Subject: sodium oxybate-Lumryz-Xyrem 3677-A SGM P2024

Drug

XYREM  (sodium oxybate)

LUMRYZ  (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
          A.  Xyrem/sodium oxybate is indicated for the treatment of cataplexy or excessive daytime
               sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
          B.  Lumryz is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in
               adults 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, documentation to support one of the following:
               1.  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.
               2.  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.


   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.  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.  Member meets one of the following:
                    a.  Member is 7 years of age or older and less than 18 years of age and meets one of
                         the following (for sodium oxybate and Xyrem only):
                         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).
                         ii.    The member has a contraindication to at least one central nervous system (CNS)
                                stimulant drug (e.g., amphetamine, dextroamphetamine, or methylphenidate).
                    b.  Member is 18 years of age or older and meets one of the following:
                         i.     The member has experienced an inadequate treatment response or intolerance
                                to modafinil or armodafinil.
                         ii.    The member has a contraindication to both modafinil and armodafinil.

          B.  Cataplexy with Narcolepsy
               1.  Authorization of 12 months (for sodium oxybate and Xyrem) may be granted for
                    treatment of cataplexy with narcolepsy when all of the following criteria are met:
                    a.  The member is 7 years or older.
                    b.  The diagnosis of narcolepsy is confirmed by a sleep lab evaluation.
                    c.  The member has a baseline history of at least 3 cataplexy attacks per week.
               2.  Authorization of 12 months for Lumryz may be granted for treatment of cataplexy with
                    narcolepsy when all of the following are met:
                    a.  The member is 18 years or older.
                    b.  The diagnosis of narcolepsy is confirmed by a sleep lab evaluation.
                    c.  The member has a baseline history of at least 3 cataplexy attacks per week.


    V.  CONTINUATION OF THERAPY

          A.  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.

          B.  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.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lumryz [package insert]. Chesterfield, MO: Avadel CNS Pharmaceuticals, LLC; May 2023.
2. Nuvigil [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; December 2022.
3. Provigil [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; January 2015.
4. Sodium oxybate [package insert]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; April 2023.
5. Xyrem [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; April 2023.
6. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed March 1, 2023.
7. 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.
8. American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual. 3^rd Westchester, IL: American Academy of Sleep Medicine; 2014.
9. 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.
10. 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.

July 27, 2024