Examining the Impact of New European Regulations and Managed Entry Schemes on the Device Marketplace
Glasgow, Scotland, UK—7 November 2017—ISPOR, the professional society for health economics and outcomes research (HEOR), held several sessions on the topic of medical devices at its 20th Annual European Congress currently being held 4-8 November 2017 in Glasgow, Scotland, UK.
Managing Regulatory and Reimbursement Evidence Requirements for Medical Devices:
On 6 November an issue panel was held entitled, “’Mind the Gap!’: How Should We Manage the Difference Between Regulatory and Reimbursement Evidence Requirements for Medical Devices?” [IP7]. The session was led by members of the ISPOR Medical Device and Diagnostics Special Interest Group. Bjoern Schwander, RN, BSc, MA, Agency for Health Economic Assessment and Dissemination, Loerrach, Germany moderated the session. Panelists included Richard Charter, MSc, Becton Dickinson, Basel, Switzerland; Karen Facey, PhD, University of Edinburgh, Edinburgh, UK; and Nneka C. Onwudiwe, PhD, PharmD, MBA, US Federal Drug Administration, Silver Spring, MD, USA.
In April 2017, the European Commission approved the new medical device directive, Regulation (EU) 2017/745 of the European Parliament and of the Council. Speakers addressed a number of issues related to the new regulations. The perspective of medical device manufacturers centered on how the regulations will impact research and development and innovation. Payers considered how they will implement decisions in light of these changing requirements. Other panelists discussed patient involvement in health technology assessment and how the new regulations will impact patient engagement.
Managed Entry Schemes for Medical Devices:
On 7 November an issue panel, “Managed Entry Schemes for Medical Devices: Great Opportunity or Major Challenge?,” [IP16] was moderated by Michael Drummond, MCom, DPhil, University of York, Heslington, York, UK. Panelists included Aleksandra Torbica, PhD, Bocconi University, Milano, Italy; Richard Charter, MSc, Becton Dickinson, Allschwil, Switzerland; and Brian Mangan, National Health Service North West Procurement Development, Wigan, UK.
The panelists noted that managed entry schemes (MEAs) are often viewed as an attractive policy approach as they facilitate market access for new technologies while limiting financial risk for the payer. To date MEAs have been developed primarily for biopharmaceuticals, however, there is a growing interest in expanding the scope of these schemes to medical devices.
While MEAs are promising, they require that critical decisions be made concerning the technologies to which they should be applied, the nature of the study to be undertaken, the funding of the research, and the ways in which research findings should influence the final reimbursement and coverage determination. The panel explored these issues through the perspectives of a variety of health care stakeholders that included manufacturers, policy makers, and researchers.
Additional information on the ISPOR 20th Annual European Congress can be found here. Released presentations from the congress can be found here. Interested parties can follow news and developments from the congress on social media using the hashtag #ISPORGlasgow.
ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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