Economic evaluation of tegaserod vs. placebo in the treatment of patients with irritable bowel syndrome: an analysis of the TENOR study.

OBJECTIVES Tegaserod is effective, safe, and well-tolerated in the treatment of patients with irritable bowel syndrome (IBS) with constipation. The aim of this study was to assess, from a payer perspective, the cost-effectiveness of tegaserod in the treatment of IBS patients, based on the TEgaserod in NORdic region (TENOR) trial data. METHODS Female and male patients (Rome II criteria) were randomized to receive tegaserod 6 mg b.i.d. or placebo for 12 weeks. Patients (247 tegaserod; 238 placebo) completed the EuroQol EQ-5D questionnaire at baseline, Week 4, and Week 12. A 12-week economic study was undertaken to assess the incremental cost-effectiveness ratio (ICER) of tegaserod in terms of cost per quality-adjusted life-year (QALY) gained. Cost-effectiveness acceptability curves were calculated to estimate the probability of tegaserod being cost-effective at different benchmark values of cost per QALY gained. RESULTS By assuming a daily drug cost to payers of Euro 2, Euro 3, and Euro 4, the ICER of tegaserod ranges between Euro 19,000 and Euro 38,000 per QALY gained, with the percentage of the bootstrap estimates below the willingness to pay level of Euro 50,000 per QALY gained ranging between 90% and 69%. CONCLUSIONS This study established directly from a randomized controlled clinical trial that tegaserod is cost-effective in the treatment of non-D-IBS patients.