Study types and reliability of Real World Evidence compared with experimental evidence used in Polish reimbursement decision-making processes

Objectives: The aim of this study was to identify the relationship and impact between Real World Evidence (RWE) and experimental evidence (EE) in Polish decision-making processes for the drugs from selected Anatomical Therapeutic Chemical (ATC) groups. Study design: Descriptive study. Methods: A detailed analysis was performed for 58 processes from five ATC code groups in which RWE for effectiveness, or effectiveness and safety were cited in Agency for Health Technology Assessment and Tariff System's (AOTMiT) documents published between January 2012 and September 2015: Verification Analysis of AOTMiT, Statement of the Transparency Council of AOTMiT, and Recommendation of the President of AOTMiT. Results: In 62% of the cases, RWE supported the EE and confirmed its main conclusions. The majority of studies in the EE group showed to be RCTs (97%), and the RWE group included mainly cohort studies (89%). There were more studies without a control group within RWE compared with the EE group (10% vs 1%). Our results showed that EE are more often assessed using Jadad, NICE or NOS scale by AOTMiT compared with RWE (93% vs 48%). When the best evidence within a given decision-making process is analysed, half of RWE and two-thirds of EE are considered high quality evidence. Conclusions: RWE plays an important role in the decision-making processes on public funding of drugs in Poland, contributing to nearly half (45%) of all the evidence considered. There exist such processes in which the proportion of RWE is dominant, with one process showing RWE as the only evidence presented. (C) 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.