Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment. EUnetHTA 21 ceases to operate on 16 September 2023, but preparations will continue for the implementation of the Regulation, under the direction of the HTA Coordination Group.

“EMA’s collaboration with EUnetHTA began in 2010 as a project to test out whether early engagement between regulators and HTA bodies could bring tangible benefits for patient access to medicines,” said Michael Berntgen, Head of Scientific Evidence Generation Department at EMA. “Together, we were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies.”

“Although the EMA-EUnetHTA cooperation is drawing to a close, the road does not end here,” said Niklas Hedberg, Chair of the EUnetHTA 21 Consortium Executive Board. “We are very proud to see that our cooperation has now been enshrined into European law. The experience gained provided essential technical input to shape the new legislation. In fact, we continue our joint work and will do this on a new footing, with more participants, additional responsibilities and high expectations from stakeholders.”

Reviewing achievements over the years at their concluding meeting on 14 September 2023 in Amsterdam, EMA and EUnetHTA 21 highlighted a number of initiatives:

• Completion of seven parallel joint scientific consultations (JSC) for medicines under the EUnetHTA 21 consortium contract. This joint work is intended to improve the generation of robust evidence that meets the needs of regulators and HTA bodies;
• Discussion on evidence needs for advanced therapy medicinal products in oncology, addressing mutual challenges such as indirect comparison and addressing evidence gaps through post-licensing evidence generation.
• Organisation of trainings for patients and healthcare professionals to facilitate their participation as experts in regulatory and HTA processes, alongside collaborative work on methodologies for engagement of patients and healthcare professionals in assessments;
• Recommendations to optimise the assessment reports of EMA’s Committee for Human Medicines (CHMP) for each medicine in order to systematically document key elements of the assessment such as the eligible patient population, choice of comparator and endpoints, as well as relevance of subgroup data.

More information on the achievements is available in a Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 – 2023 .

The new HTA regulation

The Regulation on Health Technology Assessment (EU) 2021/228 which entered into force in January 2022 and applies as of January 2025, will govern the European cooperation between medicine regulators and HTA bodies. Under the new framework, EMA and HTA bodies will collaborate in the context of joint clinical assessments, joint scientific consultations, and the identification of emerging health technologies.

While aiming to improve the availability of innovative medicines and certain medical devices for patients in the EU, it will also ensure efficient use of resources and enhance the quality of health technology assessment in the EU by ensuring the sustainability of European cooperation. The establishment of the Member State Coordination Group on Health Technology Assessment, as provided by the regulation, and of a stakeholder network, will give a transparent and inclusive framework to facilitate continued collaboration between partners and reduce duplication of efforts for national HTA authorities and industry.

Transition period to January 2025

EMA and HTA organisations have established a new framework for Parallel EMA/HTA Scientific Advice for the period September 2023 until January 2025, when the HTA Regulation applies. During this transition period, developers can request the involvement of HTA bodies when applying for EMA scientific advice. The outcome of the procedure will be a scientific advice letter from EMA and individual written recommendations from participating HTA bodies. The selection criteria are available in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period

Preparations are also continuing at EMA to pave the way for the implementation of the Regulation. The Agency has identified a number of priorities and opportunities for the next 15 months. These include defining a single evidence plan to facilitate development programmes, harmonising views on the strength of the evidence, and involving patients, clinical experts and other relevant experts in decision-making.

Notes

1. The EUnetHTA 21 consortium had been awarded the service contract for the provision of joint health technology assessment (HTA) work supporting the continuation of EU cooperation on HTA by the European Health and Digital Executive Agency (HaDEA).