Prior Auth Protocol

FDA Approved Indications:

For the treatment of cataplexy in narcolepsy
For the treatment of excessive daytime sleepiness in narcolepsy

Health Net Approved Indications and Usage Guidelines:

Patient must have excessive daytime sleepiness or cataplexy as a symptom associated with narcolepsy

Coverage is Not Authorized For:

Fibromyalgia
Use in combination with sedative hypnotics or alcohol
Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

At the joint meeting of the Arthritis Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the FDA advisory panel voted 20 to 2 against recommending that the FDA approve sodium oxybate for the treatment of fibromyalgia. Concerns cited by panel members included the possibility of increased illicit use with the expanded indication and a weak risk evaluation and mitigation strategy.
Sodium oxybate is contraindicated in patients being using alcohol or sedative hypnotics. Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of Xyrem with alcohol or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.
Xyrem is available through the Xyrem Success Program using a centralized pharmacy 1-866-XYREM88. Per FDA, the Central Pharmacy is allowed to deliver up to a 90 day medication supply at a time.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Xyrem	The recommended starting dose is 4.5 gm/day PO divided into two equal doses. Increase the dosage in increments of 1.5 gm/day at two-week intervals to a maximum of 9 gm/day.	NATL: 3 months initial therapy Continued authorization for length of benefit may be approved based on patient's response to initial therapy. HNCA/HNMC: Length of Benefit

Product Availability:

Oral Solution: 500 mg/mL, 180 mL bottles

References:

1. Xyrem [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; April 2014.
2. Practice parameters for the treatment of narcolepsy: an update for 2000. American Academy of Sleep Medicine. Sleep. 2001;24(4):451-466.
3. The U.S. Xyrem Multicenter Study Group. A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25(1):42-49.
4. Scrima L, Hartman, et al. The effects of gamma-hydroxybutyrate on the sleep of narcolepsy patients: a double-blind study. Sleep. 1990;13(6):479-90.
5. Scrima L, Hartman, et al. Efficacy of gamma-hydroxybutyrate versus placebo in treating narcolepsy-cataplexy: double blind subjective measures. Biol Psychiatry. 1989;26(4):331-43.
6. Foutz AS, Delashaw JB, et al. Monoaminergic mechanisms and experimental cataplexy. Ann Neurol. 1981;10(4):369-76.
7. Hayduk R, Mitler. Sodium oxybate therapy improves the quality of life of narcolepsy patients. Sleep. 2001;23(Suppl. 2):A326.
8. No authors listed. A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003;26(1):31-5.
9. Orphan Medical summary information on unpublished trials. 2/1/2005.
10. Xyrem. American Hospital Formulary Service Drug Information. Available at http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 5, 2015.
11. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 5, 2015.
12. Xyrem. In: DRUGDEX^R System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/ Accessed June 5, 2015.