Abstract
Objective: To assess the cost-effectiveness of prucalopride vs. continued laxative treatment for chronic constipation in patients in the Netherlands in whom laxatives have failed to provide adequate relief.Methods: A Markov model was developed to estimate the cost-effectiveness of prucalopride in patients with chronic constipation receiving standard laxative treatment from the perspective of Dutch payers in 2011. Data sources included published prucalopride clinical trials, published Dutch price/tariff lists, and national population statistics. The model simulated the clinical and economic outcomes associated with prucalopride vs. standard treatment and had a cycle length of 1 month and a follow-up time of 1 year. Response to treatment was defined as the proportion of patients who achieved “normal bowel function”. One-way and probabilistic sensitivity analyses were conducted to test the robustness of the base case.Results: In the base case analysis, the cost of prucalopride relative to continued laxative treatment was € 9015 per quality-adjusted life-year (QALY). Extensive sensitivity analyses and scenario analyses confirmed that the base case cost-effectiveness estimate was robust. One-way sensitivity analyses showed that the model was most sensitive in response to prucalopride; incremental cost-effectiveness ratios ranged from € 6475 to 15,380 per QALY. Probabilistic sensitivity analyses indicated that there is a greater than 80% probability that prucalopride would be cost-effective compared with continued standard treatment, assuming a willingness-to-pay threshold of € 20,000 per QALY from a Dutch societal perspective. A scenario analysis was performed for women only, which resulted in a cost-effectiveness ratio of € 7773 per QALY.Conclusion: Prucalopride was cost-effective in a Dutch patient population, as well as in a women-only subgroup, who had chronic constipation and who obtained inadequate relief from laxatives.
Highlights
Constipation is a common condition that may be managed by self-medication or medical consultation
One-way sensitivity analyses showed that the model was most sensitive in response to prucalopride; incremental cost-effectiveness ratios ranged from e 6475 to 15,380 per quality-adjusted life-year (QALY)
Probabilistic sensitivity analyses indicated that there is a greater than 80% probability that prucalopride would be cost-effective compared with continued standard treatment, assuming a willingness-to-pay threshold of e 20,000 per QALY from a Dutch societal perspective
Summary
Constipation is a common condition that may be managed by self-medication or medical consultation. A consensus definition of chronic constipation, known as the Rome III criteria, requires a patient to have experienced at least two of the following symptoms over the previous 3 months: fewer than three bowel movements per week; at least 25% of defecations with straining; lumpy or hard stools; sensation of anorectal obstruction; sensation of incomplete defecation; and manual manipulation required to defecate. The Rome III criteria note that loose stools are rarely present without the use of laxatives and that a patient’s symptoms should not meet the defined criteria for irritable bowel syndrome. Despite limited data supporting their use in clinical practice, these lifestyle changes promote general health and may improve bowel symptoms in some patients (Chung et al, 1999; Meshkinpour et al, 1998; Annells and Koch, 2003; Dukas et al, 2003). The management of chronic constipation is multifaceted and complex (Dennison et al, 2005)
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