PBAC's latest decision on Prucalopride: Not recommended (2012). Considered for For the initial and continuing treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
2
first 2011
Submissions
2
2011 → 2012
Eligible population
adults with chronic functional constipation who have failed to achieve adequate relief from at least three different classes of laxatives
best supportive care (BSC) defined as stimulant laxatives in patients who have failed to achieve adequate relief with bulk forming agents, osmotic laxatives and stimulant laxatives
Economic model
CUA
Eligible patients/year
75,000
ICER basis
Range aggregates 2 submissions (2011–2012) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: uncertain cost-effectiveness despite ICER within acceptable range, concerns about utility mapping methods, modest clinical efficacy (around 30% vs 10% placebo achieving ≥3 SCBMs per week), limited quality of life improvements on SF-36 (inconsistent across trials), inferior safety profile compared to placebo, uncertainty in economic model assumptions (partial responders discontinuation, intermittent use impact on QoL), underestimated utilisation and financial implications, potential for use beyond intended population
Submission history
Nov 2011: Not recommended — ICER $45k/QALY
Jul 2012: Not recommended · Restricted — ICER $45k/QALY