Pharmacy Clinical Policy Bulletins Aetna Medicare Prescription Drug Plan
Subject: Vaginal Antifungal /Anti-Infectives
Status
Drug
PR-B/D
PR
PR-QL
PR-AL
ST
M EX‡
TOC§
C
clindamax
C
fluconazole (PR for inj, susp and 50mg, 100mg and 200mg tabs ONLY; QL for 150mg ONLY)
X
X
C
metronidazole oral
C
terconazole
C
tioconazole
C
Zazole® 0.8 (terconazole vaginal cream)
NC
AVC Cream®(sulfanilamide cream)
X
NC
Cleocin® vaginal cream/ovules (clindamycin)
X
NC
Clindesse®(clindamycin vag cream)
X
NC
Diflucan®(fluconazole; PR for inj, susp and 50mg, 100mg and 200mg tabs ONLY; QL for 150mg ONLY)
X
X
X
NC
Gynazole-1®(butoconazole cream)
X
NC
Metrogel® Vaginal ®(metronidazole vaginal)
X
NC
Terazol® 3 Vaginal supp (terconazole)
X
NC
Terazol® 7 Vaginal cream ®(terconazole)
X
Non-prescription (OTC) products available (NOT covered under the standard benefit plans)
OTC
any generic or OTC vaginal antifungal
Note: Criteria for fluconazole/Diflucan is discussed in the Pharmacy Clinical Policy Bulletin: Antifungal, Oral/Inj Agents
Policy:
Precertification Criteria
NOTE: Criteria for fluconazole/Diflucan is discussed in the Pharmacy Clinical Policy Bulletin: Antifungal, Oral/Inj Agents
Medical Exception Criteria
AVC vaginal cream, Cleocin Vaginal cream/ovules, Clindesse, Diflucan 150mg, Gynazole-1, Metrogel vaginal and Terazole are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* 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 AVC vaginal cream, Cleocin Vaginal cream/ovules, Clindesse, Diflucan 150mg, Gynazole-1, Metrogel vaginal and Terazole to be medically necessary for those members who meet any of the following criteria:
For AVC vaginal cream, Diflucan 150mg, Gynazole-1 and Terazol
A. A documented:
Contraindication to one preferred alternative OR
Intolerance to one preferred alternative OR
Allergy to one preferred alternative OR
Failure of an adequate clinical trial of one course of one preferred alternative
For Cleocin Vaginal cream/ovules, Clindesse, and Metrogel vaginal
A. A documented:
Contraindication to one preferred alternative OR
Intolerance to one preferred alternative OR
Allergy to one preferred alternative OR
Failure of an adequate trial of one course of one preferred alternative
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
National guideline for the management of bacterial vaginosis. Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases). Sex Transm Infect. 1999 Aug;75 Suppl 1:S16-8.
Majeroni BA. Bacterial vaginosis: an update. Am Fam Physician. 1998;57(6):1285-9.
HayPE. Therapy of bacterial vaginosis. J Antimicrob Chemotherapy. 1998;41:6-9.
Ferris DG, Litaker MS, Woodward L,Mathis D, Hendrich J. Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream. J Fam Pract. 1995;41:443-9.
Joesoef MR, Schmid GP. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis 1999;28:S57-65.
Centers for Disease Control and Prevention. 2002 Guidelines for Treatment of Sexually Transmitted Diseases. MMWR 2002; 51(No. RR-6): 1-80.
Property of 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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
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