PrucaloprideCALOTRANS
Treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief, after failure of at least three different types of laxatives from different classes.
Decisions on record
- Meeting Nov 2012 Not recommended Treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief. no PSD
- Meeting Jul 2012 Not recommended Treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief. Before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least 6 months, bu
- Meeting Nov 2011 Not recommended Treatment of constipation.
Access path
- TGA registered · CALOTRANS
TGA label narrower than the PBS population
- Nov 2011Not recommended
uncertain clinical effectiveness in the requested PBS population, uncertain cost-effectiveness, trial population not…
- Jul 2012Not recommended
uncertain cost-effectiveness despite ICER within acceptable range, concerns about utility mapping methods, modest…
- Jul 2012Not recommended
modest and uncertain clinical effectiveness in the PBS population (small differences between prucalopride and placebo…
Cost-effectiveness
The PBAC recalled its previous concern with the different mapping techniques used to derive utility scores from the SF-36 data to AQoL in the previous submission and noted that no change had been made to the derivation of utilities in the resubmission. PBAC · 2012
Decision context
PopulationAdults with chronic functional constipation who have inadequate response to at least three different classes of laxatives (bulk forming agents, osmotic laxatives, and stimulant laxatives) at the highest tolerated recommended doses for at least 6 months.
Why it was knocked back
- modest and uncertain clinical effectiveness in the PBS population (small differences between prucalopride and placebo on primary outcome of ≥3 SCBMs per week: 10-23% across trials vs 15% in meta-analysis), inferior safety profile compared to placebo, uncertain quality of life benefits (inconsistent SF-36 results), concerns about economic model methodology (utility mapping from SF-36 to AQoL, assumption that partial responders discontinue treatment, intermittent use assumptions), potential underestimation of utilisation and financial implications
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Not recommended | best supportive care (BSC) defined as stimulant laxatives in patients who have failed to achieve adequate relief with bu | $15k–45k | RCT · SCBM per week, PAC-QOL, SF-36 |
| Jul 2012 | Not recommended | best supportive care (stimulant laxatives in patients who have failed bulk forming agents, osmotic laxatives and stimula | $15k–45k | RCT · SCBM |
| Nov 2011 | Not recommended | best supportive care | $15k–45k | RCT · SCBM per week over 1-12 weeks |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PRUCRC3001 | Ph 3 | 507 | Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movemen… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults who failed at least three different laxative classes; TGA label requires only general laxative failure.