How the HTAR will contribute to a value-based decision-making for medicinal products across the EU

The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025. HTAR includes some core domains such as Joint Clinical Assessment (JCA), which refers to the relative effectiveness assessment of new technologies that have submitted a marketing authorization application to the EMA. It further includes Joint Scientific Consultation, which allows health technology developers to seek advice at an early stage in order to plan evidence generation in line with HTA needs. Such joint work will feed into respective national decision-making processes. While a JCA report will arguably fit directly into appraisal processes based on an added benefit framework, countries performing cost-effectiveness appraisal will be expected to incorporate a JCA into their value frameworks. In assessing the value of a new technology, however, HTA agencies face challenges stemming from the complexity of new technologies, a weakened evidence paradigm and a delay in access. The authors argue that HTAR can contribute towards solving some of the challenges through the reestablishment of evidence standards even for complex technologies, reduction of redundancies and a build-up of assessment capacity. Together with the suggested changes in the pharmaceutical regulation, HTAR may shorten the delay for late-access countries. HTAR is argued to be a major step towards a longer-term goal of equitable, efficient and high-quality healthcare in Europe, potentially leading towards the direction of one European HTA body.