Subject: Ophthalmic Anti-inflammatory Steriodal Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	dexamethasone sodium ophthalmic soln
C	fluorometholone susp 0.1%
C	prednisolone acetate ophthalmic soln
NC	Alrex®  (loteprednol)						X
NC	Econopred Plus®  (prednisolone acetate)						X
NC	Flarex®  (fluorometholone)						X
NC	FML  (fluorometholone susp 0.1%)						X
NC	FML-S.O.P. ®  (fluorometholone ointment 0.1%)						X
NC	FML Forte®  (fluorometholone susp 0.25%)						X
NC	Lotemax®  (loteprednol)						X
NC	Maxidex®  (dexamethasone susp)						X
NC	Omnipred®  (prednisolone acetate susp 1%)						X
NC	Pred Mild®  (prednisolone acetate susp 0.12%)						X
NC	Pred Forte®  (prednisolone acetate)						X
NC	Vexol®  (rimexolone)						X

Policy:

1. Medical Exception Criteria

Alrex, Lotemax, Flarex, FML/FML-S.O.P. /FML Forte, Maxidex, Pred Mild, Econopred Plus, Pred Forte, Omnipred and Vexol are currently listed on the 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 Alrex, Lotemax, Flarex, FML/FML-S O.P. /FML Forte, Maxidex, Pred Mild, Econopred Plus, Pred Forte, Omnipred and Vexol to be medically necessary for those members who meet the following criteria:

A. A documented:

• Contraindication to one (1) preferred ophthalmic corticosteroid agent OR
• Allergy to one (1) preferred ophthalmic corticosteroid agent OR
• Intolerance to one (1) preferred ophthalmic corticosteroid agent OR
• Failure of an adequate trial of at least two (2) days of one (1) preferred ophthalmic corticosteroid agent OR
• Member requires an ointment dosage form (FML-S.O.P. ONLY)
  

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. McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33-35
8. Avunduk AM, Avunduk MC, Varnell ED, Kaufman HE. The comparison of efficacies of topical corticosteroids and nonsteroidal antiinflammatory drops on dry eye patients: a clinical and immunocytochemical study. Am J Ophthalmol. 2003;136(4):593-602.
9. Whitcup SM and Ferris FL. New Corticosteroids for the treatment of ocular inflammation. Am J Ophthalmol 1999;127(5)597-99.
10. Guess S, Stone DU, Chodosh J. Evidence-based treatment of herpes simplex virus keratitis: a systematic review. Ocul Surf. 2007 Jul;5(3):240-50. Review.
11. 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.
12. 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.

January 01, 2009