ArticleThe European journal of health economics : HEPAC : health economics in prevention and care2021
Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges.
Article in The European journal of health economics : HEPAC : health economics in prevention and care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evidence integration and bridging methodologies for high-risk and innovative medical devices andFrontiers in medicine · 2026Pooled it
- Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.Public health reviews · 2024Pooled it
- Leveraging generative artificial intelligence for the development of non-interventional research study protocols: a proof-of-concept feasibility study.BMC medical research methodology · 2026Article
- Health Technology Assessment and Cardiology: A Review of the Present and Future of Innovation.Journal of market access & health policy · 2025Review
- Mind the (research) gap: a retrospective observational study on the utilization of new medical technologies and related research activities in German hospitals.Health research policy and systems · 2025Observational
- Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia.Frontiers in public health · 2025Article
- Health technology assessment and innovation: here to help or hinder?International journal of technology assessment in health care · 2024Review
- Coverage with evidence development program on stereotactic body radiotherapy in Belgium (2013-2019): a nationwide registry-based prospective study.The Lancet regional health. Europe · 2024Article
- Knowledge management tools and mechanisms for evidence-informed decision-making in the WHO European Region: a scoping review.Health research policy and systems · 2023Article
- Utilization of innovative medical technologies in German inpatient care: does evidence matter?Health research policy and systems · 2023Review
- International Market Access Strategies for Artificial Intelligence-Based Medical Devices: Can We Standardize the Process to Faster Patient Access?Mayo Clinic proceedings. Digital health · 2023Article
- Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers.Journal of market access & health policy · 2023Review
- CMS Coverage With Evidence Development-Challenges and Opportunities for Improvement.JAMA health forum · 2022Article
- Coverage with evidence development for medical devices in Europe: Can practice meet theory?Health economics · 2022Article
- Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries.Health economics · 2022Article
- Exploring the misalignment on the value of further research between payers and manufacturers. A case study on a novel total artificial heart.Health economics · 2022Article
- European union regulation of health technology assessment: what is required for it to succeed?The European journal of health economics : HEPAC : health economics in prevention and care · 2022Article
- Evidence-based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved.Journal of medical imaging and radiation oncology · 2022Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
objectivesMedical devices are potentially good candidates for coverage with evidence development (CED) schemes, as clinical data at market entry are often sparse and (cost-)effectiveness depends on real-world use. The objective of this research was to explore the diffusion of CED schemes for devices in Europe, and the factors that favour or hamper their utilization.
methodsWe conducted structured interviews with 25 decision-makers from 22 European countries to explore the characteristics of existing CED programmes for devices, and how decision makers perceived 13 pre-identified challenges associated with initiating and operating CED schemes for devices. We also collected data on individual schemes that were either initiated or still ongoing in the last 5 years.
resultsWe identified seven countries with CED programmes for devices and 78 ongoing schemes. The characteristics of CED programmes varied across countries, including eligibility criteria, roles and responsibilities of stakeholders, funding arrangements, and type of decisions being contemplated at the outset of each scheme. We observed a high variability in how decision makers perceived CED-related challenges possibly reflecting country-specific arrangements and different experiences with CED. One general finding across all countries was that relatively little attention was paid to the evaluation of schemes, both during and at their completion.
conclusionsCED programmes for devices with different characteristics exist in Europe. Decision-makers' perceptions differ on the challenges associated with these schemes. More exchange of knowledge and experience will help decision makers anticipate the likely challenges in CED schemes for devices, and to learn from good practices existing elsewhere.
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Registered trials
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