Subject: Vaginal Anti-Infectives

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	clindamax
P	clindamycin vag
P	clotrimazole vag cream
P	miconazole nitrate vaginal
P	nystatin vag tab
P	terconazole cr/supp
P	tioconazole vag oint
P	vandazole
P	Zazole (terconazole)
NP	AVC  (sulfanilamide cr)
NP	Fem PH  (acetic acid-oxyquinoline gel)
FE	Cleocin® vaginal cream/ovules  (clindamycin )					X
FE	Clindesse™ Cream  (clindamycin phosphate cream)					X
FE	Gynazole-1®  (butoconazole)					X
P	Metrogel® Vaginal  (metronidazole vaginal)					X
FE	Terazol® Vaginal  (terconazole)					X
Non-prescription (OTC) products available (NOT covered under the standard benefit plans)
FE	any generic or OTC vaginal antifungal

Policy:

1. Medical Exception Criteria

Cleocin Vaginal cream/ovules, Clindesse, Gynazole-1, Metrogel vaginal,  and Terazol are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Cleocin Vaginal cream/ovules, Clindesse, Gynazole-1, Metrogel vaginal, and Terazole,  to be medically necessary for those members who meet any of the following criteria:

For Gynazole-1, Terazol,

A. A documented:

• Contraindication to two vaginal antifungal alternatives OR
• Intolerance to two vaginal antifungal alternatives OR
• Allergy to two vaginal antifungal alternatives OR
• Failure of an adequate clinical trial of one course of at least two vaginal antifungal alternatives.


For Cleocin Vaginal cream/ovules, Clindesse, and Metrogel vaginal

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 course 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. Richter SS, Galask RP, Messer SA, et al. Antifungal susceptibilities of Candida species causing vulvovaginitis and epidemiology of recurrent cases. J Clin Microbiol. 2005;43(5):2155-62.
7. Ringdahl EN. Recurrent vulvovaginal candidiasis. Mo Med. 2006;103(2):165-8.
8. Sexually transmitted diseases treatment guidelines, 2006. Centers for Disease Control and Prevention; Workowski KA, Berman SM. MMWR Recomm Rep. 2006 Aug 4;55(RR-11):1-94.
9. ACOG Committee on Practice Bulletins--Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. 2006;107(5):1195-1206.

 

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