Overview

With the implementation of the EU HTA Regulation around the corner, this year’s DIA HTA Forum changes gears. In 2024, the focus of the DIA HTA Forum goes away from exploring the concept and content of the EU HTA Regulation, towards collecting and sharing tangible advice that facilitates its implementation. With the attendance of a wide array of HTA experts from the Industry, HTA body representatives from various Member States, patient representatives and clinicians, this meeting will provide all stakeholders a neutral space to finetune together their preparedness for the impending HTA-R implementation.

The 2024 DIA HTA Forum will be the perfect opportunity to review the readiness status for phase 1 applications: Advanced Therapy Medicinal Products, and medicinal products with oncology indication; and additionally, kickstarting readiness activities for other medicinal products, medical devices, and in-vitro devices.

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Featured topics

- HTA Regulation implementation: implementing Acts, measuring HTA-R impact ahead of 2028 revision.
- Building a new EU-level system: joint work, resourcing, and capacity.
- Evidence generation that can inform the decisions of all partners along the product lifecycle.
- JCA: preparedness, experience, expectations, and potential impact for evidence generation plans.
- JSC: unleashing full potential, making sense of the advice options.
- Workshop - what constitutes an addressable PICO?
- PICO simulation case study – aligning values, differences, and solutions.
- Treatment guidelines vs. reimbursement guidelines at individual national level.

Featured

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Exhibits

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Exhibits

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Who should attend?

Regulatory Affairs professionals

Market Access professionals

National HTA Agencies

Clinicians

Statisticians

Patient representatives

Learning objectives

Goals of the Forum:
- Address various strategic elements related to the implementation of the EU HTA Regulation from the European Commission, EMA, Member States HTA Coordination Group and subgroups representatives, Industry, Patients’, Clinicians’, and Member States’ perspectives.
- Provide an opportunity to ask the burning questions that will inform internal organisation’s preparedness and discussions, such as inter-department preparedness (e.g. HTA, Regulatory and Clinical Development) or future methodologies and processes for the Joint Clinical Assessment (JCA).
- Navigating implementing acts, central IT platform, capacity building, and other hot topics
- Give insight into the work of EU HTACG and Member States’ HTA Agencies focused on their activities for 2025, to bolster internal company preparedness.

Program Committee

Claudine Sapède, PharmD Director, Global HTA Policy
NOVARTIS INTERNATIONAL, Switzerland
Inka Heikkinen, MBA, MS, MSc Regulatory Policy Lead
Lundbeck, Denmark
Tanja Podkonjak Director, Oncology Access Policy EUCAN
Takeda Pharmaceuticals International AG, Switzerland
Lara Wolfson AVP & Head, HTA Statistics
MSD Switzerland, Switzerland
Matteo Scarabelli Senior Manager Market Access
EFPIA - European Federation of Pharmaceutical Industries and Associations, Belgium
Matias Olsen, MA Senior Manager, Public Affairs & Policy
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
Christophe Hilbert, MSc Director, European Reimbursement and Access
Incyte Biosciences International Sàrl, Switzerland