A huge coordination effort is needed for a European benefit assessment (EU-HTA)

With its Joint Health Technology Assessment (EU-HTA), that the European Commission introduced in 2021 through Regulation 2021/2282, the EC has undertaken a sensible reorganisation of the scientific assessment of health technologies (HTA). The EU-HTA harmonises the benefit assessments of health technologies, including medicinal products and medical devices. Increased European coordination will make cooperation between member states more binding.

What is the EU-HTA?

With the help of HTA, the added value of new health technologies can be evaluated in comparison to current standard therapy. Up to now, HTA procedures occurred solely at national level, which meant that health technology developers had to submit their documents several times and sometimes in different formats for the evaluation procedures in the individual member states. The EU-HTA process is also intended to reduce this administrative burden on developers and to increase the quality of assessments according to the international standards for evidence-based medicine. The joint assessment will provide national HTA organisations with scientific information that they can use in their decisions on pricing and reimbursement for a health technology. It is important that the national HTA organisations can decide for themselves to what extent they will use and adopt the European evaluation results.

When will the EU-HTA start?

The EU-HTA will start gradually from 2025. New cancer drugs and advanced therapy medicinal products (ATMPs) will be assessed.In January 2025. New orphan drugs will be added from 2028 until all new medicinal products are assessed together after 2030. It is not yet clear when the procedures for medical devices will begin.

A huge amount of coordination work is still needed as the regulation came into force on 12 January 2022 and the first European assessments in so-called Joint Clinical Assessments will actually take place in 2025. A rolling plan provides an overview of the main activities planned by the EC and the member states in preparing the implementation.

Which actors are involved?

The “Member State Coordination Group (HTACG)” will play a central role in the implementation. This will be in close exchange with the EC, which will support it administratively. A common methodology is currently being developed in four subgroups so that the European evaluation results can be used meaningfully by the national HTA organisations. For Germany, the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) are both represented in the coordination group. In this context, it is possible to draw on the preparatory work of the consortium EUnetHTA 21, in which 13 member states are involved.

Who will design the transition period?

The German G-BA will have an important role to play in the transition period until 2025. As from September it will be advising health technology developers with regard to regulatory trial procedures. The G-BA will act as the central contact point and coordinate requests for parallel scientific advice ("Parallel EMA/HTA body (HTAb) Scientific Advice"). These are intended to enable an early exchanges between the applicant, the HTA organisations and the European Medicines Agency (EMA) to ensure that the different requirements are integrated in several European Member States (e.g. selecting comparators, relevant outcomes, quality of life, patient groups) in the study design and the economic evidence generation plan.

A huge amount of coordination is still needed before the EU-HTA is implemented in January 2025.