EMA touts milestones achieved in EUnetHTA 21 collaboration
The European Medicines Agency (EMA) announced that “a number of milestones” have been achieved in its work with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium in facilitating patient access to innovative medicines in the EU before the consortium’s work ends on 16 September.These achievements were noted in the EMA-EUnet HTA 2021-2023 implementation work plan.
Over the past three years, EMA and EUnetHTA 21 have delivered these milestones in preparation for Regulation on Health Technology Assessment, which takes effect in 2025. While the work of the consortium is soon ending, preparations are underway for the implementation of the regulation, which was adopted in December 2021.
The regulation aims to ease the availability of innovative health technologies, such as medicines and medical devices, to a wider patient population.
“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, EMA’s Head of Scientific Evidence Generation Department. “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.”
EMA noted that the collaboration has achieved the following:
- Completing 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,” according to EMA. The report notes that “the demand from developers exceeded the available slots.”
- Discussing the evidence needs for advanced therapy medicinal products for oncology and addressing mutual challenges such as indirect comparison. The report said “this experience served as basis for an EMA/EUnetHTA bilateral in April 2023 focusing on ATMPs, where key learnings on evidence and uncertainties with ATMPs derived from the product exchanges were discussed alongside identification of priority areas for future exchange.”
- Providing training for patients and healthcare professionals to enable their participation as experts in regulatory and HTA processes. “Collaboration on the involvement of patients and healthcare professionals was mutually beneficial with EMA and HTAs being able to learn from each other with respect to engaging with stakeholders and creating supporting material for these activities,” according to the report.
- Optimizing assessment reports of EMA’s Committee for Human Medicines (CHMP) to identify key elements of the assessment such as the eligible patient population, choice of comparator and endpoints, as well as relevance of subgroup data.
Some of these milestones have been described in earlier reports (RELATED: EMA, HTA consortium prep for HTA regulation coming into effect, Regulatory Focus 14 April 2022).
EMA announcement, Report
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