Since mid-January 2025, the health technology assessment (HTA) on the European level under the EU HTA Regulation (Regulation (EU) 2021/2282) has become applicable. It now initially applies for medicinal products with new active substances for the treatment of cancer and for advanced therapy medicinal products. In a staggered process, the EU HTA will then be extended for all other medicinal products that are authorized in a central procedure by the European Commission, including any subsequent new therapeutic indications. The new EU HTA process called "joint clinical assessment" starts at the same time, and is conducted in parallel with the central marketing authorization procedure of new medicinal products under Regulation (EU) 726/2004. This process on the EU level precedes the HTA assessments for local reimbursement in the individual EU Member States, such as the AMNOG process in Germany and the ETS process in France.

The first joint clinical assessments (JCAs) under the EU HTA Regulation started in March 2025 and are ending in early 2026. However, even without the first HTAs being concluded, some key points have already become apparent:

• Handling the amount of PICOs: In the JCA, the medicinal product is scientifically assessed under certain parameters: population, intervention(s), comparator(s) and outcomes (PICOs). The conclusion for the reimbursement of the medicinal product is subject to the processes with – and decisions by – national HTA bodies. While under national HTA procedures the medicinal product is assessed in the direct context of the respective health and reimbursement system, the relevant PICOs relate to the respective national system only. Since the JCA under the EU HTA has to cover the national needs for all EU Member States while the standard of care and patient population may vary in such states, the EU HTA must cover all PICOs relevant in all EU Member States. As expected, this puts immense pressure on pharmaceutical companies, which must not only prepare the marketing authorization dossier, but also start early evaluation of the relevant PICOs in the EU. In this regard, it is even more challenging that the EU HTA dossier has to be submitted at a time when the CHMP opinion in the marketing authorization procedure is not yet available.
• Subject of the explanation meeting: When the JCA subgroup of the HTA coordination group has finalized the scope of the JCA and identified all PICOs, a pharmaceutical company can ask for an assessment scope explanation meeting. This meeting is not mandatory and will only be initiated by request. Since the assessment scope is final at this stage, this meeting will not lead to changes of the PICO. At the same time, the meeting cannot preempt the JCA; rather, the meeting presents an opportunity for a pharmaceutical company to receive additional background on the PICOs. To date, it appears that almost every pharmaceutical company with products currently under assessment have utilized this opportunity.

Taking these lessons into account, pharmaceutical companies should thoroughly plan ahead for participation in the EU HTA process, and consider the implications that process has in the EU Member States, which will ultimately determine reimbursement prices for innovations.