ContactPanel at BIO-EUROPE: Start early, seek advice, talk to the HTA Agencies
EU-HTA will start in time in 69 days. Fundamental implementing acts adopted – preparations under time pressure but will finish in time.
Stockholm, 5. Nov 2024 (IGES Pharma) - The Expert panel discussed under the headline: "Pay The Price": Reimbursement - is there now a single HTA procedure in the European Union?” at BIO-EUROPE, 05 November 2024, with Niklas Hedberg (TLV / co-chair Member State Coordination Group on HTA), Sofia Heigis (CEO, Oncopeptides AB (publ)), Gry Stine Kopperud (Nordic Value & Access Head, Novartis), Alexander Natz (Secretary General, EUCOPE - European Confederation of Pharmaceutical Entrepreneurs) and Fabian Berkemeier (GM, IGES Institut GmbH).
Recording of the Panel Discussion: "Pay The Price: Reimbursement - is there now a single HTA procedure in the European Union?"
Watch the Panel Discussion with IGES at BIO-Europe 2024 here
Alexander Natz (EUCOPE), Sofia Heigis (Oncopeptides), Niklas Hedberg (co-chair Member State Coordination Group on HTA, Dental and Pharmaceuticals Benefits Agency, TLV), Gry Stine Kopperud (Novartis), Fabian Berkemeier (IGES) (from left).
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).
The EU-HTA regulation introduces a Joint Clinical Assessment procedure which serves as common starting point for subsequent national decisions about additional benefit, pricing and reimbursement.
As a consequence, pharmaceutical companies need to manage a highly complex hybrid procedure of centralised assessment elements based on the requirements of all member states and subsequent national decisions.
Companies need a coordinated concept of EU dossier and additional national submissions.
EU-HTA will be introduced gradually, starting with cancer medicines (including orphan oncology drugs) and ATMPs. The EU HTA Regulation will be applied from 12 January 2025 to all marketing authorisation applications submitted after that date for the products concerned.
It will also apply to selected medical devices in risk classes IIb or III. In January 2028, all other medicinal products with new active substances for orphan drugs will follow, and in January 2030, all other medicinal products with new active substances.
The panel agreed - most important for companies planning to bring a new drug to market is to start early, seek advice and talk to the HTA Agencies!
As EU HTA stakeholders, the IGES Institute and IGES Group companies have been closely involved in the discussions and consultations of EUnetHTA21, have prepared for the application of the regulation and work on EU-HTA projects.
