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A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLAND

Published online by Cambridge University Press:  19 July 2017

Iga Lipska ,
Neil McAuslane ,
Hubert Leufkens  and
Anke Hövels
Iga Lipska
Affiliation:
Department of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Universityi.j.lipska@uu.nl
Neil McAuslane
Affiliation:
Center for Innovation in Regulatory Science
Hubert Leufkens
Affiliation:
Department of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University
Anke Hövels
Affiliation:
Department of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University
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Abstract

Objectives: The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources.

Methods: We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information.

Results: The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria.

Conclusions: While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the “pragmatic” HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

Keywords

Health technology assessmentPolandDrug reimbursement
Type
Theme Submissions
Information
International Journal of Technology Assessment in Health Care , Volume 33 , Issue 3: Theme: HTA in Central-Eastern-Southern Europe , 2017 , pp. 350 - 357
Copyright
Copyright © Cambridge University Press 2017 

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References

REFERENCES

1. Garrido, MV, Kristensen, FB, Nielsen, CP, Busse, R. Health technology assessment and health policy-making in Europe. European Observatory of Health Systems and Policies 2008. http://www.euro.who.int/__data/assets/pdf_file/0003/90426/E91922.pdf?ua=1 (accessed November 9, 2016).Google Scholar
2. Cleemput, I, Franken, M, Koopmanschap, M, le Polain, M. European drug reimbursement systems' legitimacy: Five-country comparison and policy tool. Int J Technol Assess Health Care. 2012;28:358-366.Google Scholar
3. Banta, D, Kristensen, FB, Jonsson, E. A history of health technology assessment at the European level. Int J Technol Assess Health Care. 2009;25 (Suppl 1):68-73.Google Scholar
4. Gulacsi, L, Rotar, AM, Niewada, M, et al. Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria. Eur J Health Econ. 2014;(Suppl 1):S13-S25.Google Scholar
5. Nizankowski, R, Wilk, N. From idealistic rookies to a regional leader: The history of health technology assessment in Poland. Int J Technol Assess Health Care. 2009;25 (Suppl 1):156-162.CrossRefGoogle ScholarPubMed
6. Kaló, Z, Gheorghe, A, Huic, M, Csanádi, M, Kristensen, FB. HTA Implementation roadmap in central and eastern European countries. Health Econ. 2016;25:179-192.Google Scholar
7. OECD Statistics. http://stats.oecd.org/ (accessed September 13, 2016).Google Scholar
8. Ozieranski, P, McKee, M, King, L. Pharmaceutical lobbying under postcommunism: Universal or country-specific methods of securing state drug reimbursement in Poland? Health Econ Policy Law. 2012;7:175-195.CrossRefGoogle ScholarPubMed
9. The Law on the reimbursement of medicinal products, special purpose dietary supplements and medical devices. http://isap.sejm.gov.pl/DetailsServlet?id=WDU20111220696 (accessed November 9, 2016).Google Scholar
10. European Commission. Transparency directive. http://ec.europa.eu/growth/sectors/healthcare/competitiveness/products-pricing-reimbursement/transparency-directive/index_en.htm (accessed November 9, 2016).Google Scholar
11. Sagan, A, Panteli, D, Borkowski, W, et al. Poland health system review. Health Syst transit. 2011;13:1-193.Google Scholar
12. Kawalec, P, Sagan, A, Stawowczyk, E, Kowalska-Bobko, I, Mokrzycka, A. Implementation of the 2011 Reimbursement Act in Poland: Desired and undesired effects of the changes in reimbursement policy. Health Policy. 2016;120:356-361.CrossRefGoogle ScholarPubMed
13. Zagorska, A, Krol, Z, Lipska, I, et al. Case 1 Implementation of transparent process of drug reimbursement decisions in Poland. Value Health. 2008;11:A348-A349.Google Scholar
14. Lipska, I. HTA capacity building using international experience and know how. Presentation at TAIEX workshop, Croatia, Zagreb Dec 2010. http://ec.europa.eu/enlargement/taiex/dyn/taiex-events/library/detail_en.jsp?EventID=43260 (accessed June 2, 2016).Google Scholar
15. AOTMiT. Wytyczne oceny technologii medicznych (HTA). http://www.aotm.gov.pl/www/hta/wytyczne-hta/ (accessed November 9, 2016).Google Scholar
16. Skóra, K, Wilk, N. Rada swoje, urzędnicy swoje. Menedżer Zdrowia. 2014;9.Google Scholar
17. Getmedi analysis from http://getmedi.pl/static/grafika/articles/0052/wykres2.png (accessed November 9, 2016).Google Scholar
18. http://www.zdrowie.abc.com.pl/artykuly/infarma-protestuje-przeciwko-naciskom-wywieranym-na-aotmit-przez-ministra-zdrowia,2859.html (accessed November 9, 2016).Google Scholar
19. Getmedi analysis from http://getmedi.pl/static/grafika/articles/0027/wykres1a.png (accessed November 9, 2016).Google Scholar
20. Ministry of Health information from http://www.mz.gov.pl/aktualnosci/refundacja-leku-incruse/ (accessed November 9, 2016).Google Scholar
21. Ozierański, P, King, L. The persistence of cliques in the post-communist state. The case of deniability in drug reimbursement policy in Poland. Br J Sociol. 2016;67:216-241.Google Scholar
22. Niewada, M, Polkowska, M, Jakubczyk, M, Golicki, D. What influences recommendations issued by the agency for health technology assessment in Poland? A glimpse into decision makers’ preferences. Value Health Reg Issues. 2013;2:267-272. doi:10.1016/j.vhri.2013.05.002 Google Scholar
23. Getmedi analysis from http://getmedi.pl/static/grafika/articles/0065/wykres4.png (accessed November 9, 2016).Google Scholar
24. Getmedi analysis from http://getmedi.pl/static/grafika/articles/0065/wykres9.png (accessed November 9, 2016).Google Scholar
25. 2015 EY Report. “The availability of innovative oncology drugs in Poland and in European Union countries and Switzerland” for Alivia Oncology Fundation from https://www.alivia.org.pl/raport2015/15_04_2015_Raport_innowacyjne_leki.pdf (accessed November 9, 2016).Google Scholar
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