EU-HTA ahead: Experts discuss new rules at BIO-Europe Spring

The pharmaceutical industry's perspective on the initiated EU-wide assessment of new medicines is the focus of a technical discussion with IGES experts at one of the world's most important bio-pharmaceutical industry conventions in Europe, BIO-Europe Spring 2023. A second talk will focus on EUnetHTA 21’s view on the topic.

Berlin, March 14, 2023 (IGES Institut) - Claudine Sapede, Director, Global HTA Policy, Novartis, will be in talk with Fabian Berkemeier, Managing Director, IGES Institute. This chat deals with the harmonization of the health technology assessment (HTA) procedures in the EU. From 2025 onwards, medicines will no longer be assessed independently by each EU country, instead there will be a central, joint clinical assessment that applies to all EU countries. Sapede and Berkemeier discuss the industry's view of the change-over to the new process.

The conversation will be followed by a chat focussing on EUnetHTA 21’s view on the topic one day later at the same time. Anne Willemsen, Senior Project Manager EUnetHTA21, Zorginstituut Nederland (ZIN) again with Fabian Berkemeier will have this talk. The EUnetHTA 21 consortium, coordinated by ZIN, is supporting the development of guidance documents to be adopted by the Coordination Group and/or drafting of implementing legislation by the European Commission based on a service contract.

In the future, EU (EEA) member states will be obliged to take into account the results of joint clinical assessments when deciding on added value, market access, pricing and reimbursement. Starting in 2025, oncology medicines and ATMPs with a new centralized marketing authorization will be subject to mandatory joint clinical assessments at the EU level, followed by all other orphan medicines in 2028 and all new medicines with centralized marketing authorizations in 2030, regardless of their indication.

The new EU HTA procedure is a major challenge for large pharmaceutical companies and small biotech companies that do not intend to market their innovations themselves: Both need to plan clinical trials accordingly. And both urgently need to prepare for this new era, whether they are launching new drugs themselves or licensing out their innovative late-stage clinical development products to partners.

The convention "BIO EUROPE SPRING" will be held in Basel, Switzerland, March 20-22, 2023. It is one of the most important platforms for global partnerships in pharma and biotechnology.

The IGES Institute has been involved in this convention for many years with talks and panel discussions. EU-HTA and joint clinical assessments have been important topics in the past and will continue to be so in the future. IGES Group companies such as IGES Institut GmbH and HealthEcon AG participate as EU-HTA stakeholders in the public consultations of EUnetHTA 21. The IGES Group supports all stakeholders from the healthcare sector in the transition to the new procedure.

Fireside Chat 1

HTA procedures in the European Union are being harmonized – the industry’s view.

March 21, 2023, 09:30-10:00 CET/CEST (Cent Europe Summer, GMT +2)
Exhibition Hall Stage

Speakers:
Fabian Berkemeier, Managing Director at IGES Institut GmbH, Berlin (Germany)
Claudine Sapède, Director, Global HTA Policy at Novartis International

Fireside Chat 2

HTA procedures in the European Union are being harmonized – EUNetHTA’s view.

March 22, 2023, 09:30-10:00 CET/CEST (Cent Europe Summer, GMT +2)
Exhibition Hall Stage

Speakers:
Fabian Berkemeier, Managing Director at IGES Institut GmbH, Berlin (Germany)
Anne Willemsen, Senior Project Manager EUnetHTA 21, Zorginstituut Nederland