The Evolving Landscape for Real World Evidence in Poland: Physicians' Perspective

• Autorzy: Natalia Wierzbicka , Karina Jahnz-Różyk
• Języki publikacji: EN

Abstrakty

EN

Real World Evidence is increasingly being demanded by national payers and HTA agencies to substantiate and validate outcomes from clinical trials. Yet, the access and quality of existing databases is often very limited, what creates hurdles to evaluate evidence in 'normal' healthcare setting. In Poland key stakeholders have not yet fully embraced RWE as an evidence source though they have growing need for more evidence to allocate scarce resources. The coming years are crucial for the shape and accessibility of RWE in Poland - however, the standpoint and the needs of the key stakeholders are not yet recognized. Therefore, an exploratory survey was undertaken to map current awareness and expectations of physicians related to practical outcomes data and to identify pharmaceutical industry's role in RWE generation. Consideration of stakeholder needs seems to be the natural step in the beginning of preparation for real world evidence system in Poland. The analysis showed significant physicians interest in practical evidence and broad spectrum of possible actions that can be undertaken to improve formal use of RWE in Poland. The differences in priorities between specializations are a good indicator of the unmet needs in certain therapeutic areas. Broadening doctors', payers', insurers' and service-providers' knowledge on RWE significance, raising awareness of practical implementation and improving accessibility could be crucial for shaping the RWE landscape in Poland and, consequently, for improving patient treatment results(original abstract)

Słowa kluczowe

EN

Stakeholders; Databases; Pharmaceutical industry

PL

Interesariusze; Bazy danych; Przemysł farmaceutyczny

• Czasopismo: Journal of Health Policy and Outcomes Research
• Rocznik: 2015
• Numer: nr 1
• Strony: 15--33

Twórcy

autor

Natalia Wierzbicka

• Janssen-Cilag Poland

autor

Karina Jahnz-Różyk

• Military Institute of Medicine

Bibliografia

• Garrison LP. et al., Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report. Value Health 2007; 10(5): 326-338
• Eichler HG. et al. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nature Reviews Drug Discovery, 2010; 9(4): 277-291
• Act of 12 May 2011 on reimbursement of medicinal products, foodstuffs intended for particular nutritional uses and medical devices (Polish Journal of Laws 2011, No 122, item 696, as amended)
• Polish Diabetes Association. A call for support of the national program for prevention of diabetes and related complications. 19 May 2014; Available from: http://www.cukrzyca.info.pl/aktualnosci/apel_o_popracie_narodowego_programu_przeciwdzialania_cukrzycy_i_jej_powiklaniom; [Accessed: 30.01.2015]
• Raciborski F. et al. Rejestry medyczne w reumatologii: czy w Polsce potrzebny jest rejestr reumatologiczny? Reumatologia 2012; 5(50): 416-424
• Zyśk R., Krzakowski M. Możliwości poprawy systemowego dostępu chorych do innowacyjnych metod przeciwnowotworowego leczenia w Polsce. Nowotwory; Journal of Oncology 2014 Special Edition; 20-25
• Act of 29 August 1997 on the protection of personal data, as of 26 June 2014 (Polish Journal of Laws 2014, item 1182)
• Act of 28 April 2011 on the healthcare information system (Polish Journal of Laws No 113, item 657, as amended)
• Polygenis D., ed. ISPOR Taxonomy of Patient Registries: Classification, Characteristics and Terms. Lawrenceville, NJ; 2013
• Gliklich RE., Dreyer NA., eds. Registries for Evaluating Patient Outcomes: A User's Guide. Prepared by Outcome DEcIDE Center. AHRQ Publ. No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality, April 2007 (2nd ed,). September, 2010
• Noe L. et al. Utilizing Patient Registries to Support Health Economics Research: Integrating Observational Data with Economic Analyses, Models, and Other Applications. The Official News & Technical Journal of the International Society for Pharmacoeconomics and Outcomes,Research. ISPORconnections,2005; 11(5):15

Identyfikatory

DOI

10.7365/JHPOR.2015.1.3