Subject: Specialty Quantity Limit tasimelteon-Hetlioz-Hetlioz LQ 2429-H P2024

Drug

HETLIOZ  (tasimelteon)

HETLIOZ LQ  (tasimelteon)

tasimelteon

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 the 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.


II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Hetlioz (tasimelteon) 20 mg capsules	30 capsules per 30 days	Adults and patients 16 years of age and older:   20 mg daily before bedtime
tasimelteon 20 mg capsules	30 capsules per 30 days
Hetlioz (tasimelteon) LQ oral suspension 4 mg/mL	158 mL per 30 days	Pediatric patients 3 to 15 years of age:   Weight less than or equal to 28 kg: 0.7 mg/kg daily one hour before bedtime   Weight greater than 28 kg: 20 mg daily one hour before bedtime

 

Place of Service:

Outpatient

The above policy is based on the following references:

 

1. Hetlioz [package insert]. Washington, D.C.: Vanda Pharmaceuticals, Inc.; January 2023.
2. Tasimelteon [package insert]. Bridgewater, NJ.: Amneal Pharmaceuticals.; January 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.

June 09, 2024