EU-HTA: Experten raten zu Tempo bei den Vorbereitungen
EU-HTA: Experten raten zu Tempo bei den Vorbereitungen
Die HTA-Verfahren für Arzneimittel und manche Medizinprodukte in der EU werden harmonisiert. Den aktuellen Stand dazu haben Experten haben auf der Bio-Europe Spring diskutiert. Sie raten insbesondere ab 2025 respektive 2028 betroffenen Arzneimittelherstellern dringend zu Tempo bei den Vorbereitungen.
Berlin, March 28, 2023 (IGES Institut) - The Industry´s view was represented on 21 March by Claudine Sapede, Director, Global HTA Policy, Novartis and EUNetHTA’s view on 22 March by Anne Willemsen, Senior Project Manager EU-netHTA21, Zorginstituut Nederland (ZIN), both in talk with Norbert Gerbsch, Director Public Affairs, IGES Institute.
The talk with Claudine Sapede concluded that the new HTA regulation provides the opportunity for streamlined and accelerated HTA procedures but needs early preparation as the joint clinical assessment procedure will run in in parallel to the marketing authorisation review. At this stage considerable uncertainty remains regarding the rules and methods which make preparation challenging. There is also a lack of joint scientific consultations opportunities for companies until the application of the regulation in January 2025 and its limited capacity afterwards.
The talk with Anne Willemsen pointed to the fact that the uncertainties incident to the transition phase are reduced by EUnetHTA21 practical guidelines and guidances which should be consulted, even if they need to be adopted by the Coordination Committee before being binding. Also seeking HTA advice where possible may help to reduce inevitable uncertainties.
One clear message resulted from both talks: The new joint clinical assessment needs urgent awareness and preparation from companies especially for pharmaceuticals (oncology and ATMP) for which joint clinical assessment (JCA) at EU level will become mandatory from January 2025. Companies need to consider the specificity of the EU market when they design their clinical development plans, not in some distant future but now.
In the near 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. Oncology medicines and ATMPs will first fall in scope of the JCA procedure starting January 2025 followed by all other orphan medicines in 2028 and all new medicines with centralized marketing authorizations in 2030, regardless of their indication.
The convention "BIO EUROPE SPRING" was 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:
Norbert Gerbsch, Director Public Affairs 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:
Norbert Gerbsch, Director Public Affairs at IGES Institut GmbH, Berlin (Germany)
Anne Willemsen, Senior Project Manager EUnetHTA 21, Zorginstituut Nederland
