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, Pylera to be medically necessary for those members who meet the following precertification criteria:
According to the manufacturer, the H. pylori drugs Helidac, Prevpac , 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 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 Pylera are currently listed on the Aetna Formulary Exclusions List.* 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 Pylera to be medically necessary for those members who meet any of the following criteria:
A. A documented:
Contraindication to one preferred alternative combination agent indicated for the member's condition OR
Intolerance to one preferred alternative combination agent indicated for the member's condition OR
Allergy to one preferred alternative combination agent indicated for the member's condition OR
Failure of an adequate trial of one course of one preferred alternative combination agent indicated for the member's condition
Place of Service:
Outpatient
The above policy is based on the following references:
Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2007.
DrugPoints™ System. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2007.
AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2007.
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 pylorieradication: 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.
Sherman P, Czinn S, Drumm B, et al. North American Society of Gastroenterology, Hepatology, and Nutrition, USA. Helicobacter pylori infection in children and adolescents: Working Group Report of the First World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition. Pediatr Gastroenterol Nutr. 2002;35 Suppl 2:S128-33.
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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.