Coverage with evidence development schemes for medical devices in Europe: characteristics and challenges

Abstract

Objectives Medical 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. Methods We 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. Results We 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. Conclusions CED 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.

Implementation of coverage with evidence development schemes for medical devices: A decision tool for late technology adopter countries

“…In some countries the process of developing a scheme is very centralized (e.g., Germany, England), so selection of the MD for CED and the protocol is decided by national public bodies, whereas in other countries the studies are mainly a responsibility of manufacturers or health care providers. In the former group, sharing of ex‐ante information on the study design (i.e., before the scheme initiation) is more likely (e.g., details are published in the authorizing decree from the relevant health authority; Federici et al., 2021). In general, in countries where there is a more established and transparent HTA system, it is more likely to find relevant information.…”

“…The RWE generated in CED schemes through public health care financing must be a global public good that provides valuable evidence base not only to local decisions, but also for patients and health care professionals seeking for reliable information all over the world. Some countries encourage the involvement of academic groups in CED schemes, as an independent party in the collection and analysis of data (Federici et al., 2021). This might increase the chances of the data from schemes being published.…”

Evidence‐based funding of new imaging applications and technologies by Medicare in Australia: How it happens and how it can be improved

“…19 Other approaches discussed in the international literature include harmonisation and minimum standards for HTA, improved guidance, increased stakeholder participation and consultation, methods for evaluation of observational data that adequately allows assessment of bias affecting clinical outcomes, methods that can account for the impact of the "learning curve" on effectiveness data and coverage with evidence development agreements. 11,12,[19][20][21][22] Several of these approaches have been incorporated in the recent revision to the MSAC Guidelines, 2 but cannot completely address the lack of good quality primary research.…”

“…Closer integration and harmonisation of regulatory and HTA processes across different jurisdictions combined with horizon scanning and early dialogue with industry about the evidentiary requirements for specific patient populations, comparators, and outcomes may improve the quality of the evidence available for submissions, facilitate access to new technologies and reduce the period required for assessment 19 . Other approaches discussed in the international literature include harmonisation and minimum standards for HTA, improved guidance, increased stakeholder participation and consultation, methods for evaluation of observational data that adequately allows assessment of bias affecting clinical outcomes, methods that can account for the impact of the “learning curve” on effectiveness data and coverage with evidence development agreements 11,12,19–22 . Several of these approaches have been incorporated in the recent revision to the MSAC Guidelines, 2 but cannot completely address the lack of good quality primary research.…”

Early health technology assessment using the MAFEIP tool. A case study on a wearable device for fall prediction in elderly patients

“…In addition, by identifying the parameters that contribute the most to decision uncertainty, VOI could support early negotiations over the possibility to define some form of performance-based risk sharing arrangements (PBRSAs) at market access. PBRSAs, are payment schemes where the amount or level of reimbursement is made conditional to the collection of further data and the confirmation of the expected performance of a technology in a defined patient population over a specified period of time [34,35]. When considering such type of contractual agreements, VOI analyses may first inform whether further research is needed (thus supporting judgments on whether a PBRSAs would be recommended), and second outline which parameters in the model would need to be investigated further through additional data collection.…”