Executive Summary
Joint Clinical Assessment (JCA) is the European Union (EU)-wide assessment of the relative benefits and safety of new medicines. It provides the scientific basis for national Health Technology Assessment (HTA) and reimbursement decisions but does not replace them.
JCA is often described as a change to the regulatory or HTA process; however, the key strategic significance of the JCA lies in the fact that evidence-based decisions become relevant much earlier than before. The EU HTA regulation makes joint clinical assessment an important consideration in earlier evidence strategy decisions.
Requirements related to comparator therapy, patient relevance, real-world evidence (RWE) and risk management must increasingly be considered at the planning stage of evidence strategies, clinical development and investment decisions. This white paper argues that JCA should not be viewed simply as a new requirement for HTA, but rather as a catalyst for a fundamental shift in the way companies generate, manage, and utilise evidence to support patients’ access to therapies. This positions JCA readiness not as an end, but as a means to support timely patient access and better healthcare-system decision-making. It also shifts evidence planning from predominantly Global/US-first sequence towards closer, concurrent coordination of US and European requirements requiring stronger alignment between Global, US, and European evidence teams.
This paper is based on the Indegene Medical Affairs Roundtable hosted in Zurich, alongside Medical Affairs Professional Society (MAPS) Europe 2026. The discussion highlighted a central leadership challenge: While awareness of the JCA is increasing, many companies still face the task of translating JCA requirements into earlier evidence decisions, new capabilities, and more integrated ways of working.
The key question, therefore, is not whether companies understand that the JCA is coming – it's already here, but whether they are prepared to make their evidence decisions in a more integrated and strategic way.
The paper translates these insights into a strategic agenda:
Bringing evidence planning upstream before critical decisions are locked
Developing integrated evidence strategies that link JCA requirements with national market access requirements
Building the capabilities needed to navigate increasing evidence complexity
Establishing operating models that enable continuous evidence readiness
For Medical Affairs, the opportunity does not lie in taking sole responsibility for all technical components of JCA readiness. Medical Affairs will continue to support scientific exchange, publications, stakeholder engagement, and evidence generation, but can increasingly take on the role of a strategic orchestrator of evidence by bringing together clinical insights, patient relevance, local care realities, external stakeholder perspectives, and cross-functional expertise at the critical points where the evidence strategy is still being shaped.
While this paper uses Medical Affairs as the anchor for discussing JCA readiness, the intent is not to assume that all relevant capabilities sit within Medical Affairs in every organization. Capabilities such as Market Access, Health Economics & Outcomes Research (HEOR), Regulatory, Clinical Development, RWE, Publications, and affiliate engagement may be distributed across different functions. What matters is not formal reporting line, but whether the right expertise is connected early enough to shape evidence strategy.
This transformation takes place across three interconnected dimensions
Activity
from sequential evidence generation to proactive and integrated evidence planning.
Medical Affairs Influence
from participation in individual evidence activities to actively shaping the evidence strategy.
Operating Model
from functional handovers to continuous evidence readiness.
Together, these changes demonstrate the fundamental significance of the JCA: Future competitive advantage will not come from responding faster to evidence requirements, but from making right evidence decisions earlier.
JCA Scope, Implementation, and Strategic Implications
What is JCA?
Joint Clinical Assessment (JCA) is an assessment conducted at European Union (EU) level of relative clinical effectiveness and safety. It aims to establish common clinical evidence basis for EU-Member States. JCA does not determine pricing, reimbursement, budget impact, economic value, or final access decisions, which remain at the national level.
JCA establishes a common clinical reference point, but does not eliminate the need to prepare evidence for national market access.
The strategic challenge is not simply to determine whether or not many more dossiers now need to be prepared with the JCA, the focus is on developing an integrated evidence strategy that accounts for national requirements without the evidence strategy becoming fragmented later in the market access process. Integrated evidence planning therefore needs to connect the common European assessment with country-specific market access needs.
Implementation of the JCA and Insights
The implementation timeline for JCA is structured in stages across different product categories:
12 January 2025
Oncology medicines with a new active substance and Advanced Therapy Medicinal Products (ATMPs).
13 January 2028
Medicines for the treatment of rare diseases (Orphan Medicinal Products).
13 January 2030
All medicinal products falling within scope of the HTA Regulation.
As implementation progresses, initial assessments are providing practical insights into new EU HTA framework and what successful JCA preparation requires. The first completed JCA report for tovorafenib (Ojemda)2 marked an important procedural milestone. Similarly, the discontinuation of Catequentinib and Tacqell shows that process quality throughout the assessment, procedural compliance, and information completeness are as important as scientific quality. Together, these experiences highlight:
that companies must understand not only JCA timelines and evidence expectations, but also the potential implications of the assessment for subsequent national HTA and reimbursement processes.
the importance of early process readiness by anticipating evidence requirements from assessor’s perspective.
that scientific excellence alone does not ensure a successful JCA process: Systematic searches, transparent rationale for the comparator, complete presentation of results, and traceable documentation need to be established from Population-Intervention-Comparator-Outcomes (PICO)-scoping phase onward.
Impact of JCA on Evidence-Strategy and Generation
Historically, HTA evidence generation in many companies was predominantly sequential, with activities often intensified only in the later stages before market entry. JCA shifts this paradigm towards a state of continuous evidence readiness – that is towards the ongoing planning, generating, validation, and updating of evidence, in which evidence strategies increasingly help shape development programs rather than merely accompanying them.
JCA is also changing when business-critical, evidence-based decisions need to be made. Since JCA is conducted in parallel with the EMA assessment, decisions about comparative therapy, patient relevance, RWE, and approaches to managing uncertainty increasingly need to be taken while development pathways can still be influenced and strategic choices remain flexible, rather than shortly before launch or HTA submission.
Implications of JCA for Medical Affairs Leadership
For Medical Affairs leaders, JCA represents a strategic shift and not merely another regulatory requirement. It offers Medical Affairs the opportunity to take on a more strategic role in the early product development phase. Organizations that continue to view evidence planning as a late stage in their development activities risk losing important opportunities to influence subsequent evaluation and market access outcomes.
Recent stakeholder discussions show that awareness of implications of the JCA continues to vary across many companies, even across different levels of management. A common understanding of the implications of the JCA is a prerequisite. However, a sustainable commitment to the JCA requires transforming this awareness into aligned and coordinated ways of working across various functions.
In addition, the launch of the JCA comes at a time of profound change, as many companies are building innovation-driven portfolios, strengthening their clinical development capabilities, and restructuring collaboration among global, regional, and local teams. Rather than becoming yet another isolated “change initiative”, the JCA can support a broader organizational transformation by fostering earlier collaboration among Medical Affairs, Clinical Development, Market Access, HEOR, Regulatory, RWE, Patient Affairs, and affiliates around a shared evidence strategy – while strengthening patient-centred scientific leadership.
Leadership Implication
Successful JCA readiness begins with a common understanding that JCA changes more than the assessment process itself. It changes when evidence-related decisions become strategically important and when earlier action can improve patient access, system-level decision-making, and market readiness.
Figure 1. Role of JCA in expanding the role of Medical Affairs from reactive execution to proactive development of the evidence strategy
Roundtable Insights on JCA Implementation Challenges
The roundtable discussion made it clear that the real uncertainty lies not so much in the JCA process itself, but rather in how the joint assessment will interact with national expectations that remain diverse. Participants repeatedly returned to an overarching strategic question: Which comparator therapy is relevant? Who decides what is acceptable? What happens if treatment standards differ from country to country? And if national authorities can still require additional evidence - what exactly has been simplified?
Participants reflected on how the intended harmonization would affect evidence requirements, market access, and patient care in practice. If evidence expectations are based on the most demanding comparator therapy or the highest evidence standards, there is a risk that evidence requirements will be highly difficult to address - particularly for rare diseases, advanced therapies, and smaller markets.
In some cases, finite R&D resources and disproportionate evidence requirements may require companies to make difficult portfolio and launch-sequencing decisions, with investment potentially prioritized towards larger or strategically important markets. This could disadvantage smaller markets and create new barriers to equitable access. Leadership therefore needs to ensure that the JCA improves consistency without creating new barriers to timely patient access.
During the roundtable, the heterogeneity of comparator therapies also emerged as a key practical challenge. The "C" in PICO represents a significant source of uncertainty. Treatment standards vary among Member States, meaning that a comparator considered clinically relevant in one country may not be routinely used, reimbursed, or available in another. This underscores the need to take the comparator strategy into account even before the planning stage of clinical trials and evidence generation, since subsequent adjustments are often only possible to a limited extent.
In addition, participants repeatedly emphasized that a common EU process does not automatically mean that less evidence is required. A related implementation risk concerns the quality and consistency of Member States’ contributions. Since HTA capabilities and resources vary at the national level, inconsistent PICO expectations may increase the complexity of the centralised assessment without improving the quality of decision-making. This underscores the need to incorporate local insights and stakeholder perspectives into evidence planning at an early stage.
Beyond JCA: Evidence Add-on for National Pricing and Reimbursement Decisions
Organizations may need to plan for a “JCA-plus-national-addenda model”: a central EU evidence package, supplemented by targeted national materials when local comparator therapies, subgroups, epidemiology, care and usage patterns, budget impact data, or country-specific RWE are required.
Learnings from MedTech Experience Presented at the Roundtable
The Transformation of Medical Affairs
Medical Affairs transformation was another central theme in the roundtable discussion. This transformation can be viewed as an evolving role of Medical Affairs contributing to JCA readiness and in terms of three interconnected changes that collectively support continuous evidence readiness. In this context, medical affairs transformation involves earlier strategic input, cross-functional coordination, and continuous evidence readiness.
Medical Affairs transformation across three dimensions
JCA is changing more than the timing of evidence generation, it has become an important catalyst to a broader transformation in Medical affairs
Figure 2. The evolving role of Medical Affairs to drive stronger evidence, better decisions and greater patient access
Activity Shift‒Start Earlier, Plan Concurrently
Evidence decisions that were historically addressed sequentially or close to launch increasingly need to be considered during initial phases of development. Comparator strategy, patient-relevant outcomes, RWE, and local insights should inform evidence planning before pivotal decisions become limited to revise.
Expanding Strategic Influence of Medical Affairs
Earlier involvement alone is insufficient. Medical Affairs should have the mandate, capabilities, and cross-functional connectivity to help shape evidence strategy and influence the decisions that determine clinical development, comparative evidence generation, RWE planning, and national readiness.
Operating Model Shift‒Move from Handoffs to Continuous Readiness
A more strategic Medical Affairs role requires an operating model that connects global and local teams, integrates clinical and access perspectives, and continuously adapts as treatment standards, evidence expectations, and national requirements evolve.
Activity: Redesigning Evidence Generation
We have established before that Evidence-based decisions that influence future assessment outcomes often need to be considered years before market launch.
What Does This Mean in Practice?
Comparator therapies
Traditionally these are often not finalized until HTA or launch planning; under JCA, they increasingly need to be an integral part of the evidence strategy before decisions regarding pivotal study are made.
Patient-reported outcomes (PRO)
Traditionally, these are often supported by publications, PRO analyses, or additional evidence after launch; under the JCA, patient relevant needs to be considered as early as the endpoints and the planning of clinical evidence.
RWE planning
Traditionally developed after approval or in response to local evidence gaps; under JCA, RWE strategies need to anticipate questions regarding comparative efficacy, remaining uncertainties, long-term outcomes, and differences in clinical practice at an early stage.
Local insights
Traditionally collected as part of launch readiness or national adaptation; under JCA, they are increasingly incorporated into the anticipation of national PICO requirements, the assessment of local care standards, and the planning of supplementary national evidence.
For Medical Affairs, this means addressing key evidence questions much earlier in the development process: How do standards of care differ among member states? Which comparator therapies are likely to be most relevant for HTA assessments? Which endpoints are relevant to decision-making for patients, clinicians, and evaluators? Where is additional RWE needed? Which risks are likely to exist at the time of the JCA, and how can these be addressed through national or post-marketing evidence? This requires organizations to establish credible sources and structured mechanisms for gathering early clinical, patient, and healthcare system insights before traditional field medical deployment begins.
Expanding the Strategic Role and Capabilities of Medical Affairs: Shaping Evidence Strategy
Earlier involvement alone is not the true transformation. The broader change for Medical Affairs is to have the mandate, capabilities, and cross-functional connectivity to help shape evidence strategy and influence key decisions. Capability models may also account for smaller markets, where local expertise and resources may be limited.
The Evolution of Medical Affairs: From Evidence Contributor to Evidence Orchestrator
As evidence planning moves earlier in the product lifecycle, the strategic value of Medical Affairs increasingly lies in coordinating and connecting the broader evidence ecosystem rather than supporting individual evidence activities in isolation.
Medical Affairs is uniquely positioned to integrate scientific exchange, clinical practice, patient perspectives, external expertise, RWE, and local market insights into a coherent evidence decision that supports future assessment and market access decisions.
In a JCA-ready model, Medical Affairs helps ensure that evidence planning reflects how care is delivered in real-world clinical practice, which outcomes are most relevant to patients, and which evidence requirements national stakeholders are likely to raise. This does not mean that every Medical Affairs professional must become a HTA methodology expert. Rather it requires leadership culture that brings together the right expertise at the right time and supports cross-functional evidence decision-making.
Six Questions for Medical Affairs Leaders
These changes lead to six strategic questions that help position JCA readiness as part of a long-term evidence strategy rather than merely a regulatory submission requirement.
Which assets face the greatest evidence readiness challenges‒
Where could comparator complexity, evidence gaps, or national requirements influence future assessment outcomes?
Which evidence decisions must be addressed before opportunities for influence are lost‒
Which decisions can still be shaped, and where are evidence gaps at risk of becoming structural limitations?
How should investments be rebalanced to reflect the growing importance of evidence in securing access‒
and where could earlier investment reduce future evidence risks and costs?
Which capabilities need to be coordinated globally, locally, or externally‒
Are responsibilities and capabilities intentionally distributed across the evidence ecosystem and sufficiently connected?
How is local knowledge translated into evidence strategy‒
Are insights from clinical practice, patients, affiliates, and other stakeholders genuinely informing evidence-related decisions?
What operating model enables continuous evidence readiness‒
Who is accountable for evidence readiness, brings together relevant decision-makers, prioritizes evidence investments, and resolves tensions between global and local requirements?
Transforming Operating Model: From Functional Handoffs to Continuous Evidence Readiness
Organizations may need to move away from functional handoffs towards integrated and cross-functional decision-making processes, closer global and local collaboration, and an adaptive approach that continuously adjusts to changing evidence requirements, HTA expectations, and standards of care.
What Does this operating model Require?
A JCA-ready operating model does not necessarily require a new organizational structure. Rather, what is crucial are clear responsibilities, interconnected governance and decision-making processes, close collaboration between global and local functions, access to relevant expertise, and clearly defined roles throughout the evidence ecosystem. It also requires connected processes and technology that enable evidence, decision, and evolving requirements to be aligned transparently reducing reliance on fragmented offline and manual coordination.
Figure 3. Components of a Practical JCA-ready Operating Model.
For highly complex assets, closer collaboration between Medical Affairs, Market Access, HEOR, Clinical Development, and evidence-generation functions may become increasingly important. What matters is not where responsibilities are located within the organization, but whether the relevant expertise is brought together early.
Practical Capabilities as the Basis for Evidence-based decisions
Building expertise within Medical Affairs is important to identify evidence risks early on, ask the relevant questions, and bring in specialized expertise as needed.
From Medical Affairs Transformation Into JCA Readiness Priorities
The transformation described above lays the groundwork for greater JCA readiness but does not automatically determine which priorities should be set at the portfolio level.
Since evidence complexity, uncertainties regarding comparator therapies, and national market access requirements vary by asset, companies need a structured approach to assess which assets face the greatest JCA-related challenges and where evidence-related decisions can still be actively shaped.
The three dimensions of transformation described above highlight the organizational, procedural, and strategic adjustments required. A portfolio-level analysis helps translate these insights into concrete priorities and identify where the greatest risks to evidence readiness lie.
The Act–Prepare–Monitor framework helps leadership /executives prioritize appropriate measures based on the complexity of evidence, the potential risk to future HTA and market access outcomes, and the remaining scope for action to still influence evidence strategy and planning.
Identifying Readiness Risks at the Portfolio Level for Prioritized Assets
A portfolio wide perspective on evidence readiness helps companies identify which assets still present evidence or market risks that can be actively addressed, and where early action can yield the greatest strategic benefit
Once these risks become apparent, senior management can move from risk identification to prioritizing measures, investments, and resources. This transforms JCA readiness from a retrospective risk assessment into a tool for the proactive management of evidence and market access strategies.
Specifically, this translates the portfolio perspective on evidence readiness into a practical decision-making model that can be used to assess risks, prioritize assets, and allocate resources, where they will have the greatest impact on future evaluation and market access outcomes.
Act-Prepare-Monitor: Turning Readiness Insights into Prioritized Actions
The APM framework translates identified readiness risks into concrete priorities for activities, investments, and resource allocation. It distinguishes between three categories of activity:
Act
“Act” category involves decisions where there is still an opportunity to influence the evidence strategy and future evaluation results. These include decisions with the potential to impact study design, comparator strategy, endpoint selection, RWE planning, and the generation of patient-centred evidence.
Prepare
“Prepare” covers evidence-generation activities for which the key clinical development decisions have already been made, but which remain critical for JCA readiness and national market access requirements. These include, for example, indirect comparisons, publication strategies, RWE activities, and the planning of supplementary national evidence.
Monitor
“Monitor” encompasses areas characterized by high uncertainty or changing conditions that require continuous monitoring. These include updates to guidelines, methodological expectations of member states, HTA-related requirements, and practical experience gained from implementing the JCA. Clear monitoring criteria and defined triggers for future decisions should be established for these areas
A key finding of the roundtable was that the JCA creates pressure to act before complete clarity or certainty is available. Companies therefore often have to make decisions under conditions of uncertainty while simultaneously continuing to develop their evidence strategy in a flexible manner.
The APM Framework helps leaders prioritize actions, allocate resources strategically, and focus investments on those areas with greatest strategic impact. As a result, JCA readiness evolves from a reactive compliance task into a structuring tool for evidence and market access strategy.
From Transformation to Action: A JCA Readiness Agenda for Medical Affairs Leaders / Executives
The transformation described in this white paper requires more than just isolated process adjustments. It demands a systematic enhancement of evidence planning, decision-making, and organizational capabilities throughout the entire product lifecycle.
The following five areas of action form a practical JCA Readiness Agenda for Medical Affairs executives. Together, they support the transition from reactive evidence generation to proactive management of evidence readiness at the portfolio level. These priorities connect EU joint clinical assessment requirements with practical decisions on evidence generation and organizational readiness.
Conduct a structured JCA readiness assessment across priority assets and functions.
Prioritized assets should be assessed in terms of JCA PICO framework and requirements. The portfolio perspective on readiness described above can serve as a structure for this assessment, while the Act-Prepare-Monitor framework helps translate the results into a practical roadmap of prioritized actions.
Develop integrated evidence plans on a JCA-plus-national-addenda model.
In the future, evidence planning should no longer be carried through separate regulatory, medical, and market access processes. Instead, companies should establish integrated evidence plans that bring together regulatory requirements, the JCA, national HTA requirements, market access, real-world evidence, publication strategies, patient-centred evidence, patient experience data, uncertainty management from the outset into a single strategic plan.
Early Anticipation of European PICO, Evidence and Care Requirements.
Companies should develop an early understanding of which populations, comparators and endpoints are likely to be relevant for the European clinical assessment. This includes, in particular, analysing standards of care and potential differences across priority member states. Insights from national healthcare systems should be incorporated early into the evidence strategy, while clinical development programs, study designs, and evidence plans can still be actively influenced.
Position European Medical Affairs as a strategic partner in evidence planning.
The role of Medical Affairs is increasingly expanding beyond traditional evidence generation and scientific communication. European Medical Affairs can make a critical contribution by bringing forward JCA requirements at an early stage. Its greatest influence comes during development phases when the Target Product Profile (TPP), pivotal study programs, and integrated evidence strategy are being shaped.
Establish a JCA-Ready Operating Model.
Sustainable evidence readiness requires an operating model with clear accountabilities, defined decision-making processes, connected capabilities, and structured access to specialised HTA, RWE, and evidence expertise. Companies should deliberately determine which capabilities are best provided centrally, locally, or through external partners to ensure both scalability and flexibility.
For smaller pharmaceutical and biotech companies, a hybrid model may be particularly suitable. Under this model, strategic responsibility for evidence prioritization remains internal, while specialized external expertise can be brought in flexibly for areas such as PICO mapping, comparator assessments, evidence synthesis, country-specific HTA analyses, RWE strategies, and planning for national evidence requirements.
Larger pharmaceutical companies can also benefit from such models, particularly where specialized capabilities are limited, or development and launch timelines require greater agility.
Conclusion
JCA will not be judged by whether it introduces another process. It will be judged by whether it enables better-informed, more consistent, and more transparent evidence decisions across Europe. For companies, the same principle applies: Regulation provides the framework, but leadership determines whether evidence generation and planning evolve to meet these new expectations.
For Medical Affairs, this presents an opportunity to assume a more strategic role in evidence planning and decision-making. The function creates the greatest value when it connects scientific expertise, patient relevance, external stakeholder perspectives, real-world insights and local healthcare system knowledge early enough to inform evidence strategy and evidence-related decisions, rather than explaining outcomes after decisions have already been made.
The call to action is clear: Assess portfolio readiness proactively, identify where Medical Affairs can contribute to evidence strategy at an earlier stage, invest in capabilities before critical evidence gaps emerge, and establish an integrated evidence model that combines JCA readiness with anticipated national evidence requirements.
Organizations that view JCA as a catalyst for transforming evidence planning, cross-functional collaboration, and long-term evidence readiness, rather than solely a new regulatory requirement will be better positioned to deliver timely patient access, informed decision-making, and sustainable value creation across Europe.
Acknowledgements
The authors thank the participants of the JCA Expert Roundtable for sharing expertise and practical perspectives that informed this paper.
The views expressed in this paper are those of the authors and do not necessarily reflect the views of participating individuals or their organizations.
Expert Contributors / Roundtable Participants
References
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How Can Indegene Support JCA Readiness?
Indegene partners with life sciences organizations to translate JCA readiness into an integrated evidence strategy. Combining Medical Affairs, HTA, RWE, and technology expertise, we help organizations strengthen evidence planning, build fit-for-purpose operating models, and achieve sustainable evidence readiness across the product lifecycle.