Subject: Specialty Quantity Limit Xywav 4047-H P2025

Drug

XYWAV  (calcium, magnesium, potassium, and sodium oxybates)

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
Xywav oral solution 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)	540 mL (270 grams) per 30 days

FDA-recommended Dosing

Cataplexy or excessive daytime sleepiness with narcolepsy

For adult patients

Initial dose: 4.5 grams per night orally, divided into two doses.

May titrate to effect in increments of up to 1.5 grams per night per week.

Recommended dosage range: 6 grams to 9 grams per night orally.

For pediatric patients (7 years of age and older)

The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight.

Idiopathic hypersomnia

For initial dose

Either 4.5 grams per night orally divided into two doses or 3 grams per night orally as one dose.

May titrate to effect in increments of up to 1.5 grams per night per week.

Maximum total nightly dose

6 grams when dosed once nightly to 9 grams per night when divided into two doses per night.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xywav [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; April 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 07, 2025