By blending expertise in clinical science, data analysis, and reimbursement decision-making Pharmatelligence help our clients demonstrate the true value of their products.

Typically we start by understanding the burden-of-illness for a given therapeutic indication as measured by healthcare resource use, quality of life impact and societal cost. This often involves primary analysis of anonymised patient-level routine health databases.

Next we examine the pivotal clinical study data to understand how clinical effectiveness translates into cost-effectiveness. Key to this is understanding the relationship between study endpoints and health gain. This often involves post hoc analysis to identify high-efficacy patient sub-groups.

Case study 1 - Analogue Basal Insulin

Economic evaluation in diabetes is usually based on a surrogate biochemical endpoint, glycated haemoglobin. The pivotal clinical trial data for this novel basal analogue insulin suggested a stronger value case for reducing nocturnal and symptomatic hypoglycaemia, common events among users of insulin. We co-ordinated a multinational survey of patients with diabetes to objectively assess how hypoglycaemia affected their quality of life. Click here to find out more.

From this we were able to determine that in addition to instantaneous loss of QoL with each hypoglycaemic episode, patients with diabetes experienced longer-term anxiety about future hypoglycaemia leading to more persistent loss of utility. Economic evaluation based on reduction in hypoglycaemia helped convince UK authorities that this product represented good value for money.

Case study 2 - Transdermal Neuropathic Pain Treatment

Our client sought reimbursement approval across major European markets for a novel transdermal treatment for neuropathic pain requiring only quarterly application. We worked extensively with the client to broaden their understanding of high efficacy subgroups within the pivotal clinical trial data. Economic evaluations based on these subgroups have supported positive approval decisions from several European governmental healthcare reimbursement agencies.