CurrentHealth NetPolicy CP.PHAR.442

Fedratinib (Inrebic)

Criteria and authorization requirements for coverage of fedratinib (Inrebic) for adults with intermediate-2 or high‑risk primary, post‑PV, or post‑ET myelofibrosis and certain off‑label myeloid/lymphoid neoplasms with JAK2 arrangement; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyFedratinib (Inrebic)

Policy CodePolicy CP.PHAR.442

Change TypeNo material changes

Effective DateDec 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization with documentation including recent thiamine >=70 nmol/L and platelet count >=50,000/mcL, prescriber specialty, and evidence of ruxolitinib failure unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

400 mg/dayMax FDA dose

>=70 nmol/LMin thiamine

>=50,000/mcLMin platelets

6 moInitial auth (Medicaid/HIM)

12 moInitial/renewal (Commercial)

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Coverage Criteria for Fedratinib (Inrebic)

Initial Therapy (FDA‑indication)

Covered when ALL of the following are met:

Initial MF coverage: Member is an adult (>= 18 years) with a diagnosis of intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis; therapy is prescribed by or in consultation with a hematologist or oncologist; documentation of a recent (within 30 days) thiamine level >= 70 nmol/L (3 mcg/dL); documentation of a recent (within 30 days) platelet count >= 50,000/mcL; prior failure of Jakafi (ruxolitinib) unless contraindicated or intolerant; dose does not exceed 400 mg per day and 4 capsules per day; for brand Inrebic requests, member must use generic fedratinib if available unless contraindicated or intolerant; prescribed regimen must be FDA-approved or recommended by NCCN.see nodes

Prior authorization for Jakafi may be required; prescriber must submit supporting evidence if dose exceeds FDA limits or for off-label dosing

Initial Therapy (Off‑label JAK2‑arrangement)

Covered when ALL of the following are met:

Off-label JAK2‑arrangement neoplasm: Diagnosis of a myeloid or lymphoid neoplasm with eosinophilia and a JAK2 arrangement (chronic or blast phase); therapy prescribed by or in consultation with a hematologist or oncologist; documentation of a recent (within 30 days) thiamine level >= 70 nmol/L (3 mcg/dL); age >= 18 years; documentation of a recent (within 30 days) platelet count >= 50,000/mcL; prior failure of Jakafi (ruxolitinib) unless contraindicated or intolerant; dose does not exceed 400 mg per day and 4 capsules per day, or dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); for brand Inrebic requests, member must use generic fedratinib if available unless contraindicated.see nodes

Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued therapy: Member is currently receiving fedratinib via the Centene benefit or documentation shows the member has been receiving Inrebic for a covered indication for at least 30 days; member is responding positively to therapy; if request is for a dose increase, the new dose does not exceed 400 mg per day and 4 capsules per day, or the new dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); for brand Inrebic requests, member must use generic fedratinib if available unless contraindicated or intolerant.see nodes

Approval duration for continuation: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less

Authorization duration and continuation

Referenced policy-level coverage considerations and historical edits

Authorization durations: Initial authorization duration consolidated to 6 months; continued therapy approvals up to 12 months per historical policy revisions and template consolidation noted in policy history.

From policy history (see references for dates of revisions)

Requests for fedratinib (Inrebic) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless an evidence of coverage document supports the use.

The excerpt does not list a discrete set of current explicit exclusions. Policy history notes in the references section document prior edits (for example, removal of some previously required failures and consolidation of authorization durations), but no current exclusion list is provided in this fragment of the policy.

This policy excerpt does not contain explicit statements labeling specific uses or scenarios as "not medically necessary". The references and historical notes describe revisions to requirements and approval durations but do not include any explicit 'not medically necessary' declarations in the provided text.

Coding and Related Clinical Thresholds

No explicit codes in excerptmixed

No codes listed

Thiamine level required prior to approval

Required value>= 70 nmol/L (3 mcg/dL)

TimingRecent within the last 30 days (documentation required)

Applies toInitial therapy for MF and off-label JAK2‑arrangement indications

Platelet count required prior to approval

Required value>= 50,000/mcL

TimingRecent within the last 30 days (documentation required)

Applies to

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Required Documentation

Prior Authorization Required: Prior authorization is required. Provider must submit documentation (including office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Documented diagnosis and consultation notes (hematologist/oncologist)
Recent thiamine level within 30 days ≥ 70 nmol/L (3 mcg/dL)
Recent platelet count within 30 days ≥ 50,000/mcL
Age ≥ 18 years
For brand requests, member must use generic fedratinib if available unless contraindicated or adverse effects

Documentation Required

Required Documentation

Documentation requirements — include office notes, lab results, and any other clinical information that demonstrates each criterion is met. For off‑label indications, provide supporting evidence such as NCCN guideline references or peer‑reviewed literature.

Dosing, Formulation, and Regimen Limits

Regimen	Indication	Coverage
400 mg once daily (capsule: 100 mg; max 4 capsules/day)	Myelofibrosis (intermediate-2 or high-risk). Dose must not exceed FDA-listed maximum of 400 mg/day.	Covered with criteria

Formulation	Maximum daily dose	Coverage
Capsule, 100 mg strength	400 mg/day (maximum listed)	Covered with criteria

Definitions and Safety Warnings

Myelofibrosis (MF) is a myeloproliferative neoplasm that may be primary or secondary to polycythemia vera or essential thrombocythemia. Clinical guidance (including NCCN recommendations) supports the use of JAK‑targeted therapies such as ruxolitinib and fedratinib for initial treatment of intermediate‑2 or high‑risk MF, with goals including reduction in splenomegaly and improvement in constitutional symptoms. Fedratinib carries a boxed warning for serious and potentially fatal encephalopathy (including Wernicke encephalopathy), and prescribers should follow product labeling and guideline recommendations when considering therapy.

myelofibrosis — short label/definition

Short labelMyelofibrosis (MF)

IncludesPrimary MF, post‑polycythemia vera MF, post‑essential thrombocythemia MF

Clinical contextMyelofibrosis is a myeloproliferative neoplasm; NCCN recommends ruxolitinib and fedratinib for initial treatment of intermediate‑2 or high‑risk disease

Boxed warning — encephalopathy/Wernicke encephalopathy boxed warning for fedratinib

Line of Therapy Considerations

first-line

first-line: NCCN recommends ruxolitinib and fedratinib for initial treatment of intermediate-2 or high-risk myelofibrosis; fedratinib is considered among initial therapy options after clinical trial therapies and transplant considerations per NCCN guidance.

mixed

line of therapy notes: Policy history references removal of prior requirements including failure of hematopoietic cell transplant and hydroxyurea; explicit current sequencing or mandatory prior therapies beyond Jakafi are not specified in this excerpt.

See policy revision history

Biomarker and Variant Requirements

JAK2 (Janus kinase 2) — biomarker label (presence/arrangement referenced for off‑label coverage)

BiomarkerJAK2 (Janus kinase 2)

RolePresence/arrangement required for off‑label coverage of myeloid/lymphoid neoplasms with eosinophilia per NCCN category 2A

DocumentationPrescriber must provide evidence (diagnosis and supporting literature) for off‑label use when JAK2 arrangement is the rationale

Policy Revision History

Note

Authorization duration (historical context)

Authorization duration context: historical edits consolidated initial authorization to 6 months and continued therapy approvals to 12 months; commercial approvals are typically 12 months or the duration of request.

WCG-specific policy retired; initial auth consolidated to 6 months
Continued therapy approvals consolidated to 12 months

Policy Summary

PayerHealth Net

PolicyFedratinib (Inrebic)

Policy CodePolicy CP.PHAR.442

Change TypeNo material changes

Effective DateDec 1, 2019

Next Review DateN/A

SourceLink

On This Page

Initial therapy for MF and off-label JAK2‑arrangement indications

Maximum daily dose (key dosing parameter)

Maximum daily dose400 mg per day

Maximum capsules/day4 capsules per day (100 mg capsule strength)

ContextDose must not exceed FDA‑listed maximum for myelofibrosis unless supported by guidelines or peer‑reviewed literature (prescriber must submit evidence)

Office chart notes showing diagnosis and specialist involvement
Laboratory reports for thiamine and platelet counts within 30 days
Rationale and literature for off‑label use when applicable

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy: Failure of ruxolitinib (Jakafi) is required prior to approval unless contraindicated or the member experienced clinically significant adverse effects. Prior authorization for Jakafi may also be required.

Document prior ruxolitinib therapy and reason for discontinuation (lack of efficacy, intolerance, or contraindication)
Indicate if Jakafi prior authorization was obtained when applicable

Note

Authorization Duration Note

Authorization duration: Initial and continued approval durations have changed historically. Current standard durations (per business line) should be confirmed in the policy header and history; typical durations noted in policy history include 6 months for initial authorization (Medicaid/HIM) and 12 months for commercial (or duration of request, whichever is less).

Medicaid/HIM initial: 6 months
Commercial: 12 months or duration of request, whichever is less
Continuation authorizations: commonly 12 months (see policy header for current guidance)

Denial Risk

Non‑FDA Indications Risk

Denial risk: Requests for non‑FDA approved indications not addressed by this policy may be denied unless sufficient off‑label documentation of efficacy and safety is provided per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid).

Include NCCN category and supportive literature for off‑label indications to mitigate denial risk

Note

Historical Policy Edits (Provider Action)

Historical policy edits: Prior versions removed or revised requirements (for example: removal of prior requirements for failure of hematopoietic cell transplant, hydroxyurea, and concurrent treatment with Jakafi within 14 days). The WCG-specific policy was retired and approval durations were consolidated (initial auth moved to 6 months for some lines, continued therapy to 12 months). Review policy history for specific past edits that may affect documentation or duration.

Removal of requirement for failure of HCT, hydroxyurea, and concurrent Jakafi within 14 days (4Q2021)
Retirement of WCG-specific policy and consolidation of approval durations (4Q2022)
Template and duration revisions reflected in subsequent annual reviews (2022–2024)

Boxed warning summarySerious and fatal encephalopathy, including Wernicke encephalopathy

Associated productFedratinib (Inrebic)

Clinical implicationMonitor for signs of encephalopathy; review prescribing information for contraindications and monitoring

definition added to continuation of therapy section — intermediate-2 or high-risk disease

Definition addedIntermediate‑2 or high‑risk disease

Criteria referenceDefined by presence of two or more risk factors (e.g., age >65, Hgb <10 g/dL, constitutional symptoms, WBC >25 x10^9/L, platelets 100 x10^9/L, peripheral blasts >=1%, transfusion dependence, unfavorable karyotype)

ApplicationUsed in continuation of therapy and initial approval eligibility