Future of Data Analytics in the Era of the General Data Protection Regulation in Europe

The development of evidence to demonstrate ‘value for money’ is regarded as an important step in facilitating the search for the optimal allocation of limited resources and has become an essential component in healthcare decision making. Real-world evidence collected from de-identified individuals throughout the continuum of healthcare represents the most valuable source in technology evaluation. However, in the European Union, the value assessment based on real-world data has become challenging as individuals have recently been given the right to have their personal data erased in the case of consent withdrawal or when the data are regarded as being no longer necessary. This act may limit the usefulness of data in the future as it may introduce information bias. Among healthcare stakeholders, this has become an important topic of discussion because it relates to the importance of data on one side and to the need for personal data protection on the ot

What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries

Background Decisions on the reimbursement of the same cancer drugs are different across European countries, but empirical work on the reasons behind these differences has been scarce. The main objective of this paper is to make a methodological contribution to existing research, specifically by outlining the systematic process of analysis to address such questions and determining the factors that might lead to different drug reimbursement decisions, and to explore its application in the field of oncology. Methods Reimbursement decisions on cancer drugs in six European countries (Belgium, England, Poland, Portugal, Scotland, and Sweden) between 2006 and 2014 were included in the study. A taxonomy was developed, comprising two groups of variables (system-level and product-specific) and an econometric model was specified (multilevel mixed-effects ordered probit). Results Only one in six evaluations in the sample reach the same reimbursement recommendation. Most health system variables were not determinants of a higher or lower probability of a positive reimbursement recommendation. However, the probability of reimbursement was higher when a drug was considered cost-effective by NICE/SMC and when there was a financial Managed Entry Agreement. This work also demonstrated a possible econometric approach for analysing differences in reimbursement decisions and contributes a structured approach for collecting and preparing data for such analyses. Conclusions Drug reimbursement decisions can be analysed in detail along a set of factors that are related to each decision. This information is essential, not only for understanding why a particular drug is accepted in one country and not in another but also when trying to implement a new HTA system or reform an existing one. This analysis provides policy makers and stakeholders with a model that enables a better understanding of the factors that drive HTA decisions and is adaptable to answer similar questions. Moreover, the data collection limitations encountered and described in this work shed light on the need for greater accessibility and transparency in HTA systems and regarding HTA outcomes.This research was funded under the European 7th Framework Programme with Advance-HTA (no305,983). The results presented reflect the author’s views. The EC is not liable for any use of the information communicated