Impact of patient outcomes and cost aspects on reimbursement recommendations in Poland in 2012-2014.

The aim of this study was to assess the influence of different factors on the final reimbursement recommendations for drugs in Poland and to identify the correlation between these factors and the probability of a positive reimbursement recommendation for an applicant drug issued by the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT). We analysed all recommendations for the period of 2012-2014 in Poland, three years following the launch of the new Reimbursement Act of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices. For each recommendation we collected data on efficacy, safety, cost of therapy, cost-effectiveness, quality of evidence, orphan drug status and others. Logistic regression was used to identify factors that increase the odds of a positive reimbursement recommendation. We analysed 221 recommendations for drugs, of which 78% were positive. We observed significant associations of all selected factors with positive recommendations. Proven efficacy and safety were associated with much greater odds for a positive reimbursement recommendation (123.5 and 42.6, respectively) than cost factors, which may suggest that patient outcome is much more important than the results of the cost-effectiveness analysis (odds ratio of 3.5) and the general cost of therapy (odds ratio of 3) in the analysed period.