Contributed by:
Emma Hawe, MSc
Head, Data Analytics and Design Strategy
RTI Health Solutions
From the pharmaceutical manufacturer’s perspective, there are several key inflection points in the joint clinical assessment (JCA) process. The first is when they receive a dossier submission request from the Health Technology Assessment (HTA) Coordination Group. This request will include the scope of the assessment, the deadline for submission, the dossier template, and its requirements.
The deadline for dossier submission is within 100 days of the request. The scope and requirements of the request are crucial. The scope is defined by the PICOs, which stands for Population, Intervention, Comparator, and Outcomes. Manufacturers will have little opportunity to interact with the PICO scoping process. That means they may not have enough information up front to adequately prepare for the JCA. The time to gather, analyse, and submit the requested information will be extremely limited.
Without the ability to comment on the PICOs, manufacturers are concerned about requests for subpopulations, comparators, and outcomes that cannot be addressed in a scientifically adequate way within the 100-day deadline. This could especially be the case for complex, less well-known or understood conditions with smaller, heterogeneous populations where the standard of care across the EU might vary considerably.
Joint clinical assessment will require additional data analyses within a compressed timeframe, putting pressure on pharma biostatisticians, epidemiologists, and real-world researchers. There appears to be a highly compressed time allowance in the JCA process for companies to respond to clarification questions and additional information requests. It also leaves little time to perform factual checking of the final report.
The pressing question is this: Will this framework and timeline be effectively workable in practice, or will it result in a loss of scientific quality?
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