EU-HTA: G-BA coordinates parallel scientific advice for manufacturers from September onwards
Berlin, 3rd of July 2023 – With the help of Health Technology Assessment (HTA), the added value of new health technologies for patients can be evaluated in comparison to the current standard therapy. From 2025, such a systematic assessment of clinical studies for new medicinal products and medical devices will take place at European level in so-called EU HTA reports (Joint Clinical Assessments, JCA) within the framework of the EU HTA Regulation. Also, in 2025, the European Joint Scientific Consultations (JSC) will start, which will enable an early exchange between manufacturers, the European Medicines Agency (EMA) and HTA bodies in Europe.
In preparation for the application of the EU HTA Regulation, health technology developers will have the opportunity from September 2023 until the end of 2024 to seek advice for the planning of pivotal studies from the national HTA bodies and the EMA in a parallel procedure ("Parallel EMA/HTA body (HTAb) Scientific Advice"). The G-BA acts as the central HTA coordination contact: it coordinates all incoming requests for parallel scientific advice and facilitates the procedure with the national HTA bodies.
Prof. Josef Hecken, impartial chair of the G-BA, comments: "In order to obtain meaningful EU HTA reports, robust data must be generated already via the pivotal studies. The European consultations are an important opportunity for manufacturers to obtain advice on their development plan from the HTA authorities and the EMA. The G-BA – together with IQWiG – has already been involved at European level in recent years and has prepared the implementation of the EU HTA Regulation within the framework of EUnetHTA 21. As the central coordination contact, the G-BA is now taking on an important organisational task for parallel scientific consultations that will be offered to manufacturers in the transitional period until the full application of the EU HTA Regulation. I am sure that our wealth of experience from the consultations for manufacturers at national and European level will help to prepare and implement the future EU-HTA procedures well.
Request for parallel scientific advice
Parallel scientific advice for manufacturers can be requested via the G-BA. The application documents and more detailed information are available on the G-BA website: Offer of parallel scientific advice from EMA and HTA bodies ("Parallel EMA/HTA body (HTAb) Scientific Advice") in the interim period until the application of the EU HTA Regulation.
Background: EU HTA Regulation
The assessment of the clinical study situation of new medicinal products and medical devices at European level will be published in so-called EU HTA reports (Joint Clinical Assessments, JCA) and is to be given due consideration by the EU Member States in their country-specific decisions on additional benefit and reimbursement. The legal basis is the EU HTA Regulation, which regulates the future cooperation of the national HTA agencies of the EU Member States and the European Economic Area (EEA).
The application of the EU HTA Regulation will start in January 2025 with EU HTA reports on new cancer medicines and advanced therapies (ATMPs). The preparatory work for the implementation is done by the EUnetHTA 21 consortium until September 2023.