The cost effectiveness of misoprostol prophylaxis alongside long-term nonsteroidal anti-inflammatory drugs. Implications of the MUCOSA trial.

OBJECTIVE This study considered the cost effectiveness of misoprostol prophylaxis for nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal damage, using data from the Misoprostol Ulcer Complications Outcomes Safety Assessment (MUCOSA) trial. The initial aim was to gain listing of misoprostol on the Australian National Formulary. DESIGN The economic evaluation followed a 2-stage approach in considering the cost effectiveness of misoprostol, a 'within-trial' analysis followed by a simple modelled analysis which explored the implications of the trial results for life-years saved beyond the trial setting. The perspective of the evaluation is that of the healthcare system. SETTING Three different populations were considered: the total trial population; patients with a history of peptic ulcer disease; and patients over 65 years of age. STUDY POPULATION Patient data were taken from the MUCOSA trial, which involved 8843 patients receiving continuous NSAID therapy for the control of rheumatoid arthritis. INTERVENTIONS Misoprostol plus any NSAID therapy was compared with placebo (no misoprostol) plus any NSAID therapy. MAIN OUTCOME MEASURES AND RESULTS The study found the incremental cost per definite serious gastrointestinal complication avoided with misoprostol was 39,603 Australian dollars ($A) for the total trial population, $A5599 for patients with a history of peptic ulcer disease and $A35,405 for patients over 65 years of age. The incremental cost per life-year saved with misoprostol was $A41,866 for the whole group, $A6244 for patients with a history of peptic ulcer disease and $A40,322 for patients over 65 years of age. CONCLUSIONS The study found misoprostol to be cost effective in this setting.