Williams, Marta M;
Smith, Nathan R;
Uyl-de Groot, Carin A;
Den Uil, Corstiaan A;
Ross, Joseph S;
Mohamed, Mohamed O;
Mamas, Mamas A;
... Cram, Peter; + view all
(2025)
Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries.
Circulation: Cardiovascular Quality and Outcomes
, 18
(4)
, Article e011636. 10.1161/CIRCOUTCOMES.124.011636.
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Abstract
BACKGROUND: The authorization process and coverage/reimbursement mechanisms for medical devices play critical roles in device adoption and usage. However, international variation in these processes remains poorly characterized, especially with regard to data transparency and the effects of reimbursement on usage. // METHODS: This study examined publicly available databases, governmental agency recommendations and policies, and press releases from the United States, Canada, the United Kingdom, and the Netherlands to compare the regulatory approval processes and coverage/reimbursement mechanisms for 2 novel cardiovascular devices introduced in the early and late 2000’s: the Watchman left atrial appendage occlusion device and the Impella percutaneous ventricular assist device. In addition to qualitative comparisons for each country, this study compared the date of the first regulatory review, time from submission to review completion, device approval date, agency approval requirements, number of review cycles, and necessity of postapproval studies as determined by the regulator, date of funding decision, final funding decision, and requirements for device reimbursement by relevant government payors. // RESULTS: Authorization data were easily accessible for the United States and Canada but extremely limited for the United Kingdom and the Netherlands. Chronologically, authorization occurred ≈10 years earlier in Europe (United Kingdom and the Netherlands) than in North America (United States and Canada) for both devices. The United States was the only country where the principal public payor (Medicare) explicitly reimbursed both procedures. The United States was similarly notable for more rapid adoption and higher utilization of both devices than the other countries, with the Watchman implanted at 3.4 devices per 100 000 adults annually and Impella used in 7 to 8 procedures per 100 000 people annually. In contrast, uptake was far lower in Canada and Europe. // CONCLUSIONS: This research provides insights into how differences among countries in authorization and reimbursement mechanisms may impact the adoption and usage of medical devices, and may inform future policies on these processes.
| Type: | Article |
|---|---|
| Title: | Variations in the Medical Device Authorization and Reimbursement Landscape: A Case Study of 2 Cardiovascular Devices Across 4 Countries |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1161/CIRCOUTCOMES.124.011636 |
| Publisher version: | https://doi.org/10.1161/circoutcomes.124.011636 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Atrial fibrillation; biomedical technology; equipment and supplies; Health Care Economics and Organizations; heart failure; heart-assist devices; left atrial appendage closure |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics > Clinical Epidemiology |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10207067 |
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