EU JCA: Health Technology Developers' Roadmap

Contents Introduction3Areas of challenge for HTDs4How HTDs can prepare for the JCA implementation6Case study: JCA preparation in action : JCA in a crowded oncology indication9Optimize your JCA readiness10Authors11 Introduction The Joint Clinical Assessment (JCA) framework (Regulation (EU) 2021/2282) was implemented on 12January 2025 for all new medicinal products for oncology, and advanced therapy medicinal products(ATMPs).1This process will apply to orphan medicinal products from 2028, and from 2030 onwards, Who are the 27 EU member states? The countries participating in the EU JCA: Austria, Belgium, Bulgaria, Croatia,Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, The goal of the JCA framework is to improve the process for evaluating the clinical evidence of newmedicines across the 27 EU member states, addressing concerns regarding equity, timeliness and While not EU members, Norway, Iceland and Liechtenstein (as part of the EuropeanEconomic Area) also participate in the EU HTA cooperation. The JCA process produces a comprehensive report that describes the relative effects of themedicinal product or medical device. The report is factual and will not contain any value judgments,ranking of health outcomes, conclusions on overall benefit or added clinical value of the assessed JCA does not grant reimbursement. Member states retain responsibility for determining the addedclinical value of health technologies within their specific healthcare contexts, as the practical impactand utility of the JCA analyses on national decision making’ may vary by country. This approach allows member state level. Information and data submitted as part of the JCA process cannot be requested JCA is expected to simplify and standardize the comparative effectiveness analysis of new products,increasing collaboration and efficiency by avoiding duplication of efforts. This approach has thepotential to facilitate more equitable and quicker access to new, innovative treatments across member As of April 2026, the JCA process is underway for 15 medicinal products, including ATMPs, with thefirst assessment expected to be published in May/June 2026. In November 2025, the annual HTAWork Programme for 2026 was adopted, which estimates that around 35 JCAs for oncology products Areas of challenge for HTDs Based on our experience on supporting pharmaceutical companies and sponsors (known ashealth technology developers or HTDs in JCA nomenclature) with their JCA submissions, we 1.Identifying and defining the PICO (Population, Intervention, Comparator, Outcome) What is PICO? All 27 EU member states will submit their requested PICOs, creating substantial challengesfor evidence generation. Each variation in the four PICO elements can generate multipledistinct PICOs. This is compounded by variations in clinical practice across Europe; including, The PICO framework provides a standard format for specifying research questions: P (population)– including full patient population and/or relevant subpopulations I (intervention) Even after JCA consolidation, the final scope often contains a high number of requestedPICOs, driven by the diversity of patient populations and comparators. The scope documentdoes not specify which member states requested particular PICOs, requiring HTDs to O (outcomes) If a comparison against multiple comparators is required, each will have a Additionally, the treatment landscape can shift between PICO scoping and JCA reportpublication, making ongoing local-level PICO monitoring essential for preparing effective 5. Addressing resource and organizational challenges 2. Preparing evidence simultaneously for all member states Biotechs with limited affiliate presence and in-house regulatory/market access capabilities mayface particular challenges given the growing resource demands of the JCA process, which runsalongside the EMA regulatory pathway. This includes developing a JCA, reimbursement/HTAand market access strategy for Europe (that is aligned to the EMA strategy), preparing evidence As JCA includes evidence requirements for all 27 European member states, evidence will berequested by all member states at the same time. Therefore, evidence will need to be generatedsimultaneously. Whereas previously, a stepwise approach allowed HTDs to prioritize key markets This parallel approach is further complicated by the need to prepare the JCA submissionconcurrently with the EMA Marketing Authorisation Application (MAA) submission. This dualtimeline places substantial demands on resources, requiring careful coordination to avoid duplication In more established organizations, with global or regional functions alongside market affiliates,challenges will include sharing of information across functions and from global to regional tolocal levels. Identifying the correct stakeholders to input into the JCA st