Pharmacy Clinical Policy Bulletins Aetna Medicare Prescription Drug Plan
Subject: Quinolones
Status
Drug
PR-B/D
PR
PR-QL
PR-AL
ST
M EX‡
TOC§
C
ciprofloxacin
X
C
ofloxacin
X
C
Avelox®, Avelox® ABC(moxifloxacin)
X
NC
Cipro®(ciprofloxacin)
X
X
NC
Cipro XR®(ciprofloxacin)
X
X
NC
Factive®(gemifloxacin)
X
X
NC
Floxin®(ofloxacin)
X
X
NC
Levaquin®(levofloxacin)
X
X
NC
Maxaquin®(lomefloxacin)
X
X
NC
Negram®(nalidixic acid)
X
X
NC
Noroxin®(norfloxacin)
X
X
NC
Proquin XR®(ciprofloxacin sr)
X
X
NC
Tequin®(gatifloxacin)
X
X
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Avelox, Cipro, Cipro XR, Factive, Floxin, Levaquin, Maxaquin, Negram, Noroxin, Proquin XR, Tequin, generic ciprofloxacin and ofloxacin are subject to precertification for members less than 10 years of age. Aetna considers Avelox, Cipro, Cipro XR, Factive, Floxin, Levaquin, Maxaquin, Negram, Noroxin, Proquin XR, Tequin, generic ciprofloxacin and ofloxacin to be medically necessary for those members who meet ANY of the following precertification criteria:
A. Documented diagnosis of cystic fibrosis
OR
B. Documented diagnosis of a life-threatening infection untreatable by other first line antibiotics
OR
C. Documented diagnosis of recurrent resistant urinary tract infection
OR
D. Member needs prophylaxis or treatment of anthrax after known or suspected exposure (Cipro/ciprofloxacin only)
OR
E. Documented diagnosis of complicated UTI or Pyelonephritis due to E. coli and is being used as second line treatment (Cipro/ciprofloxacin^, Negram† only)
Medical Exception Criteria
Cipro, Cipro XR, Factive, Floxin, Levaquin, Maxaquin, Negram, Noroxin, Proquin XR and Tequin are currently 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 Cipro, Cipro XR, Factive, Floxin, Levaquin, Maxaquin, Negram, Noroxin, Proquin XR and Tequin to be medically necessary for those members who meet the following criteria:
A. A documented:
Contraindication to two covered fluoroquinolones OR
Intolerance to two covered fluoroquinolones OR
Lack of bacterial sensitivity to two covered fluoroquinolones OR
History of failure of an adequate trial of three days each of two covered fluoroquinolones
* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.
Place of Service:
Outpatient
The above policy is based on the following references:
McEvoy GK, editor.AmericanHospitalFormulary Service First Professional Edition(online).Bethesda,Maryland2004
Sandford, Jay P. , Gilbert, David N., Moellering, R.C., Sande, M.A. : Sanford Guide to Antimicrobial Therapy, 34th edition, Copyright 2004, Antimicrobial Therapy Inc. Hyde Park, VT.
Product Information Insert. Factive ®, Genesoft Pharmaceuticals, San Francisco, CA. April 2003.
Olin BR, editor. Drugs Facts and Comparison (online).St. Louis: J.B. Lippincott Company, Facts and Comparisons. 2004.
Medispan Drug Information. 2004
British Thoracic Society. Guidelines for the Management of Community Acquired Pneumonia in Adults. Thorax 2001; 56(suppl 4).
Niederman, Michael S. Guidelines for the Management of Community Acquired Pneumonia: Current Recommendations and Antibiotic Selection Issues. Medical Clinics ofNorth AmericaNov.2001; 85(6): 1493-509
Mandell (2003) Guidelines for CAP in Adults. Clin Infect Dis 37:1405-1433
Guidelines for the Management of Adults with Community-acquired Pneumonia; diagnosis assessment of severity, antimicrobial therapy and prevention; Am J Respir Crit Care Med Vol 163. pp 1730-1754, 2001
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.
Zahn C, Sangl J,BiermanAS, 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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.