Dataset Information

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands.

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.

SUBMITTER: Nuijten MJ

PROVIDER: S-EPMC4396353 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands.

Nuijten Mark J C MJ Dubois Dominique J DJ Joseph Alain A Annemans Lieven L

Frontiers in pharmacology 20150414

<h4>Objective</h4>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.<h4>Methods</h4>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, publish ...[more]

PMID: 25926794

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Project description:Prucalopride is a selective, high-affinity, 5-hydroxytryptamine (serotonin) type 4 (5-HT4) receptor agonist with gastrointestinal prokinetic activities. This integrated analysis of data from three double-blind phase III trials (ClinicalTrials.gov: NCT00488137, NCT00483886, NCT00485940) compared the efficacy and safety of prucalopride 2?mg once daily in women with chronic constipation [?2 spontaneous complete bowel movements (SCBM) per week] in whom laxatives had failed to provide adequate relief with that in the all-patient (AP) population of men and women with chronic constipation who had or had not obtained relief from laxatives.Patients received prucalopride 2?mg or placebo once-daily for 12 weeks. Efficacy endpoints included an average of ?3 SCBM/week and average increases of ?1 SCBM/week and ?1 SBM/week over this period. A response on any of these three endpoints was considered to be clinically relevant, and an overall response rate was derived for patients satisfying any of these endpoints.Of the AP population (n?=?1318), 936 were women in whom laxatives had failed to provide adequate relief (WLF). More patients on prucalopride 2?mg than placebo had an average of ?3 SCBM/week (AP 24.4 vs 11.0%; WLF 24.7 vs 9.2%), an average increase of ?1 SCBM/week (AP 43.5 vs 24.8%; WLF 44.2 vs 22.6%), and an average increase of ?1 SBM/week (AP 66.7 vs 38.4%; WLF 68.3 vs 37.0%) (all p?<?0.001). Significant differences from placebo were evident in week 1 and sustained thereafter. Overall response rates in the AP and WLF populations, respectively, were 69.7 and 71.0% with prucalopride 2?mg and 44.5 and 41.6% with placebo (p?<?0.001). Early (weeks 1-4) response predicted ultimate response over time. Common (>10%) adverse events were abdominal pain, nausea, diarrhoea, and headache.Prucalopride 2?mg once daily is effective in WLF. The efficacy and safety profile observed in WLF was similar to that in the total evaluated population of patients with chronic constipation who had or had not obtained adequate relief from laxatives.

Dataset Information

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands.

Publications

Cost-effectiveness of prucalopride in the treatment of chronic constipation in the Netherlands.

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