Saturday, April 20, 2024

The Critical Role of Joint Clinical Assessment in Accelerating EU Access to New Therapies

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A recent study underscores the critical need for detailed guidance on the European Union’s Joint Clinical Assessment (JCA) process to enhance patient access to groundbreaking cancer treatments. This call to action comes as the healthcare industry prepares for the implementation of a new regulatory framework aimed at expediting the introduction of oncology medications and advanced therapy medicinal products (ATMPs) to the market.

With the countdown to the application of this new system to oncology medicines and ATMPs now under a year, health technology developers (HTDs) are expressing an urgent need for clear, pragmatic, and evidence-based guidelines. These guidelines are essential for understanding how the upcoming changes will influence the development, assessment, and eventual integration of new treatments into national healthcare systems. The European Federation of Pharmaceutical Industries and Associations (EFPIA) emphasizes the industry’s goal to deliver the latest cancer treatment advances to patients as swiftly as possible, highlighting the role of Joint Clinical Assessments in achieving this aim.

The introduction of EU-level Joint Clinical Assessments stands at the heart of the new Regulation on Health Technology Assessment (HTA), which is set to assess the clinical effectiveness of new technologies against existing treatments. JCA reports are expected to bolster access and reimbursement decisions at the national level, with the overarching objective of enhancing the rapid availability of innovative therapies for patients, ensuring efficient resource use, and elevating the quality of HTA by standardizing clinical assessments across the EU.

Joint Clinical Assessment

The Imperative for Clear Joint Clinical Assessment Guidelines in European Health Assessments

However, as the HTA Coordination Group (HTACG) puts the finishing touches on how Joint Clinical Assessments will be conducted, the pharmaceutical sector awaits detailed operational guidelines. The urgency for this information stems from the need for companies to strategically plan for the development of new medicines. A report by Evidera simulated a Joint Clinical Assessment report for three recently approved cancer medicines using the proposed methods by EUnetHTA21, revealing potential complexities in the assessment scope. The findings suggest a necessity for flexible analysis methods and the consideration of all oncology-relevant endpoints, beyond just overall survival, to fully capture the impact of treatments on patient lives.

EFPIA’s Director-General, Nathalie Moll, reflects on the progress in oncology and the anticipation of further breakthroughs, underscoring the importance of aligning innovation in medical science with advancements in the HTA Regulation to ensure swift access for European patients. EFPIA is committed to collaborating with the Coordination Group, the European Commission, and the HTA Stakeholder Network to establish a clear, effective, and predictable framework that supports the rapid assessment and access to new medicines.

 

Resource: European Federation of Pharmaceutical Industries and Associations, March 28, 2024

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