title: Study types and reliability of Real World Evidence compared with experimental evidence used in Polish reimbursement decision-making processes.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Arcana Institute, ul. Płk. Dąbka 8, 30-732 Kraków, Poland. Electronic address: nwilk@inar.pl.
authors.forename: N
authors.initials: N
authors.lastname: Wilk
authors.affiliation: Janssen-Cilag, ul. Iłżecka 24, 02-135 Warszawa, Poland. Electronic address: nwierzbi@its.jnj.com.
authors.forename: N
authors.initials: N
authors.lastname: Wierzbicka
authors.affiliation: Janssen-Cilag, ul. Iłżecka 24, 02-135 Warszawa, Poland. Electronic address: iskrzeko@its.jnj.com.
authors.forename: I
authors.initials: I
authors.lastname: Skrzekowska-Baran
authors.affiliation: Arcana Institute, ul. Płk. Dąbka 8, 30-732 Kraków, Poland. Electronic address: pmocko@inar.pl.
authors.forename: P
authors.initials: P
authors.lastname: Moćko
authors.affiliation: Arcana Institute, ul. Płk. Dąbka 8, 30-732 Kraków, Poland. Electronic address: jtomassy@inar.pl.
authors.forename: J
authors.initials: J
authors.lastname: Tomassy
authors.affiliation: Arcana Institute, ul. Płk. Dąbka 8, 30-732 Kraków, Poland. Electronic address: kkloc@inar.pl.
authors.forename: K
authors.initials: K
authors.lastname: Kloc
mesh_terms: D003657:Decision Making; D019317:Evidence-Based Medicine; D019981:Health Care Sector / Q000458:organization & administration*; D006291:Health Policy; D006801:Humans; D011044:Poland; D012051:Reimbursement Mechanisms; D015203:Reproducibility of Results; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000458:organization & administration*
keywords: Decision making; RWE; Real World Evidence; Reimbursement