Subject: Ophthalmic Anti-Allergy Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	cromolyn
C	Optivar®  (azelastine)
C	Pataday®  (olopatadine)
C	Patanol®  (olopatadine)
NC	Alamast®  (pemirolast)						X
NC	Alocril®  (nedocromil)						X
NC	Alomide®  (lodoxamide)						X
NC	Elestat®  (epinastine)						X
NC	Emadine®  (emedastine)						X

Policy:

1. Medical Exception Criteria

Alamast, Alocril, Alomide, Elestat and Emadine 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Alamast, Alocril, Alomide, Elestat and Emadine to be medically necessary for those members who meet any of the following criteria:

A.  A documented:

• Contraindication to one covered ophthalmic anti-allergy agent OR
• Intolerance to one covered ophthalmic anti-allergy agent OR
• Allergy to one covered ophthalmic anti-allergy agent OR
• Failure of an adequate trial of one week of one covered ophthalmic anti-allergy agent

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. Alomide, Product Information.  Alcon Ophthalmic, Alcon Laboratories.  Fort Worth, TX.  2001.
5. Patanol, Product Information.  Alcon Ophthalmic, Alcon Laboratories. Fort Worth, TX.  August 2002. 
6. Livostin, Product Information.  Novartis Ophthalmics, Duluth, GA.  May 2001.
7. Crolom, Product Information.  Bausch & Lomb.  Tampa, FL. March 2002.
8. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
9. Emadine, Product Information.  Alcon Ophthalmic, Alcon Laboratories. Fort Worth, TX.  August 2002.
10. Opticrom, Product Information.  Allergan, Inc., Irvine, CA.  October 2000
11. Alocril, Product Information.  Allergan Inc.  Irvine, CA.  2002.
12. Alamast, Product Information.  Santen, Inc.  Napa, CA.  2002.
13. Zaditor, Product Information.  Novartis Ophthalmics, Duluth, GA.  August 2001.
14. Alocril, AHFS Formulary Information – Product Information, Allergan Opthalmic. Irvine, CA 2000.
15. Berdy GJ, Stoppel JO, Epstein AB.  Comparison of the clinical efficacy and tolerability of olopatadine hydrochloride 0.1% ophthalmic solution and loteprednol etabonate 0.2% ophthalmic suspension in the conjunctival allergen challenge model.  Clin Ther. 2002;24:918-29.
16. Elestat Product Information.  Allergan, Inc., Irvine, CA.  October 2003
17. Spangler DL, Abelson MB, Ober A, Gomes PJ.  Randomized, double-masked cmparison of olopatadine ophthalmic solution, mometasone furoate monohydrate nasal spray, and fexofenadine hydrochloride tablets using the conjunctival and nasal allergen challenge models.  Clin Ther.  2003;25:2245-67.
18. Abelson MB, Pratt S, Mussoline JF, Townsend D.  One-visit, randomized, placebo-controlled, conjunctival allergen challenge study of scanning and imaging technology for objective quantification of eyelid swelling in the allergic reaction with contralateral use of olopatadine and artificial tears.  Clin Ther.  2003;25:2070-84.
19. 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.
20. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

 

 

ARCHIVE VERSION

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.

July 30, 2009