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
tobramycin-dexamethasone
P
Vigamox®(moxifloxacin)
NP
Ciloxan®(ciprofloxacin)
NP
Cortisporin®(neomycin/polymyxin/hc)
NP
Polytrim®(polymycin b/trimethoprim)
NP
Natacyn®(natamycin)
NP
Neosporin®(neomycin/polymyxin/gramicidin)
NP
Ocuflox®(ofloxacin)
NP
Tobrex®(tobramycin)
FE
Azasite™(azithromycin)
X
FE
Iquix®(levofloxacin)
X
FE
Quixin®(levofloxacin)
X
FE
Zymar®(gatifloxacin)
X
Antiinfective /steroid combinations
P
neomycin/polymyxin/dexamethasone
P
sulfacetamide sodium/prednisolone
NP
Maxitrol®(neomycin/polymyxin/dexamethasone)
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
Tobradex®(tobramycin-dexamethasone)
X
FE
Zylet®(loteprednol-tobramycin)
X
Policy:
Medical Exception Criteria
Azasite, Blephamide, FML-S, Iquix, Poly Pred, Pred G, Pred G SOP, Quixin, Tobradex, Zylet and Zymar 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, Zylet and Zymar 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, Zymar
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:
DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
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.
Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
Robert PY and Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001;61:175-85
Smith A, Pennefather PM, Kaye ST, and Hart CA. Fluoroquinolones. Place in ocular therapy. Drugs. 2001;61:747-61
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
Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003;16(1):11-27
Tipperman R. Pharmacologic considerations for cataract surgery. Curr Opin Ophthalmol. 2004;15(1):51-5.
Hwang DG. Fluoroquinolone resistance in ophthalmology and the potential role for newer ophthalmic fluoroquinolones. Surv Ophthalmol. 2004;49 Suppl 2:S79-83.
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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.