The benefit assessment debate needs a bit of impetus from Europe
Diseases do not recognize European national borders, so why should the benefit assessment? Does someone living in Portugal have different disease symptoms from someone living in Germany? Hardly! So why should the benefit assessment be governed by a European's nationality? Certainly, there is a difference in cost of living between Germany and Portugal. So, there is some point in differentiating according to nationality when it comes to price negotiations but not as far as the medical assessment is concerned.
The assessment of medicinal products stands and falls by the quality of the studies. And it doesn't make any difference whether the assessment originates from the licensing authorities or the German Federal Joint Committee. Both require a good basis for assessment: in the case of the licensing authority, when it evaluates the risk-benefit ratio and, in the case of the German Federal Joint Committee, when it determines the additional benefit:
If the licensing and additional benefit assessment authorities are in agreement, then this reduces attrition losses and ensures that patients benefit from good studies.
A future European additional benefit assessment can operate in exactly the same way as the European approval system. There, the various national authorities cooperate well in a structured procedure under the leadership of an EU body. In doing so, the national authorities can apply their particular expertise and experience in a focused manner, while the European authorities ensure that they are called upon.
The Federal Joint Commission and the Institute for Quality and Efficiency in Health Care can also play a part in this future European cooperation. The National Association of Statutory Health Insurance Funds is still, as before, responsible for downstream price negotiations because, even within the EU concept, implementing the benefit assessments remains a national competency.
A European additional benefit assessment sets a clear signal to patients everywhere in Europe.
This is why several associations within the health economy are arguing for a European benefit assessment: EU-HTA - European evidence, national decision (PDF)