The Joint Clinical Assessment (JCA) is now mandatory for advanced therapy medicinal products (ATMPs) and oncology products, and soon will be for other products (January 2028 for orphan drugs and January 2030 for all other drugs). Although it presents some uncertainty for sponsors, the JCA can be turned to a clinical and commercial advantage.
Having teams collaborate on both the marketing authorisation and reimbursement processes can mean better, more focused endpoints, a better understanding of the patient population, and a clearer understanding of the healthcare system that will treat those patients.
While there will be hurdles to overcome, done properly it can benefit a sponsor’s overall global strategy by helping them to build a good statistical plan and process.
Plan early to manage the parallel process
However, successfully navigating the parallel JCA and marketing authorisation process will mean early planning. So, even sponsors planning a submission in five years need to be thinking about it now.
For those wanting the combined advice offered through Joint Scientific Consultations (JSC), plan now in order to build the advice into your protocol and make any adjustments to your phase 2 or pivotal studies, particularly with oncology products where a pivotal study can stretch on for several years. There are huge implications of having to adjust or even stop and redesign studies part way through, so planning now for studies you expect to start in a couple of years can help you to mitigate those risks.
For sponsors developing ATMPs as well as other orphan drug products, consider also what makes clinical sense and any clinical obstacles you could confront, such as requirements around ongoing monitoring and testing.
- What barriers might this present and how can you address any potential issues in your clinical development strategies?
- Should you be working with an in vitro device partner to address any potential issues before they occur?
These considerations could be key when presenting clinical data during both the JCA process and to EMA during the MAA process.
Think broader as you develop and plan your strategy
As health technology assessment (HTA) bodies and regulators adapt and refine the parallel JCA/MAA process, it will become increasingly important for sponsors to consider the broader elements that are integral to their products, such as testing and monitoring, to both prove the safety and efficacy of their product and to drive down the cost of administering it to patients.
Ask yourself what the potential obstacles are, what you can do in the clinical development process to mitigate these, what clinical endpoints will be needed to address these obstacles or at least to show how you are planning to manage these. And be aware that the regulators and HTA authorities will be sharing notes, so ensure what you share through the MAA process and JCA process are consistent.
Find the right partner to prepare for new processes
By working with regulatory and reimbursement experts, sponsors can ensure that they stay on top of evolving JCA and MAA expectations and developments. Regulations and guidelines change over time and inevitably as experience with the JCA grows, process updates will occur.
Having partners that stay on top of these as well as regulatory developments will be key and can help sponsors as they plan their clinical studies within the context of global development and market access strategies.
By working with regulatory and reimbursement experts, sponsors can ensure that they stay on top of evolving JCA and MAA expectations and developments.