Subject: Cephalosporins

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	cefaclor
P	cefadroxil
P	cefdinir
P	cefpodoxime proxetil
P	cefuroxime axetil
P	cephalexin
P	cephradine
P	cefprozil
FE	Cedax®  (ceftibutin)					X
FE	Cefzil®  (cefprozil)					X
FE	Duricef®  (cefadroxil)					X
FE	Omnicef®  (cefdinir)					X
FE	Panixine™  (cephalexin disperse tab)					X
FE	Raniclor™  (cefaclor chew tab)					X
FE	Spectracef®  (cefditoren pivoxil)					X
FE	Suprax®  (cefixime)					X
FE	Vantin®  (cefpodoxime)					X

Policy:

1. Medical Exception Criteria

Cedax, Cefzil, Duricef, Omnicef, Panixine, Raniclor, Spectracef, Suprax and Vantin 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 Cedax, Cefzil, Duricef, Omnicef, Panixine, Raniclor, Spectracef, Suprax and Vantin to be medically necessary for those members who meet any of the following criteria:

A.  A documented:

• Contraindication to two preferred alternatives indicated for the member's condition (see table below), one of which was a preferred cephalosporin OR, 
• Intolerance to two preferred alternatives indicated for the member's condition (see table below), one of which was a preferred cephalosporin OR, 
• Allergy to two preferred alternatives indicated for the member's condition (see table below), one of which was a preferred cephalosporin OR, 
• Documented lack of bacterial sensitivity to two preferred alternatives indicated for the member's condition (see table below), one of which was a preferred cephalosporin OR, 
• Failure of an adequate trial of 3 days each of two preferred alternatives indicated for the member's condition (see table below), one of which was a preferred cephalosporin.
  
  

Indication	Preferred Alternatives
Skin/structure infection	amoxicillin amoxicillin/clavulanate ampicillin azithromycin cefaclor cefaclor ER cefadroxil cefpodoxime proxetil cefprozil cefuroxime cephalexin cephradine ciprofloxacin clarithromycin cloxacillin dicloxacillin erythromycin moxifloxacin (AVELOX®) penicillin VK
Pharyngitis	amoxicillin ampicillin azithromycin cefaclor cefaclor ER cefadroxil cefpodoxime proxetil cephalexin cephradine cefprozil cefuroxime clarithromycin erythromycin penicillin VK
Ear,Nose and Throat	amoxicillin amoxicillin/clavulanate ampicillin azithromycin cefaclor cefaclor ER cefadroxil cefpodoxime proxetil cefprozil cefuroxime cephalexin cephradine ciprofloxacin clarithromycin erythromycin penicillin VK sulfamethoxazole/trimethoprim (cotrimoxazole) sulfisoxazole/erythromycin
Urinary tract infection	amoxicillin amoxicillin/clavulanate ampicillin cefaclor cefadroxil cefuroxime cefpodoxime proxetil cephalexin cephradine ciprofloxacin nitrofurantoin sulfamethoxazole/trimethoprim (cotrimoxazole) sulfisoxazole trimethoprim

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. Product  Information Insert. Spectracef TM tablets,  Purdue Pharmaceuticals, Stamford, CT  August 2003.
7. Product Information Insert.  Cedax  capsules,suspensio; BioVail Pharmaceuticals Inc. Morrisville , NC March 2002.
8. Product Information Insert. Duricef® tablets, suspension; Bristol-Myers Squibb, Princeton, NJ February 2000.
9. Product Information Insert. Ceftin® tablets, suspension; Glaxo SmithKline, Research Triangle Park, NC September  2003.
10. Product Information Insert. Cefzil® tablets, suspension; Bristol-Myers Squibb, Princeton, NJ June 2002.
11. Product Information Insert. Lorabid® capsules, suspension; Eli Lilly and Co., Indianapolis, IN May 2002.
12. Product Information Insert. Vantin® tablets, suspension; Pharmacia and Upjohn Company, Kalamazoo, Michigan August 2003.
13. Product Information Insert. Suprax® tablets, suspension; Lederle Pharmacetuical, Pearl River, NY 10965.
14. Product Information Insert. Omnicef® capsules, suspension; Abbott Laboratories, North Chicago, IL October 2001.
15. Centers for Disease Control and Prevention. "2002 Guidelines for Treatment of Sexually Transmitted Diseases". MMWR 2002; 51(RR06); 1-170
16. Sandford, Jay P., Gilbert, David N., Moellering, R.C. Sande, M.A.: Sandford Guide: Guide to Antimicrobial Therapy, 34st edition, Copyright 2004, Antimicrobial Therapy Inc. Hyde Park, Vt
17. Guay, David. Formulary Forum: Cefdinir: An Extended-Spectrum Oral Cephalosporin. The Annals of Pharmacotherapy 2000; 34: 1469-77.

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.

January 01, 2009