Value & Access

Key Questions Ahead of the First EU JCA Reports

EU Joint Clinical Assessment (JCA) represents one of the most significant paradigm shifts for European market access in recent memory. Since its introduction and subsequent implementation in early 2025, manufacturers have closely monitored JCA developments and assessed their potential implications on global product launch strategy. Such vigilance has been crucial given the increasing number of products subject to mandatory JCA, the broad range of markets that will leverage its outputs, and other mounting pressures in the global access landscape (e.g. the impact of US most-favoured nation [MFN] pricing reforms) that heighten the importance of achieving favourable JCA outcomes.

An Opportunity to Validate JCA Strategy and Resolve Uncertainty

Due to the complex landscape of EU JCA, manufacturers are paying a great deal of attention to planning for JCA – both in terms of strategic due diligence (e.g. in considering what the scope of the assessment will be in terms of populations, interventions, comparators and outcomes [PICOs]) and in terms of optimising evidence generation methodology to be JCA-compliant (e.g. for indirect treatment comparisons [ITCs]).

Up until now, manufacturers have planned for JCA by reviewing the various published guidance documents that offer a view into how JCA might manifest.^1,2Discussions during EU Joint Scientific Consultations have also provided insight for those manufacturers fortunate to secure a slot, and expert opinion pieces sharing recommendations for manufacturers have also been published; for example, we have shared our own thoughts on:

However, while 15 interventions are undergoing JCA at the time of writing, no reports have yet been made publicly available that shed light on how assessors interpret and implement the JCA methodological guidance in their judgments.³ Excitingly, this is soon set to change; the first product to undergo JCA (tovorafenib for the treatment of paediatric low-grade glioma) recently received its EU marketing authorisation on 22^nd April 2026.⁴The HTA Coordination Group overseeing the JCA process endorsed the concurrently-prepared JCA report on 30^th April 2026, and this is set to be published within 10 working days of the endorsement date by the European Commission.

Publication of the first ever JCA report will be a watershed moment for manufacturers; the outcomes of the tovorafenib assessment will provide valuable insights on how evidence is reviewed by the assessors and set precedent for future assessment.

Our Wishlist: Questions That We Hope Will Be Answered by the First JCA Reports

Ahead of the publication of the first JCA report, Costello Medical’s Value & Access and Evidence Development teams have reflected on the JCA process methodological guidance and our thoughts on remaining uncertainties for manufacturers, that we hope will be addressed by the tovorafenib JCA report and subsequent JCA reports published over the coming months. We plan to share the answers to some of these questions in future pieces:

1.

Uncertainties in the JCA Scope

JCA aims to assess the comparative effectiveness of a product, and the remit of this assessment is defined by a PICO scope that JCA assessors determine 100 days before the manufacturer submits their JCA dossier. There is inherent uncertainty in the number of potential PICOs that manufacturers may need to address, given that the PICO identification process remains a black box and that simulations (including our own PICO simulation) reveal the potentially high number of analyses that may be required.

Accordingly, it is hoped that the tovorafenib JCA report will provide the first public insights on how the PICOs were determined and consolidated, and how the assessors have responded to those included:

How many PICOs were initially proposed by EU Member States in their responses to the PICO scoping survey, and how many were included in the final consolidated PICO scope?
- How many individual member states responded to the PICO scoping survey?
  Given that HTA bodies in many Member States are resource-constrained, the need to list PICOs for several concurrent JCAs may restrict their capacity to respond to all PICO scoping surveys.
- Is there transparency on which Member States contributed which PICOs?
  This could reveal trends on individual Member State preferences (e.g. whether they consider off-label comparators in scope) and also on the extent to which particular Member States drive the final scope.
- Does the report provide any more clarity on how the PICOs were consolidated/prioritised, particularly where member states’ national perspectives diverge?

How did assessors decide what constitutes a ‘subpopulation’ (which defines separate PICOs) versus a ‘subgroup’?
Were there any variations in the intervention component of the PICO (e.g. as a result of permitted/prohibited concomitant therapies)?
How many outcomes needed to be addressed?
- Do these reflect the extensive evidence requirements needed in some member states (e.g. extensive safety reporting requirements for G-BA appraisals)?

What were the consequences of a given PICO not being addressed in the JCA dossier?
- How have manufacturers attempted to disregard particular PICOs, and how successful were these attempts? What constitutes “sufficient justification” for excluding a PICO?

2.

Uncertainties in the JCA Process

The first JCA reports could provide useful insight into how some of the steps outlined in the JCA process played out in reality:

What level of involvement did individual patients, clinicians and other experts play in the JCA process, and how transparently was this documented?
- How were clinicians/patients selected to be an EU-representative sample?
- How were conflicts-of-interest managed, in particular when an indication has a very small pool of key opinion leaders?

What number of clarification questions did the manufacturers receive during the post-submission process? What topics did these questions focus on and how detailed were they?
- How extensive were JCA assessors’ post-submission requests for additional analyses from the JCA group?

To what extent did the assessors’ local HTA body preferences influence the outcomes and conclusions of the JCA report?
The JCA for tovorafenib was conducted by the National Centre for Pharmacoeconomics, Ireland [NCPE] and Institute for Quality and Efficiency in Health Care, Germany [IQWiG], which have well-defined and sometimes divergent preferences.

3.

Uncertainties in the Application of JCA Methodological Requirements

The first published JCA report should also provide concrete insight into how clinical evidence is assessed and presented within the report, and how the evidence and expert inputs are translated into the final outcomes:

What were assessors’ perceptions on the quality of evidence from single-arm studies, and their use in ITCs (e.g. as part of unanchored comparisons)?
What were assessors’ perceptions on the quality of real-world evidence studies?
- To what extent was geographic location and transportability of RWE discussed by the assessors?
What were assessors’ perceptions on the level of certainty in clinical effectiveness of a product, when clinical evidence was largely based on surrogate endpoints?
How did the report handle and communicate uncertainty or evidence limitations?
To what extent did judgements/conclusions take account of extenuating circumstances for rare diseases?

From Questions to Answers: What is Coming Next

Given that, until now, the exact details of the JCA process and assessments have not been disclosed publicly, we remain cautiously optimistic that the outputs of the initial JCA reports will provide practical real-life insights on this new approach to health technology assessment across Europe.

Following the publication of the first JCA reports, Costello Medical’s Value & Access and Evidence Development teams will reflect on how the strategic and methodological questions listed above have been addressed, and how manufacturers’ approaches to future JCA submissions may evolve accordingly. We will also be keeping an eye on and exploring how these JCA reports are leveraged in Health Technology Assessments (HTA) and decision-making in individual member-states HTA, and therefore what their downstream impact on local access could be.

We also invite you to share any additional thoughts or topics you would like us to explore as we conduct an in-depth assessment of the initial JCA reports.

If you would like any further information or advice on the themes presented above, please get in touch, or visit our EU Joint Clinical Assessment page to learn how our expertise can benefit you. Lukass Jursins (Senior Analyst), Naman Kochar (Consultant), and Fern Woodhouse (Principal Consultant) created this article on behalf of Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients or affiliated partners.

References

European Commission. Joint Clinical Assessments. Access this guidance. Last accessed May 2026.
European Commission. PICO exercises. Access this guidance. Last accessed May 2026.
European Commission. List of Joint Clinical Assessments. Access this guidance. Last accessed April 2026.
Ipsen. Ojemda® approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration. Access this article. Last accessed April 2026.