The Joint Clinical Assessment, which came into effect in the European Union in January 2025, represents a fundamental shift in the health technology assessment (HTA) decision-making process.
Since 12 January 2025, new oncology medicines and advanced therapy medicinal products (ATMPs) have been subject to the JCA, which is a key mechanism within the Health Technology Assessment Regulation (HTAR).
The JCA also brings major timeline changes for industry since the assessment will run alongside the regulatory evaluation of a new medicine by the European Medicines Agency (EMA). While the focus of the EMA will be on quality, safety, and efficacy of a product, the JCA will assess the relative effectiveness of a new therapy and how it compares to those that are already on the market.
What this means for sponsors is that if you aren’t thinking about your JCA requirements early, your submission will be at risk or delayed, because the HTA bodies and the regulators will be collaborating. The EMA has noted that the HTAR will “enable our collaboration across decision-makers reinforcing efforts to improve access to medicines for all patients in the EU.”
Patients at the centre
The point about patient access is an important one to emphasise because that is a key component of the JCA. This has long been a problem, with many instances of products waiting years to get HTA and reimbursement approval.
This is a particularly notable issue for oncology products, where clinical development timelines are already very long. For example, we have worked with a sponsor that carried out a nine-year follow up on some patients in their Phase 2 studies. Once you have the body of data needed to get through the safety and efficacy requirements from an EMA perspective, to then have to wait another two to three years for HTA approval places an enormous burden on patients.
Long delays in the HTA process have been found to create significant holdups in getting treatments to patients and access remains uneven across the EU. According to the Patient W.A.I.T. Indicator 2024 Survey, the average time for innovative treatments to be reimbursed across EU and European Economic Area countries is 578 days, with a significant difference between Germany, at 128 days, and Portugal, at 840 days.
Such long delays pose significant risk to intellectual property. As the supplementary protection certification (SPC) that provides patent protection to a product begins with marketing authorisation approval (MAA), the risk that it will expire or at least be substantially reduced by commercial launch is very real if the reimbursement process drags on.
The JCA streamlines that regulatory/HTA process, and although decisions on reimbursement remain at a national level, a centralised clinical assessment should facilitate those payment decisions.
Nevertheless, the JCA does bring its own complications – timelines, diverse PICO (Patient, Intervention, Comparison, Outcome) requirements, and methodological and procedural challenges. For smaller companies, and in particular for non-EU sponsors, there can be huge knowledge gaps about what all of this will mean for them.
To make sure these important medicines reach patients quicker, it’s vital that sponsors understand the why behind the JCA and what they need to do to prepare for this parallel regulatory/HTA process. These steps need to be considered earlier in clinical development – that’s the driver behind JCA.
Eventually the JCA will be mandatory for all drugs. By 2028, rare disease products will have to go through the JCA and by 2030 it will be mandatory for all new products. Even if your product is not yet in scope, these timelines are pressing, so early preparation is crucial.
Understanding the requirements and working with consultants that can guide you through the regulatory journey, alongside experts in the HTA process, will be key to avoiding delays and getting products to patients faster.
To make sure these important medicines reach patients quicker, it’s vital that sponsors understand the why behind the JCA.