CurrentCentenePolicy CP.PHAR.654

Momelotinib (Ojjaara) — Clinical Policy

Centene clinical policy governing medical necessity criteria, prior authorization, and coverage conditions for momelotinib (Ojjaara) in adults with myelofibrosis and select off‑label myeloproliferative neoplasm (MPN) uses; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyMomelotinib (Ojjaara) — Clinical Policy

Policy CodePolicy CP.PHAR.654

Change TypeAdded off-label MPN criteriaextended approval duration

Effective Date12.01.23

Next Review Date

Key ActionSubmit prior authorization with documentation that member meets all approval criteria including diagnosis, prescriber specialty, age, recent hemoglobin <10 g/dL, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added off-label criteria for MPN per NCCN category 2A.

Initial approval duration changed from 6 to 12 months.

200 mg/dayFDA maximum dose for MF

Age ≥ 18Minimum age for coverage

Hgb <10 g/dLRequired recent lab for MF approval

12 monthsAuthorization period

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Continuation Therapy

Covered when ALL of the following are met for Continuation/Renewal:

Continuation Therapy: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Ojjaara for a covered indication and has received this medication for at least 30 days. 2. Member is responding positively to therapy (e.g., reduced spleen size or symptom improvement). 3. For brand Ojjaara requests, member must use generic momelotinib if available unless contraindicated or clinically significant adverse effects are experienced. 4. If request is for a dose increase, request meets one of the following: (a) new dose does not exceed both (i) 200 mg per day and (ii) 1 tablet per day; OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN; approval duration: 12 months.

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

Requests to use momelotinib for indications not listed in this policy will be considered not authorized unless the prescriber provides evidence of efficacy and safety consistent with the referenced off‑label use policies. Absent such documentation, these off‑label uses are treated as non‑covered.

Dosing and Regimens

Indication	Regimen	Notes
Myelofibrosis (MF)
200 mg PO once daily
Maximum 200 mg/day; tablets available in 100 mg, 150 mg, and 200 mg strengths

Indication	Regimen	Prescriber requirements / Notes
Accelerated/blast phase myeloproliferative neoplasms (MPN)
Single agent near start of conditioning OR in combination with azacitidine or decitabine per NCCN
Prescriber must submit supporting evidence if dose exceeds FDA maximum; regimen should be FDA‑approved or recommended by NCCN

Policy Identifier and Key Values

Policy identifiermixed

CP.PHAR.654

Policy reference number

inv-07: Hemoglobin — required recent lab for MF approval

Required labRecent (within 30 days) hemoglobin < 10 g/dL

ContextRequired for Initial Approval — Myelofibrosis (primary, post-PV, post-ET)

Documentation sourceProvider must submit laboratory results as part of prior authorization request

inv-08: Maximum daily dose — FDA maximum dose for MF (200 mg/day)

Maximum daily dose (MF)200 mg/day

Tablet dosingTablets available: 100 mg, 150 mg, 200 mg

Dose limit conditionsDose must not exceed 200 mg/day and 1 tablet/day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — documentation that member meets all approval criteria including diagnosis and prescriber specialty.

Diagnosis of myelofibrosis (primary, post‑PV, post‑ET)
Prescribed by or in consultation with a hematologist or oncologist
Age ≥ 18 years
Recent (within 30 days) hemoglobin level < 10 g/dL
Approval duration: 12 months

Billing Rule

Generic Substitution Requirement

Generic substitution requirement — brand Ojjaara requests require use of generic momelotinib if available unless contraindicated or clinically significant adverse effects are experienced.

Applies to both initial and continuation requests
If generic unavailable or contraindicated, prescriber must document reason

Documentation Required

Required Clinical Documentation

Required clinical documentation — provider must submit office notes, laboratory results (including a recent hemoglobin), and other clinical information supporting that the member meets all approval criteria and is responding to therapy.

Examples: office chart notes, lab results, documentation of positive response (e.g., spleen size reduction, symptom improvement)
If requesting dose above standard limits, submit supporting practice‑guideline or peer‑reviewed evidence for off‑label use

Denial Risk

Non‑Covered Indications Risk

Non‑covered indications risk — requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies and evidence of coverage.

Non‑FDA approved indications not addressed in this policy require documentation of efficacy and safety per off‑label policies
Coverage is not authorized for such indications unless requirements are met

Line of Therapy / Salvage Use

salvage

Transplant candidate use: Use as single agent near to the start of conditioning therapy or in combination with azacitidine/decitabine for bridging therapy.

salvage

Non-transplant palliation: If not a candidate for transplant, use in combination with azacitidine or decitabine for palliation of splenomegaly or other disease-related symptoms.

Definitions

inv-14: Myelofibrosis (MF) definition — includes primary MF and secondary MF post‑PV and post‑ET.

DefinitionMyelofibrosis (MF) includes primary MF and secondary MF following polycythemia vera (post-PV) or essential thrombocythemia (post-ET)

FDA indicationOjjaara is indicated for intermediate or high-risk MF, including primary MF or secondary MF (post-PV and post-ET), in adults with anemia

Age requirementApplies to adults age ≥ 18 years per policy

inv-15: Accelerated/blast phase MPN — definition for advanced phases considered for transplant or bridging/palliative use.

DefinitionAccelerated/blast phase MPN refers to advanced phases of myeloproliferative neoplasms (MPN) characterized as accelerated or blast phase

Intended use scenariosConsidered for transplant candidates as single-agent near conditioning or combined with azacitidine/decitabine for bridging; if not transplant candidate, used in combination with azacitidine/decitabine for palliation

Evidence requirementDose and use must be within FDA maximum or supported by practice guidelines/peer-reviewed literature (prescriber must submit supporting evidence)

Background

Momelotinib (Ojjaara) is a kinase inhibitor indicated for use in intermediate or high‑risk myelofibrosis; this policy excludes coverage of non‑FDA indications unless the provider documents adequate evidence per the off‑label use policies cited above. For off‑label accelerated or blast‑phase myeloproliferative neoplasms included by reference (when supported by NCCN or peer‑reviewed literature), prescribers must submit supporting clinical evidence to justify use under those pathways.