During ISPOR we heard that the Joint Clinical Assessment (JCA) aims to enhance the quality of streamlined clinical assessments, ultimately promoting better equality of access to therapy. However, the current process remains largely unknown, and manufacturers are still learning how to navigate this new landscape.
With the proposed timelines, manufacturers will have a very short window to prepare their dossiers—typically a process that can take months or even years. Compounding the challenge, they will be doing this without a complete understanding of the necessary PICOs.
As we adapt to these changes, Artificial Intelligence (AI) is emerging as a powerful ally for manufacturers. AI can streamline data collection and analysis, helping to meet the stringent requirements of the JCA more efficiently. It is expected that AI will even predict which PICOs to prepare for, minimising surprises and unpreparedness during the submission process. This will enable manufacturers to focus on generating high-quality evidence and improving their overall readiness for assessments.
In the long run, assuming the implementation of the JCA yields neutral or positive effects, manufacturers will adapt, as they have with many changes in the past. However, the road ahead may be bumpy.
We can only hope that this transition does not divert resources from critical activities such as research and innovation.
In the short term, we can anticipate a shift in how manufacturers allocate their resources. The journey is just beginning—let’s stay informed and supportive as we navigate this evolving landscape together!
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