After several years of discussions, the EU will start to conduct joint HTAs in 2024. This process will be organized and overseen by the EUnetHTA21 consortium, which consists of 13 organizations. Amongst these are not just one, but two German groups, the IQWiG and G-BA. The other countries represented within EUnetHTA21 are Spain, Austria, Belgium, France, Italy, Portugal, Ireland, Hungary, Norway, Sweden, and the Netherlands.
The IQWiG was already involved in joint HTAs as a EUnetHTA founding member since 2006. Over the years, EUnetHTA worked on three overarching projects, called Joint Actions 1 to 3. The IQWiG has supported these on the topics of method development, information gathering, and quality assurance, especially the introduction of a modern quality management system.
Between 2021 and 2023, EUnetHTA21 will now determine the methodological basis for joint assessments. These would be mainly based on the EUnetHTA project Joint Action 3. The overarching goal is to establish uniform standards for joint benefit assessments of health technologies in Europe.
The joint HTA program will be rolled out in a staggered approach:
- From 2024, joint HTAs will be conducted for oncology drugs as well as ATMPs will undergo these joint assessments.
- After three years, i.e. from 2027, also orphan drugs will be assessed in joint HTAs.
- Lastly, another two years later, i.e. from 2029, all other drugs as well as medical devices will be subject to the joint HTAs.
The assessment of the additional benefit and reimbursement decisions will remain at the national level, so will stay in the hands of the G-BA.