Subject: Relistor

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	Relistor®  (methylnaltrexone bromide injection)	X	X

Policy:

1. Precertification Criteria

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

A documented:

A. Diagnosis of opioid-induced constipation

AND

B. Diagnosis of an advanced illness with life expectancy less than 6 months*

AND

C. Concomitant use of opioid therapy**

AND

D. Trial and failure of two (2) laxatives***

AND

E. A quantity of Relistor as indicated below will be considered medically necessary, if Member fulfills criteria A, B, C, and D above:

Drug	Maximum Daily Dose/ Dosing Interval	Dosage Strength	Quantity Limits
Relistor	12 mg/ Once daily	12mg/0.6mL	Up to 10 vials per 30 days
Relistor Kit	12 mg/ Once daily	12mg/0.6mL	1 kit (7 syringes) per 30 days





For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of Relistor will be considered medically necessary for those members who meet ANY of the following criteria:

• Member requires dosing of one vial/syringe every other day (maximum quantity of 15 vials or 2 kits per 30 days).
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  

Special Notes:

*Advanced illness can be associated with diagnoses of incurable cancer, end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer’s disease/dementia, HIV/AIDS, or other advanced illness with a life expectancy of less than 6 months.

**Examples of opioid therapy – any single entity or combination product containing any of the following: codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, propoxyphene or tramadol. Please refer to the Analgesics CPB: http://aetnet.aetna.com/pharmacy_pcpb/rxnonmedicare/data/2009/CNS2009/narcotic-analgesics_2009.html

***Examples of laxatives –
Generic                                      Brand
Bisacodyl                                   Alphen, Bisac-Evac, Biscolax, Correctol, Dacodyl, Doxidan, Dulcolax,
                                                 Ex-Lax, Femilax, Fleet
Glycerin                                     Colace, Fleet, Sani-Supp
Lactulose                                   Constulose, Enulose, Generlac, Kristalose
Magnesium citrate                      Citroma
Magnesium hydroxide                 Phillips’ Milk of Magnesia
Polyethylene glycol 3350             Miralax
Senna                                        Ex-lax, Perdiem, Peri-Colace, Senna-Gen, Senokot, SenoSol
Sodium phosphate                      Fleet, OsmoPrep, Visicol
Sorbitol

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Relistor® Product Information. Wyeth, Philadelphia, PA, April 2008.

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.

August 15, 2009