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 Regulators and payers sometimes differ in their perspectives on medical advances
and the weight they place on components of the evidence base. These contrasting
priorities can lead to divergence between regulatory and payer decisions and delays
or barriers in patients’ access to new therapies.
 Those involved in coverage decisions have not routinely been integrated in the drug
development process pre-approval, specifically with respect to clinical trial design.
Inclusion of payer representatives sooner in the development process would provide
opportunities to detect discordance among stakeholders in terms of data priorities,
facilitate cooperation to align objectives, agree on the evidence required for approval
and reimbursement, improve transparency and accountability of payer decision
making, and ideally minimize delays in patient access to new therapies.
 Research on the benefits and performance of devices differs between ‘therapeutic’
devices (e.g. pacemakers, nerve stimulators, prostheses) and ‘non-therapeutic’
devices (e.g. diagnostic, monitoring, screening or prognostic tests).
 “Value-based healthcare”, focuses on outcomes that are relevant to patients,
including, but not limited to, clinical outcomes
 Therefore a linked or network of evidence approach may be better suited to device
evaluations than a ‘hierarchy of evidence’ approach.
 Health ministers in EU recently mandated that the OECD develop an instrument to
collect information (PaRIS) to be able to compare the performance of health
systems, as well as the performance of clinicians and technology.
 MedTech companies and organizations in Europe and the USA currently has
programs in place to drive “value-based healthcare”
 Device evaluations are enhanced when device developers, manufacturers, trialists,
regulators, payers, health professionals and patients collaborate to agree on the
“Burden of proof” and describe at an early stage the potential mechanisms/pathways
through which achieve “value-based healthcare”, ultimately improving timely patient
access to new treatments that reduce the burden of disease or prolong life.
Panel on Evaluation Systems for New Technology: Overview & comparison of
evaluation systems. Discussion on whether certain evaluation systems are better suited
for certain types of devices/ disease states/ healthcare system. Identification of one
evaluation system that is preferred over others.
· Evidence based evaluations of Medical Technology and Biomarkers: what
does it actually mean and what do we want?
o The EU perspective
Karl Moons (Utrecht, NED)

· Medicare Evaluation: What is the process & what evidence is required for
coverage today?
Joseph Chin (CMS, USA)
· Willingness-to-pay: Europe’s Most Economically Advantageous Tender
pilot (MEAT)
Yves Verboven (MedTech Europe, Brussels, BEL)
Panel on Streamlining Clinical Trial Data Collection with Evaluation System
Requirements: Overview & comparison of relevant types of clinical data, with a focus
on how each serves (or does not serve!) one of the respective evaluation systems.
Discussion on why and how evaluation systems must evolve to take such critical data
into account.
· Patient-Reported Outcomes: How should they be valued?
Michael Nassif (Kansas City, USA)
· Real-world data collection: What is the value of this for device therapy?
Dalal Nirav (Abbott, USA)
Industry viewpoint:
Philip Adamson (St Jude, USA), Robin Bostic (Abbot, USA), Julia Stubben (MedTech
Europe, CVRx, CHE), Nadim Yared (AdvaMed, CVRx, USA)
Regulatory viewpoint
John Whyte (FDA, USA), Bram Zuckerman (FDA, USA)
Payers’ perspective:
Joseph Chin (CMS, USA), Leeza Osipenko (NICE, GBR)
The Forum. Moderated discussion with the audience
The Role of Payers in Cardiovascular Clinical Research: Addressing the
Misalignment Between Approval and Reimbursement.
Chairpersons: Jeffrey Borer (New York, USA), Nadim Yared (CVRx, USA)
Panelists: Philip Adamson (St Jude, USA), Jeffrey Borer (New York, USA), Robin Bostic
(Abbot, USA), Joseph Chin (CMS, USA), Karl Moons (Utrecht, NED), Michael Nassif
(Kansas City, USA), Dalal Nirav (Abbott, USA), Leeza Osipenko (NICE, GBR), Julia
Stubben (MedTech Europe, CVRx, CHE), Yves Verboven (MedTech Europe, Brussels,
BEL), John Whyte (FDA, USA), Nadim Yared (CVRx, USA), Bram Zuckerman (FDA,