CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ojjaara (momelotinib) for myelofibrosis - Coverage Criteria

Defines clinical coverage criteria and requirements for authorization of Ojjaara (momelotinib) for treatment of intermediate- or high-risk myelofibrosis in adults with anemia; applies to medication requests processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOjjaara (momelotinib) for myelofibrosis - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent documenting intermediate/high‑risk myelofibrosis, hemoglobin < 10 g/dL, and failure/intolerance/contraindication to ruxolitinib.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

<10 g/dLHgB threshold

200 mgsingle dose max

30monthly tablet limit

J8999HCPCS

Commercial/Medicaidlines of business

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inv-01: Myelofibrosis - Initial Therapy

Covered when ALL of the following are met

Myelofibrosis coverage criteria: Member has intermediate- or high-risk myelofibrosis (primary or secondary post-PV/ET)

Myelofibrosis coverage criteria: Member has failed, is intolerant to, or has a contraindication to Jakafi (ruxolitinib)

Presence of anemia is not a contraindication to ruxolitinib; consider ruxolitinib starting dose based on platelet count and a maximum of 10 mg twice daily for 12 weeks before escalation in patients with baseline anemia.

Myelofibrosis coverage criteria: Member has hemoglobin (HgB) < 10 g/dL

Coverage will be denied when any of the following exclusion criteria apply: disease progression that occurred while the member was taking Ojjaara (momelotinib); concurrent use of momelotinib with other anticancer therapies; dosing that exceeds the single dose maximum of 200 mg; or treatment that exceeds the listed monthly tablet limits (maximum of 30 tablets/month at the listed strengths). These exclusions reflect explicit safety and utilization limits for momelotinib and are applied when assessing prior authorization requests.

Requests for momelotinib for off-label indications that are not supported by adequate evidence are considered investigational and not medically necessary. Evidence is considered insufficient when the patient or regimen is not adequately represented in the published literature, study outcomes are not clinically meaningful (for example, lacking ASCO-recommended thresholds such as a Hazard Ratio < 0.80 or at least a 3-month benefit in OS/PFS), or when supporting data consist only of uncontrolled case reports or abstracts without full peer-reviewed publication. Uses lacking support in CMS-recognized compendia or acceptable peer-reviewed literature will be declined.

Dosing and Regimen Limits

Regimen	Dose / Frequency	Maximum tablets per month	Notes
Ojjaara (momelotinib) oral regimen for myelofibrosis	Up to a single dose of 200 mg (oral)	30 tablets/month for 100 mg strength; 30 tablets/month for 150 mg strength; 30 tablets/month for 200 mg strength	Coverage requires intermediate- or high-risk MF, prior failure/intolerance/contraindication to ruxolitinib, and hemoglobin < 10 g/dL; dosing must not exceed single-dose limit of 200 mg or monthly tablet limits; concurrent use with other anticancer therapies excluded.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization required; requests processed by Evolent

Prior authorization is required for Ojjaara (momelotinib) and all medication requests are processed by Evolent; the authorization must document an indication consistent with FDA labeling or accepted compendia/guidelines and the clinical criteria for myelofibrosis described in this policy.

Step Therapy

Step therapy: trial of ruxolitinib required prior to momelotinib

Member must have failed, be intolerant to, or have a documented contraindication to Jakafi (ruxolitinib) before momelotinib is authorized.

Policy notes that presence of anemia is not a contraindication to ruxolitinib and provides guidance on ruxolitinib starting dose and escalation in patients with baseline anemia.

Documentation Required

Required supporting documentation and evidence sources

Requests must be supported by FDA-approved product labeling, a CMS-recognized compendium, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature; documentation should substantiate the diagnosis of intermediate- or high-risk myelofibrosis and hemoglobin < 10 g/dL and prior ruxolitinib failure/intolerance/contraindication.

Denial Risk

Denial triggers: progression, concurrent therapy, or dosing limits

Requests may be denied if any of the exclusion criteria are met, including disease progression while taking momelotinib, concurrent use with other anticancer therapies, or dosing that exceeds policy limits.

Disease progression while taking Ojjaara (momelotinib).
Concurrent use with other anticancer therapies.
Dosing exceeds single dose limit of 200 mg or monthly tablet limits (30 tablets/month by listed strengths).
Investigational or off-label use without sufficient evidence from CMS-recognized compendia or acceptable peer-reviewed literature.

Key Definitions

inv-11: Myelofibrosis — acquired myeloproliferative neoplasm (primary or secondary post-PV/ET) authorized when intermediate/high-risk and anemic

DefinitionAn acquired myeloproliferative neoplasm (primary or secondary post‑PV/ET) for which momelotinib is authorized when intermediate or high‑risk and the member is anemic.

Authorized disease statesPrimary myelofibrosis; secondary MF post‑polycythemia vera (PV) or post‑essential thrombocythemia (ET)

Risk requirementMember must have intermediate or high‑risk myelofibrosis

Background

Momelotinib (Ojjaara) is addressed in this policy in the context of its use for myelofibrosis; the exclusions and investigational-use criteria highlight the required evidentiary standards and dosing limits that guide authorization decisions. The policy specifies clear thresholds for single-dose and monthly tablet limits and requires that off-label indications be supported by CMS-recognized compendia or acceptable peer-reviewed literature to be considered approvable.