The JCA is here – are you generating the right evidence? 

Five success pillars — your JCA evidence-generation checklist 

From 12^th January 2025, the European Union (EU) Joint Clinical Assessment (JCA) became a reality for oncology and advanced therapy medicinal products (ATMPs), with 8 products currently under evaluation and the first JCA report expected in 2026.¹ The JCA will become mandatory for orphan drugs in 2028 and for all other medicines in 2030.² 

Compared to most national Health Technology Assessments (HTAs), the JCA: 

• Expands requirements — demanding a much broader scope, with additional PICOs (population, intervention comparator, outcomes), including more comparators and subpopulations to be addressed in a single submission, aiming to meet the evidence needs of all Member States. 

• Compresses timelines — giving manufacturers just 100 days from consolidated PICOs list (e.g., assessment scope) communication to dossier submission. 

• Runs in parallel with European Medicines Agency (EMA) review — starting earlier and stretching the same cross-functional teams and resources. 

For manufacturers, this is not just another procedural step — it represents a fundamental shift in the European market access environment.  

If you want to answer “yes” to this article’s question — Are you generating the right evidence for access to EU markets now that the JCA is here, i.e., in a fundamentally different Pricing and Market Access (PMA) environment compared to the one you are familiar with? — you must adapt your evidence generation process now. We believe this means mastering five success pillars to address the operational challenges introduced by the JCA: the first four are core activities you must deliver to generate the right evidence; the fifth is the organisational enabler that ensures the others can be delivered on time and to the right standard (Figure 1). Consider this your JCA evidence-generation checklist. 

1. Predict PICOs early and map them to specific countries 

Operational challenge (why) 
The JCA scope will include many more PICOs than a typical national HTA, covering more comparators, subpopulations, and possibly outcomes, in order to meet the evidentiary requirements across all 27 EU Member States. All PICOs must be addressed simultaneously within ~100 days after communication of the consolidated PICOs list.³ As a result, work must begin at risk based on predicted PICOs, as there is no time to start work after the official consolidated PICO list is communicated. Without starting early, manufacturers will struggle to address all PICOs effectively and risk public “no evidence” statements in the JCA report. Although it remains unclear how each country will interpret the report, it will form the basis for national HTAs and decision-making. 

Manufacturer actions (what) 

• Predict likely PICOs, using HTA guidelines and historical national HTA reports. 

• For each PICO, determine the likely evidence required (e.g., direct Randomised Controlled Trial [RCT], anchored indirect treatment comparisons [ITC], unanchored ITC, or Real World Evidence [RWE]) and flag any ITCs or RWE analyses that will require early initiation.  

• Map predicted PICOs to specific Member States to understand whose needs will be met with direct evidence and where indirect evidence or post-JCA work for national HTAs will be required. 

• Inform affiliates in advance about supplementary national-level evidence generation in markets where PICOs will not be sufficiently addressed. 

2. Determine ITC feasibility and start earlier than ever before 

Operational challenge (why) 
Under the JCA, the volume of PICOs from all Member States will significantly increase the likelihood that head-to-head trial evidence will not be available for every comparison. ITCs will therefore play a more prominent role. However, the tight JCA timelines of 100 days from finalised PICOs to dossier submission leaves insufficient time to initiate all potential ITCs that may be required once the official scope is confirmed. There is a risk of ending up with poorly planned or rushed ITCs that will be challenged during the JCA and subsequent national HTAs. 

Manufacturer actions (what) 

• For ITCs flagged during PICO prediction, conduct detailed feasibility assessments early 

• Find relevant data sources well in advance of PICO finalisation. 

• Initiate priority ITCs at risk before the consolidated PICOs list is communicated, ensuring robust methodology and alignment with both JCA guidance and key national HTA acceptability criteria. 

• Clearly document all methodological decisions to withstand scrutiny at both JCA and national HTA stages. 

3. Identify RWE needs, design and source studies upfront 

Operational challenge (why) 
PICOs may require evidence on comparators not studied in RCTs, rare subgroups, outcomes missing from trials, or long-term follow-up in real-world populations. RWE can address these gaps, for example, through external control arms, collection of additional endpoints, or extended follow-up in broader patient populations. However, unlike in the past, it must now be ready before JCA submission, not generated years later. 

Multi-country, methodologically harmonised RWE may be required to address PICOs that span multiple Member States, while still allowing the data to be broken down for use in country-specific HTA submissions. Designing and running such studies takes significant time, and securing access to relevant data sources can involve lengthy approval processes. Therefore, without early action, manufacturers risk leaving visible evidence gaps in the JCA report. 

Manufacturer actions (what) 

• Identify potential RWE gaps during PICO prediction (e.g., missing comparators, long-term outcomes, real-world patient characteristics). 

• Decide whether to address needs through multi-country harmonised studies (preferred where possible) or country-specific studies, considering use in both JCA and national HTAs. 

• Prioritise high-quality, multi-country data sources that can be analysed at the EU level and segmented for national use. 

• Begin RWE study design, protocol development, and data access requests well before the consolidated PICOs list is communicated , allowing time for ethics approvals and data collection. 

• Ensure transparency and methodological rigour to withstand scrutiny from all 27 Member States. 

4. Get a strategic mix of key stakeholders’ early scientific advice 

Operational challenge (why) 

To generate the right evidence under the new JCA environment — where uncertainty around evidence expectations is higher than ever — early scientific advice, can be invaluable. Early scientific advice allows manufacturers to obtain feedback on trial designs, ITC plans, and RWE strategies. Additionally, through national-level advice, manufacturers may gain insight into how JCA outputs may be interpreted locally.  

However, formal early scientific advice, including Joint Scientific Consultations (JSCs), is resource-intensive and not always accessible (e.g., JSCs have specific eligibility criteria and limited slot availability). As a result, only a limited number of formal engagements are feasible and informal channels — such as payer interviews and advisory boards — can help fill these gaps. Without targeted early scientific advice, manufacturers risk investing in evidence that fails to meet the needs of either the JCA or national HTAs. 

Manufacturer actions (what) 

• Identify formal early scientific advice opportunities. 

• Prioritise formal advice requests for high-impact countries with strict or unique evidence requirements (i.e., those that would add the greatest value). 

• Develop a strategic early advice plan that combines formal (EU/national) and informal (payer interviews and ad-boards) channels to ensure broad and relevant input. 

• Use both formal and informal feedback to refine PICO prediction, test ITC assumptions, and shape RWE studies design. 

5. Ensure organisational readiness to perform core activities 

Operational challenge (why) 

Predicting PICOs, initiating ITCs and RWE early, and securing targeted advice all require cross-functional coordination, rapid decision-making, and internal resources earlier than in the national-only HTA world. Without organisation-wide awareness, updated processes, and dedicated resources, even the best evidence plan will fail in execution.  

Manufacturer actions (what) 

• Educate cross-functional teams on JCA timelines and evidence needs across clinical, regulatory, market access, HEOR, and affiliates. 

• Update internal process maps to integrate PICO prediction, early ITCs, RWE, and early scientific advice into the development timeline. 

• Allocate dedicated resources to JCA workstreams, separate from EMA submission teams and to early scientific advice workstreams 

• Train teams on JCA-specific methodological standards so outputs meet multi-country scrutiny. 

Conclusion 

The JCA is here — and with it, a transformed EU market access environment. If you want to confidently answer “yes” to Are you generating the right evidence? your checklist is clear: 

• Predict PICOs early and map them to specific countries 

• Determine ITC feasibility and start to conduct ITCs earlier than ever before 

• Identify RWE needs, design and source studies earlier than ever before 

• Get a strategic mix of key stakeholders’ early advice 

• Ensure organisational readiness to perform core activities 

Do these five things well, and you won’t just survive the JCA era — you’ll be positioned to succeed in it. 

The JCA brings a fundamentally different evidence generation environment — one where the scope is broader, timelines are tighter, and critical activities must happen earlier and in parallel with EMA submissions. By following these five pillars, manufacturers can ensure they are generating the right evidence for both the JCA and subsequent national HTAs. 

At Remap Consulting, we can support you at every stage — from robust PICO prediction and early ITC planning to strategic RWE design and targeted early scientific advice engagement, through to ensuring your organisation is ready, resourced, and aligned to deliver all of these successfully. Whether you need methodological expertise, country-specific insights, or internal capability building, our team can help you navigate this new landscape with confidence. To discuss how we can support you, email:  contact@remapconsulting.com 

References

1. https://health.ec.europa.eu/document/download/d947533e-7e4e-4e82-a9c6-e06830d708f8_en?filename=hta_ongoing-jca_en.xlsx 
2. https://eur-lex.europa.eu/eli/reg/2021/2282/oj/eng 
3. https://eurlex.europa.eu/eli/reg/2021/2282/oj/eng