Cost-effectiveness analysis of two protocols of sequential combinations of Helicobacter pylori eradication treatments

Objective: To compare the costs and outcomes of two different protocols of three consecutive combinations of eradication therapies in patients with Helicobacter pylori (HP)-positive dyspepsia with or without peptic ulcer disease, from the perspective of the Italian National Health System (INHS). Design: An open comparative study with a one-year follow-up was performed. A decision tree was used to calculate cost-effectiveness. Setting: Department of Infectious and Tropical Diseases of the University “La Sapienza”, Rome, Italy. Interventions: Three different eradication therapies were tested: Amoxicilline + Metronidazole + Omeprazole [AMO]; Clarithromycin + Metronidazole + Omeprazole [CMO]; Tetracycline + Clarithromycin + Bismuth [TCB]. These eradication therapies were consecutively arranged in the CAT protocol (CMO-AMO-TCB) and in the ACT protocol (CMO-AMO-TCB). Patients and participants: The patients enrolled in the study were 229 and distributed as follows: 104 in the ACT protocol and 125 in the CAT protocol. Main outcome measures and results: The CAT protocol resulted more effective and costly than the ACT protocol after the first two eradication therapies. The incremental effectiveness was 12 and 22 eradicated patients while the incremental cost was Lit. 221,461 and Lit. 279,948 in patients with and without peptic ulcers, respectively. However, considering the entire therapeutic cycle (three eradication treatments), the total direct cost per patient with initial ulcer was Lit. 1,166,919 for CAT patients (Lit. 1,157,368 for those without ulcer) and Lit. 1,196,571 for ACT ones (Lit. 1,330,648 for those without ulcers). Conclusions: The CAT protocol resulted more effective and less costly than the ACT ptotocol at the end of the full therapeutic cycle. After a year from diagnosis, the CAT protocol could produce saving to the INHS ranging from Lit. 60 to 520 billions due to lower drug consumption and lower use of diagnostic tests