* Program subject to change
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).
Marcus Guardian, MBA
EUnetHTA, Diemen, Netherlands
Jochen Klucken, Prof. Dr.
University of Luxemburg, Luxembourg, Luxembourg
Aymeric Perchant, Projects Director
French Ministry of Health and Prevention, Gif-sur-Yvette, Île-de-France, France
Yves Verboven, Director
MedTech Europe, Brussels, Belgium
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.
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.
Richard Charter, MSc
Alira Health, Basel, BS, Switzerland
David Lawson, CIPS
Guys & St Thomas' NHS Foundation Trust, London, United Kingdom
Mark Sculpher, PhD, MSc
University of York, York, NYK, United Kingdom
Michelle Sullivan, MSc
Boston Scientific, Oxted, United Kingdom
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.
Maureen Rutten-van Mölken, PhD
Erasmus University Rotterdam, Rotterdam, ZH, Netherlands
Kevin Marsh, PhD
Evidera, London, LON, United Kingdom
Tufts University School of Medicine, Henderson, NV, USA
Kimberley Kallsen, PhD
Boehringer Ingelheim, 55218 Schwabenheim, Germany