Subject: Ophthalmic Anti-Allergy Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	cromolyn sodium
C	Optivar®  (azelastine)
C	Pataday™  (olopatadine 0.2%)
C	Patanol®  (olopatadine 0.1%)
NC	Alamast®  (pemirolast)						X
NC	Alocril®  (nedocromil)						X
NC	Alomide®  (lodoxamide)						X
NC	Bepreve™  (bepotastine besilate)						X
NC	Crolom®  (cromolyn)						X
NC	Elestat®  (epinastine)						X
NC	Emadine®  (emedastine)						X

Policy:

1. Medical Exception Criteria

Alamast, Alocril, Alomide, Bepreve, Crolom, 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, Bepreve, Crolom, Elestat and Emadine to be medically necessary for those members who meet any of the following criteria:

A.  A documented:

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

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Bonini S, Gramiccioni C, Bonini M, Bresciani M.  Practical approach to diagnosis and treatment of ocular allergy: a 1-year systematic review. Curr Opin Allergy Clin Immunol. 2007 Oct;7(5):446-9. Review.
8. Manzouri B, Flynn TH, Larkin F, Ono SJ, Wyse R. Pharmacotherapy of allergic eye disease. Expert Opin Pharmacother. 2006 Jun;7(9):1191-200. Review.
9. Bielory L, Buddiga P, Bigelson S.Ocular allergy treatment comparisons: azelastine and olopatadine. Curr Allergy Asthma Rep. 2004 Jul;4(4):320-5. Review.
10. Lanier BQ, Finegold I, D'Arienzo P, Granet D, Epstein AB, Ledgerwood GL. Clinical efficacy of olopatadine vs epinastine ophthalmic solution in the conjunctival allergen challenge model. Curr Med Res Opin. 2004 Aug;20(8):1227-33.
11. Bielory L, Katelaris CH, Lightman S, Naclerio RM. Treating the ocular component of allergic rhinoconjunctivitis and related eye disorders. MedGenMed. 2007 Aug 15;9(3):35. Review.
12. 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.
13. Spangler DL, Abelson MB, Ober A, Gomes PJ.  Randomized, double-masked comparison 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.
14. 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.
15. 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.
16. 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.

October 16, 2009