Contributed by:
Emma Hawe, MSc
Head, Data Analytics and Design Strategy
RTI Health Solutions
Drug manufacturers are preparing to navigate joint clinical assessment (JCA) in several ways. On one hand, companies are adjusting their organisational structure, capacities, and resourcing because JCA centralizes the clinical domains of the HTA process that formerly resided within each of the EU 27 countries.
On the other hand, companies are seeking greater alignment between the preparation of the EMA regulatory dossier and JCA, as both procedures will be running in parallel. This emphasises the need for joint ownership of regulatory affairs and market access functions on an EU level.
Given the timeline and scoping challenges, success will depend on anticipating the PICOs likely to determine the scope of the JCA dossier request.
Just as comprehensive support is needed in preparation for global HTAs, working in advance to anticipate likely and appropriate PICOs is of utmost importance. Manufacturers should be ready to prepare evidence in advance and nimbly adjust to the final scope and label changes.
Having a range of strategy, planning, evidence preparation, and support services will be vital to enabling a successful JCA submission within the given timelines. Given the 100-day deadline for the JCA dossier, including epidemiology, systematic literature review (SLR), and indirect treatment comparisons, these services should include advanced estimation of likely PICOs and timely updates of SLRs.
Obtaining early scientific advice through joint scientific consultations will be advantageous given the current unknowns in the JCA process. At the center of everything, continuous stakeholder engagement will be essential - including early dialogues with patients, caregivers, payers, and HTA opinion leaders.
Take a look at our additional articles on the topic of Joint Clinical Assessments
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Joint Clinical Assessments and Joint Scientific Consultations: Let's All Work Together
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Navigating EU Joint Clinical Assessments and Joint Scientific Consultations from January 2025 Onward