Economic Evaluation of Tegaserod vs. Placebo in the Treatment of Patients with Irritable Bowel Syndrome: An Analysis of the TENOR Study

• Published in: Value in health 2007-07, Vol.10 (4), p.238-246
• Main Authors: Bracco, Andrea, PharmD, Jönsson, Bengt, PhD, Ricci, Jean-Francois, PhD, Drummond, Michael, PhD, Nyhlin, Henry, MD
• Format: Article
• Language: English
• Subjects: Adult; clinical trial; constipation; Cost-Benefit Analysis; Female; Health Care Costs; Humans; Indoles - economics; Internal Medicine; irritable bowel syndrome; Irritable Bowel Syndrome - drug therapy; Irritable Bowel Syndrome - economics; Irritable Bowel Syndrome - physiopathology; Male; Middle Aged; Nordic; Placebos - economics; quality of life; Quality-Adjusted Life Years; Serotonin Receptor Agonists - economics; Sweden; tegaserod; therapeutic
• ISSN: 1098-3015; 1524-4733; 1524-4733
• DOI: 10.1111/j.1524-4733.2007.00179.x

Abstract Objective 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 toestimate 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 &U20AC;2, &U20AC;3, and &U20AC;4, the ICER of tegaserod ranges between &U20AC;19,000 and &U20AC;38,000 per QALY gained, with the percentage of the bootstrap estimates below the willingness to pay level of &U20AC;50,000 per QALY gained ranging between 90% and 69%. Conclusion This study established directly from a randomized controlled clinical trial that tegaserod is cost-effective in the treatment of non-D-IBS patients.