Subject: Daybue 5833-A SGM P2024
Policy:
I. 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 Indication
Daybue is indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years
of age and older.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for
initial requests:
A. Genetic testing results confirming a mutation in the MECP2
B. Medical records documenting clinical manifestations of disease.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a physician who specializes in
the treatment of Rett syndrome.
IV. CRITERIA FOR INITIAL APPROVAL
Rett Syndrome
Authorization of 12 months may be granted for treatment of Rett syndrome when all of the
following criteria are met:
A. Member is 2 years of age or older.
B. The diagnosis is confirmed by a mutation in the MECP2
C. Member exhibits clinical manifestations of disease (e.g., hand wringing, apraxia, gait
abnormalities, developmental delays).
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section IV who are experiencing benefit from therapy
(e.g., stabilization or improvement in repetitive movements, mood dysfunction/disruptive
behavior, vocalization, ambulation).
Place of Service:
Outpatient
The above policy is based on the following references:
- Daybue [package insert]. San Diego, CA: Acadia Pharmaceuticals, Inc.; March 2023.
- Neul JL, Percy AK, Benke TA, et al. Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome. Contemp Clin Trials. 2022;114:106704.
- Neul JL, Eskind AS. Rett syndrome: NORD. National Organization for Rare Disorders. https://rarediseases.org/rare-diseases/rett-syndrome/#complete-report Published March 15, 2023. Accessed February 2, 2024.
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
