Formulary Management of Eradication Therapies for Helicobacter pylori: Drug Selection by Means of the SOJA Method

Objective: To use the System of Objectified Judgement Analysis (SOJA) method for the rational selection of Helicobacter pylori eradication therapies for formulary inclusion. Design: Drug selection for the eradication therapy of H. pylori is made by means of the SOJA method. In this formulary decision-making model, selection criteria for a given class of drugs are prospectively defined and weighted by a panel of experts. The following criteria (relative weight) were used: variability of pharmacokinetics; drug interactions; resistance to antibacterials; efficacy; general adverse effects; complexity of the regimen; acquisition cost and clinical documentation. Only published studies with at least 30 evaluable patients were considered, at least 3 studies had to be available per treatment regimen and efficacy had to be assessed on an intent-to-treat basis. Main outcome measures and results: The regimens containing clarithromycin and an imidazole antibacterial in combination with omeprazole or ranitidine bismutrex showed the highest scores for eradication of H. pylori. The combinations amoxicillin/ clarithromycin and omeprazole or lansoprazole showed slightly lower eradication rates and were more costly. The eradication rates obtained with 2-drug regimens were low, resulting in a low overall SOJA score. No quadruple regimens could be included, as none of the regimens fulfilled the inclusion criteria. This was also true for the classical triple therapy with bismuth/metronidazole/tetracycline. Conclusion: The present score is specific for the Netherlands, as Dutch acquisition costs and data on resistance were used. In other countries, with different degrees of imidazole and clarithromycin resistance, other regimens may be more appropriate. The SOJA score will be regularly updated through the internet to include relevant new studies or new successful eradication regimens. The interactive program offers groups of physicians the opportunity to discuss the optimal H. pylori eradication regimen, based on their weighting of the criteria.