Subject: Specialty Quantity Limit Onureg 4195-H P2025

Drug

ONUREG  (azacitidine)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for treatment of all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Onureg (azacitidine) 200 mg tablets	14 per 28 days
Onureg (azacitidine) 300 mg tablets	14 per 28 days

FDA-recommended Dosing

Recommended dosing

300 mg orally once daily on Days 1 through 14 of each 28-day cycle.

Dose modifications may be needed based on adverse reactions.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Onureg [package insert]. Princeton, NJ: Celgene Corporation; October 2022.

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 07, 2025