EU Regulator & HTA Bodies Prepare The Ground For New Collaborations
Executive Summary
The European Medicines Agency and EU national health technology assessment agencies have agreed a joint work plan to prepare for implementation of the new HTA regulations, including joint clinical assessments.
The European Medicines Agency and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint work plan outlining several key areas for collaboration as they prepare for the implementation of the new HTA rules. These areas include joint scientific consultations, real world evidence and generating patient relevant data.
“The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 after a 3-year implementation period,” the EMA said.
The New HTA Regulation
Regulation (EU) 2021/2282 will bring major changes for industry and the HTA landscape in the EU. The most important is the introduction of joint clinical assessments (JCAs), which are essentially relative effectiveness assessments that will be conducted by national HTA experts at an EU level. (Also see "The Implications Of The New EU HTA Regulation For Companies" - Pink Sheet, 30 Mar, 2022.)
In addition, the regulation includes provisions to allow companies to seek joint scientific advice through joint scientific consultations with the Member State Coordination Group. This group is made up of representatives from national HTA bodies and will be responsible for overseeing the JCAs.
The joint work plan runs until 2023 and will extend the “close collaboration” between the EMA and HTA bodies in Europe that began in 2010 through EUnetHTA joint actions, according to the EMA. “This collaboration has demonstrated many synergies between regulatory evaluation and HTA along the lifecycle of a medicine and aims to facilitate patients' access to medicines in the European Union.”
The EUnetHTA 21 consortium was established in September 2021 to build on EUnetHTA Joint Action programs and prepare for the implementation of the new regulation. (Also see "New EU HTA Consortium Prepares To Launch" - Pink Sheet, 8 Nov, 2021.) It is led by the Dutch ZIN and is made up of the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden).
The joint work plan sets out several focus areas for collaborations, including joint scientific consultations “for robust evidence generation, including post-licensing/launch evidence generation.”
To this end, the European procedure for joint scientific consultations involving HTA bodies and the EMA - previously known as parallel scientific advice or the parallel consultation or early dialog - has been relaunched. According to the plan, this should lead to a single process that reflects the needs of both regulators and HTA bodies.
Also relating to joint scientific consultations, the EMA and the consortium will work together on optimizing the use of registries for post-licensing or post- launch evidence generation with a view to supporting decision making.
Another priority area for collaboration is generating patient-relevant data or information to support decision making. This will involve fostering the development of methodologies to enable stronger reliance on patient-relevant data for decision making, which should contribute to the EMA’s initiative to establish an EU network of experts on patient related outcomes.
The collaboration also wants to work on the “continuous optimization of regulatory outputs as reference for down-stream decision making.”
Another key area is developing study methods and guidelines for real-world evidence, including for registries. Among the activities envisaged are collaborating on registry methodologies and establishing evidentiary value of real world evidence, and supporting access to and analysis of real-world data.
Other points of interest are:
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Exchange of information on the respective assessments of medicinal products by regulators and HTA bodies.
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Extrapolation/evidence transfer as a tool to support assessments in smaller populations.
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Horizon scanning and preparedness of HTA and regulatory systems.
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Practices in the context of assessment work related to companion diagnostics.
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Methodologies for engaging patients and health care professionals.