EU HTA regulation: methodological preparation for implementation has started with the involvement of IQWiG and the G-BA

The policy decision-makers in the European Union (EU) agree: from 2024, the EU member states will prepare joint benefit assessments of health technologies (health technology assessments, HTA). In order to develop the basic methods for these joint assessments, the EU issued a call for tenders for a competent service provider.

The contract has now been awarded to the EUnetHTA21 consortium, which comprises 13 organizations from the well-established European HTA network EUnetHTA, including the Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA). The project will start in September 2021 and will run for two years. Over these two years, the EU Commission will fund the further development of the basic methods for implementing the EU HTA regulation with a total of three million euros.

Jürgen Windeler, IQWiG’s Director, emphasizes: “The project is very important for the quality of the future benefit assessments of drugs and medical devices that will be jointly prepared in the EU. It is therefore good that IQWiG and the G-BA, two German institutions with a high level of methodological competence, are represented in the consortium – we will complement each other well here.”

Until 2021: voluntary collaboration within EUnetHTA

As a founding member, IQWiG has been involved in EUnetHTA since 2006. Since then, the initiative has developed from a loose network with 15 partners into an international one with more than 80 participating institutions. In recent years, numerous joint HTA reports, methods guidelines, tools and databases have been developed across countries. The EU Commission has funded EUnetHTA’s work, especially for three major “Joint Actions” (Joint Action 1 to 3) since 2010. Funding for Joint Action 3 expired in May 2021.

IQWiG’s involvement in EUnetHTA projects has increased steadily over the years. For instance, the Institute has recently participated in many work packages and steering committees of this complex large-scale project. IQWiG researchers were particularly involved in the development of methods, information retrieval and quality assurance. Within Joint Action 3, the Institute headed the introduction of a modern quality management system, which now both facilitates the preparation of joint HTA reports and ensures compliance with quality standards.

2021 to 2023: establish basic methods for joint assessments

With EUnetHTA21, a consortium of 13 EUnetHTA member organizations has now been commissioned to prepare the implementation of the EU HTA regulation and thus the future binding joint HTA work. Besides IQWiG and the G-BA, the consortium includes HTA agencies from Spain, Austria, Belgium, France, Italy, Portugal, Ireland, Hungary, Norway, Sweden, and the Netherlands.

The tasks to be performed under the current contract are to be explicitly based on the methods, procedures and materials already developed and implemented in EUnetHTA Joint Action 3. The overarching goal is to establish uniform standards for joint benefit assessments of health technologies in Europe.

From 2024: joint health technology assessments

Since the delegations of the EU Commission, the European Parliament and the EU Council of Ministers agreed on the formulation of a resolution in June 2021, it is foreseeable that the EU HTA regulation will come into force in 2024 after a transitional phase. Initially, joint HTA reports will be prepared for all cancer drugs and for all advanced therapy medicinal products (e.g. cell therapy and gene therapy). In a second step after three years, drugs for rare diseases will also be jointly assessed, followed by all other drugs and medical devices after a further two years.

In contrast to what was initially formulated, decisions on the added benefit and reimbursement of interventions remain national responsibilities. Jürgen Windeler welcomes this approach: “Only in this way can the specific health care features in the individual countries, as well as the financial resources of the individual health care systems, be adequately taken into account.”