The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment regulation. The document outlines how to determine the scope of joint clinical assessments, how to share information between the relevant entities, how to select experts to help make joint clinical assessments, and more.
On 5 March, the commission announced a consultation on its draft implementing regulation outlining the joint clinical assessment framework. The JCA framework is part of the commission’s work to implement the HTA Regulation, which is set to take effect in January 2025. The Commission notes that it is planning issue a total of six implementing acts related to the HTA Regulation for public consultation in 2024.
In 2022, a Member State Coordination Group on Health Technology Assessment (HTACG) was established to facilitate cooperation on HTA between member states at the European Union level. The HTACG is comprised of subgroups that address JCA, joint scientific consultations (JSC), identifying emerging health technologies, and methodologies for assessing HTAs.
“[According to regulations] the Commission is to adopt detailed procedural rules for the cooperation, in particular by exchange of information, with the European Medicines Agency on the preparation and update of joint clinical assessments of medicinal products and for the interaction, including timing thereof, with and between the Coordination Group, its subgroups and the health technology developers, patients, clinical experts and other relevant experts during joint clinical assessments and updates,” the commission noted in the proposed draft JCA regulation. “[Furthermore] the Coordination Group is to adopt further rules on conducting joint clinical assessments, namely methodological guidance on joint work, detailed procedural steps and the timeframe for the conduct of joint clinical assessments and their updates and guidance on the appointment of assessors and co-assessors for joint clinical assessments.”
To realize cooperation between the various stakeholders on JCA, the draft regulation proposes a framework that addresses several issues, starting with determining whether the subject matter is appropriate for a JCA. It outlines explicitly how various entities should cooperate, interact, consult external experts, and present information when determining whether the subject matter is appropriate.
The framework also details the relevant information needed to assess the scope of a JCA assessment. The draft regulation states that health technology developers should provide the HTA secretariat with relevant information for developing a JCA’s assessment scope while submitting a marketing authorization application to EMA.
A significant portion of the draft regulation addresses how key stakeholders should share information. For instance, it states that EMA should notify the HTA secretariat when it receives a marketing authorization application that requires a JCA or an application that requests a variation to the terms of an existing marketing authorization.
It also lays out how information should be shared with the Coordination Group.
“The HTA secretariat shall ensure that all the information received from the health technology developer, the European Medicines Agency, patients, clinical experts and other relevant experts and Member States related to joint clinical assessments and updates of joint clinical assessments is communicated to the Coordination Group, to its relevant subgroups and/or to the assessor and co-assessor, as appropriate, upon receipt of that information,” the document states.
“Upon the appointment by the JCA Subgroup of an assessor and a co-assessor to conduct the joint clinical assessment, the HTA secretariat shall inform the health technology developer of the start of the joint clinical assessment,” the document added.
Other important issues addressed in the draft regulation include how to ensure confidential information is protected between the major stakeholders, conducting an assessment scope proposal based on parameters in the JCA, and developing documents necessary for conducting the JCA.
Stakeholders can comment on the proposed JCA regulation until 2 April. If finalized, it will go into effect on 12 January 2025.
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