Spotlight Sessions

* Program subject to change

Mon 7 Nov13:30 - 14:30Spotlight SessionRecommendations for a Harmonized Health Technology Assessment for Digital Medical Devices (DMDs) Across Europe: A Multi-Stakeholder DiscussionIn-person

ISSUE: To harmonise the innovative health technology assessment procedures across Europe, a European Taskforce has been generated by France, Germany, coordinated by EIT Health and co-chaired by EUnetHTA, with the overall goal of enabling a joint approach for European access to reimbursement for digital medical devices (DMDs). The Taskforce - composed of academic experts, policy makers and representatives of national competent authorities - is committed to harmonise the taxonomy of the digital medical devices, evidence criteria and (re-)assessment methodologies in order to support Europe-wide patient access to DMDs through reimbursement.

OVERVIEW: The session will start with emphasising the need for a harmonised health technology assessment procedure to avoid a fragmented European approach on reimbursement of DMDs and improve patient access to digital health solutions. Mr. Guardian will elaborate on the scope and goals of the Taskforce as well as the External Advisory Group, responsible for external validation of recommendations from an industry perspective (10 min). Prof. Dr. Klucken will present the proposed framework to operationalise a harmonised regulatory and assessments framework across Europe with a special focus on (A) the conceptual clarity around DMDs, (B) the evidence criteria for reimbursement and (C) the healthcare system integration & social health evaluation framework (13 min). Taking into account the similarities and disparities of already existing evidence outcome categories and clinical study design definitions across EU Member States (including France, Germany, Belgium, Luxemburg, etc.), a recommendation for harmonisation of evidence criteria and assessment methodologies will be made (Stuwe, 13 min). Considering the practical implementation of the recommendations, perspective of technology developers and industry players will be discussed, including how real-world evidence and other innovative study designs can be utilised in assessment and re-assessment procedures of DMDs (Verboven, 13, min). The session will be concluded by a discussion between audience and panel members (11 min).

Moderators

Marcus Guardian, MBA

EUnetHTA, Diemen, Netherlands

Panelists

Jochen Klucken, Prof. Dr.

University of Luxemburg, Luxembourg, Luxembourg

Prof. Dr. med. Jochen Klucken is the FNR-PEARL Chair of Digital Medicine and head of the Digital Medicine (dMed) research group that works in very close collaboration with the NCER-PD project (National Centre for Excellence in Research on Parkinson’s Disease https://parkinson.lu/) and is located at the LCSB (Luxembourg Center for Systems Biomedicine) of the University of Luxembourg, the LIH (Luxembourg Institute of Health) and the CHL (Centre Hospitalier de Luxembourg). The dMed group focuses on I) shaping and innovating personalised digital healthcare solutions, and II) understanding and evaluating the new benchmarks of a new ecosystem for digital medicine. Prof. Klucken is also involved in the EU taskforce for harmonized Evaluation of digital medical devices with a strong focus on Digital Therapeutics/DiGAS and their clinical evaluation criteria. Future digital medicine ecosystems will provide real world data for continuous quality monitoring of existing healthcare procedures and innovative evaluation concepts providing real world evidence for digital medicine.

Aymeric Perchant, Projects Director

French Ministry of Health and Prevention, Gif-sur-Yvette, Île-de-France, France

Yves Verboven, Director

MedTech Europe, Brussels, Belgium

Tue 8 NovThe Economics of Survival: A Discussion on the Role of Health Policy, Environmental Policy, and Economic Policy in Healthcare Decision MakingIn-person

ISSUE:

If healthcare systems were a country, they would collectively be the 5th largest emitter of greenhouse gases globally. Healthcare decision makers are already grappling with increased demand for healthcare, and highly constrained budgets. However, unless we act immediately the climate emergency will quickly supersede both challenges. As with public health policy, environmental policy is highly influenced by economic decision makers. This panel will have a robust discussion on the intersection of health, environmental, and economic policy and how to enable more sustainable healthcare systems.

OVERVIEW:

The IPCC Report 2022 set forth an agenda that highlights the need to reduce Carbon Emissions by 90% by 2050. Unless this happens, the environmental impact will increase the incidence of major public health threats including destructive weather, and increased pandemic situations. This will more frequently place over-stretched healthcare systems on an unmanageable emergency footing. Therefore, health economic dialogue that includes environmental considerations are the economics of survival. The 4 main areas health systems can focus to support sustainability: Prevention, Patient self-care, lean-service delivery, and low-carbon alternatives span each of the Scope 1, 2 & 3 emission reduction plans. This panel will enable the dialogue on the economics of healthcare system sustainability, and initiate discussion on forming an ISPOR SIG: "The Economics of Healthcare System Sustainability".

This structure will be:

(10min - Introduction) The intersection of health, economic and environmental policy: setting the landscape and providing a roadmap to sustainability

(15min - Policy Perspective) An Equilibrium in Care Provision: Balancing individual, population, & planetary outcomes

(15min - Industry Perspective) A Roadmap for Industry Support: How to reduce Carbon-footprint.

(15min - Provider/Hospital Perspective) The role of hospitals: The Economics of Scope 1, 2 & 3 emission reductions.

(20min - Questions and Answers)

Any stakeholder involved in healthcare decision making will benefit, including physicians, providers (hospitals), payers, policy makers, procurement, and patients.

Moderators

Richard Charter, MSc

Alira Health, Basel, BS, Switzerland

Panelists

David Lawson, CIPS

Guys & St Thomas' NHS Foundation Trust, London, United Kingdom

David Lawson MCIPS Director of Medical Technology - Commercial, Strategy and Policy Department for Health and Social Care (DHSC) Newly appointed Med Tech Director for DHSC with responsibility for setting the direction of future UK MedTech policy. Previous Chief Procurement Officer for 21 years at Guy’s and St Thomas’ NHS Foundation Trust. Double winner of the Supply Chain Excellence Award for Supply Chain Innovation (2008) and Urban Logistics (2021) and finalist for City Sustainability Award (2021).

Mark Sculpher, PhD, MSc

University of York, York, NYK, United Kingdom

Mark Sculpher is Professor of Health Economics and Director of the Centre for Health Economics, University of York. He is also Co-Director of the Policy Research Unit in Economic Evaluation of Health and Care Interventions, a programme of research for the UK Department of Health and Social Care funded by the National Institute for Health Research (NIHR).

Michelle Sullivan, MSc

Boston Scientific, Oxted, United Kingdom

Michelle’s career in pharmaceuticals and medical devices started in 1990. Through roles in sales, management, marketing, and market development, Michelle has followed the needs of the current market by re-training in Health Economics, adding the value ‘spectacles’ and ‘hearing-aids’ necessary in today’s world. A graduate of the Cambridge Institute of Sustainability Leadership, it is her goal to make this topic simple to understand and execute within the healthcare sector, currently leading the Commercial Environmental Sustainability Workstream within Boston Scientific in Europe. She sits on the Board of HealthTech Ireland, chairs the ABHI Sustainability working group, and vice-chairs the Commercial policy group for this UK Medical device industry body.

Wed 9 Nov10:00 - 11:15Developments in the Use of Health Economics and Outcomes Research to Improve Enrollment and Retention in Clinical TrialsIn-person

Purpose: This session will summarize and illustrate how the health economics and outcomes research (HEOR) community is supporting the design and implementation of clinical studies and how this is improving enrolment and retention.

Outline: Engaging patients in the design of clinical trials has been demonstrated to improve enrollment and retention. To date this has often been limited to engagement with small, non-representative samples of patients. However, recent efforts have enabled the insights of HEOR to be applied to the design of clinical studies. After summarizing the state of the art in engaging patients in clinical study design, the session will illustrate how HEOR is enabling study design optimization. The development of a patient study experience instrument will be covered as well as recent applications of preference methods to understand how study design impacts patients’ willingness to participate in studies. The use of both experience instruments and preference data to improve study design will be described.

Moderators

Maureen Rutten-van Mölken, PhD

Erasmus University Rotterdam, Rotterdam, ZH, Netherlands

Maureen Rutten-van Mölken is full professor of Economic Evaluation of Innovations for Health at the Erasmus School of Health Policy & Management, where she is head of the Health Technology Assessment department. She is also scientific director of the Institute for Medical Technology Assessment, a company fully owned by the Erasmus University Holding. She holds an MSc in health sciences and a PhD in health economics, both from the University of Maastricht. She teaches Health Technology Assessment and Pharmaceutical Pricing and Market Access in the Master-program Health Economics Policy and Law and in the European Master in Health Economics and Management.Her expertise includes cost-effectiveness analysis alongside clinical trials and observational studies, probabilistic decision analytic modeling, health economic outcomes research and innovative payment models. She worked in many disease areas, including respiratory diseases (COPD, asthma), rheumatology, diabetes, cardiovascular disease, and Pompe disease. She has a special interest in the cost-effectiveness, and financing and payment of complex multi-faceted interventions that involve system-level changes (e.g., integrated care programs, disease management programs, hospital at home programs, outpatient rehabilitation programs, remote patient monitoring). She also has an interest in the health economics of personalized and precision medicine. She was the coordinator of SELFIE, a Horizon2020 project on multi-criteria decision analysis of integrated care programmes for patients with multi-morbidity. She was a principal investigator in Horizon2020 project HEcoPerMed that developed guidance on health economic modelling of personalised medicine and applied this guidance to various pharmacogenetic interventions. She also coordinates the Medical Delta program From Prototype to Payment.

Speakers

Kevin Marsh, PhD

Evidera, London, LON, United Kingdom

Kevin Marsh, PhD, is Vice President at Evidera in London, UK. He specializes in the use of preference data and decision analysis to inform health decisions, including pipeline optimisation, authorisation, reimbursement, and prescription decisions. Dr Marsh’s research interests include stated and revealed preference methods, decision modelling, and MCDA. He has applied these and other research techniques for a range of organisations, including both regulatory and industry clients. He actively contributes to the methodological development of these techniques. He is currently co-Chairing ISPOR Health Preference SIG and is a member of the ISPOR Task Force on qBRA. He has previously chaired the ISPOR Task Force on the Use of MCDA in Health Care Decision-Making and an ISPOR working group on the use of preference data in Europe.

Zachary Smith

Tufts University School of Medicine, Henderson, NV, USA

Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics and innovation adoption. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University, and has worked at Tufts CSDD for 6 years.

Discussants

Kimberley Kallsen, PhD

Boehringer Ingelheim, 55218 Schwabenheim, Germany

Kimberley Kallsen is a cell biologist by training and holds a PhD and a master in public health. She joined Boehringer Ingelheim in 2013, worked in different global strategic and operational roles including medical writing, scientific publications, patient engagement, and is currently Head of Global Clinical Development & Operations Patient & Site Engagement. She is passionate about early partnerships with patient representatives and healthcare professionals to ensure patient- and site-centric clinical trials.

ISPOR Europe 2022

6 - 9 November

Spotlight Sessions

The Professional Society for
Health Economics and Outcomes Research