As we support our global clients to prepare for the upcoming introduction of Joint Clinical Assessment (JCA) in the European Union (EU), the Tolley team have been devoting time to engaging in internal discussions on the knowns and unknowns of JCA. While the procedures and requirements for JCA have been made much clearer during 2024 (as well as introducing a whole host of new acronyms to the HTA arena) and seem rather familiar to those of us well-versed in the NICE methods of evidence identification and relative effectiveness assessment, the wider impact of EU JCA on UK HTA, remains unclear.
Across LinkedIn, there is much speculation and a variety of contrasting views about the potential impact of JCA on the UK, including suggestions that EU JCA may:
Lead to later engagement with UK HTA by…
• Reducing the global reach and influence of NICE further, following cessation of the formal role of NICE in EU HTA since Brexit.
• Resulting in companies making less investment in preparing the UK evidence package, instead re-using the potentially broader JCA package which may not be decision-focused enough for efficient decision making with NICE and SMC.
Lead to earlier engagement with UK HTA by…
• Not delivering on promised timelines, which could see companies prioritising UK activities during this period of flux in Europe while the concurrent JCA and EMA regulatory assessment beds in.
• Seeing companies opting to engage with NICE sooner and press for early submissions and NICE guidance very soon after marketing authorisation, since NICE have a dialogue with the submitting company and several inbuilt engagement points during the HTA process, which is not currently a part of JCA. This interaction affords companies’ vital opportunity to engage with the HTA process and take their learnings over to EU countries.
• Pushing NICE and SMC submissions and the UK launch down the priority list due to the substantial time and financial investment required by a company to participate in JCA at the same time as EU regulatory assessment.
See NICE and SMC developing a working relationship with the EU member states and the JCA process in the future.
Do you think JCA will have a knock-on effect on UK HTA?
What are your predictions?
Will this be an overall positive, negative, or neutral influence on delivering new technologies to UK patients?