PHP56 - Does Real World Evidence Support Conclusions From Experimental Evidence In Decision-Making Processes In Poland?

Abstract

The aim of the study was to identify and quantify the relation between Real World Evidence (RWE) and experimental evidence (EE) in decision-making processes on public funding of drugs in Poland. The analysis included data published by the Agency for Health Technology Assessment and Tariff System between 01.2012-09.2015. Both for RWE and EE the study type, number of participants and reliability score were analysed. Of the 58 decision-making processes RWE confirmed results of EE in 61% of cases. In 23% there was no data available for assessment of relationship between RWE and EE. The remaining 16% related to RWE negating EE both in favour or disfavour of a drug (7% and 9%, respectively). RWE accounts for less than half of the evidence considered in the processes (45%) weighted by number of patients. The patients weighted share of RWE in a single process ranges from 2% up to 100%. Studies with a control group represent 99% of EE and 90% of RWE, all weighted by number of patients. RWE was twice less frequently assessed for reliability compared to EE (48% vs. 93%). High quality evidence was more often found in EE (66%) compared to RWE (50%). In a small fraction of processes the best available evidence were low quality EE and RWE (4% vs. 6%). RWE is playing important role as it stands for nearly half of all the evidence considered in decision-making processes on public funding of drugs in Poland. In the majority of processes RWE confirms conclusions based on EE. RWE is of high quality slightly less often than EE, however it is twice less frequently assessed for reliability. As pharma companies strive to develop high quality RWE it still does not receive the attention it deserves from public funding decision makers.