Subject: Ojjaara SGM 6174-A P2026

Drug

OJJAARA  (momelotinib)

Policy:

Indications

The indications below including FDA-approved indication and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indication¹

Ojjaara is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

Compendial Uses²

·        Accelerated/blast phase myeloproliferative neoplasms

·        Myelofibrosis (MF)-associated anemia

·        Myeloid/lymphoid neoplasms with eosinophilia

·        Symptomatic high-risk MF

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: testing or analysis confirming JAK2 rearrangement, where applicable.

Coverage Criteria

Myelofibrosis, Myelofibrosis-Associated Anemia, and Accelerated/Blast Phase Myeloproliferative Neoplasms^1,2

Authorization of 12 months may be granted for treatment of myelofibrosis (MF), MF-associated anemia, or myeloproliferative neoplasms when any of the following criteria are met:

·        Member has intermediate-risk MF with anemia.

·        Member has high-risk MF with anemia or symptomatic splenomegaly and/or constitutional symptoms (e.g., fatigue, night sweats, fever, weight loss).

·        Member has MF-associated anemia with symptomatic splenomegaly and/or constitutional symptoms (e.g., fatigue, night sweats, fever, weight loss).

·        Member has symptomatic accelerated/blast phase myeloproliferative neoplasms and the requested agent will be used as a single agent or in combination with azacitidine or decitabine.

Myeloid/Lymphoid Neoplasms with Eosinophilia²

Authorization of 12 months may be granted for the treatment of myeloid and/or lymphoid neoplasms with eosinophilia and JAK2 rearrangment in blast or chronic phase, if ruxolitinib (Jakafi) is unavailable or member has experienced intolerance with ruxolitinib (Jakafi).

Continuation of Therapy

Myelofibrosis, Myelofibrosis-Associated Anemia, and Accelerated/Blast Phase Myeloproliferative Neoplasms

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization who have improvement in symptoms and no unacceptable toxicity.

Myeloid/Lymphoid Neoplasms with Eosinophilia

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Ojjaara [package insert]. Durham, NC: GlaxoSmithKline; April 2025.

2.     The NCCN Drugs & Biologics Compendium® 2026 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed January 14, 2026.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 14, 2026