WORKSHOP by Celine Le Bailly de Tilleghem (MSD Belgium & Luxembourg)

Applied statistics workshop on "The role of a statistician in pharmaceutical industries in supporting Health Technology Assessment (HTA)" by Celine Le Bailly de Tilleghem (MSD Belgium & Luxembourg)

Abstract:
In the last 10 years, Health Technology Assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Pharmaceutical companies do not only need to submit clinical trial data to regulatory agency (i.e. Food and Drug Administration or European Medicines Agency) to get marketing authorization for their innovative drugs but they also need to demonstrate clinical benefit-risk, including relative effectiveness and cost-effectiveness, to country-specific health authorities for pricing and reimbursement decisions in order to ultimately bring their drugs to the patients.
In this talk, background information on HTA processes will be provided and key differences between regulatory submission and HTA submission will be highlighted. Some of the statistical methods used in HTA submission will be presented and illustrated on oncology trials, including survival analysis with or without adjusting for treatment-switching, cost-effectiveness models, indirect treatment comparisons, matching-adjusted indirect comparisons, network meta-analysis…