Subject: Xywav 4045-A SGM P2021b

Drug

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

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.   Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
B.   Treatment of idiopathic hypersomnia 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):
      i.     Documentation of a sleep lab evaluation
      ii.    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
      iii.    Documentation of the multiple sleep latency test 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
      iv.    Mean sleep latency on MLST of less than or equal to 8 minutes
      v.     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. 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 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 experienced an inadequate treatment response, intolerance, or contraindication to at
            least one central nervous system (CNS) stimulant (amphetamine, dextroamphetamine, methylphenidate)
      4.   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 MLST 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 

IV.  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:

1. Xywav [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; August 2021.
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 March 2021.
4. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed March 2021.
5. Satela, M. International Classification of Sleep Disorders- third edition: highlights and modifications. Nov 2014; 146(5)L 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 April 23, 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.

May 14, 2022