Subject: Ophthalmic Anti-inflammatory Agents - Steroidal and Nonsteroidal

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	dexamethasone sodium ophthalmic soln
C	flurbiprofen ophthalmic
C	fluorometholone
C	prednisolone acetate ophthalmic soln
C	Acular®/ Acular LS® / Acular PF®  (ketorolac tromethamine)
C	Alrex®  (loteprednol)
C	Lotemax®  (loteprednol)
C	Nevanac®  (nepafenac)
C	Voltaren® ophthalmic  (diclofenac sodium)
NC	Econopred Plus®  (prednisolone acetate)						X
NC	Flarex®  (fluorometholone)						X
NC	FML®/FML-S.O.P.®/ FML Forte®  (fluorometholone)						X
NC	HMS Liquifilm®  (medrysone)						X
NC	Inflamase Mild®/ Inflamase Forte®  (prednisolone sodium)						X
NC	Maxidex®  (dexamethasone)						X
NC	Ocufen®  (flurbiprofen)						X
NC	Pred Forte®  (prednisolone acetate)						X
NC	Vexol®  (rimexolone)						X
NC	Xibrom®  (bromfenac)						X

Policy:

1. Medical Exception Criteria

Econopred Plus, Flarex, FML/FML-S.O.P./FML Forte, HMS Liquifilm, Inflamase, Maxidex, Ocufen, Pred Forte, Vexol and Xibrom currently are 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 Econopred Plus, Flarex, FML/FML-S.O.P./FML Forte, HMS Liquifilm, Inflamase, Maxidex, Nevanac, Ocufen, Pred Forte, Vexol and Xibrom to be medically necessary for those members who meet the following criteria:

A. A documented:

• Contraindication to one preferred alternative ophthalmic anti-inflammatory agent OR
• Allergy to one preferred alternative ophthalmic anti-inflammatory agent OR
• Intolerance to one preferred alternative ophthalmic anti-inflammatory agent OR
• Failure of an adequate trial of at least two days of one preferred alternative ophthalmic anti-inflammatory 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. 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. Alrex Package Insert, Bausch & Lomb Pharmaceuticals, Inc., Tampa, FL, March 1998
5. Lotemax Package Insert, Bausch & Lomb Pharmaceuticals, Inc., Tampa, FL, March 1998
6. Vexol Package Insert. Alcon Laboratories, Fort Worth, TX. 2000
7. HMS Package Insert. Allergan Pharmaceuticals.  Irvine, CA: Allergan Pharmaceuticals, 1994.
8. McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25(1):33-35
9. 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.
10. Whitcup SM and Ferris FL. New Corticosteroids for the treatment of ocular inflammation. Am J Ophthalmol 1999;127(5)597-99.
11. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
12. 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.
13. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
14. Acular, Acular PF Product Information.  Allergan.  Irvine, CA.  February 2002.
15. Ocufen, Product Information.  Allergan.  Irvine, CA. 2002.
16. Profenal, Product Information.  Alcon Ophthalmic, Alcon Laboratories. Fort Worth, TX.
17. Voltaren, Product Information.  Novartis Ophthalmics, Duluth, GA.  July 2002.
18. Xibrom Package Insert. ISTA Pharm, Irving Ca,.

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.

November 14, 2007