Subject: H-Pylori Agents

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	amoxicillin
C	clarithromycin
C	metronidazole
C	tetracycline
C	omeprazole (Rx only)			X
C	pantoprazole			X
C	Nexium®  (esomeprazole)			X
C	Prevacid ®  (lansoprazole)			X
C	Protonix®  (pantoprazole)			X
C	Pylera™  (bismuth subcitrate potassium/metronidazole/ tetracycline)
NC	Helidac®  (bismuth subsalicylate/metronidazole/ tetracycline)			X			X
NC	Prevpac®  (amoxicillin/clarithromycin/ lansoprazole)			X			X
Note: Criteria for PPIs are discussed in Pharmacy Clinical Policy Bulletin: Proton Pump Inhibitors

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Helidac and Prevpac are subject to precertification.  If precertification requirements apply, Aetna considers Helidac and Prevpac to be medically necessary for those members who meet the following precertification criteria:


A.  Quantity limits:  According to the manufacturer, the H-Pylori drugs Helidac and Prevpac can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below.  A quantity of each drug will be considered medically necessary as indicated in the table below:

Drug	Maximum Daily Dose/ Dosing Interval	Dosage Strength	Quantity Limits
Helidac	1 pack/ Once daily	metronidazole 250 mg, tetracycline 500 mg, bismuth subsal. 262.4 mg therapy pack	Up to 56 packs (one box) in 365 days
Prevpac	1 pack/ Once daily	amoxicillin 500 mg, clarithromycin 500 mg, lansoprazole 30 mg therapy pack	Up to 28 packs (2 boxes) in 365 days





For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of H-Pylori drugs Helidac and Prevpac will be considered medically necessary for those members who meet the following criterion:

• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  



2. Medical Exception Criteria

Helidac and Prevpac 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Helidac and Prevpac to be medically necessary for those members who meet the following criteria:

A. Member has a documented diagnosis of H. Pylori infection

AND

B. Member has failed an adequate trial (one course) of one of the below combinations of preferred alternatives indicated in the treatment of H.Pylori infection.

OR  

C. Member has a documented contraindication, intolerance or drug allergy precluding Member's  treatment with one of the following combinations of preferred alternatives:

i. Pylera ™ ORALLY 4 times daily (after meals and at bedtime) for 10 days, in combination with omeprazole 20 mg ORALLY twice daily 

OR

ii. A preferred PPI (omeprazole, Nexium, Prevacid, pantoprazole or Protonix) in combination with two of the following preferred antibiotics indicated in the treatment of H. Pylori : 

• amoxicillin
• clarithromycin
• metronidazole
• tetracycline
  

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. 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.
8. Zahn C, Sangl J, Bierman AS, 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.

January 01, 2009