Health technology assessment bodies

The EMA / EUnetHTA joint work plan for 2017-2021 and report on its implementation is available:

• Report on the implementation of the EMA-EUnetHTA work plan 2017 - 2021
• EMA-EUnetHTA work plan 2017-2021

Between 2017 and 2021, EMA and EUnetHTA:

• provided parallel consultations to medicine developers to allow them to obtain feedback from regulators and HTA bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time;
• exchanged information on the outcome of the regulatory assessment at the time of marketing authorisation as part of EUnetHTA's framework for production of relative effectiveness assessments;
• worked on optimising post-authorisation data generation tools, such as patient registries, to serve data needs for various decision-makers;
• explored how HTA bodies and regulators apply the concepts of unmet medical need and therapeutic innovation in view of possible synergies;
• explored the conceptual similarities and differences between the significant benefit of orphan medicines versus their added therapeutic value.

The EMA / EUnetHTA joint work plan for 2012-2025 and report on its implementation is available:

• Report on the implementation of the EMA-EUnetHTA three-year work plan 2012-2015
• EMA-EUnetHTA three-year work plan

Between 2012-2015, EMA and EUnetHTA:

• participated in each other's pilot projects to explore efficient processes by which regulators and HTA bodies can give medicine developers simultaneous feedback on their development plans;
• updated the EPAR template. They also discussed options to display key effects observed for a medicine in a structured manner, making value judgment in scientific decision-making more transparent;
• explored approaches for collecting robust post-authorisation data relevant for both organisations, including patient registries;
• worked to facilitate a framework to allow timely provision of information from the regulatory benefit-risk assessment reports in the rapid relative effectiveness assessments of medicines;
• held discussions on the therapeutic indication for medicines which will contribute to the future development of principles for optimisation, as well as an exchange of views on how to document the scientific reasoning behind it.

Further information on the EMA / EUnetHTA project to improve the EPAR template is available in a scientific article published in the Value in Health journal:

• Value in Health: Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments — A Collaboration between the European Medicines Agency and the European network for Health Technology Assessment

The first joint EMA-EUnetHTA project in 2010 responded to a political recommendation to consider how the assessment of the benefits and risks of a medicine contained in European public assessment reports (EPAR) can best be used to inform the assessment of the relative effectiveness of new medicines for HTA purposes in EU Member States. This has resulted in a series of improvements to the EPAR template.

EMA and EUnetHTA have published the outcomes of this project in a scientific journal.

The cooperation had been subsequently expanded to other areas to help ensure that data generated by medicine developers is relevant for the needs of both regulators and HTA bodies.