Subject: Specialty Quantity Limit Danyelza 4377-H P2023

Drug

DANYELZA  (naxitamab-gqgk)

Policy:

I.  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.


II.  COVERED QUANTITIES

Medication	Standard       Limit	FDA-recommended dosing
Danyelza   (naxitamab-gqgk)   40 mg/10 mL (4 mg/mL)   in a single-dose vial	12 vials every 28 days	•   3 mg/kg/day (up to 150 mg/day) IV on Days 1, 3, and 5 of        each treatment cycle, in combination with GM-CSF        subcutaneously   •   Treatment cycles are repeated every 4 weeks until complete        response or partial response, followed by 5 additional cycles        every 4 weeks. Subsequent cycles may be repeated every 8        weeks   •   Dose modifications may be needed for adverse reactions.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Danyelza [package insert]. New York, NY: Y-mAbs Therapeutics, Inc.; November 2020.

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.

December 31, 2023