Subject: Specialty Quantity Limit Xywav 4047-H P2021a

Drug

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

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
Xywav Oral Solution  0.5 g/mL total salts  (equivalent to 0.413 g/mL  of oxybate)	540 mL (270 grams) per  30 days	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.; August 2021.

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.

October 25, 2021