The Cancer Drug Development Forum (CDDF) held a live webinar on the “EU HTA Regulation” on 12 March at 17:00 CET. This webinar featured a lively discussion between Michael Berntgen (EMA, NL), Niklas Hedberg (TLV, SE) and Dr. Vanessa Schaub (Roche, CH). Dr. Rosa Giuliani (Guy’s and St Thomas’ NHS Foundation Trust, UK) and Dr. Christian Schneider (Cencora PharmaLex, UK) moderated this webinar.
WEBINAR OUTLINE
With the Health Technology Assessment Regulation (HTAR) having come into force in January 2025, regulators’ and payers’ assessments are converging. The Regulation aims at harmonizing the HTA process across EU member states, and a Joint Clinical Assessment (JCA) for medicines against cancer has become a reality. In this panel discussion, organized by the Cancer Drug Development Forum as a webinar, leading EU experts from the HTAR Coordination Group, the European Medicines Agency, and Innovator Industry are looking at these new developments and the opportunities it will bring to anticancer medicines and patients. Having a debate between HTA, the Regulatory Authority and industry is timely since the treatment of cancer has seen a considerable evolution of new treatments, with novel paradigms continuously nearing the approval stage.
Learning Objectives/Meeting Objective
From this panel debate, participants will achieve the following outcomes:
- To learn what are the new rules, and how did they come about;
- To understand what this means for cancer drug development and patients;
- To hear reflections on what myths need to be debunked.
Agenda: (CET time zone)
17:00 – 17:05 Welcome & Introduction to the webinar by the moderators
17:05 – 17:10 Niklas Hedberg (TLV, SE) will give an introduction to the EU HTA regulation
17:10 – 17:15 Michael Berntgen (EMA, NL) will give a brief explanation on the interface
17:15 – 17:20 Vanessa Schaub (Roche, CH) will touch upon the industry perspective on the regulation in relation to the cancer drug development part
17:20 – 18:00 Fire-side chat and questions from the audience – moderated by Rosa Giuliani (CDDF, UK) and Christian Schneider (CDDF, UK)
Michael Berntgen
Michael Berntgen is Head of the Scientific Evidence Generation Department at the European Medicines Agency (EMA), Amsterdam. This department supports the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders (e.g. patients, HTAs). Activities include the provision of scientific advice and methodology qualification, management of the PRIME scheme, support to medicines for the paediatric population and for orphan diseases, as well as provision of expertise and support in translational sciences. Furthermore, Michael coordinates across the Agency the collaboration with HTA bodies and payers, to foster timely access to medicines.
Dr Vanessa Schaub
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.
Niklas Hedberg
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). Niklas is the Co-Chair of the HTAR Coordination Group with special expertise in pharmaceuticals. He was the Chair of the Consortium Executive Board for EUnetHTA21 (2021-2023) as well as the Chair of the EUnetHTA JA 3, Executive Board between 2018 and 2021. Niklas has been working with pricing and reimbursement since 2001. He has held positions as medical assessor, project leader, Head of the Department for New Submissions (between 2009 and 2014) and he is now the Chief Pharmacist. Niklas has a broad experience of different aspects of value based evaluation and over time has seen the increasing importance for health technology assessment (HTA) both across health care systems and on local level to prepare accurate decision. making.Among Niklas special interests have been the early development of joint scientific advice in 2009 and onwards (pilots both nationally with MPA and on European level with EMA) and strategic discussions about RWD.