Subject: Xywav 4045-A SGM P2023
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XYWAV
(calcium, magnesium, potassium, and sodium oxybates)
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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 Indications
A. Xywav is indicated for the treatment of cataplexy or
excessive daytime sleepiness (EDS) in patients 7 years of
age and older with narcolepsy.
B. Xywav is indicated for the treatment of idiopathic
hypersomnia (IH) in adults.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. For initial requests, all of the following (if applicable):
1. Documentation of a sleep lab evaluation.
2. 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.
3. 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.
4. Mean sleep latency on MSLT of less than or equal to 8
minutes.
5. 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.
B. For continuation of therapy requests, chart notes or medical
record documentation supporting a beneficial response to
therapy (e.g., decrease in daytime sleepiness, decrease in
cataplexy episodes from baseline).
III. 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).
IV. CRITERIA FOR INITIAL APPROVAL
A. Cataplexy with Narcolepsy
Authorization of 12 months may be granted for treatment of
cataplexy with narcolepsy when all of the following criteria
are met:
1. The member is 7 years of age or older.
2. The diagnosis of narcolepsy has been confirmed by a
sleep lab evaluation.
3. The member has a baseline history of at least 14
cataplexy attacks in a typical 2-week period.
B. Excessive Daytime Sleepiness with Narcolepsy
Authorization of 12 months may be granted for treatment of
excessive daytime sleepiness (EDS) with narcolepsy when all
of the following criteria are met:
1. The diagnosis of narcolepsy has been confirmed by a
sleep lab evaluation.
2. If the member is 7 years of age or older and less than 18
years of age:
i. 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) OR
ii. The member has a contraindication to at least one
central nervous system (CNS) stimulant drug (e.g.,
amphetamine, dextroamphetamine,
methylphenidate).
3. If the member is 18 years of age or older:
i. The member has experienced an inadequate
treatment response or intolerance to armodafinil or
modafinil OR
ii. The member has a contraindication to both
armodafinil and modafinil.
C. Idiopathic hypersomnia
Authorization of 12 months may be granted for treatment of
idiopathic hypersomnia when the diagnosis of idiopathic
hypersomnia has been confirmed by all of the following:
1. Presence of daytime lapses into sleep or daily
irrepressible periods of need to sleep for at least 3
months.
2. 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.
3. 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 was less than or equal to 15
minutes.
4. Presence of at least one of the following:
i. Mean sleep latency on MSLT of less than or equal to
8 minutes.
ii. 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.
5. The member does not have cataplexy.
6. Hypersomnolence or multiple sleep latency test results
are not better explained by another sleep disorder, other
medical or psychiatric disorder, or use of drugs or
medications.
V. CONTINUATION OF THERAPY
A. Cataplexy with Narcolepsy
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.
B. Excessive Daytime Sleepiness with Narcolepsy
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.
C. Idiopathic hypersomnia
Authorization of 12 months may be granted for continued
treatment of idiopathic hypersomnia 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:
- Xywav [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; March 2022.
- 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.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed March 1, 2023.
- Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed March 1, 2023.
- Satela, M. International Classification of Sleep Disorders- third edition: highlights and modifications. Nov 2014; 146(5)L 1387-1394.
- 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.
October 14, 2023
