By Politico

Europe’s health care systems aren’t feeling very well–something the current pandemic isn’t improving -and Health Technology Assessments (HTAs) are at the heart of the strategy to improve their quality, efficiency,and sustainability. They have been put in place to move towards a more value-based and evidence-driven decision-making in health care, concerning everything from pharmaceuticals to devices and procedures.

While HTAs are key in ensuring new drugs and medical devices deliver meaningful innovation for patients and good value for money for health systems, cooperation between the more than 50 HTA bodies in the EU is still voluntary. The European Commission’s proposal to strengthen HTA cooperation between members states has been mired in talks since it was first put forward in 2018 —but trialogues with the Parliament and Council have finally reached an informal deal. If planned out successfully, this text could open the door to more cooperation, more efficiency, and a less fragmented internal market –resulting in a more competitive sector, and a fairer access to valuable drugs across the EU.

The negotiations on HTA cooperation in the EU are also a good opportunity to look at HTA processes more broadly: what works well, what needs to be improved to make them future proof, what are the best practices in the EU and how they can be used to improve HTAs across the bloc.

Main questions for discussion include:

• What were the sticking points in HTA negotiations and why? If cooperation is not mandatory, what are its concrete benefits? How would greater collaboration across member states improve HTA processes?

• And how is the regulation as it stands now fulfilling its objectives of improving patient access to innovation, ensuring the efficiency and quality of HTA resources, and improving business predictability1? What could it do better?

• What is the public health cost and impact on patients of the delay on the HTA deal, particularly in countries who stand to benefit the most from cooperation?

• Patient involvement in HTAs vary widely across Europe, even though they are directly impacted by the decisions. What role can the EU play in further incentivizing and streamlining meaningful patient involvement in HTA processes?

• Some therapies do not go through an HTA procedure. What are the lessons learned when it comes to putting on the market products without assessing their added value first?

• What has the past year highlighted on the use of real-world data and real-world evidence in health decision-making? Could this mean more widespread use of RWD/RWD in HTAs process –like in Germany for instance –throughout the EU? Do systems have the data and interoperability to do so?