Subject: Cataplexy Agents - Xyrem

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
NP	Xyrem®  (sodium oxybate)	X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Xyrem is subject to precertification. If precertification requirements apply Aetna considers Xyrem to be medically necessary for those members who meet ALL of the following precertification criteria:

A Documented:

A.  Diagnosis of either excessive daytime sleepiness associated with narcolepsy OR 
      cataplexy associated with narcolepsy OR
B.  Diagnosis of hypnagogic hallucinations OR
C.  Diagnosis of sleep paralysis

AND

D.  Member is documented to be  enrolled in the Xyrem Success Program per
      treating physician.

Special Notes:

The FDA approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted. Information is available at the FDA web site: http://www.fda.gov/cder/drug/infopage/xyrem/default.htm.

November 2005:Approval for the most recent indication of excessive daytime sleepiness in patients with narcolepsy was based on two clinical trials that showed Xyrem at doses of 6 g/night and 9 g/n was effective at improving excessive daytime sleepiness, measured both subjectively (using the Epworth Sleepiness Scale) and objectively (using the Maintenance of Wakefulness Test).

Some basic information is given here:

The Xyrem Success Program is a limited distribution program designed to ensure safe use of the drug. Under the program, it will be available to prescribers through a single centralized pharmacy, which is Express Scripts Specialty Distribution Services (1-866-997-3688). Contacts at this pharmacy are Kim and/or Mika.

The program involves many risk management components, such as:

physician education
patient education
registration
detailed patient surveillance

Xyrem can cause serious side effects including:

trouble breathing while asleep
confusion
abnormal thinking
depression
loss of consciousness.

Abuse of Xyrem could also lead to dependence, craving for the medicine, and severe withdrawal symptoms.

Xyrem for proper medical use is controlled under Schedule III of the Controlled Substances Act (CSA). Illicit use of Xyrem will be subject to penalties under Schedule I, the most restrictive schedule of the CSA. This means that anyone who sells, distributes, or gives Xyrem to anyone else, or who uses Xyrem for purposes other than what it is prescribed for, may be punished under Federal and state law by jail and fines.

Xyrem is required to be taken at bedtime while in bed anda gain 2.5 to 4 hours later. The recommended starting dose is 4.5 g/day divided into 2 equal doses; the dose can be increased to a maximum of 9 g/day. Doses of Xyrem are prepared prior to bedtime. Each dose must be diluted with 2 ounces of water.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Xyrem Product Information. Orphan Medical Inc., Minneapolis, MN. May 2002.
2. FDA website. Xyrem Information: http://www.fda.gov/cder/drug/infopage/xyrem/default.htm.
3. FDA website. Xyrem new or modified indication accessed 11-30-2005: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
4. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
5. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacistey s®, Bethesda, MD. Updated periodically.
6. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
7. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
8. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
9. Guilleminault C, Zvonkina V, Tantrakul V, Kim JH. Advances in Narcolepsy syndrome and challenges in the pediatric population. Sleep Medicine Clin 2007;2(3):397-404.
10. Morgenthaler TI, Kapur VK, Brown TM, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. AnAmerican Academy of Sleep Medicine Report. Sleep 2007;30(12):1705-11.

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.

January 01, 2009