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

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
COMBINATION AND MISC ANTIBIOTICS
C bacitracin              
C bacitracin/polymyxin b              
C erythromycin              
C gentamicin              
C neomycin/polymyxin/gramicidin              
C neomycin/bacitracin/polymyxin b              
C polymycin b/trimethoprim              
C sulfacetamide sodium              
C tobramycin              
NC Azasite®  (azithromycin)           X  
NC Bleph-10®  (sulfacetamide sodium)           X  
NC Neosporin ®  (neomycin/polymixin/gramicidin)           X  
NC Polytrim®  (polymyxin b/trimethoprim)           X  
NC Tobrex®  (tobramycin)           X  
FLUOROQUINOLONE ANTIBIOTICS
C ciprofloxacin              
C ofloxacin              
C Vigamox®  (moxifloxacin)              
C Zymar®  (gatifloxacin)              
NC Besivance™  (besifloxacin)           X  
NC Ciloxan®  (ciprofloxacin)           X  
NC Iquix®  (levofloxacin soln 1.5%)           X  
NC Quixin®  (levofloxacin soln 0.5%)           X  
NC Ocuflox®  (ofloxacin)           X  
STEROID and ANTIBIOTIC COMBINATIONS
C neomycin/polymyxin/hc              
C neomycin/polymyxin/bacitracin/hc              
C neomycin/polymyxin/dexamethasone              
C sulfacetamide/sodium prednisolone              
C tobramycin-dexamethasone              
NC Blephamide®  (sulfacetamide sodium-prednisolone)           X  
NC FML-S Liquifilm®  (sulfacetamide sodium-fluorometholone)           X  
NC Cortisporin®  (neomycin/polymyxin/hc)           X  
NC Maxitrol®  (neomycin-polymyxin-dexamethasone)           X  
NC Poly-Pred®  (neomycin-polymyxin-prednisolone)           X  
NC Pred-G®/Pred-G SOP®  (gentamicin-prednisolone)           X  
NC Tobradex®  (tobramycin-dexamethasone)           X  
NC Zylet®  (loteprednol-tobramycin)           X  
ANTIVIRAL
C trifluridine              
NC Viroptic®  (trifluridine)           X  


Policy:

  1. Medical Exception Criteria
  2. Azasite, Besivance, Bleph-10, Neosporin, Polytrim, Tobrex, Ciloxan, Iquix, Quixin, Ocuflox,  Blephamide, FML-S Liquifilm, Cortisporin, Maxitrol, Poly-Pred, Pred-G/Pred-G SOP, Tobradex, Zylet, and Viroptic are currently Not Covered Part D drugs.  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, Besivance, Bleph-10, Neosporin, Polytrim, Tobrex, Ciloxan, Iquix, Quixin, Ocuflox, Blephamide, FML-S Liquifilm, Cortisporin, Maxitrol, Poly-Pred, Pred-G/Pred-G SOP, Tobradex, Zylet, and Viroptic to be medically necessary for those members who meet any of the following criteria:

    For Azasite, Bleph-10, Neosporin, Polytrim, and Tobrex

    A.  A documented:

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

    For BesivanceCiloxan, Iquix, Quixin and Ocuflox

    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

    For Blephamide, FML-S Liquifilm, Cortisporin, Maxitrol, Poly-Pred, Pred-G/Pred-G SOP, Tobradex, and Zylet

    A.  A documented:

    • Contraindication to one preferred ophthalmic steroid/antibiotic combination alternative indicated for the member's condition OR
    • Intolerance to one preferred ophthalmic steroid/antibiotic combination alternative indicated for the member's condition OR
    • Allergy to one preferred ophthalmic steroid/antibiotic combination alternative indicated for the member's condition OR
    • Lack of bacterial sensitivity to one preferred ophthalmic steroid/antibiotic combination alternative indicated for the member's condition OR
    • Failure of an adequate trial of three days of one preferred ophthalmic steroid/antibiotic combination alternative indicated for the member's condition
    • Patient is a poorly controlled glaucoma patient or has elevated intraocular pressure (Zylet ONLY)


    For Viroptic

    A.  A documented:

    • Contraindication to generic trifluridine ophthalmic solution OR
    • Intolerance to generic trifluridine ophthalmic solution OR
    • Allergy to generic trifluridine ophthalmic solution OR
    • Failure of an adequate trial of three days of generic trifluridine ophthalmic solution

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.  Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003;16(1):11-27
8. Constantinou M, Daniell M, Snibson GR, Vu HT, Taylor HR. Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. Ophthalmology. 2007;114(9):1622-9.
9. Holland EJ, Bartlett JD, Paterno MR, Usner DW, Comstock TL.  Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. Cornea. 2008;27(1):50-5
10. Cantor LB, WuDunn D, Yung CW, Valluri S, Catoira YP, Hoop JS, Morgan LS. Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. Br J Ophthalmol. 2008;92(3):345-7
11. Everitt HA, Little PS, Smith PW. A randomized controlled trial of management strategies for acute infective conjunctivitis in general practice. BMJ. 2006;333(7563):321.
12. Constantinou M, Daniell M, Snibson GR, Vu HT, Taylor HR.  Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial. Ophthalmology. 2007;114(9):1622-9.
13. Wilhelmus KR. Therapeutic interventions for herpes simplex virus epithelial keratitis. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD002898.

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.

June 12, 2009
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