Subject: Xywav SGM 4045-A P2025

Drug

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

Policy:

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 Indications¹

• Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
• Treatment of idiopathic hypersomnia (IH) in adults.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

For initial requests, all of the following (if applicable):

• Documentation of a sleep lab evaluation.
• Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.
• Documentation of the multiple sleep latency test (MSLT) showing fewer than two sleep onset rapid eye movement periods (SOREMPs) or no SOREMPs if the REM latency of the preceding polysomnogram was less than or equal to 15 minutes.
• Mean sleep latency on MSLT of less than or equal to 8 minutes.
• Total 24-hour sleep time of greater than or equal to 660 minutes on 24-hour polysomnographic monitoring or by wrist actigraphy in association with a sleep log.

For continuation of therapy requests, documentation to support one of the following:

• For cataplexy with narcolepsy: chart notes or medical record documentation supporting a beneficial response to therapy as demonstrated by a decrease in cataplexy episodes from baseline.
• For excessive daytime sleepiness with narcolepsy: Chart notes or medical record documentation supporting a beneficial response to therapy as demonstrated by a decrease in daytime sleepiness with narcolepsy from baseline.
• For idiopathic hypersomnia: Chart notes or medical record documentation supporting a beneficial response to therapy as demonstrated by a decrease in daytime sleepiness from baseline.

Prescriber Specialties

• This medication must be prescribed by or in consultation with a sleep specialist (e.g., neurologist experienced with sleep disorders, physician certified in sleep medicine).

Coverage Criteria

Cataplexy with Narcolepsy^1-4

Authorization of 12 months may be granted for treatment of cataplexy with narcolepsy when all of the following criteria are met:

• The member is 7 years of age or older.
• The diagnosis of narcolepsy has been confirmed by a sleep lab evaluation.
• The member has a baseline history of at least 3 cataplexy attacks per week.

Excessive Daytime Sleepiness (EDS) with Narcolepsy^1-4

Authorization of 12 months may be granted for treatment of excessive daytime sleepiness (EDS) with narcolepsy when all of the following criteria are met:

• The diagnosis of narcolepsy has been confirmed by a sleep lab evaluation.
• Member meets one of the following:
  • Member is 7 years of age or older and less than 18 years of age and meets either of the following:
    • The member has experienced an inadequate treatment response or intolerance to at least one central nervous system (CNS) stimulant drug (e.g., amphetamine, dextroamphetamine, methylphenidate).
    • The member has a contraindication to at least one central nervous system (CNS) stimulant drug (e.g., amphetamine, dextroamphetamine, methylphenidate).
  • Member is 18 years of age or older and meets either of the following:
    • The member has experienced an inadequate treatment response or intolerance to armodafinil or modafinil.
    • The member has a contraindication to both armodafinil and modafinil.

Idiopathic hypersomnia^1,5,6

Authorization of 12 months may be granted for treatment of idiopathic hypersomnia in adults when the diagnosis of idiopathic hypersomnia has been confirmed by all of the following:

• Presence of daytime lapses into sleep or daily irrepressible periods of need to sleep for at least 3 months.
• Insufficient sleep syndrome has been ruled out such as by lack of improvement of sleepiness after an adequate trial of increased nocturnal time in bed, preferably confirmed by at least a week of sleep log with wrist actigraphy.
• A multiple sleep latency test (MSLT) documents fewer than two sleep onset rapid eye movement periods (SOREMPs) or no SOREMPs if the REM latency on the preceding polysomnogram (PSG) was less than or equal to 15 minutes.
• Presence of at least one of the following:
  • Mean sleep latency on MSLT of less than or equal to 8 minutes.
  • Total 24-hour sleep time of greater than or equal to 660 minutes on 24-hour polysomnographic monitoring after correcting any chronic sleep deprivation or by wrist actigraphy in association with a sleep log and averaged over at least 7 days of unrestricted sleep.
• The member does not have cataplexy.
• Hypersomnolence or multiple sleep latency test results are not better explained by another sleep disorder, other medical or psychiatric disorder, or use or withdrawal of drugs or medications.

Continuation of Therapy

Cataplexy with Narcolepsy^1-4

Authorization of 12 months may be granted for continued treatment of cataplexy with narcolepsy when the member has demonstrated beneficial response to treatment as defined by a decrease in cataplexy episodes from baseline.

Excessive Daytime Sleepiness (EDS) with Narcolepsy^1-3

Authorization of 12 months may be granted for continued treatment of excessive daytime sleepiness (EDS) with narcolepsy when the member has demonstrated beneficial response to treatment as defined by a decrease in daytime sleepiness with narcolepsy from baseline.

Idiopathic hypersomnia^1,5

Authorization of 12 months may be granted for continued treatment of idiopathic hypersomnia in adults when the member has demonstrated beneficial response to treatment as defined by a decrease in daytime sleepiness from baseline.

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.
2. Morgenthaler TI, Vishesh KK, Brown T, et al. Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin. Sleep 2007; 30(12):1705-11.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed December 5, 2024.
4. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed December 5, 2024.
5. Satela, M. International Classification of Sleep Disorders- third edition: highlights and modifications. Chest. Nov 2014; 146(5):1387-1394.
6. Maski K, Trotti LM, Kotagal S, Auger RR, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Published online September 1, 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.

June 07, 2025