Adoption of Real World Evidence in decision-making processes on public funding of drugs in Poland

Abstract

Background: The aim of the study was to assess the use and impact of RWE in decision-making processes on public funding of drugs in Poland. Methods: The analysis was based on data from the Agency for Health Technology Assessment and Tariff System (AOTMiT) in Poland published between January 2012 and September 2015 in Verification Analyses (VA), Statements of the Transparency Council (STC) and Recommendations of the President of AOTMiT (RPA). Results: RWE related to effectiveness or safety was identified in 53% of VAs, 21% of STCs and 35% of RPAs. Predominantly, RWE was included in reimbursement applications by MAH, however in 4% of VAs AOTMiT analysts found RWE themselves. Most of RWE related to safety (89%) and less to effectiveness (55%). The longitudinal analysis of RWE in AOTMiT evaluations shows steady increase in the number of processes with RWE in 2012–2014 with apparent decline in 2015 to estimated 36 processes p.a. Furthermore, the share of processes with RWE had a peak in 2014 (59% vs. 48% in both 2012 and 2013). Conclusions: RWE on effectiveness or safety is identified in surprising 53% of decision-making processes on public funding of drugs in Poland. Applications with RWE more often had a positive Statement/Recommendation/Decision compared to those without RWE. There is a considerable lack of consistency in identification of RWE on the three distinct levels of assessment and appraisal within the HTA Agency. A growing importance of RWE can be observed in Poland, however, the pace of the growth will mainly depend on building capabilities of the stakeholders in healthcare system.