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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Opthalmic Anti-infectives and Combinations

Status Drug PR PR-QL PR-AL ST M EX‡
P bacitracin          
P bacitracin/polymyxin b          
P ciprofloxacin          
P erythromycin          
P gentamicin          
P neomycin/polymyxin/gramicidin          
P neomycin/bacitracin/polymyxin          
P neomycin/polymyxin/dexamethasone          
P neomycin/polymyxin/hc          
P ofloxacin          
P oxytetracycline-polymyxin b          
P polymycin b/trimethoprim          
P sulfacetamide sodium/prednisolone          
P tobramycin          
P Vigamox®  (moxifloxacin)          
P Zymar®  (gatifloxacin)          
NP Ciloxan®  (ciprofloxacin)          
NP Cortisporin®  (neomycin/polymyxin/hc)          
NP Polytrim®  (polymycin b/trimethoprim)          
NP Maxitrol®  (neomycin/polymyxin/dexamethasone)          
NP Natacyn®  (natamycin)          
NP Neosporin®  (neomycin/polymyxin/gramicidin)          
NP Ocuflox®  (ofloxacin)          
NP Tobrex®  (tobramycin)          
FE Azasite™  (azithromycin)         X
FE Iquix®  (levofloxacin)         X
FE Blephamide®  (sulfacetamide sodium-prednisolone)         X
FE FML-S®  (sulfacetamide sodium-fluorometholone)         X
FE Poly Pred®  (neomycin-polymyxin-prednisolone)         X
FE Pred G®  (gentamicine-prednisolone)         X
FE Pred G SOP®  (gentamicin-prednisolone opth oint)         X
FE Quixin®  (levofloxacin)         X
FE Tobradex®  (tobramycin-dexamethasone)         X
FE Zylet®  (loteprednol-tobramycin)         X


Policy:

  1. Medical Exception Criteria
  2. Azasite, Blephamide, FML-S, Iquix, Poly Pred, Pred G, Pred G SOP, Quixin, Tobradex and Zylet are currently listed on the Aetna Formulary Exclusions List.* 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 Azasite, Blephamide, FML-S, Iquix, Poly Pred, Pred G, Pred G SOP, Quixin, Tobradex and Zylet to be medically necessary for those members who meet any of the following criteria:

    For Azasite, Blephamide, FML-S, Poly Pred, Pred G, Pred G SOP, Tobradex and Zylet

    A. A documented:

    • Contraindication to two preferred alternatives indicated for the member's condition OR
    • Intolerance to two preferred alternatives indicated for the member's condition OR
    • Allergy to two preferred alternatives indicated for the member's condition OR
    • Lack of bacterial sensitivity to two preferred alternatives indicated for the member's condition OR
    • Failure of an adequate trial of three days each of two preferred alternatives indicated for the member's condition OR
    • Patient is a poorly controlled glaucoma patient; or patient has elevated intraocular pressure (Zylet-only )

    For Iquix, Quixin

    A.  A documented:

    • Contraindication to one preferred ophthalmic fluoroquinolone alternative indicated for the member's condition OR
    • Intolerance to one preferred ophthalmic fluoroquinolone alternative indicated for the member's condition OR
    • Allergy to one preferred ophthalmic fluoroquinolone alternative indicated for the member's condition OR
    • Lack of bacterial sensitivity to one preferred ophthalmic fluoroquinolone alternative indicated for the member's condition OR
    • Failure of an adequate trial of three days of one preferred ophthalmic fluoroquinolone alternative indicated for the member's condition

Place of Service:

Outpatient

The above policy is based on the following references:
  1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
  2. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006.
  3. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  4. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  5. PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
  6. Robert PY and Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001;61:175-85
  7. Smith A, Pennefather PM, Kaye ST, and Hart CA. Fluoroquinolones. Place in ocular therapy. Drugs. 2001;61:747-61
  8. Prajna NV, George C, Selvaraj S, et al. Bacteriologic and clinical efficacy of ofloxacin 0.3% versus ciprofloxacin 0.3% ophthalmic solutions in the treatment of patients with culture-positive bacterial keratitis. Cornea. 2001;20:175-8
  9. Product Information Iquix® accessed at http://iquix.com/

  10. Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003;16(1):11-27
  11. Tipperman R. Pharmacologic considerations for cataract surgery. Curr Opin Ophthalmol. 2004;15(1):51-5.
  12. Hwang DG. Fluoroquinolone resistance in ophthalmology and the potential role for newer ophthalmic fluoroquinolones. Surv Ophthalmol. 2004;49 Suppl 2:S79-83.
  13. Product Information Azasite accesed 06-26-07 at http://www.insitevision.com/wt/page/index

 

Copyright 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 28, 2007
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