Cilostazol

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.

The PBAC considered that the transformation of treadmill walking distance to flat ground equivalent walking distances undertaken to be representative of real life was probably reasonable. However, the clinical significance for treated patients of improvements in walking distance of 40.6m in a treadmill test or 94.61m after conversion to real life remained uncertain as the incremental distance is small, and it remained unclear what impact this improvement would have on a patient’s day-to-day quality of life. PBAC · 2010

Populationpatients with intermittent claudication who do not have rest pain and who do not have evidence of peripheral tissue necrosis

• 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

The Consumers Health Forum prepared a Consumer Impact Statement on the impact of intermittent claudication on daily living, identifying nocturnal cramping as a major issue and noting that the impact of claudication varied considerably among patients.

The PBAC noted the Consumer Impact Statement on the impact of intermittent claudication (IC) on daily living prepared by the Consumers Health Forum and that nocturnal cramping was identified as a major issue. Consumer comments · PSD

Label equal than PBS population — Both TGA label and PBAC recommendation specify identical patient populations and clinical endpoints for intermittent claudication.