Reimbursement Guide[1]

In 2007, XYREM^® was covered by over 80% of all private insurance plans. While XYREM does receive favorable reimbursement, there are occasions where additional information may be necessary to ensure that your patient does get his/her prescription of XYREM reimbursed. This Reimbursement Guide is a simple tool for you to address some of the reimbursement issues that may be associated with XYREM.

Medicare/Medicaid

In 2007, XYREM was on the formulary of most Medicare Part D plans. The XYREM Success Program^® continues to expand coverage as new patients enroll. Please contact the XYREM Success Program for specific patient coverage regarding Medicare Part D.

In 2007, XYREM was covered by Medicaid in 44 states. Medicaid did not cover XYREM in the following states: Delaware, Massachusetts, New Jersey, Texas, Louisiana, and New York.

Veteran's Administration (VA)

XYREM has been added to the FSS contract with Jazz Pharmaceuticals, Inc.

Patient Assistance Program

In the event that a patient is unable to afford his or her XYREM, the patient may be eligible to apply for assistance through the Patient Assistance Program through the National Organization of Rare Disorders, Inc. Please contact the XYREM Success Program for more information (1-866-XYREM88^®).

Diagnosis Codes

XYREM is currently approved for excessive daytime sleepiness and/or cataplexy in persons with narcolepsy. Possible ICD-9 codes associated with narcolepsy/cataplexy are:

347.00	Narcolepsy, without cataplexy
347.01	Narcolepsy, with cataplexy
347.10	Narcolepsy, in conditions classified elsewhere, without cataplexy
347.11	Narcolepsy, in conditions classified elsewhere, with cataplexy

If the insurance plan requires further information about a diagnosis, the XYREM Success Program Reimbursement Services will forward a Certificate of Medical Need (CMN) to document the diagnosis for the insurance plan requirement.

If you have questions, Reimbursement Specialists are available between 8 am–5:30 pm Central Standard Time Monday-Friday to assist physicians and patients with reimbursement issues. 1-866-XYREM88 (1-866-997-3688)

Sample Letter of Medical Necessity

[Date]
[Title]
[Pharmacy or Medical Director Name]
[Name of Insurer]
[Address of Insurer]
[City, State Zip]
Patient Name:
Member Name:
Subscriber ID:
Insurer Group:
Subject: Request for coverage of XYREM (sodium oxybate) oral solution, for the above patient.

Dear [Name of Director]:

[Patient Name] is currently under my care for the treatment of excessive daytime sleepiness (EDS) and/or cataplexy associated with Narcolepsy. I am forwarding this letter on my patient's behalf to request coverage for the medication, XYREM (sodium oxybate) oral solution. Excessive daytime sleepiness (EDS) occurs in 100% of narcoleptic patients. Cataplexy occurs in 60-100% of narcoleptic patients.[1-3] XYREM is approved by the FDA for the treatment of EDS and cataplexy in patients with narcolepsy. In XYREM clinical trials, approximately 80% of patients maintained concomitant stimulant use. (See BOXED WARNINGS)

Clinical studies with XYREM indicated that administration of XYREM resulted in Epworth Sleepiness Scores having a statistically significant median reduction from baseline of 2 and 5 in the 6 g/night and 9 g/night doses, respectively.[4] Significant improvement in MWT scores (sleep latency) was seen with and without modafinil. Clinical studies with XYREM also indicated that administration of XYREM resulted in a median percentage reduction in cataplexy attacks of 49% and 69%, in the 6 g/night and 9 g/night doses, respectively.[5]

[Patient Name] was treated with [previous medical treatment pathways tried and failed] over a period of [length of therapy]. [Patient Name] is being prescribed XYREM because [indicate reasons and planned course of treatment and duration]. The clinical expectations of treatment with XYREM include [expectation for patient].

It is my opinion that it is medically necessary for [Patient Name] to be treated with XYREM and that you will understand why I have decided to pursue treatment with XYREM for my patient. Thank you for your expeditious manner in reviewing this case for consideration of approval of coverage for my patient, [Patient Name].

Sincerely,

[Physician's Name]

Important Information

Neither Jazz Pharmaceuticals nor the XYREM Success Program guarantees reimbursement coverage for XYREM. In addition, neither Jazz Pharmaceuticals nor the XYREM Success Program assumes liability related to coverage and reimbursement for XYREM.

These materials are provided to you as guidance only and not a substitute for direct discussions with payers. Proper coding of claims is solely the responsibility of providers. Jazz Pharmaceuticals and the XYREM Success Program do not guarantee or warrant reimbursement coverage or reimbursement levels, as this is at the exclusive discretion of the payer. The information is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. Local payers, even local Medicare contractors, establish their own coverage, coding, and payment policies that might vary from what is provided in the guide. Information provided is for example only.

References:

^ XYREM® Reimbursement Guide, Jazz Pharmaceuticals, Inc.

Important Safety Information

1. XYREM^® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

2. It is very important to keep XYREM out of reach of children and pets.

3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.

BOXED WARNING:

!Warning

Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

XYREM is available through the XYREM Success Program^®, using a centralized pharmacy 1-866-XYREM88^® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.