EU HTA harmonisation under time pressure: discussion at the biotech congress "BIO Europe 2023"
The time pressure due to EU HTA harmonisation is growing. In less than 15 months, the first medicinal products must undergo a central, EU-wide clinical evaluation procedure. The procedure itself is also taking place under high time pressure - with very tight deadlines and largely parallel to the marketing authorisation. What companies should urgently do now to successfully bring their new developments through the procedure is the topic of an IGES expert event at BIO Europe 2023 on 07 November in Munich.
Berlin, 18. Oktober 2023 (IGES Institut) - From January 2025, oncology medicines and advanced therapy medicinal products (ATMPs) with a new centralised marketing authorisation will undergo a mandatory joint clinical evaluation at EU level, followed by all other orphan medicines from the beginning of 2028. From 2030, all centrally authorised medicines with a new active substance will follow, regardless of the indication.
It is a challenge for developers of innovative therapies to adapt to this new procedure and, for example, to set up clinical trials in such a way that they meet the new requirements. But the very tight deadlines within the trial procedure that runs parallel to the approval also require forward-looking planning.
How can developers of innovative therapies still use the remaining time until the changeover to get off to a good start with the European Health Technology Assessment (HTA) procedure from 2025? Which procedural questions are currently still unresolved? What changes are still to be expected, for example, with regard to the questions to be posed to the developer (PICO schemes)?
These questions will be discussed by Fabian Berkemeier, Managing Director Pharma & Biotech at the IGES Institute, in an expert discussion at BIO Europe together with Kevin Rieger, Director Corporate Affairs of the biotechnology company BeiGene.
The new, centralized assessment process relevant for reimbursement of pharmaceuticals in the EU
Tuesday, 7. November 2023, 11:00 - 11:30 CET/CEST (Cent Europe Summer, GMT +2)
Fabian Berkemeier, Managing Director Pharma & Biotech, IGES Institut, Berlin (Germany)
Kevin Rieger, Direcor Corporate Affairs, BeiGene
EU HTA harmonisation is one of the most far-reaching changes in EU pharmaceutical legislation since the introduction of centralised authorisation about two decades ago. The EU HTA process will take place in parallel with the authorisation process of the European Medicines Agency (EMA) and will be subject to very strict deadlines. EU (EEA) member states will be obliged to take the results of the joint clinical evaluations into account when deciding on added value, market access, pricing and reimbursement, but are not bound by them.
The congress "BIO EUROPE" will take place from 6 to 8 November 2023 in Munich, Germany. The event is one of the most important platforms for global partnerships in pharmaceuticals and biotechnology.
The IGES Group has participated in this congress for many years with presentations and panel discussions. IGES Group companies such as the IGES Institut and HealthEcon also participate as EU HTA stakeholders in the public consultations of EUnetHTA 21. The IGES Group supports all stakeholders in the healthcare sector in the transition to the new procedure.
The IGES participation is accompanied by the publication of a new edition of the information brochure: The publication "Reimbursement and Pricing of Pharmaceuticals in Europe 2023/2024" explains the reimbursement procedures in the five largest EU countries, describes the respective health care markets and explains the innovations of the harmonised HTA procedure. It is already in its sixth edition.
If you would like a copy of our guide, please email Ms. Agata Daroszewska.