First Joint Clinical Assessments (JCAs): Key Lessons for EU HTA

 The First JCAs Are Revealing More Than a New Process: Early Lessons and JCA Readiness

As the first Joint Clinical Assessments (JCAs) moved from planning into practice, a clearer picture is emerging of what the new European HTA framework will mean for Health Technology Developers (HTD). The initial focus across the industry has largely been on operational readiness—timelines, templates, governance, and submission requirements. Early experience suggests the bigger story lies elsewhere.

The JCA is not simply introducing a new assessment process. It is changing expectations around how evidence is generated, how launch strategies are developed, and how organizations prepare for market access across Europe.

Evidence Planning Is Moving Upstream

Many companies have traditionally addressed HTA challenges late in development, often supplementing evidence packages with additional analyses or local adaptations. The JCA leaves less room for this approach.

Clinical data are now expected to withstand scrutiny from multiple healthcare systems simultaneously. Questions around comparators, endpoints, subgroups, and data maturity can no longer be treated as late-stage access considerations. They increasingly influence development decisions years before launch. 

Organizations that connect regulatory and market access thinking early will be better positioned than those following a sequential approach.

PICO Discussions Matter More Than Ever

One of the clearest signals from the first assessments is the importance of early PICO strategy.

Different treatment pathways, standards of care, and clinical practices across Europe create inevitable tensions when defining the evidence requirements for a single assessment. Companies that enter these discussions without a clear understanding of potential differences may discover that critical evidence gaps become visible too late.

Rather than viewing PICO development as a procedural exercise, leading organizations are treating it as a core component of launch planning.

Organizational Alignment Is Becoming Essential

The JCA is also exposing the limitations of siloed decision-making. 

Clinical, regulatory, medical, HEOR, market access, and affiliate teams all influence the evidence story that ultimately reaches assessors. Decisions made in one function increasingly have consequences across the entire product lifecycle.

Organizations that establish integrated governance and shared accountability are likely to move more effectively than those relying on traditional functional boundaries.

Transparency Creates Opportunity

The new framework brings greater visibility to both strengths and limitations within an evidence package. While some organizations may view this as a risk, it also creates an opportunity to build credibility.

Companies that acknowledge uncertainty, explain its context, and demonstrate a clear plan to address remaining questions are often better positioned than those focused solely on defending every aspect of the data.

Scientific credibility may become as important as the evidence itself.

Implications for Innovative Medicines

The impact may be greatest for biotech companies, rare disease therapies, and advanced therapeutic products where evidence packages are often built around smaller patient populations and evolving clinical practice.

Success will depend not only on generating evidence but on clearly communicating the relevance of that evidence, its limitations, and its implications for patients and healthcare systems.

What About MedTech?

How JCA Requirements Will Impact Medical Devices

Medical devices will soon become subject to JCA requirements with many of the underlying trends being highly relevant. Payers and HTA bodies are placing greater emphasis on comparative evidence, real-world outcomes, and demonstrable healthcare value. For diagnostics, digital health technologies, AI-enabled solutions, and complex devices, evidence strategies will increasingly need to go beyond regulatory approval and demonstrate meaningful impact in routine clinical practice.

Looking Beyond Compliance

The first JCA experiences suggest that success will not be determined by procedural readiness alone. The organizations that benefit most will be those that use the new framework to strengthen evidence generation, improve internal decision-making, and create a more coherent value story across Europe.

The JCA may have been introduced as a clinical assessment process. In practice, it is becoming a test of how effectively organizations connect development, evidence, and access strategy. Those that adapt early are likely to gain advantages that extend well beyond the assessment itself.

Turning JCA Readiness into a Competitive Advantage

As the European HTA landscape continues to evolve, one thing is becoming increasingly clear: organizations that begin preparing early will be better positioned to navigate both Joint Clinical Assessments and broader market access requirements.

Success under the EU HTA Regulation will depend on more than meeting submission deadlines; it will require integrated planning, cross-functional collaboration, and evidence strategies that align regulatory, clinical, and market access objectives from the earliest stages of development.

ProPharma’s integrated Regulatory Sciences, HEOR, and Market Access experts help applicants develop evidence strategies that support successful regulatory submissions while preparing for the evolving demands of HTA and JCA. From PICO strategy and evidence planning to JCA readiness assessments, dossier development, and end-to-end HTA support, we help organizations build a cohesive approach that reduces risk, strengthens value demonstration, and supports successful patient access across Europe.

Whether you are preparing your first JCA, developing an orphan or innovative therapy, or looking to align your regulatory and market access strategies earlier in development, our team has the expertise to help you navigate this new landscape with confidence.