Do You Really Need a €1 Million Programme to Launch Your Drug in Europe?
September 15, 2026
Here is a number every biotech CEO looking at Europe should know: in the average European country, only about half of recently approved medicines are actually available to patients.
Approval is not access.
In Europe, these are two different doors. And the second is now shaped by a shared review of the clinical evidence that national payers use afterwards: the Joint Clinical Assessment, or JCA.
Preparing for it has quickly become an industry of its own — extra studies, literature reviews, statistical modelling, additional analyses and dossiers. It is easy to end up with a seven-figure evidence programme before anyone asks:
Which of this actually changes whether Europe pays for your drug?
The first real assessments are now in. And they show that an “evidence gap” is not one problem with one solution.
Across the first four assessments, the problems were very different. Treating every gap as something that needs to be closed wastes money — and can create more uncertain evidence without reducing the uncertainty that matters to payers. Here is what happened.
Sometimes the comparison Europe wants cannot be built credibly.
There was no fair comparison group in the trial. The statistical workaround eventually rested on the equivalent of fewer than six patients. Even the two studies judged tumour response differently, so response was not being measured on the same basis.
No additional modelling fixes that.
The useful decision is to know this before paying for the analysis.
Sometimes you can run the comparison, but still cannot rely on the answer.
The patients in the two studies differed in important ways that the available data could not correct for. The analysis produced a number, but no one could establish how much those remaining differences had distorted it.
That is not a closed evidence gap. It is an uncertainty that has been made smaller — and should be presented as such.
Sometimes the evidence is already there and direct, and the problem is when you measure it.
In one assessment, the survival benefit was stronger at the first planned analysis and smaller when more patients had been followed for longer. The first result did not disappear, but the later data changed the estimate of how large and durable the benefit was.
That is not a reason to commission another model.
It is a reason to plan early for the evidence that will exist when reimbursement decisions are actually being made — not only for the earliest statistical win.
And sometimes the right answer is not to force a comparison at all.
In the fourth assessment, some comparisons were performed but remained highly uncertain. Another was tested for feasibility and not performed because the patient populations could not be compared reliably.
That was the right distinction to make.
Running an analysis is not the same as closing an evidence gap.
If a comparison can genuinely reduce uncertainty, do it. If it cannot produce a credible answer, document why rather than generate another number that every payer downstream still has to interpret.
Four assessments. Different problems. Applying the same instruction — “close the gap” — to all of them is not an evidence strategy.
Before spending money on an evidence gap, I would ask five questions:
- What exactly is missing?
- Who does it affect — how many patients, which markets, which price?
- Can we close it credibly, or only reduce the uncertainty?
- If we did, would the reimbursement decision actually change?
- Is that change worth what it costs to prove?
Answer those questions with Clinical Development, Regulatory, Market Access and Commercial around the same table, and the choices become much clearer.
Close the gaps that matter and can genuinely be answered.
Mitigate the ones you cannot fully close but can meaningfully reduce.
Accept the ones where more analysis will not produce a credible answer or change the decision. Document them, plan around them, and stop spending.
This is increasingly bigger than Europe.
If you are a Chinese biotech planning to license an asset westward, European evidence gaps are exactly the kind of issue a partner will find during due diligence.
And as the US moves towards linking its drug prices more closely to prices in other wealthy countries, what happens to your price in Europe may increasingly matter elsewhere too.
The moment someone identifies an evidence gap, the reflex is often: run the model, add the study, generate more evidence.
The better question comes first:
Will answering this gap change the decision?
Some gaps decide whether Europe pays for your drug. Some can be narrowed but not removed. Some cannot credibly be closed at all.
The expensive programme is not the better programme. The better programme knows early which gaps are worth closing, which to manage, and which to accept.
Source: EFPIA / IQVIA Patients W.A.I.T. Indicator 2025, covering 168 medicines across 36 European countries. Availability varies substantially between countries.