Challenges and Opportunities With Routinely Collected Data on the Utilization of Cancer Medicines. Perspectives From Health Authority Personnel Across 18 European Countries
Pisana, Alice (Karolinska Institutet (Estocolm, Suècia))
Wettermark, Björn (Vilnius University)
Kurdi, Amanj (Sefako Makgatho Health Sciences University)
Tubic, Biljana (University of Banja Luka)
Pontes García, Caridad (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Zara, Corinne (Servei Català de la Salut)
Van Ganse, Eric (Croix Rousse University Hospital (Lyon, França))
Petrova, Guenka (PharmacoEpidemiology Lyon)
Mardare, Ileana ("Carol Davila" University of Medicine and Pharmacy)
Fürst, Jurij (Health Insurance Institute)
Roig-Izquierdo, Marta (Servei Català de la Salut)
Melien, Oyvind (Oslo University Hospital (Oslo, Noruega))
Bonanno, Patricia Vella (University of Malta)
Banzi, Rita (Istituto di Ricerche Farmacologiche Mario Negri IRCCS)
Marković-Peković, Vanda (University of Banja Luka)
Mitkova, Zornitsa (PharmacoEpidemiology Lyon)
Godman, Brian (Ajman University)

Date:	2022
Abstract:	Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines. To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making. A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions. 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data accessibility as well as possibilities for linkage, and data collection is time-consuming, necessitating dedicated staff and better systems to facilitate the process. Cross-national collaboration is challenging but the engagement of multiple stakeholders is a key step to reach common goals through research. This study acts as a starting point for future research on patient-level databases for oncology across Europe. Future recommendations will require continued engagement in research, building on current initiatives and involving multiple stakeholders to establish guidelines and commitments for transparency and data sharing.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cross-national collaboration ; European countries ; Funding concerns ; New cancer medicines ; Patient-level datasets ; Pharmaceutical policy ; Pricing and reimbursement
Published in:	Frontiers in Pharmacology, Vol. 13 (june 2022) , ISSN 1663-9812

DOI: 10.3389/fphar.2022.873556
PMID: 35865969

16 p, 1.7 MB

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