 x 10^9/L prior to start of treatment

Use restrictionsInrebic (fedratinib) covered as single-agent therapy; use after disease progression with the same regimen is excluded

Background

Inrebic (fedratinib) is a JAK2 inhibitor indicated for use as a single agent in adults with primary or secondary myelofibrosis, including post‑polycythemia vera and post‑essential thrombocythemia myelofibrosis. Policy coverage for myelofibrosis requires documentation of splenomegaly and a pre‑treatment platelet count of >= 50 x 10^9/L. Requests are reviewed through the Utilization Management process and are subject to the exclusions and quantity limits described in this policy (for example, the 120 (100 mg) capsules per month limit and the 400 mg single‑dose maximum).