ArticleHealth economics2022
Coverage with evidence development for medical devices in Europe: Can practice meet theory?
Article in Health economics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- Waiting for Trial Evidence or Using Real-World Evidence: Trade-Offs for Coverage with Evidence Development.PharmacoEconomics · 2026Review
- Breaking the "idling dilemma" of donated medical equipment: a TDABC-based analysis of health policy failure and a pathway to reform.Frontiers in public health · 2026Article
- Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia.Frontiers in public health · 2025Article
- Evidence Following Conditional NICE Technology Appraisal Recommendations: A Critical Analysis of Methods, Quality and Risk of Bias.PharmacoEconomics · 2024Article
- 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
- 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
- Pricing Treatments Cost-Effectively when They Have Multiple Indications: Not Just a Simple Threshold Analysis.Medical decision making : an international journal of the Society for Medical Decision MakingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Health economists have written extensively on the design and implementation of coverage with evidence development (CED) schemes and have proposed theoretical frameworks based on cost-effectiveness modeling and value of information analysis. CED may aid decision-makers when there is uncertainty about the (cost-)effectiveness of a new health technology at the time of reimbursement. Medical devices are potential candidates for CED schemes, as regulatory regimes do not usually require the same level of efficacy and safety data normally needed for pharmaceuticals. The purpose of this research is to assess whether the actual practice of CED for medical devices in Europe meets the theoretical principles proposed by health economists and whether theory and practice can be more closely aligned. Based on decision-makers' perceptions of the challenges associated with CED schemes, plus examples from the schemes themselves, we discuss a series of proposals for assessing the desirability of schemes, their design, implementation, and evaluation. These proposals, while reflecting the practical challenges with developing CED programs, embody many of the principles suggested by economists and should support decision-makers in dealing with uncertainty about the real-world performance of devices.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.