Vaginal Anti-Infectives

Document Utilities

Pharmacy Clinical Policy Bulletins

Subject: Vaginal Anti-Infectives

Class Edit Summary*

Status Drug PR PR-QL PR-AL ST M EX‡

P clindamycin oral,vag

P clotrimazole vag cream

P fluconazole (PR-QL for 150mg) X

P metronidazole oral

P miconazole nitrate vaginal

P nystatin vag tab

P terconazole

P tioconazole vag oint

NP Diflucan^® (fluconazole; PR-QL for 150mg) X

FE Cleocin^® vaginal cream/ovules (clindamycin) X

FE Clindesse^™ cream (clindamycin phosphate) X

FE Gynazole-1 ^® (butoconazole) X

FE Metrogel^® Vaginal (metronidazole vaginal) X

FE Terazol^® Vaginal (terconazole) X

FE Vagistat^® (tioconazole oint) X

FE Zazole^® 0.8% (terconazole) X

Non-prescription (OTC) products available (NOT covered under standard benefit plans)

OTC any generic or OTC vaginal antifungal

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.

Policy

Precertification Criteria

Quantity limits:

According to the manufacturer, a single oral dose of Diflucan or fluconazole 150mg tablets is indicated for vaginal candidiasis. Diflucan or fluconazole can be dosed at interval(s) as indicated in the table below. A quantity of Diflucan or fluconazole 150mg tablets will be considered medically necessary as indicated in the table below.

Drug

Dosing Interval

Dosage Strength

Quantity Limits

Diflucan fluconazole

Once daily

150mg

Up to 1 tablet in 30 days

For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. A prior authorization will be granted for coverage of additional quantities of fluconazole or Diflucan for those members who meet the following criterion:

Member’s physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose

Medical Exception Criteria
Cleocin Vaginal cream/ovules, Clindesse, Gynazole-1, Metrogel vaginal, Terazol , Vagistat and Zazole 0.8% 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, Terazole, Vagistat and Zazole 0.8% to be medically necessary for those members who meet any of the following criteria:

For Gynazole-1, Terazol, Vagistat and Zazole 0.8%:
1. 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:
1. 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.

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select “Doctors & Hospitals” and choose “Physician Self-Service.” Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for “preferred” status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term “precertification” relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or “verification” as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

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, 2005.
USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
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.
Hay PE. 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.
Cleocin Vaginal Cream Product information. Pharmacia & Upjohn. Kalamazoo, MI. February 1997.
Cleocin Vaginal Ovules Product Information. Pharmacia & Upjohn. Kalamazoo, MI. August 1999.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Product information. MetroGel-Vaginal Gel, 3M, May 1997
Terazol 3 Vaginal Cream 0.8% Product information. Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ, July 1996

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.

March 1, 2006