The launch of the EU Joint Clinical Assessment (JCA) in January marks a transformative moment for pharmaceutical market access in Europe. For the first time, clinical Health Technology Assessments (HTA) for new medicines are being coordinated at the EU level, with the aim of aligning the fragmented, country by-
country clinical evaluations previously conducted by individual Member States (MS). This harmonized process is designed to streamline and standardize assessments,
minimize duplication, and accelerate patient access to new therapies.
Initially, the JCA framework applies to oncology medicines and advanced therapy medicinal products (ATMPs). Orphan drugs will join the process by 2028, with all new medicines expected to be included by 2030. To help companies navigate this
new landscape, the Health Technology Assessment Coordination Group (HTACG) has released a suite of methodological and operational guidance documents.
As the first wave of JCA submissions unfolds, the industry is entering a period of transition — interpreting and adapting to evolving guidelines and operational nuances. While the overarching objectives of the JCA are well-defined, many practical aspects remain in flux, particularly regarding the integration and value of Real World Evidence (RWE).
Lumanity has been at the forefront of this transition, actively supporting several early JCA submissions and closely monitoring developments. Based on this experience, we share our perspective on the critical role of RWE in the JCA. We believe RWE is not simply an optional supplement, but a vital component for addressing evidence gaps and strengthening JCA submissions.
Download the full paper to review the role of RWE in JCA guidelines and our advice for companies utilizing RWE for JCA submissions.
Download our paper
"*" indicates required fields
