Payers and EMA discussed evidence generation along the life-cycle of medicines

On 12 March, representatives from the European Social Insurance Platform (ESIP), the payer platform Medicines Evaluation Committee (MEDEV), the International Association of Mutual Benefit Societies (AIM) and the European Medicines Agency (EMA) met for the third time to further explore synergies and foster mutual understanding and cooperation on evidence generation, with the aim of better aligning evidence requirements for the different decision-making processes. On this occasion the focus was on evidence generation along the life-cycle of medicinal products.

Today an increasing number of novel health technologies such as CAR-T cell and gene therapies are entering the market with the potential to significantly improve the life of patients. Nonetheless challenges persist in relation to higher level of uncertainty regarding effectiveness and safety at the point of market entry. This leads to the need for reassessment by regulatory, HTA and payer bodies post-market authorisation based on post-licensing evidence generation. 

Enhanced cooperation in this field is part of EMA’s Regulatory Science Strategy 2025, the European Commission’s Pharmaceutical Strategy and is addressed by the MEDEV Reflection paper on Payer Strategies for new products coming to the market.

The meeting served to highlight the common challenges facing the payer organisations and EMA related to the collection and use of real-world data for decision making and identify key areas which EU payers and EMA will take forward as part of their continued collaboration in the future. 

The results of the meeting have been summarised in a highlight report available on the EMA website.

Find out the minutes prepared by the EMA as well as a joint presse release prepared by ESIP, MEDEV and AIM here.