CurrentCentenePolicy CP PHAR.654

Momelotinib (Ojjaara) coverage

Defines medical necessity, authorization, dosing, and continuation criteria for momelotinib (Ojjaara) for treatment of intermediate or high‑risk myelofibrosis in adults with anemia for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyMomelotinib (Ojjaara) coverage

Policy CodePolicy CP PHAR.654

Change TypeNo material change

Effective Date12.01.23

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis of MF, hemoglobin <10 g/dL within 30 days, and hematology/oncology prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200 mg/daydose (max)

6 moinitial approval

12 mocontinued approval

100/150/200tablet strengths

Coverage Criteria

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Policy Summary

PayerCentene

PolicyMomelotinib (Ojjaara) coverage

Policy CodePolicy CP PHAR.654

Change TypeNo material change

Effective Date12.01.23

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis of MF, hemoglobin <10 g/dL within 30 days, and hematology/oncology prescribing or consultation.

SourceLink

On This Page

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Initial Approval for MF: 1) Diagnosis of myelofibrosis (primary MF, post‑PV MF, or post‑ET MF). 2) Prescribed by or in consultation with a hematologist or oncologist. 3) Documentation of a recent (within 30 days) hemoglobin level < 10 g/dL. 4) Patient is >= 18 years of age. 5) For brand Ojjaara requests, member must use generic momelotinib if available unless contraindicated or clinically significant adverse effects are experienced. 6) Dose does not exceed both: (a) 200 mg per day (maximum dose), and (b) 1 tablet per day; dose above this must be supported by practice guidelines or peer‑reviewed literature with prescriber submission of supporting evidence. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 6 months

inv-02: Continued Therapy Criteria

Covered when ALL of the following are met:

Continued Therapy for MF: 1) 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 (examples: reduction in spleen size or improvement in MF symptoms such as pruritus, fatigue, night sweats, bone pain). 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, the new dose must not exceed both: (a) 200 mg per day, and (b) 1 tablet per day; or (alternatively) the new dose must be supported by practice guidelines or peer‑reviewed literature. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 12 months

Requests for indications that are not FDA‑approved and not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with off‑label use policies. Supporting documentation should follow the applicable off‑label policies (see CP.CPA.09, HIM.PA.154, CP PMN.53) and may include peer‑reviewed literature, practice guidelines, or other evidence demonstrating benefit for the requested off‑label indication.

Initial Therapy

inv-13: Initial therapy — dosing and prescriber requirements

Initial therapy dosing and prescriber requirements

Initial therapy nodes: 1) Diagnosis of MF (primary MF, post‑PV MF, post‑ET MF). 2) Prescribed by or in consultation with a hematologist or oncologist. 3) Recent (within 30 days) hemoglobin < 10 g/dL. 4) Patient is >= 18 years of age. 5) For brand Ojjaara requests, member must use generic momelotinib if available unless contraindicated or clinically significant adverse effects are experienced. 6) Dosing: 200 mg PO once daily (maximum 200 mg/day; 1 tablet per day). Prescribed regimen must be FDA‑approved or recommended by NCCN; any dose exceeding these limits must be supported by practice guidelines or peer‑reviewed literature with prescriber documentation.

Continuation Criteria

inv-14: Continuation criteria — requirements for continued therapy approval (positive response, prior use)

Continued therapy approval requires positive response and prior use.

Continued therapy nodes: 1) Member has used Ojjaara for at least 30 days. 2) Member is responding positively to therapy (examples: reduction in spleen size or improvement in MF symptoms such as pruritus, fatigue, night sweats, bone pain). 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, the new dose must not exceed both 200 mg per day and 1 tablet per day, or the increase must be supported by practice guidelines or peer‑reviewed literature with prescriber documentation.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ojjaara (momelotinib). Providers must submit a prior authorization request demonstrating the member meets all initial or continued therapy criteria outlined in the policy (diagnosis of myelofibrosis, hematology/oncology involvement, recent hemoglobin <10 g/dL for initiation, age ≥18, dosing within limits or supported by guidelines/literature). Approval durations: initial = 6 months; continuation = 12 months.

Prior authorization required for Ojjaara (momelotinib).
Initial approval duration: 6 months.
Continued approval duration: 12 months.

Prior Authorization

Brand vs Generic Requirement

For brand Ojjaara requests, the member must use generic momelotinib (if available) before coverage of brand Ojjaara will be approved, unless the member has a documented contraindication or clinically significant adverse effects to the generic product. Requests for doses above the standard regimen must be supported by practice guidelines or peer‑reviewed literature; prescriber must submit supporting evidence.

Generic-first requirement: trial of generic momelotinib required unless contraindicated or adverse effects.
Dose limits: generally 200 mg per day and 1 tablet per day unless higher dose is supported by guideline/literature.

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request, such as office chart notes, laboratory results (including a hemoglobin level within the last 30 days), and any relevant consult notes or peer‑reviewed literature when requesting nonstandard dosing or off‑label use. Documentation should demonstrate diagnosis (primary MF, post‑PV MF, or post‑ET MF), hematology/oncology involvement, treatment response for continuation requests, and rationale for dose changes.

Office chart notes documenting diagnosis and prescriber specialty (hematologist/oncologist).
Recent hemoglobin result (<30 days) showing <10 g/dL for initiation requests.
Evidence of positive response for continuation (member has received medication ≥30 days).
Peer‑reviewed literature or guideline citations when requesting nonstandard dosing or off‑label use.

Denial Risk

Non‑Covered Indications / Denial Risk

Requests for indications that are not FDA‑approved and are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided according to applicable off‑label use policies (CP CPA.09 for commercial, HIM.PA.154 for HIX, CP PMN.53 for Medicaid) or the plan’s evidence of coverage. Ensure supporting literature and rationale are submitted with the request to avoid denial.

Non‑FDA approved indications not addressed in this policy are not covered unless sufficient off‑label documentation is provided.
Refer to off‑label use policies: CP CPA.09 (commercial), HIM.PA.154 (HIX), CP PMN.53 (Medicaid).

Step	Requirement
1	Brand Ojjaara requests are authorized only if generic momelotinib is unavailable, contraindicated, or causes clinically significant adverse effects.

Background

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that may occur as primary MF or secondary MF following polycythemia vera (post‑PV) or essential thrombocythemia (post‑ET). Clinical features frequently include anemia, splenomegaly, and constitutional symptoms such as fatigue, night sweats, pruritus, and bone pain. Ojjaara (momelotinib) is a kinase inhibitor FDA‑approved for treatment of intermediate or high‑risk MF in adults with anemia and is intended for patients meeting the clinical and laboratory criteria outlined in this policy.

Definitions and Abbreviations

inv-11: Myelofibrosis (MF) — definition including post‑PV and post‑ET

DefinitionMyelofibrosis (MF): includes primary MF and secondary MF (post‑polycythemia vera [post‑PV] and post‑essential thrombocythemia [post‑ET]).

Indication contextOjjaara indicated for intermediate or high‑risk MF in adults with anemia

Criteria linkageDiagnosis of MF (primary, post‑PV, post‑ET) is required for initial and continued therapy approvals

inv-12: Abbreviations — PV, ET, NCCN, FDA definitions

PVPolycythemia vera

ETEssential thrombocythemia

NCCNNational Comprehensive Cancer Network

FDAFood and Drug Administration

OpenPayer