The European Commission has recently announced that the first Joint Clinical Assessment (JCA) is finalised and undergoing final checks prior to publication. This means that in short time the outcome of the very first and much anticipated JCA will become public.
The JCA certainly reshaped how pharmaceutical and biotech companies prepare for market access in Europe. One pattern has become increasingly clear from our recent project work: companies that invest early in PICO anticipation are far better positioned for a successful JCA dossier submission and those that underestimate its complexity could find themselves under significant time pressure.
What Are PICOs and Why Do They Matter?
PICO stands for Population, Intervention, Comparator, and Outcomes. In the context of the JCA, PICOs define the exact clinical questions that will be assessed, and by extension, they determine what evidence is considered relevant. Member States each propose country-specific PICOs, which are then consolidated and finalized at EU level before being communicated to the developer.
This multi-country process has a direct and important consequence: if countries request a large number of PICOs, comparators that go beyond those tested in the pivotal trial could suddenly become relevant. In one of our analyses covering 5 to 10 key EU markets, we have identified as many as 30 distinct PICO combinations for a single product. Each additional comparator drives the need for indirect treatment comparisons (ITCs) which require time and resources and are expected to be included in the JCA dossier. If the manufacturer was unable to address a PICO, a justification will be required.
The Time Challenge Is Real
On top of the complexity of having many PICOs, the JCA fundamentally changed the timing of the HTA process. Because it runs in parallel with the EMA procedure, developers are effectively engaging with HTA requirements much earlier than under traditional country-by-country submissions. Add to this the 100-day window between the communication of consolidated PICOs and dossier submission (or 60 in case of an accelerated EMA procedure), and it becomes clear why preparation must begin well in advance. We recommend a lead time of at least 12 to 18 months.
This tight operational timeline is one of the most underappreciated aspects of the JCA. There is simply not enough time, once PICOs are confirmed, to commission and complete all the analyses from scratch. JCA dossier preparation, including ITCs for anticipated comparators, must already be underway.
Two Implications for Dossier Strategy
Our experience points to two key strategic implications for companies preparing for JCA.
The first concerns dossier diversification. National reimbursement decisions need to take the JCA outcome into account (so far, no one knows to which extent this will be the case), meaning the dossier can no longer be optimized for a single priority market. It must represent the full evidence base and be sufficiently aligned with the needs of multiple key EU markets simultaneously. This is a meaningful shift for companies accustomed to tailoring submissions country by country.
The second is the tight submission timeline. Once consolidated PICOs are communicated to the developer, the 100-day clock starts (or 60 in case of an accelerated EMA procedure). Meeting that deadline requires that dossier preparation, including the most resource-intensive analytical components, has already been well advanced.
A Robust Approach to PICO Anticipation
Given this landscape, PICO anticipation has emerged as a structured, high-value activity in its own right. At Justin Stindt Consultants, our approach combines two complementary research methods:
Secondary research, including review of clinical guidelines, HTA appraisals, and official publications, allows us to build a detailed picture of national standards of care and identify the comparators that payers in each market are likely to consider relevant. This forms the analytical backbone of the anticipation exercise.
Primary research through payer interviews and advisory boards allows us to test assumptions, validate hypotheses, and deepen our understanding of how decision-makers in key markets are likely to approach a given clinical question. This also allows predictions for future/emerging comparators.
While the industry eagerly anticipates the outcomes of the first JCAs, one thing is certain: companies that proactively anticipate the PICO landscape will be in a far stronger position to respond, regardless of how the process continues to evolve.
Start Earlier Than You Think
For any company with a product moving toward EMA submission in the coming years, the message from our recent project experience is clear: PICO anticipation should be treated as a priority activity, not an afterthought. The combination of broad country-level PICO requests, the need for multi-market dossier alignment, and the compressed timeline between PICO communication and submission leaves little margin for delay.
Why Work With Justin Stindt Consultants
Our team specialises in guiding pharmaceutical, biotech, medtech and diagnostic companies through the evolving European market access environment.
Our expertise includes:
JCA Dossiers & PICO Assessments
Designing and delivering evidence packages aligned with EU HTA expectations.
Joint Scientific Consultations
Preparing high-impact interactions with HTA bodies at the EU level to optimise clinical plans.
Pricing & Reimbursement Strategy
Pathway definition, analogue research, price benchmarks and launch sequencing.
HTA Scientific Advice
Guiding clinical and economic strategy to meet national payer expectations.
Payer Advisory Boards
Facilitating strategic dialogue to refine value messaging and ensure payer resonance.
Our mission is to help health-technology developers navigate a complex, shifting EU landscape and achieve timely, sustainable market access.
Interested in learning more about how to successfully prepare for a JCA?
Get in touch: info@jstindt.com
