Subject: Antiviral (oral/topical/inj) Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	acyclovir oral
C	Famvir®  (famciclovir)
C	Valtrex®  (valacyclovir)
C	foscarnet inj.
C	ganciclovir
C	Valcyte®  (valganciclovir)
C	Vistide® inj  (cidofovir)						X
NC	Cytovene®  (ganciclovir)						X
NC	Denavir®  (penciclovir, topical cream)						X
NC	Foscavir®  (foscarnet, inj)						X
NC	Virazole®  (ribavirin for inh solution)						X
NC	Zovirax®  (acyclovir, oral)						X
NC	Zovirax®  (acyclovir, topical ointment, cream)						X

Policy:

1. Medical Exception Criteria

Cytovene, Denavir, Foscavir, Virazole, Vistide, Zovirax ointment/cream and Zovirax oral 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 Cytovene, Denavir, Foscavir, Virazole, Vistide, Zovirax ointment/cream and Zovirax oral to be medically necessary for those members who meet any of the following criteria: 

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 week of one preferred alternative indicated for the member's condition
  

* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Famvir internet site accessed 05-17-04 at http://www.famvir.com/hcp/tools/resources/pi.jsp.
2. Product Information, Famvir tablets, Novartis Pharmaceuticals, East Hanover, NJ, February 2002.
3. Olin BR, editor.  Drug Facts and Comparisons (online version).  St Louis: J.B.Lippincott Company, Facts and Comparisons division, 2004.
4. McEvoy GK, editor. American Hospital Formulary Service Drug Information 2004.  STAT!Ref Online Electronic Medical Library Bethesda, MD: The American Society of Health-System Pharmacists, Inc, 2004.
5. Medispan Drug Information 2004.
6. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.     
7. Sexually Transmitted Diseases: Treatment Guidelines 2002 accessed at: http://www.cdc.gov/std/treatment/2-2002TG.htm#GenitalHerpes
8. New anti-herpes drugs tested http://www.genomenewsnetwork.org/articles/04_02/herpes.shtml
9. Kimberlin D. W., Rouse D. J. Genital Herpes.  N Engl J Med. 2004; 350:1970-7.
10. Crumpacker CS. Use of Antiviral Drugs to Prevent Herpesvirus Transmission, N Engl J Med 2004; 350:67-68, Jan 1, 2004.
11. Global epidemiology of genital herpes and the interaction of herpes simplex virus with HIV. In: Corey L, ed. HERPES: the Journal of the IFHM.  2004;11(Suppl 1).
12. Lawrence Corey, MD, Clinical Tools for Preventing Sexual Transmission of Genital Herpes; Medscape Infectious Diseases 6(1), 2004
13. Zovirax internet site accessed 05-17-04  at  http://www.gsk.com/products/zovirax_us.htm
14. Denavir internet site accessed 05-17-04 at  http://www.denavir.com/html/index-about.htm
15. Product Information, Denavir cream, Novartis Pharmaceuticals, East Hanover, NJ, October 2003.
16. Product Information, Zovirax ointment, GlaxoSmithKline, Research Triangle Park, NC, May 2001
17. The Medical Letter. Drugs for Non-HIV Viral Infections. Vol. 44, February 4, 2002
18. Evans, T, et. al, Double-Blind, Randomized, Placebo-controlled Study of Topical 5% Acyclovir-1% Hydrocortisone Cream (ME-609) for Treatment of UV Radiation-induced Herpes Labialis. Antimicrob Agents Chemother 2002; 46:1870-4
19. Chen X, et. al, A comparison of topical application of penciclovir 1% cream with acyclovir 3% cream for treatment of genital herpes: a randomized, double-blind, multicentre trial. Int J STD AIDS 2000; 11:568-73
20. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
21. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

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.

September 18, 2006