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
Birgitte Klindt Poulsen, .
Danish Medicines Council, Copenhagen, Denmark
Valérie Paris, MSc
OECD, Paris, Ile-de-France, France
Tue 19 Nov
Ready, Set, Go: The Last Sprint for the EU HTAR
Digital Conference Pass
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
Michal Stanak, Dr.phil, AKC
National Institute for Value and Technologies in Healthcare (NIH), Bratislava, Slovakia
Valentina Strammiello, MA, BA
European Patients’ Forum, Brussels, Brussels-Capital Region, 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
Reality Check: Are we Bridging the Evidence Gaps for Patients?
Digital Conference Pass
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 is the Head of the Real World Evidence (RWE) Workstream at the European Medicines Agency (EMA). He is a medical doctor, specialist in epidemiology. 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
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.