Safety, efficacy and costs of pharmacotherapy for functional XXXX : the case of alosetron and its implications.

@entity1 @entity294 @entity1744 @entity344
BACKGROUND: Functional @entity344 cause substantial morbidity, but not mortality. Alosetron may achieve 'adequate relief ' in @entity294 -predominant @entity1744 , but may cause major complications, including death. AIM: To appraise, quantitatively, the trade-off between possible symptomatic improvement and serious complications in the treatment of functional @entity344 . METHODS: A decision analytical model was used to examine alosetron or standard treatment for 6 months in 45-year-old @entity1 with @entity294 -predominant @entity1744 using the health care system's perspective. RESULTS: Assuming a 14% higher 'adequate relief' rate with alosetron compared to standard care, and a complication rate of four per 1000 @entity1 in 6 months, alosetron gained 0.00081 quality-adjusted life-years (QALYs) per @entity1 at a cost of 358,700 US dollars per QALY gained. Alosetron gained QALYs if 'adequate relief' increased the @entity1 ' utility by more than 0.01 in the base case. In probabilistic analysis, alosetron gained QALYs in 98.2% of iterations at a median cost of 212,600 US dollars per QALY (interquartile range, 138,000-338,900 US dollars per QALY). Results were highly sensitive to the utility gain with 'adequate relief' and alosetron's response and complication rates. CONCLUSIONS: Alosetron's benefit-to-risk profile appears to be favourable, but its cost per QALY gained may be substantial. Decision analyses on treatments for functional @entity344 are likely to be highly sensitive to the utility estimates used. There is a pressing need for direct utility measurements in functional @entity344 .
