In 1989, Poland started to slowly release itself not only from the burden of a half-century of communist indoctrination and soviet exploitation, but also from the consequences of the Semashko model of healthcare organization: low doctors' salaries, primary care based on multispecialty groups, overdeveloped hospital infrastructure, and limited access to sophisticated interventions overcome by patients' unofficial payments. A few years after the 1998 workshop on health technology assessment (HTA) in Budapest, the first HTA reports were elaborated in the National Center for Quality Assessment in Health Care, which could mark the beginning of HTA in Poland. Several individuals and organizations have been involved in developing HTA, both from noncommercial and commercial standpoints. A goal to establish a national HTA agency appeared among the priorities of the Polish Ministry of Health in 2004 and was realized a year later. The Agency for HTA in Poland published guidelines on HTA and established a sound and transparent two-step (assessment-appraisal) process for preparing recommendations on public financing of both drugs and nondrug technologies. The recommendations of the Agency's Consultative Council were warmly welcomed by the public payer. However, the recent major restructuring of the Agency and new drug reimbursement decisions aroused doubts as to keeping transparency of the decision-making processes.
A449drugs 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.
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.
Tło: Działalność w obszarze refundacji, ze względu na silne otoczenie konkurencyjne oraz uwarunkowania prawne, wymaga doskonałej wiedzy na temat wszystkich szans i zagrożeń refundacyjnych.Metoda: W tym celu opracowano narzędzie umożliwiające sprawne i kosztowo-efektywne identyfikowanie oraz przekazywanie wszelkich informacji związanych z finansowaniem technologii medycznych ze środków publicznych. W ramach monitoringu obserwacją objęte jest ponad 1 50 różnorodnych źródeł informacji, w tym czasopisma naukowe, agencje rejestracyjne, instytucje wydające wytyczne kliniczne oraz rekomendacje refundacyjne a także internetowe wydania prasy branżowej oraz codziennej. Monitoring prowadzony jest z wykorzystaniem specjalistycznych narzędzi informatycznych.Wyniki: Odnalezione i przeselekcjonowane informacje, w postaci codziennego newslettera, przekazywane są odbiorcom za pośrednictwem zaprojektowanej w tym celu bazy komputerowej.Wnioski: Monitoring refundacyjny to użyteczne narzędzie umożliwiające identyfikację istotnych informacji związanych z refundacją oraz sprawne codzienne ich przekazywanie do określonych odbiorców.
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