The process officially began on January 12, 2025, and we expect the first JCA assessments to be finalised in the first quarter of 2026. While no submissions have been made yet, we anticipate approximately 20 to 30 applications going through the process this year. As this is a new framework, there is some uncertainty, but we expect more clarity as the year progresses.
JCA applies exclusively to new products entering the EMA process for the first time in the fields of oncology and advanced therapy medicinal products (ATMPs). It does not include line extensions, additional indications, or other subsequent authorisations.
The German HTA body, IQWiG, which is similar to the UK’s NICE, has overseen the development of the methodology. Looking at how the methodology has been shaped, it's clear that Germany's influence is very strong. While other European member states, particularly France, would argue they have had a significant impact as well, the methodology closely resembles the existing AMNOG process in Germany. In fact, there's about a 90 percent alignment between the two methodologies.
This will represent a significant challenge for other JCA and HTA bodies in various countries to match the methodological rigor of the German process.
As we know, the Maastricht Treaty did not include an agreement on harmonising the social security systems within the European Union. This has created ambiguity between Europe’s promotion of free trade in goods and services, including drugs, which are also considered goods. As a result, while there has been free movement of goods and services in the medical system across Europe, the social security and payment systems have not been harmonised.
This discrepancy has led to a situation where, while the marketing authorisation for a drug has been harmonised for over 20 years, the question of whether individual countries' social security systems would pay for the drug was not addressed uniformly. As a result, the availability of the same drug varied across different countries, depending on the reimbursement policies. Countries such as those in Scandinavia, France, Germany, and Southern Europe faced different reimbursement situations, creating a “paper wall” between them.
This issue has been particularly challenging for the pharmaceutical industry, as it had to navigate 27 different reimbursement processes. Initially, shortly after receiving marketing authorisation, companies only had access to the pivotal trials from the registration process. These trials were the same for all markets, but they were interpreted differently depending on the country, leading to varying levels of access to the drug.
The harmonisation of these processes is long overdue. Smaller European countries, in particular, would have otherwise needed to invest in their own resources. Therefore, a more centralised assessment makes sense, both for these countries and the pharmaceutical industry. For European patients, this new process is a significant improvement. It makes the process more predictable, which is beneficial both for patients and the pharmaceutical industry. It also helps make the European market more uniform than it has been in the past. I worked for GlaxoSmithKline for many years, and our European head at the time said,
“The industry prefers a single process over 27 separate processes, as long as it is predictable and offers a fair chance of getting drugs to patients.”
Reflecting on my time in the industry 20 years ago, there has always been a discussion about the relationship between regulatory affairs and market access, and the extent to which they are interlinked. My core advice is as follows:
Firstly, learn about the process.
Secondly, tailor your clinical trial programme to maximise the value of your investment in the products. It is not just about registering your drug; it is more important to ensure that the drug reaches the patient. This means you need to secure reimbursement through social security systems, otherwise, there will be no sales. In fact, the Secretariat for this new process is now located in the same building in Amsterdam as the EMA. This indicates that the process is closely interconnected. It actually begins with the submission of your EMA application for authorisation, which will lead to more connections between the various assessment methods.
There is ongoing discussion about using real-world data in certain circumstances, particularly in personalised medicine and oncology, where you have single-arm trials and rare diseases. However, rare diseases will only come into play starting in 2028.
One key piece of advice is to ensure that your trial programme is as smart as possible to address the challenges posed by the later Health Technology Assessment (HTA) process. These two agencies will be in communication with each other and will exchange methodologies.
PHAROS is a network of boutique access consultancies with an industry-leading commercial and HTA success rate of over 96%. The network brings together specialized health economics consultancies, such as FIECON (UK) and SmartStep (Germany), to leverage their expertise in regulatory and market dynamics across different countries. This collaboration provides valuable insights into Joint Clinical Assessment (JCA) methodologies and the challenges within the pharmaceutical market. With in-depth knowledge of national requirements for patient access throughout Europe, PHAROS ensures comprehensive service delivery across the EU, backed by the local presence of its partners.
