PBAC's latest decision on Cilostazol: Not recommended (2010). Considered for the symptomatic improvement of intermittent claudication as indicated by increased maximal and pain-free walking distances in patients who do not have rest pain and who do not have evidence of peripheral tissue necrosis.
PBAC outcome
Not recommended
2010
ICER (AUD/QALY)
$200k/QALY
$105k/QALY–$200k/QALY · across 2 submissions
Submissions
2
first 2009
Submissions
2
2009 → 2010
Eligible population
patients with intermittent claudication who do not have rest pain and who do not have evidence of peripheral tissue necrosis
Therapy area
Other
Evidence base
RCT
Primary endpoint
QoL, walking distance
Key trials
O’Donnell 2009a, O’Donnell 2009b
Comparator
placebo
Economic model
CUA
ICER note
Sponsor claimed cost per QALY is not meaningful and could not be reliably estimated. PBAC considered the attempted cost per QALY not reliable nor informative due to methodological and dataset issues.
ICER basis
Range aggregates 2 submissions (2009–2010) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: uncertain clinical benefit, uncertain cost-effectiveness, no statistically significant differences in quality of life (QoL) between cilostazol and placebo, uncertain clinical significance of walking distance improvements (40.6m treadmill or 94.61m real-life equivalent), unclear impact on day-to-day quality of life, high and uncertain cost-effectiveness ratio, uncertain estimates of use