The presented review of methodological guidelines for health economic evaluations and the consequent recommendations will hopefully improve the comparability, transferability and overall usefulness of economic evaluations performed within EUnetHTA. Nevertheless, there are still methodological issues that need to be investigated further.
Objectives: The aim of this study was to review and compare current health
technology assessment (HTA) activities for medical devices across non-European Union HTA
agencies.Methods: HTA activities for medical devices were evaluated from three
perspectives: organizational structure, processes, and methods. Agencies were primarily
selected upon membership of existing HTA networks. The data collection was performed in
two stages: stage 1–agency Web-site assessment using a standardized questionnaire,
followed by review and validation of the collected data by a representative of the agency;
and stage 2–semi-structured telephone interviews with key informants of a sub-sample of
agencies.Results: In total, thirty-six HTA agencies across twenty non-EU countries
assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies
were judged at stage 1 to have adopted HTA-specific approaches for medical devices
(MD-specific agencies) that were largely organizational or procedural. There appeared to
be few differences in the organization, process and methods between MD-specific and
non–MD-specific agencies. Although the majority (69 percent) of both categories of agency
had specific methods guidance or policy for evidence submission, only one MD-specific
agency had developed methodological guidelines specific to medical devices. In stage 2,
many MD-specific agencies cited insufficient resources (budget, skilled employees), lack
of coordination (between regulator and reimbursement bodies), and the inability to
generalize findings from evidence synthesis to be key challenges in the HTA of medical
devices.Conclusions: The lack of evidence for differentiation in scientific methods
for HTA of devices raises the question of whether HTA needs to develop new methods for
medical devices but rather adapt existing methodological approaches. In contrast,
organizational and/or procedural adaptation of existing HTA agency frameworks to
accommodate medical devices appear relatively commonplace.
SARS-CoV-2, a serious threat to sustainable development prospects, is spreading within countries at varying speeds, among other things depending on their population density, behavioural responses, cultural factors, personal hygiene practices and habits. This has led to significant variation in countries’ policy responses aimed at stemming the proliferation of the virus. Using crisp-set qualitative comparative analysis, we conducted a comparative study at the European level to study the performance of different combinations of COVID-19 containment measures along with the response speeds. A set of configurations for two different scenarios (above- and below-median death rates) helps to illustrate how specific containment measures in each examined European country are related to the number of deaths. The main observation arising from the analysis is that the speed of response along with the decision to suspend international flights might determine the epidemic outbreak’s impact on fatality. The results also imply that several different combinations of containment measures are associated with death rates across Europe. The outcome of this analysis can assist in identifying which set of containment measures in the event of an epidemic outbreak is beneficial/detrimental.
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