Joint Clinical Assessment – Anticipating your PICOs

Starting in 2025, pharmaceutical and medical device manufacturers looking to introduce innovative cancer treatments and advanced therapy medicinal products (ATMPs) will need to navigate the Joint Clinical Assessment (JCA) process. This new system promises to revolutionize health technology assessment (HTA) across Europe. It will achieve this by consolidating clinical assessment needs from all member states, ultimately speeding up market entry and reimbursement.

At the heart of JCA is the scoping process which sets the stage for the research questions manufacturers must address in their submissions. Utilizing the Population, Intervention, Comparator, Outcome (PICO) framework, the scoping process collects input from each EU member state, merging their unique requirements into one unified scope. That said, the real challenge lies in anticipating and aligning with the diverse needs of different countries, and this makes compliance a more difficult and complex task for pharmaceutical manufacturers to achieve.

One of the major hurdles manufacturers will face with the PICO framework is the uncertainty about how member states’ feedback will be integrated. The number of PICOs can vary widely, increasing the burden on manufacturers to provide rigorous evidence for each scenario. This unpredictability, coupled with strict timelines, has raised concerns within the industry about being able to prepare for unexpected research questions and the potential impact on market access in Europe. Early precision in defining PICOs and meticulous planning will be all-important to avoid delays in submissions and reimbursement.

Although JCA signals a new era in European HTA, strategies are emerging to help companies calmly navigate this new process and prepare for successful HTA submissions across Europe. As companies embark on this journey, it will be important that they carefully plan their timelines and assess all available resources. Beyond considering your financial budget, which is essential, it is also worth tapping into internal resources. For instance, your local affiliates could be full of valuable internal information waiting to be utilized. Ask your medical affairs, market access, and sales teams for their insights and contributions. What they have to say could prove instrumental in crafting a robust and effective submission.

When anticipating and planning your PICOS you might feel you are in uncharted territory. The steps outlined here are a route to navigating the challenges optimally, contributing to JCA success.