The European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (EMA) have published a Technical Report on their achievements since 2017.
The report covers the latest phase of an open and successful collaboration that began in 2010, and demonstrated that the synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine can be harnessed to speed up patients’ access to innovative medicines.
By working together, EUnetHTA and EMA were able to help medicine developers to enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies (HTAs). They provided guidance to developers on 59 development plans for new medicines and 16 post-licensing and/or post-launch evidence generation plans. Furthermore, they encouraged new ways to generate evidence to address both regulatory and HTA information needs, such as the use of patient registries.
As the relative effectiveness assessment of national HTA bodies builds on the outcome of the regulatory assessment performed by EMA, the collaboration fostered a more effective exchange of information. For 14 newly approved medicines, regulatory information was provided to HTAs at the time of authorisation to facilitate their production of joint HTA reports as a basis for national decisions on access. Another example is in the area of orphan medicines: a review of the evidence assessed by EMA and HTAs showed that the data needed for the regulatory assessment of the ‘significant benefit’ of an orphan medicine was similar to what is needed by HTAs to determine their added value. Therefore, early interaction with developers in this area would be mutually beneficial.
The positive experience over the past decade highlights the importance of a sustainable HTA network as a partner for EMA to facilitate cross-fertilization and collaborative work on methodologies and products.
Towards a sustainable cooperation between regulators and HTAs at European level
Whilst the current EUnetHTA Joint Action 3 is drawing to a close, the collaboration between EMA and the European HTA community will continue. A legislative proposal from the European Commission aiming to boost EU cooperation between Member States on health technology assessment is currently being discussed at EU level. The collaboration between EMA and EUnetHTA provided essential technical input to inform this future legislative framework that aims to provide the legal foundations for a sustainable cooperation of HTAs at the European level, including their cooperation with regulators.
For the transition phase, the European Commission is currently working on new arrangements to bridge the gap between the end of Joint Action 3 and the entry into force of the possible new legislation. The collaborative work during this interim period will be guided by a list of priority areas currently being finalised by EMA and HTAs. It will include aspects such as assessment methodologies or particular scientific approaches and will be published once agreed.
- This press release, together with all related documents, is available on the Agency’s website.
- EUnetHTA is a network of organisations (from EU Member States, EEA and accession countries) and a large number of relevant regional agencies and not-for-profit organisations that produce or contribute to health technology assessment in Europe. EUnetHTA enables scientific cooperation between HTA bodies in Europe. It is co-funded by the Public Health Programme of the European Commission, DG Health and Consumers and performs the function of the scientific and technical cooperation of the HTA network established as per the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare.
- The EMA-EUnetHTA work plan 2012-2015 is available here and the EMA-EUnetHTA work plan 2017-2021 is available here.
- The reports from the most recent EMA/EUnetHTA bilateral meetings are published here.
- Article published in British Journal of Clinical Pharmacology (BrJClinPharmacol 2020 Jun;86(6):1034-1051): “Regulatory and health technology assessment advice on Post-licensing and Post-Launch Evidence Generation”
- Article published in Drug Discovery Today (Volume 25, Issue 7, July 2020, Pages 1223-1231): “Assessment of significant benefit for orphan medicinal products by European regulators may support subsequent relative effectiveness assessments by health technology assessment organizations”
- More information on the work of the European Medicines Agency can be found on its website: www.ema.europa.eu