Subject: Antiviral-HIV specific

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	didanosine ec cap
C	zidovudine
C	Atripla®  (efavirenz-emtricitabine-tenofovir disoproxil fumarate)
C	Combivir®  (lamivudine-zidovudine)
C	Crixivan®  (indinavir)
C	Emtriva®  (emtricitabine)
C	Epivir®  (lamivudine)
C	Fortovase®  (saquinavir-sg)
C	Hivid®  (zalcitabine)
C	Invirase®  (saquinavir-hg)
C	Kaletra®  (lopinavir-ritonavir)
C	Lexiva™  (fosamprenavir)
C	Norvir®  (ritonavir)
C	Retrovir®  (zidovudine)
C	Sustiva®  (efavirenz)
C	Videx®  (didanosine)
C	Viracept®  (nelfinavir)
C	Viramune®  (nevirapine)
C	Zerit ®  (stavudine)
C	Ziagen®  (abacavir)
C	Aptivus®  (tipranavir)
C	Fuzeon®  (enfuvirtide)
C	Prezista®  (darunavir)
C	Rescriptor®  (delavirdine)
C	Reyataz®  (atazanavir)
C	Epzicom®  (abacavir-lamivudine)
C	Trizivir®  (abacavir-lamivudine-zidovudine)
C	Truvada®  (emtricitabine-tenofovir)
C	Viread®  (tenofovir disoproxil fumarate)
C	Agenerase®  (amprenavir)
NC	Videx EC®  (didanosine)						X

Policy:

1. Medical Exception Criteria

Videx EC is currently a Not Covered Part D drug under the Aetna Medicare Prescription Drug Plan.* Therefore, it is excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Videx EC to be medically necessary for those members who meet the following criteria:

A. A documented

• Contraindication to one preferred alternative agent OR
• Intolerance to one preferred alternative agent OR
• Allergy to one preferred alternative agent OR
• Failure of an adequate trial of one month of one preferred alternative agent
  

* 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. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
4. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
5. 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.
6. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
7. Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: April 14, 2005).
8. Product Information Insert. Agenerase® Oral Solution, Glaxo Smith Kline, Research Triangle Park, NC October 2002.
9. Product Information Insert. Agenerase® Capsules,  Glaxo Smith Kline, Research Triangle Park, NC October 2002
10. Thomson Micromedex USPDI; Antiretrovirals: (online version thru Stat!ref). Montvale, NJ. 2003.
11. McEvoy GK, editor. American Hospital Formulary Service First Professional Edition , Antiretrovirals (online version thru Stat!ref), Bethesda, Maryland 2002.
12. Thomson Physicians Desk Reference; HIV specific agents: (online version). Montvale, NJ. 2003
13. Olin BR, editor.  Drug Facts and Comparisons (online version).  St Louis: J.B.Lippincott Company, Facts and Comparisons division, 2003.
14. Product Information Insert. Lexiva ^TM tablets,  Glaxo Smith Kline, Research Triangle Park, NC October 2003.
15. http://www.gsk.com/press_archive/press2003/press_10212003a.htm
16. US Department of Health and Human Services Pediatric guidelines that were last  updated January 2004 accessed  05-28-04 at http://aidsinfo.nih.gov/guidelines/default_db2.asp?id=50.
17. US Department of Health and Human Services Adult and Adolescent  guidelines that were last  updated March  2004 accessed  05-28-04 at http://aidsinfo.nih.gov/guidelines/default_db2.asp?id=50.
18. Gulick  RM,  et.al. Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS Clinical Trials Group protocol 373 J Infect Dis. 2001 Mar 1;183(5):715-21.
19. Important Interim Results from a Phase III, Randomized, Double-Blind Comparison of Three Protease-Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection (AACTG Protocol A5095) http://www.nlm.nih.gov/databases/alerts/hiv.html National Institute of Allergy and Infectious Diseases (NIAID) March 2003
20. Joly V; Flandre P et al Efficacy of zidovudine compared to stavudine, both in combination with lamivudine and indinavir, in human immunodeficiency virus-infected nucleoside-experienced patients with no prior exposure to lamivudine, stavudine, or protease inhibitors (novavir trial).Antimicrob Agents Chemother 2002 Jun;46(6):1906-13.
21. Hammer SM -Dual vs single protease inhibitor therapy following antiretroviral treatment failure: a randomized trial. JAMA - 10-JUL-2002; 288(2): 169-80
22. Antiretroviral Therapy: Protease Inhibitors Rakel: Conn’s Current Therapy 2003, 55^th ed. Copyright 2003 Elsevier.55-56
23. 23.   Graham NM Metabolic disorders among HIV-infected patients treated with protease inhibitors: a review Acquir Immune Defic Syndr. 2000 Oct 1;25 Suppl 1:S4-11.
24. Hoffman-Kamps HIV Medicine 2003 found at www.hivmedicine.com

 

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 14, 2006