Subject: Specialty Quantity Limit Nubeqa 3148-H P2025

Drug

NUBEQA  (darolutamide)

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 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
Nubeqa (darolutamide) 300 mg tablets	120 per 30 days

FDA-Recommended dosing

Initial dose

600mg (two 300mg tablets) twice daily.

Dose adjustments due to adverse reactions

Withhold dosing or reduce to 300mg twice daily until symptoms improve. Then the treatment may be resumed at a dose of 600mg twice daily.

Dose reduction below 300mg twice daily is not recommended.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Nubeqa [package insert]. Whippany, NJ: Bayer Healthcare Pharmaceuticals Inc.; October 2023.

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.

October 12, 2025