Subject: Interstitual Cystitis Agents

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	dmso-dimethylsulfoxide
NP	Rimso™  (dmso-Dimethyl Sulfoxide)
FE	Elmiron®  (Pentosan Polysulfate)					X

Policy:

1. Medical Exception Criteria

Elmiron is currently listed on the Aetna Formulary Exclusions List.* Therefore, Elmiron is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Elmiron to be medically necessary for those members who meet the following criteria:

A. A documented:

• Contraindication to one preferred alternative indicated for the member's condition OR,
• Intolerance to one preferred alternative indicated for the member's condition OR,
• Allergy to one preferred alternative indicated for the member's condition OR,
• Failure of an adequate trial of one month of one preferred alternative indicated for the member's condition.
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
2. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006 .
3. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
4. DRUGDEX^® System: Klasco RK (Ed):DRUGDEX^® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
5. PDR^® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
6. PDR^® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
7. author initial.  Title of article.  Journnal title in italics.  2005;xx:77-88.
8. Hampson, SJ, Woodhouse, CR. Sodium pentosanpolysulphate in the management of haemorrhagic cystitis: experience with 14 patients. Eur Urol 1994; 25:40.
9. Sandhu, SS, Goldstraw, M, Woodhouse, CR. The management of haemorrhagic cystitis with sodium pentosan polysulphate. BJU Int 2004; 94:845.
10. Br J Obstet Gynecol 1996;103:621. Postgrad Med 1996;99(5):201. Urology 1990;35:552.

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.

November 12, 2007