Sodium oxybate (Xyrem®); calcium, magnesium, potassium, and sodium oxybates (Xywav™)
SELF ADMINISTERED
Diagnosis considered for coverage:
- Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
- Indicated for the treatment of idiopathic hypersomnia (IH) in adults
Coverage Criteria:
For diagnosis of narcolepsy with cataplexy (narcolepsy type 1):
- Dose does not exceed 9 grams total per night, AND
- Patient is at least 7 years of age, AND
- Prescribed by or in consultation with one of the following:
- Neurologist
- Psychiatrist
- Sleep medicine specialist, AND
- Chart note documentation confirms diagnosis of narcolepsy, AND
- Symptoms of cataplexy are present, AND
- Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present, AND
- For patients under age 65: Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to TWO of the following antidepressants: venlafaxine, fluoxetine, atomoxetine, clomipramine, or protriptyline, AND
- Xyrem or Xywav will not be used in combination with a H3 receptor antagonist/inverse agonist (e.g. Wakix®), AND
- For Xywav requests: chart notes document a medical reason for intolerance or contraindication to Xyrem
For diagnosis of narcolepsy without cataplexy (narcolepsy type 2):
- Dose does not exceed 9 grams total per night, AND
- Patient is at least 7 years of age, AND
- Prescribed by or in consultation with one of the following:
- Neurologist
- Psychiatrist
- Sleep medicine specialist, AND
- Chart note documentation confirms diagnosis of narcolepsy, AND
- Symptoms of cataplexy are absent, AND
- Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present, AND
- BOTH of the following (1 and 2):
- 1) Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to BOTH of the following:
- Generic modafinil or armodafinil
- Sunosi
- 2) One of the following:
- Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant, OR
- History of or potential for a substance use disorder, AND
- 1) Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to BOTH of the following:
- Xyrem or Xywav will not be used in combination with a H3 receptor antagonist/inverse agonist (e.g. Wakix), AND
- For Xywav requests: chart notes document a medical reason for intolerance or contraindication to Xyrem
For diagnosis of idiopathic hypersomnia:
- Dose does not exceed 9 grams total per night if taken twice nightly OR 6 grams per night if taken once nightly, AND
- The request is for Xywav, AND
- Patient is at least 18 years of age, AND
- Prescribed by or in consultation with one of the following:
- Neurologist
- Psychiatrist
- Sleep medicine specialist, AND
- Chart note documentation confirms diagnosis of idiopathic hypersomnia as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible), AND
- Symptoms of excessive daytime sleepiness (e.g., nap duration of longer than 60 minutes) are present, AND
- Trial and failure, contraindication, or intolerance to generic modafinil, AND
- Trial and failure, contraindication, or intolerance to generic methylphenidate agent
Reauthorization Criteria:
For diagnosis of narcolepsy with cataplexy (narcolepsy type 1):
- Dose does not exceed 9 grams total per night, AND
- One of the following:
- Documentation demonstrating a reduction in the frequency of cataplexy attacks associated with therapy, OR
- Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy, AND
- Xyrem or Xywav will not be used in combination with a H3 receptor antagonist/inverse agonist (e.g. Wakix)
For diagnosis of narcolepsy without cataplexy (narcolepsy type 2):
- Dose does not exceed 9 grams total per night, AND
- Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy, AND
- Xyrem or Xywav will not be used in combination with a H3 receptor antagonist/inverse agonist (e.g. Wakix)
For diagnosis of idiopathic hypersomnia:
- Dose does not exceed 9 grams total per night if taken twice nightly OR 6 grams per night if taken once nightly, AND
- The request is for Xywav, AND
- Documentation demonstrating a reduction in symptoms of excessive daytime sleepiness associated with therapy
Coverage Duration:
- Initial: 6 months
- Reauthorization: 1 year
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Dosing for Narcolepsy:
- Recommended starting adult dose: 4.5 grams per night orally, divided into two doses
- Recommended starting pediatric dosage, titration regimen, and maximum total nightly dosage are based on patient weight
- Doses higher than 9 g per night have not been studied and ordinarily should not be administered
- Xyrem and Xywav are administered orally twice per night
- Dosing for adults with IH:
- Twice nightly:
- Starting dose: Less than or equal to 4.5 g per night divided into two doses
- Maximum dose: 9 g (divided into two doses)
- Once nightly:
- Starting dose: Less than or equal to 3 g per night
- Maximum dose: 6 g per night
- Twice nightly:
- Schedule III controlled substance
- Contraindicated for use in:
- Combination with sedative-hypnotics
- Combination with alcohol
- Patients with succinic semialdehyde dehydrogenase deficiency
- Black box warnings:
- Central Nervous System depression
- Abuse and misuse
- Xyrem and Xywav are available only through a restricted program called the Xywav and Xyrem REMS
- Warnings: Respiratory depression and sleep-disordered breathing, depression and suicidality, other behavioral and psychiatric adverse reactions, and parasomnias. Additional warning for high salt content in Xyrem
Policy Updates:
- 10/17/2017– New policy for Xyrem
- 9/3/2021 – New policy approved by P&T for Xywav and criteria update for Xyrem
- 2/15/2022 – New criteria for new indication for idiopathic hypersomnia
References:
- Xyrem [package insert], Palo Alto, CA: Jazz Pharmaceuticals, Inc.; October 2018.
- Xywav [package insert], Palo Alto, CA: Jazz Pharmaceuticals, Inc.; August 2021.
- Morgenthaler TI, Kapur VK, Brown T, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine report. Sleep. 2007 Dec;30(12):1705-11.
- Wise MS, Arand DL, Auger RR, et al. Treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine review. Sleep. 2007 Dec;30(12):1712-27.
- International classification of sleep disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
- Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
- Scammell TE. Clinical features and diagnosis of narcolepsy. UpToDate Website. March 2017. www.uptodate.com. Accessed October 24, 2018.
- Per clinical consult with neurologist/sleep specialist, October 9, 2012 (confirmed on March 20, 2015).
- Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. JCSM. 2021 Sept; 17(9): 1881-1893.
Last review date: December 1, 2023