Real‐world evidence in health technology assessment of high‐risk medical devices: Fit for purpose?

Klein, Philip Charles Gerard; Blommestein, Hedwig M.; Al, Maiwenn; Pongiglione, Benedetta; Torbica, Aleksandra; Groot, Saskia de

doi:10.1002/hec.4575

Cited by 6 publications

(3 citation statements)

References 54 publications

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“…What our findings add to these studies is the understanding that, although HTA practitioners recognize the relevance of other types of evidence and methods, they are committed to existing epistemological principles (e.g., evidence hierarchy, risk of bias) that automatically downgrade non-RCT data, effectively excluding it from having an impact on recommendations as previously observed in a study on real-world data policies for HTA of drugs (27). HTA scholars have also expressed critique on the quality of real-world evidence used in HTAs of high-risk medical devices (28).…”

Section: Discussionmentioning

confidence: 99%

Assessing medical devices: a qualitative study from the validate perspective

Bloemen,

Oortwijn

2024

Int J Technol Assess Health Care

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Objectives: Our objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods. Methods: An online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the "values in doing assessments of health technologies" approach towards HTA, which states that HTA addresses value-laden questions and information. Results: The current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult. Conclusions: There is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.

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Section: Discussionmentioning

confidence: 99%

Assessing medical devices: a qualitative study from the validate perspective

Bloemen,

Oortwijn

2024

Int J Technol Assess Health Care

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“…The COMED project offered new insights for addressing these challenges, providing novel empirical evidence on the actual and potential use of RWD and RWE in the HTA of medical devices. In reference to the actual use of RWD to inform HTA of medical devices, Klein and colleagues investigated the type and the quality of evidence used to assess the (cost) effectiveness of high‐risk medical devices (Class III) by HTA agencies in Europe (Klein et al., 2022). Their results suggest that even though HTA agencies have paid increasing attention to the RWD and RWE, the quality of evidence included in HTA reports is generally of poor quality.…”

Section: Research Aim 1: Improving the Evaluation Of Medical Devicesmentioning

confidence: 99%

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

Torbica

Tarricone

Schreyögg³

et al. 2022

Health Economics

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Health technologies defined broadly embrace a range of applications of organized knowledge and skills in the form of pharmaceuticals, medical devices, vaccines, medical and surgical procedures, and systems developed to improve health. Within this broad definition, medical devices include a wide-ranging and heterogeneous group of health technologies that are used to diagnose illness, to monitor treatments, to treat acute and chronic illnesses, and to assist disabled people. The European Union (EU) market has over 500,000 types of medical devices. With an estimated market size of roughly €100 billion, medical devices account for about 7.5% of healthcare expenditure in most publicly funded healthcare systems. These technologies are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to policy makers. The challenge is to adopt policies to allow access to safe and effective technologies while providing adequate incentives to the industry to invest in research and development of new products.In the effort to properly address these challenges and overcome the gaps of the past, policy makers in Europe have for years discussed new rules for licensing and market access of medical devices in the EU market. These long discussions resulted in

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“…1 Regulatory agencies from several countries now recognize the usefulness of RWE, [1][2][3][4][5] as do health technology assessment (HTA) agencies, payers, physicians, and other key decision makers. [6][7][8][9] While the increasing importance of RWD is clear, the challenges associated with its use to generate robust and rigorous RWE are less well understood.…”

Section: Introductionmentioning

confidence: 99%

Use of Healthcare Claims Data to Generate Real-World Evidence on Patients With Drug-Resistant Epilepsy: Practical Considerations for Research

Stamas,

Vincent,

Evans

et al. 2024

Journal of Health Economics and Outcomes Research

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Objectives: Regulatory bodies, health technology assessment agencies, payers, physicians, and other decision-makers increasingly recognize the importance of real-world evidence (RWE) to provide important and relevant insights on treatment patterns, burden/cost of illness, product safety, and long-term and comparative effectiveness. However, RWE generation requires a careful approach to ensure rigorous analysis and interpretation. There are limited examples of comprehensive methodology for the generation of RWE on patients who have undergone neuromodulation for drug-resistant epilepsy (DRE). This is likely due, at least in part, to the many challenges inherent in using real-world data to define DRE, neuromodulation (including type implanted), and related outcomes of interest. We sought to provide recommendations to enable generation of robust RWE that can increase knowledge of “real-world” patients with DRE and help inform the difficult decisions regarding treatment choices and reimbursement for this particularly vulnerable population. Methods: We drew upon our collective decades of experience in RWE generation and relevant disciplines (epidemiology, health economics, and biostatistics) to describe challenges inherent to this therapeutic area and to provide potential solutions thereto within healthcare claims databases. Several examples were provided from our experiences in DRE to further illustrate our recommendations for generation of robust RWE in this therapeutic area. Results: Our recommendations focus on considerations for the selection of an appropriate data source, development of a study timeline, exposure allotment (specifically, neuromodulation implantation for patients with DRE), and ascertainment of relevant outcomes. Conclusions: The need for RWE to inform healthcare decisions has never been greater and continues to grow in importance to regulators, payers, physicians, and other key stakeholders. However, as real-world data sources used to generate RWE are typically generated for reasons other than research, rigorous methodology is required to minimize bias and fully unlock their value.

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Real‐world evidence in health technology assessment of high‐risk medical devices: Fit for purpose?

Cited by 6 publications

References 54 publications

Assessing medical devices: a qualitative study from the validate perspective

Assessing medical devices: a qualitative study from the validate perspective

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

Use of Healthcare Claims Data to Generate Real-World Evidence on Patients With Drug-Resistant Epilepsy: Practical Considerations for Research

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