“The European Health Technology Assessment Regulation: the political will” webinar

THE WEBINAR

On 28 February 2023, Pancreatic Cancer Europe (PCE) and Cancer Patients Europe (CPE) held a webinar to exchange views on how best to enhance cooperation on the HTA process and in total, 53 attendees participated in the webinar, out of 145 registrants.

The webinar aimed to discuss the new European Health Technology Assessment (HTA) regulation, which will come into force in May 2023. The regulation will establish a common framework for assessing medical technologies’ health benefits and economic impact across the EU.

The speakers included representatives from patient organisations, industry, medical society and policymakers. They discussed the importance of the new regulation and how it could improve access to innovative treatments for patients with pancreatic cancer and other diseases.

The speakers also highlighted the challenges of implementing the new regulation, such as ensuring that patient perspectives are adequately considered in the HTA process and addressing the potential impact on small and medium-sized enterprises.

Overall, the webinar provided a valuable opportunity to discuss the new HTA regulation and its potential impact on patients, industry, medical society and policymakers in the EU.

Click here to access the playlist of the recording of the event: 

https://www.youtube.com/playlist?list=PLooaopQKiPDAERV4sl_qPauwoW4PTdIVT

PROGRAMME

Jacqueline Daly, Cancer Patients Europe (CPE): Opening

Maya Matthews, Head of Unit, European Commission, DG SANTE Directorate-General for Health and Food Safety, Unit C2 – Health Technology Assessment: Keynote speech on The European Regulation on Health Technology Assessment

MEP Tomislav Sokol, EU Parliamentary Intergroup Challenge Cancer: Welcome message

Panel discussion: Opportunities and challenges of the HTA process

Tit Albreht, Head of the Centre for Health Care, National Institute of Public Health, Ljubljana

(Slovenia), Moderator

Elisabeth de Vries, European Society of Medical Oncology (ESMO)

Ansgar Hebborn, The European Federation of Pharmaceutical Industries and Associations (EFPIA)

Antonella Cardone, Cancer Patients Europe (CPE)

Elaine Julian, The European Access Academy (EAA)

Ali Stunt, Pancreatic Cancer Action, UK, and member of PCE Board

Q&A Alfredo Carrato, Chair of PCE Board: Conclusions and final remarks

Closing of the event

BIOGRAPHY OF SPEAKERS

Jacqueline Daly, Cancer Patients Europe (CPE)

Jacqueline Daly co-founded East Galway & Midlands Cancer Support in 2012 and is the Director of Services. A member of Cancer Patients Europe (CPE). She is a dedicated patient advocate and campaigner, bringing awareness to local and national government agencies.

Maya Matthews, Head of Unit, European Commission, DG SANTE Directorate-General for Health and Food Safety, Unit C2 – Health Technology Assessment

Maya Matthews is the Acting Director for Digital, EU4health and health systems modernisation as well as Head of Unit for State of health, European Semester, Health Technology Assessment at the European Commission’s Health and Food Safety Directorate General.

MEP Tomislav Sokol, EU Parliamentary Intergroup Challenge Cancer

MEP Tomislav Sokol is a Member of the Committee on the Internal Market and Consumer Protection (IMCO), Special Committee on the COVID-19 pandemic (COVI), a Substitute Member of the Committee on the Environment, Public Health and Food Safety (ENVI) and Committee on Regional Development (REGI) in the European Parliament.

Tit Albreht, Head of the Centre for Health Care, National Institute of Public Health, Ljubljana

He is Head of the Centre for Health Care at the National Institute of Public Health of Slovenia, President-elect of the European Public Health Association (EUPHA), Member of the Scientific Committee of EUPHA. He has worked on national and EU policies in cancer control and cancer care since 2006.

Elisabeth de Vries, European Society of Medical Oncology (ESMO)

Elisabeth de Vries, MD, PhD is Professor of Medical Oncology at the University Medical Centre Groningen, Groningen, the Netherlands. She has been ESMO Cancer Medicines Committee Chair (2018-2019), the ESMO-Magnitude of Clinical Benefit Scale Working Group Chair (2016 – 2019) and also serves as a member of ESMO Council.

Ansgar Hebborn, The European Federation of Pharmaceutical Industries and Associations (EFPIA)

Ansgar Hebborn is Roche’s Head of European Access Policy Affairs. He chairs EFPIA’s European HTA Working Group which coordinates EFPIA’s engagement on the EU HTA regulation. During the past 15 years, Ansgar has taken active roles as advisor and stakeholder representative in various HTA collaboration networks. He has co-authored a number of HTA-related publications.

Antonella Cardone, Cancer Patients Europe (CPE)

Antonella Cardone is the CEO of CPE Cancer Patients Europe. She has an extended expertise in Patient Advocacy, and is currently Advisor to the Board of Pancreatic Cancer Europe (PCE). She has been Vice-Chair of PCE.

Elaine Julian, The European Access Academy (EAA)

Elaine Julian is a member of the Secretariat of the European Access Academy, a multi-stakeholder initiative aiming to facilitate and support the development of a joint European value framework for the assessment of innovative health technologies. Elaine holds a PhD in Biomedical Sciences, Master’s in Medical Biotechnology and Bachelor’s in Molecular Biotechnology.

Ali Stunt, Pancreatic Cancer Action, UK, and member of PCE Board

Founder and CEO of Pancreatic Cancer Action, UK Ali is a key opinion leader and spokesperson, founding board member and President of Pancreatic Cancer Europe 2018/19. She is presently a PCE Board member.

Prof Alfredo Carrato, Chairperson of PCE

Alfredo Carrato is presently Emeritus Professor of Medical Oncology at Alcala University and Director of the Research Group on Pancreatic Cancer at Ramon y Cajal Research Institute- IRYCIS, as well as at the Spanish Network of Cancer Research – CIBERONC, both in Madrid, Spain. He is the Chairperson of Pancreatic Cancer Europe.

PRESENTATION

After introductions were made by Jacqueline Daly (of Cancer Patients Europe), Maya Matthews, Head of Unit, European Commission, DG SANTE Directorate-General for Health and Food Safety, Unit C2 – Health Technology Assessment gave a keynote presentation on The European Directive on Health Technology Assessment. 

The full presentation can be found here. (link to presentation) 

DISCUSSION

Following the presentation, a selection of panellists answered key questions asked by the moderator, Tit Albreht, Head of the Centre for Health Care, National Institute of Public Health, Ljubljana (Slovenia) on HTA issues.

Antonella Cardone, Cancer Patients Europe was asked two questions: 1) What are the opportunities and challenges for cancer patients in the implementation of the new HTA regulation? & 2) How is Cancer Patients Europe preparing for the implementation of the new HTA regulation? 

In response to these questions, she shared the perspective of patients and how the HTA regulation should aim to accelerate patient access by reducing the time between EMA regulatory approval and reimbursement decisions across MSs through an efficient Joint Clinical Assessment (JCA) framework. 

The full written answers can be found here. (link to pdf)

Ansgar Hebborn, European Federation of Pharmaceutical Industries and Associations (EFPIA) was asked two questions, 1) What are the opportunities and challenges of the EU-HTA-Regulation (EU-HTA-R) and its implementation? & 2) How are EFPIA and its member companies preparing for the implementation of the new HTA regulation? 

In response to these questions, he shared the perspective of pharma companies, and how it is important to provide support to national associations and their members that are asked to constructively support the national implementation of the EU HTA Regulation and to adjust to changing national HTA processes.

The full written answers can be found here. (link to pdf) 

Elisabeth de Vries, European Society of Medical Oncology (ESMO) was asked two questions, What are the opportunities and challenges for ESMO and the Health Professionals community in the implementation of the new HTA regulation? & How is ESMO preparing for the implementation of the new HTA regulation?

In response to these questions, she shared the perspective of the medical society and how the new legislation provides an opportunity to enhance the sustainability of healthcare systems, as it will improve the value of care by prioritising market access to high-value therapies. 

The full written answers can be found here. (link to pdf) 

Elaine Julian, The European Access Academy (EAA) was asked two questions, How is the EAA preparing for the implementation of the new HTA regulation? & What are the opportunities and challenges for a multi-stakeholder approach with the new HTA regulation?

In response to these questions, she shared the EAA group perspective and believed that combining different stakeholder/ collaborator perspectives from different geographical locations within the EU is much rather an “additional benefit” for contribution to the implementation of the EU HTA Regulation than it might be a challenge.

The full written answers can be found here. (link to pdf)

Ali Stunt, Pancreatic Cancer Action, UK was asked two questions, What are the opportunities and challenges of patients’ participation in the HTA process based on your practical experience in Scotland? & How is Pancreatic Cancer Action, a national organisation, preparing for the implementation of the new HTA regulation?

In response to these questions, Ali Stunt shared the patient perspective and how that the regulation could improve access to innovative treatments and technologies that could improve patient outcomes and quality of life. 

Watch the video to listen to the full answers. 

FINAL REMARKS AND Q&A

MEP Tomislav Sokol, EU Parliamentary Intergroup Challenge Cancer, also shared his message on the issue of HTA regulation and Alfredo Carrato, Chairperson of PCE concluded the event. 

Watch the video on MEP Tomislav Sokol’s message

Watch the conclusion and Q&A video by Alfredo Carrato

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