Blood Beta-Ketone Electrode Strips

A modelled economic evaluation was not presented. The PBAC considered that this was not appropriate since diabetes is a chronic condition and a 6-month study period may be inadequate to capture full clinical and economic consequences.

The PBAC considered that the cost effectiveness of the blood β-ketone electrodes based on a price at about twenty times the cost of the comparator was unacceptable, given the doubts about the clinical claims, and that the corresponding claimed cost off-sets would be unlikely to be realised in an Australian population. PBAC · 2006

PopulationType 1 diabetic patients (aged 3 to 22 years in the key trial) on insulin therapy who are at risk of diabetic ketosis or ketoacidosis or require management during diabetic ketosis or ketoacidosis.

• uncertain clinical benefit, uncertain and unacceptable cost-effectiveness, doubts about predicted usage and applicability to Australian patients, weak evidence based on single small trial of poor quality, concerns about false negative or false positive test results, results likely overestimated for reasons outlined