Abstract
This study outlines the ways in which different health technology assessment (HTA) organizations deal with uncertainty in relative effectiveness assessments (REAs), using the GRADE framework as a common reference. Guidelines regarding REA and uncertainty assessment methods and three most recent HTA reports (as of April 2020) of seven HTA organizations in Germany, England and Wales, France, the Netherlands, Europe (EUnetHTA), the USA, and Canada were included. First, it was analyzed how each organization addressed uncertainty on the following levels of evidence: (i) individual studies, (ii) body of evidence for one outcome, (iii) body of evidence across all outcomes, and (iv) added net benefit. Second, the extent to which HTA organizations considered the eight domains of certainty of evidence defined by GRADE was assessed. For individual studies, checklists were the most common approach to express uncertainty (4/7 organizations). Uncertainty in the body of evidence for all outcomes and in added benefit was combined in a single conclusion by five organizations. All organizations reported on at least 4/5 downgrading domains of GRADE, while the three upgrading domains were reported less. The operationalization of the assessment of multiple domains was unclear due to vague or absent guidelines. HTA organizations consider most domains of the GRADE framework, but approaches to assess uncertainty within REAs on different levels of evidence differ substantially between organizations. More alignment and guidance on the best methods to deal with uncertainty within HTA could lead to more clarity for stakeholders and to more aligned reimbursement recommendations.
Highlights
In order to benefit from approved drugs, patients usually require drugs to be reimbursed by publicly funded healthcare systems
To assess the methods employed by the different health technology assessment (HTA) organizations, we aimed to analyze and compare the role that uncertainty played within their relative effectiveness assessments (REAs), based on publicly available guidelines and a set of three assessment reports per organization
In the guidelines of IQWiG, certainty is explicitly stated as a goal of the REA process, with the relevant guidelines giving a clear picture on the approach that IQWiG pursues
Summary
In order to benefit from approved drugs, patients usually require drugs to be reimbursed by publicly funded healthcare systems. Funding of drugs often follows a positive recommendation by a health technology assessment (HTA) organization. HTA bodies perform at least a relative effectiveness assessment (REA) compared with existing care standards (comparators), and sometimes incorporate other aspects in their evaluations, for example, cost-effectiveness assessments (CEA). Each HTA organization has its own set of preferred methods and processes and codifies its conclusions in different ways. HTA bodies follow evidence-based medicine (EBM) principles and endorse international frameworks assisting evidence assessment and decision-making [e.g., the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework], the criteria considered, and the weight attributed to each of them may vary widely [2;4]
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