Mon 18 Nov
8:30 - 9:45
Plenary Session
The Evidence-Price Conundrum: What Is the Way Forward for Patient Access?
Digital Conference Pass
This session will discuss policy interventions and solutions to tackle the dual problem of high prices of some medicines and the weak evidence that these products oftentimes come on to the market with. Both elements become even more pertinent for the implementation of the new EU-wide HTA system which will come into effect in 2025. The successful implementation of the EU HTA system will contribute to a rationalization of pharmaceutical expenditure which is essential in the context of limited health budgets and competing national priorities. Speakers will analyze the progress achieved by intergovernmental initiatives of collaboration such as Beneluxa, reflect on points where EU-level action is desirable and feasible, look at the trends in pharmaceutical expenditure and share their insights into how European countries can work together to ensure patients’ timely access to effective, affordable medicines and evidence-based healthcare.
Moderators
Yannis Natsis, MA, BA
European Social Insurance Platform (ESIP), Brussels, Belgium
Yannis Natsis is the Director of the European Social Insurance Platform (ESIP), the umbrella organisation bringing together 45 national statutory social security institutions from 18 countries. ESIP is the voice of social protection and security in Europe or as Yannis puts it one of Europe’s truest treasures.
He has more than 10 years of experience in EU advocacy and policymaking. Prior to joining ESIP in February 2022, he led the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA). In May 2019, he was appointed by EU Member States to the Management Board of the European Medicines Agency (EMA), a position he held until December 2021. Additionally, Yannis has been a Board member of the European Health Forum Gastein (EHFG), the leading EU health policy platform since 2018.
Yannis previously worked for the TransAtlantic Consumer Dialogue (TACD) focusing on health and pharmaceutical policies. From 2006-2010, he was an investigative reporter for Greece's award-winning TV news programme "Fakeli" and a contributor to one of Greece’s most respected dailies “Kathimerini”.
He has a Master's degree in International Conflict Analysis from the University of Kent, UK and a Bachelor's degree in European Studies from Pantion University of Social and Political Sciences, Athens, Greece. A Greek national, he is fluent in Greek, English and French.
Speakers
Richard Bergstrom, .
IQVIA, Zug, Switzerland
Pedro Facon, .
National Institute for Health and Disability Insurance, Brussels, Belgium
Pedro Facon (°1981) is a public management professional in public health, social security and health crisis governance and management. He worked successively in research, teaching, advisory and management positions at the Public Management Institute (KULeuven), the National Institute for Health and Disability Insurance, the Cabinet Office of the Belgian federal minister of Social Security and Public Health and the Belgian Ministry of Health.
In October 2020 he was designated Government Commissioner COVID-19 by the Belgian federal government.
In April 2022 he was designated deputy administrator general by RIZIV/INAMI/NIHDI
He’s Fellow at the Medical Campus of the Free University of Brussels and Guest Professor at the Department of Public Health & Primary Care of the University of Ghent.
Birgitte Klindt Poulsen, .
Danish Medicines Council, Copenhagen, Denmark
Birgitte Klindt Poulsen is a medical doctor and specialist in clinical pharmacology. She serves as Chief Physician at the Department of Clinical Pharmacology at Aalborg University Hospital and holds the position of Associate Professor at the Clinical Institute, Aalborg University. In addition to these roles, she plays a pivotal part as Vice-Chair of the Danish Medicines Council, which undertakes health technology assessments (HTA) of new pharmaceuticals, new indications for existing medications, and formulates treatment guidelines in areas with significant economic impact.
Dr Poulsen has been deeply involved in the implementation of recommendations from the Danish Medicines Council and actively monitors their adherence across healthcare settings. She also participates in various Nordic and national working groups, centered on the use of medicines with a particular focus on efficacy, safety, and cost-effectiveness.
Valérie Paris, MSc
OECD, Paris, Ile-de-France, France
Valérie Paris joined the OECD Secretariat in September 2005 to contribute to the work undertaken by the Health Division. Since then, she has contributed to several projects on health systems’ characteristics and performance, providers’ payments, pharmaceutical policies and regional variations in health care use. She co-ordinated and co-authored the OECD reports New Health Technologies - Managing Access, Value and Sustainability (2017) and Pharmaceutical Innovation and Access to Medicines (2018). She is responsible for most OECD projects related to pharmaceuticals and medical devices.
Between 2020 to 2023, Valérie Paris was appointed member of the Board of French National Authority for Health, Chair of the HAS Economic Evaluation and Public Health Committee and Vice-Chair of the Vaccine Committee.
Previously, she was researcher at the French Institute of Research and Information on Health Economics (IRDES), a non-for-profit organization. She participated in research projects on pharmaceutical policies, physicians’ payment schemes, health accounts and comparative analysis of health systems.
She holds a master’s degree in Economics, statistics and econometrics from the University of Paris 1-Sorbonne (1990).
Welcome Remarks and Keynote Address
Digital Conference Pass
Welcome Remarks Rob Abbott, CEO & Executive Director,
ISPOR - The Professional Society for Health Economics and Outcomes Research
Keynote Address
Translating from EU to Africa to Empower Patient Involvement and Access to Healthcare
African healthcare is at a crossroad. African leaders take bold steps to push patient involvement in healthcare decision-making and access to the forefront of health policy. The continent finds itself at a critical juncture as the new frontier for research and innovation. While developing sustainable, evidence-based health system strategies to meet expanding population needs presents significant challenges, opportunities to leverage global perspectives and knowledge abound-- and HEOR is poised to play a critical role.
Through her extensive advocacy work in Africa, the NGO she has been involved with for almost 3 decades has been recently selected as the partner of choice by the Pan African Parliament of the African Union to codify a continental strategy around patient access. Mimi Choon-Quinones will share her experience on building healthcare capacity to beat cancer in Africa and reflect on what can and cannot be translated to the region based on the EU’s Beating Cancer Plan. Dr Choon-Quinones will also highlight initiatives between African decision-makers and European leaders and how global HEOR stakeholders can come together to move the needle for health in Africa.
Speaker
Rob Abbott
ISPOR, Lawrenceville, NJ, USA
Mr Abbott is a highly accomplished, visionary leader with more than 20 years’ experience providing executive-level strategic and operational leadership in businesses, nongovernmental organizations (NGOs), government environments, as well as professional societies and associations. Most recently, he served as executive director and CEO of Health Technology Assessment International, a global nonprofit society focused on health technology assessment (HTA). He is recognized for his knowledge in HTA, strategy, and stakeholder relations. He has successfully guided a number of organizations through their transformation and growth. He is also a pioneering social responsibility thinker and advisor who has authored 2 books and numerous articles on the nature of business and society. Mr Abbott holds an undergraduate honors degree from the University of Victoria and graduate degrees from the University of Toronto. Additionally, he holds professional designations as both a management consultant and an ICF-accredited coach.
Mimi Choon-Quinones, PhD, MBA, LL.M
Partners For Patients NGO, Basel, Switzerland
Mimi has an International Commercial Law Degree & has written her legal research thesis in EU GDPR law and EU Competition Law. Mimi worked at Merck-Medco, Novartis and Roche. During her most recent role at Roche, Mimi led clinical trial strategies. In her role as Vice- Director at Roche, Mimi led 88 EEMEA countries to close the health disparity gaps in access to innovative treatment options. Mimi has achieved multiple research awards at Roche by bringing together international disease area leaders, healthcare policy makers and drug agencies from around the globe to discuss and agree on how to best improve patient care, solidifying and executing health equity legal memorandum of understandings, to benefit patients to have access to affordable medicines and treatments. Mimi also helped pave the road in decentralized clinical trials to address diversity, inclusion, and health equity.
Tue 19 Nov
ISPOR President's Address and Avedis Donabedian Lifetime Achievement Award Presentation
Digital Conference Pass
Welcome & ISPOR President’s Address Eberechukwu Onukwugha
Professor
University of Maryland, Baltimore
Avedis Donabedian Lifetime Achievement Award Presentation
Speaker
Eberechukwu Onukwugha, PhD
University of Maryland School of Pharmacy, Baltimore, MD, USA
Eberechukwu Onukwugha, PhD is a Professor in the Department of Practice, Sciences, and Health Outcomes Research and is the Executive Director of Pharmaceutical Research Computing at the University of Maryland School of Pharmacy. She received a Master of Science in agricultural and applied economics as well as a Doctor of Philosophy in economics (concentration: econometrics) from Virginia Tech. Dr. Onukwugha has approximately 20 years of experience conducting health economics and outcomes research. She examines the costs and health outcomes associated with health-related decisions as well as the institutional and environmental context framing these decisions.
Ready, Set, Go: The Last Sprint for the EU HTAR
Digital Conference Pass
Welcome & ISPOR President’s Address Eberechukwu Onukwugha
Professor
University of Maryland, Baltimore
Avedis Donabedian Lifetime Achievement Award Presentation
Plenary Panel
With only a few more months before the start of the EU HTAR in January 2025, everyone is in full speed ahead towards successful implementation in all organizations. The HTA Coordination Group, it’s subgroups and the European Commission are working hard to finalize all documents, guidances and implementing acts required for a well-functioning system. The session will explore if we are advanced enough and if we are ready for the HTAR to be applied. The session will specifically address how the stakeholders are preparing for the HTAR in their organizations and how they are implementing changes, as well as what key challenges are still ahead. These challenges will differ between the stakeholders. How is industry preparing for the high number of PICO and related analysis they see coming and is AI part of this adaptation? How are HTA bodies getting ready, specifically in Eastern EU countries, the late-access countries, how do they anticipate the usability of the JCA? How are patients and patient organizations preparing and what factors impact a sustainable future for patient input under the HTAR? Lastly, the panel will explore how the HTAR links to already existing regional initiatives, e.g Beneluxa as well as the International Horizon Scanning Initiative (IHSI). Are they mutually beneficial to each other, and how can we leverage the benefits of these collaboratives under the HTAR?
Moderators
Anne Willemsen, MSc
Dutch National Healthcare Institute, Diemen, Netherlands
Anne Willemsen holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute (Zorginstituut Nederland) over the past years. Between 2016 and 2023 she has been working for EUnetHTA and has been coordinating Joint Clinical Assessments (JCA). Since April 2023, she was elected as the co-chair of the HTA Coordination Group JCA subgroup under the HTA Regulation.
Speakers
Roisin Adams, MPharm, MSc., PhD
National Centre for Pharmacoeconomics, Dublin, Ireland & Discipline of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland
Vanessa Schaub, PhD
F. Hoffmann-La Roche Ltd, Basel, Switzerland
Dr Vanessa Schaub, Head of Global/EU HTA Strategy, Roche | Dr Vanessa Schaub has been working at Roche for almost 20 years, starting at the German affiliate where she held diverse access and commercial positions. In her current role, she ensures fit for purpose Global HTA strategies to stay ahead of emerging health systems trends and patient needs globally. Since August 2021 she also leads a cross functional Access SQUAD for external and internal EU HTA readiness. Her passion is around working in partnership with internal and external partners to foster rapid, broad and sustainable patient access to Health care innovations. Her team is guiding portfolio-related HTA strategies on the local market level as well as overseeing the implementation of above country level HTA approaches with a current strong focus on EU HTA. A health economist by training, Vanessa has disease area experience in oncology, neurology and respiratory diseases.
Michal Stanak, Dr.phil, AKC
National Institute for Value and Technologies in Healthcare (NIH), Bratislava, Slovakia
Michal Stanak has been the director of the Slovak national HTA body, National Institute for Value and Technologies in Healthcare, since January 1st 2022. In the years leading up to it, he served as the director of the HTA department at the Slovak Ministry of Health. From 2015 to 2020, he worked as a researcher at the Austrian Institute for HTA, where he worked on a number of HTA assessments for Austria, Germany and EUnetHTA. Since 2019, he has been a lecturer at the Comenius University, Bratislava, Slovakia.
Michal Stanak studied in England and Austria. He received a bachelor's degree in Philosophy from King's College London, a master's degree in Politics, Philosophy and Health economics from University College London and a doctorate in applied ethics in the field of decision-making in healthcare from University of Vienna.
Valentina Strammiello, MA, BA
European Patients’ Forum, Brussels, Belgium
Valentina Strammiello works as Head of Programmes and oversees the EPF project portfolio and Youth Strategy. She represents EPF in HTA-related activities and in the European Health Parliament initiative.
Before joining EPF, Valentina has had a long collaboration with the CIPI Network and has worked as freelance OSINT analyst on Security and Energy issues. Self-trained in website management and web 2.0 applications, she is among the founders of ecpa2.0 (European Center for Public Affairs 2.0), a forum of young professionals. She holds a BA in International Relations and a Master’s Degree in European Studies.
Wed 20 Nov
11:30 - 12:45
ISPOR CEO and CSO Updates
Digital Conference Pass
Welcome & CEO's Updates Rob Abbott, CEO & Executive Director
ISPOR - The Professional Society for Health Economics and Outcomes Research
Science & Health Policy Updates
Speaker
Rob Abbott
ISPOR, Lawrenceville, NJ, USA
Mr Abbott is a highly accomplished, visionary leader with more than 20 years’ experience providing executive-level strategic and operational leadership in businesses, nongovernmental organizations (NGOs), government environments, as well as professional societies and associations. Most recently, he served as executive director and CEO of Health Technology Assessment International, a global nonprofit society focused on health technology assessment (HTA). He is recognized for his knowledge in HTA, strategy, and stakeholder relations. He has successfully guided a number of organizations through their transformation and growth. He is also a pioneering social responsibility thinker and advisor who has authored 2 books and numerous articles on the nature of business and society. Mr Abbott holds an undergraduate honors degree from the University of Victoria and graduate degrees from the University of Toronto. Additionally, he holds professional designations as both a management consultant and an ICF-accredited coach.
Laura Pizzi, PharmD, MPH
ISPOR, Lawrence Township, NJ, USA
Dr. Laura Pizzi is Chief Science Officer for ISPOR and Research Professor at Rutgers University. For nearly 25 years, she has led interdisciplinary teams of methodologists, statisticians, and clinicians to design and conduct economic and outcomes analyses on healthcare interventions and is a frequent author, speaker, and mentor on the topic.
At ISPOR, she leads the organization’s scientific strategy and initiatives in collaboration with ISPOR's global members and stakeholders.
Reality Check: Are We Bridging the Evidence Gaps for Patients?
Digital Conference Pass
Welcome & CEO's Updates Rob Abbott, CEO & Executive Director ISPOR - The Professional Society for Health Economics and Outcomes Research
Science & Health Policy Updates
Plenary Address
This plenary session will take place after the two others that will address first the payers’ perspective and then the HTA’s perspective. This last session will focus on the regulatory step and discuss how the needs from all the stakeholders could be better anticipated, considering the discussions that would have taken place during the two other sessions.
We, regulators, HTA agencies, payers and pharmaceutical industry, are all working closely with patients to ensure that innovative drugs can benefit patients as early as possible. This collaboration is guided by the ambition to enable and use the generation of reliable and valid evidence that will address and answer different questions, e.g. for benefit/risk assessment, for relative effectiveness assessment... We are relying on the totality of evidence generated, either from randomized controlled trials, or from other designs such as studies using real-world data. Even if differences in scope may exist, there are overlapping commonalities in what constitutes meaningful evidence generation. We also must deal with (remaining) uncertainties at different stages of decision making. How can we limit these uncertainties, and ensure that at the end of the overall approval process, all stakeholders get the needed evidence to take an informed decision and ensure an innovative drug reach the patients if appropriate?
Moderators
Patrice Verpillat, MD, MPH, PhD
European Medicines Agency (EMA), Amsterdam, Netherlands
Dr. Patrice Verpillat (MD, MPH, PhD) is the Head of the Real World Evidence (RWE) Workstream at the European Medicines Agency (EMA). He is a medical doctor, specialist in epidemiology. Before joining the EMA, he has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research, access and life-cycle product management.
Dr. Verpillat has published over 70 articles in Medline referenced journals. He has been involved in many organisations such as ENCePP, ICH M14 working group, European pharma association (efpia) and ISPE
Speakers
Nikos Dedes, BA
Greek Patients' Association, Athens, Attika, Greece
Peter Mol, PhD
College ter Beoordeling van Geneesmiddelen, Utrecht, Netherlands
Peter Mol is professor of drug regulatory science at the University Medical Center Groningen. His research focus is on developing new tools to support regulatory decision-making and the exchange of knowledge between regulatory authorities, health care professionals and lay people. He is currently involved in projects around personalized medicine, new data sources (RWE), patient-centric ways to weigh drug benefit-risk; e.g., using Patient Relevant Outcomes, Quality of Life, and Patient Preference information, and on risk communication (Direct Healthcare Provider Communication). He is Principal Investigator of the HORIZON More-EUROPA project (More-Europa - Research (umcgresearch.org)).
He is also the Committee for Medicinal Products for Human Use (CHMP) member for the Dutch Medicines Evaluation Board. He was from 2012 to 2023 member (vice chair 2016-2022) of EMA’s Scientific Advice Working Party. He has coordinated over 300 EMA and national scientific advice procedures for drug development programs for cardiometabolic, gynecology and hematology products. He was chair of the EMA Cross-Committee Task force on Registries (2016-2023).
Yannis Natsis, MA, BA
European Social Insurance Platform (ESIP), Brussels, Belgium
Yannis Natsis is the Director of the European Social Insurance Platform (ESIP), the umbrella organisation bringing together 45 national statutory social security institutions from 18 countries. ESIP is the voice of social protection and security in Europe or as Yannis puts it one of Europe’s truest treasures.
He has more than 10 years of experience in EU advocacy and policymaking. Prior to joining ESIP in February 2022, he led the advocacy for better and affordable medicines at the European Public Health Alliance (EPHA). In May 2019, he was appointed by EU Member States to the Management Board of the European Medicines Agency (EMA), a position he held until December 2021. Additionally, Yannis has been a Board member of the European Health Forum Gastein (EHFG), the leading EU health policy platform since 2018.
Yannis previously worked for the TransAtlantic Consumer Dialogue (TACD) focusing on health and pharmaceutical policies. From 2006-2010, he was an investigative reporter for Greece's award-winning TV news programme "Fakeli" and a contributor to one of Greece’s most respected dailies “Kathimerini”.
He has a Master's degree in International Conflict Analysis from the University of Kent, UK and a Bachelor's degree in European Studies from Pantion University of Social and Political Sciences, Athens, Greece. A Greek national, he is fluent in Greek, English and French.
Almath Spooner, .
Abbvie, Dublin, Ireland
Anne Willemsen, MSc
Dutch National Healthcare Institute, Diemen, Netherlands
Anne Willemsen holds double Masters Degrees in Health Sciences, specialising in both Health Technology Assessment and Health Policy. This led her through research and project management roles within the Dutch National Healthcare Institute (Zorginstituut Nederland) over the past years. Between 2016 and 2023 she has been working for EUnetHTA and has been coordinating Joint Clinical Assessments (JCA). Since April 2023, she was elected as the co-chair of the HTA Coordination Group JCA subgroup under the HTA Regulation.
