Subject: Specialty Quantity Limit Daybue 5834-H P2024

Drug

DAYBUE  (trofinetide)

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
Daybue (trofinetide) oral solution 200 mg/mL	3600 mL per 30 days	•   Recommended dosage is twice daily (morning and evening) with or       without food based on patient weight:   Patient Weight   Dosage   Volume   9 kg to < 12 kg   5,000 mg twice daily   25 mL twice daily   12 kg to < 20 kg   6,000 mg twice daily   30 mL twice daily   20 kg to < 35 kg   8,000 mg twice daily   40 mL twice daily   35 kg to < 50 kg   10,000 mg twice daily   50 mL twice daily   50 kg or more   12,000 mg twice daily   60 mL twice daily

 

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Daybue [package insert]. San Diego, CA: Acadia Pharmaceuticals, Inc.; March 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.

August 18, 2024