Subject: Inqovi SGM 4002-A P2025

Drug

INQOVI  (decitabine and cedazuridine)

Policy:

Indications

The indications below including FDA-approved indications 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 Indications¹

Inqovi is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Compendial Uses^2-3

Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasm

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

Coverage Criteria

Myelodysplastic syndromes (MDS)^1,2

Authorization of 12 months may be granted for the treatment of myelodysplastic syndromes (MDS).

Myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap neoplasms^1,2,3

Authorization of 12 months may be granted for the treatment of MDS/MPN overlap neoplasms (i.e., chronic myelomonocytic leukemia (CMML), BCR-ABL negative atypical chronic myeloid leukemia (aCML), MDS/MPN with neutrophilia, unclassifiable MDS/MPN, MDS/MPN not otherwise specified (NOS), MDS/MPN with ring sideroblasts and thrombocytosis, or MDS/MPN with SF3B1 mutation ).

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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. Inqovi [package insert]. Princeton, NJ: Taiho Oncology, Inc; March 2022.
2. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. Available at http://www.nccn.org. Accessed January 7, 2025.
3. Zoi K, Cross NC. Molecular pathogenesis of atypical CML, CMML and MDS/MPN unclassifiable. Int J Hematol 2015;101:229-242.

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 02, 2025