Contact"Pay The Price": Reimbursement - is there now a single HTA procedure in the European Union?
BIO-EUROPE: Panel Discussion with Niklas Hedberg (TLV / co-chair Member State Coordination Group on HTA), Alexander Natz (EUCOPE), Gry Stine Kopperud (Novartis), Sofia Heigis (Oncopeptides) and Fabian Berkemeier (IGES)
Stockholm, 05 November 2024, 14:00, Exhibit Hall Stage
In the European Union (EU), medicines are authorized centrally, but reimbursement is carried out at the national level: the EU member states conduct national assessment procedures for this purpose, known as health technology assessments (HTAs).
Harmonization of these procedures is one of the most important innovations in the regulatory framework for medicines in Europe. From January 2025, a joint clinical assessment will come into force in the EU. This will be introduced gradually, starting with cancer medicines (including orphan oncology drugs) and ATMPs.
A whole series of important EU regulations were adopted in 2024. Currently, national regulations are being adapted to the new European procedure in the EU member states. And now, in the fall of 2024, many details regarding the implementation and execution of the new procedure are clarified.
This panel will discuss how small and large biopharmaceutical companies need to adapt to the new procedure to reach Europe’s patients quickly and successfully with their innovative therapies.
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Co-Chair of the HTAR Coordination Group with special expertise in pharmaceuticals and the Chair of the Consortium Executive Board for EUnetHTA21 and was the Chair of the EUnetHTA JA 3, Executive Board between 2018 and 2021.
Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.
Gry Stine Kopperud is Nordic Value & Access Head, Innovative Medicines Novartis. She is skilled in HTA strategy, submission and negotiation, Market Access, RWE and in Nordic tenders.
Sofia Heigis, CEO of Oncopeptides - a biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers.
Fabian Berkemeier, General Manager of IGES Institute will moderate the panel. As EU HTA stakeholders, the IGES Institute and IGES Group companies have been closely involved in the discussions and consultations of EUnetHTA21 and have prepared for the application of the regulation.
In addition, the IGES Pharma division is represented by its Basel-based subsidiary HealthEcon as a co-exhibitor at the Swiss joint stand (Booth 53) at Bio Europe.
