The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a report on their achievements and reflections from the EMA-EUnetHTA 2017-2021 work plan.
Initially created as a plan for 2017-2020, it was extended by a year in 2020 to continue until May 2021. The collaboration’s overall goal is to demonstrate that joint work between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine can be utilised to accelerate patient access to innovative medicines.
Collaboration between the EMA and EUnetHTA allowed medicine developers to develop more efficient clinical research and evidence generation methodologies for both regulators and HTA bodies. They also encouraged new evidence generation tools such as the use of patient registries. The collaboration also saw improvements in early dialogue with developers and increased information exchange between the EMA and EUnetHTA. These are some of the priority areas for collaboration identified during the inception of the work plan and the report demonstrates areas of success in these fields. The reflections on these topics highlight the benefits of schemes/workshops in these areas (as identified by positive stakeholder feedback) and specify the need for their continuation in future work plans.
Whilst the current work plan is winding down, the collaboration between the EMA and EUnetHTA will continue. A legislative proposal from the European Commission (EC) is being introduced with the aim of increasing cooperation between European Union (EU) Member States on HTA. The outcomes of the EMA-EUnetHTA collaboration will inform this future legislative framework. Concurrently, the reflections in the report that identify areas for improvement will also help develop any future collaborative work plan. For instance, the report highlights better utilisation of patient-reported outcomes and the sharing of information and experiences with Advanced Therapy Medicinal Product (ATMP) manufacturers as areas that will be of great importance for the future and consequently require more attention in future work plans.
Click here for the full report.