PHP57 - Real World Evidence In Decision-Making Processes On Public Funding Of Drugs In Poland

Abstract

Real World Evidence (RWE) is data from actual medical practice related to efficacy, safety and costs in opposition to experimental settings. The aim of this study was to assess the use and impact of RWE in decision-making processes in Poland. The analysis was based on data from the Agency for Health Technology Assessment and Tariff System (AOTMiT) published between 01.2012-09.2015 in Verification Analyses (VA), Statements of the Transparency Council (STC) and Recommendations of the President of AOTMiT (RPA). RWE 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%). In up to ¾ of RWE including processes, RWE was not evaluated. When RWE was assessed, AOTMiT analysts and the President slightly more often judged that it was insufficient than sufficient (10% vs 9% and 14% vs 12%, respectively), while the TC was nearly twice more restrictive (19% vs 10%). The longitudinal analysis of RWE in AOTMiT evaluations shows steady increase in the number of processes with RWE in 2012-2014 (31, 40, 64 processes) with apparent decline in 2015 to estimated 36 processes p.a. The share of processes with RWE had a peak in 2014 (59% vs 48% in both 2012 and 2013). The share for 2015 including September data is 36%, which is the lowest in the analysed period. 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 AOTMiT. A growing importance of RWE can be observed, however, the sustainability of this growth remains uncertain.