Subject: sodium oxybate-Xyrem 3677-A SGM P2022b

Drug

XYREM  (sodium oxybate)

sodium oxybate

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 Indication
          Treatment of cataplexy or excessive daytime sleepiness (EDS) in
          patients 7 years of age and older with narcolepsy.

          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
          B.  For continuation 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.

 
    IV.  CRITERIA FOR INITIAL APPROVAL

           A.  Excessive Daytime Sleepiness with Narcolepsy
                Authorization of 12 months may be granted for treatment of
                excessive daytime sleepiness when all of the following
                criteria are met:
                1.  The diagnosis of narcolepsy is 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, or
                             methylphenidate) OR
                     ii.     The member has a contraindication to at least one
                             central nervous system (CNS) stimulant drug (e.g.,
                             amphetamine, dextroamphetamine, or
                             methylphenidate)
                3.  If the member is 18 years of age or older:
                     i.      The member has experienced an inadequate
                             treatment response or intolerance to modafinil or
                             armodafinil OR
                     ii.     The member has a contraindication to both
                             modafinil and armodafinil

           B.  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 is 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

 
      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.

 

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xyrem [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; October 2022.
2. Sodium oxybate [package insert]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; October 2022.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed March 1, 2023.
4. 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.
5. American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual. 3^rd Westchester, IL: American Academy of Sleep Medicine; 2014.
6. Krahn L, Hershner S, et al. Quality Measures for the Care of Patients with Narcolepsy; Journal of Clinical Sleep Medicine; 2015; 11(3): 335-55.
7. Nuvigil [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; December 2023.
8. Provigil [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; December 2023.
9. 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.

May 28, 2023