Note: Criteria for other PPIs are discussed in Pharmacy Clinical Policy Bulletin: Proton Pump Inhibitors
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, Helidac, Prevpac and Pylera are subject to precertification. If precertification requirements apply, Aetna considers Helidac, Prevpac and Pylera 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, Prevpac and Pylera 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:
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, Prevpac and Pylera 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.
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 any of the following criteria:
A. A documented:
Contraindication to one combination of covered alternatives which should include at least one covered generic antibiotic indicated for the member's condition OR
Intolerance to one combination of covered alternatives which should include at least one covered generic antibiotic indicated for the member's condition OR
Allergy to one combination of covered alternatives which should include at least one covered generic antibiotic indicated for the member's condition OR
Failure of an adequate trial of one course of one combination of covered alternatives which should include at least one covered generic antibiotic indicated for the member's condition.
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Helidac Package Insert. Prometheus Laboratories, San Diego, CA. September 2000
Prevpac Package Insert, Tap Pharmaceutical, North Chicago, IL, September 2001
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
Anderson J, Gonzalez J. H pylori infection. Review of the guideline for diagnosis and treatment. Geriatrics 2000;55(6):44-9.
Cohen H. Peptic ulcer and Helicobacter pylori. Gastroenterol Clin 2000;29(4):775-89.
Weijnen CF, Numans ME, de Wit NJ et al. Testing for Helicobacter pylori in dyspeptic patients suspected of peptic ulcer disease in primary care: cross sectional study. BMJ 2001;323:71-5.
Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol 1998;93:2330-8.
Shiotani A, Nurgalieva ZZ, Yamaoka Y, Graham DY. Helicobacter pylori. Med Clin North Am 2000;84(5):1125-36.
Fendrick AM. The role of economic evaluation in the diagnosis and treatment of Helicobacter pylori infection. Gastroenterol Clin North Am 2000;29(4):837-51
Megraud F, Marshall BJ. How to treat Helicobacter pylori. First-line, second-line, and future therapies. Gastroenterol Clin North Am 2000;29(4):759-73, vii.
Childs SM, Roberts AP, Meineche-Schmidt V, et al. The management of Helicobacter pylori infection in primary care: a systematic review of the literature. Fam Pract 2000;17:S6-11.
Van Oijen AH, Verbeek AL, Jansen JB, De Boer WA. Review article: treatment of Helicobacter pylori infection with ranitidine bismuth citrate or proton pump inhibitor-based triple therapies. Aliment Pharmacol Ther 2000;14(8):991-9.
Gisbert JP, Gonzalez L, Calvet X, et al. Helicobacter pylori eradication: proton pump inhibitor vs. ranitidine bismuth citrate plus two antibiotics for 1 week-a meta-analysis efficacy. Aliment Pharmacol Ther 2000;14(9):1141-50.
Harford W et al. Double-blind, multi-center evaluation of lansoprazole and amoxicillin dual therapy for the cure of Helicobacter pylori infection. Helicobacter 1996; 1: 243-250
Meyer JM, Sillman NP, Wang W, et al. Risk factors for Helicobacter pylori resistance in the United States: The surveillance of H. pylori antimicrobial resistance partnership (SHARP) study, 1993-1999. Ann Intern Med. 2002;136:13-24.
Laine L, Schoenfeld P, Fennerty MB. Therapy for Helicobacter pylori in patients with nonulcer dyspepsia. A meta-analysis of randomized, controlled trials. Ann Intern Med 2001;134:361-9.
Treiber G, Wittig J, Ammon S, et al. Clinical outcome and influencing factors of a new short-term quadruple therapy for Helicobacter pylori eradication. A randomized controlled trial (MACLOR study). Arch Intern Med. 2002;162:153-160.
Goh KL. Update on the management of Helicobacter pylori infection, including drug-resistant organisms. J Gastroenterol Hepatol. 2002;17(4):482-7.
Vallve M, Vergara M, Gisbert JP, Calvet X. Single vs. double dose of a proton pump inhibitor in triple therapy for Helicobacter pylori eradication: a meta-analysis. Aliment Pharmacol Ther 2002;16(6):1149-56.
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, Bierman AS, et al. Potentially inappropriate medication use in the community-dwelling elderly.JAMA. 2001;286:2823-29.
ARCHIVE VERSION
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
CS = Covered under Specialty Tier
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.
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