Why this matters now ?
Authorities increasingly want exactly what digital measures are built to deliver: continuous, patient-relevant outcomes from wearables, sensors and apps. At the same time, the rules for how Europe assesses that evidence have changed. Since January 2025, every new cancer medicine and advanced therapy entering the EU is subject to a Joint Clinical Assessment (JCA): the EU now runs the clinical comparison once, centrally, for all member states. The remit widens from here - high-risk devices from 2026, orphan medicines from 2028, all remaining medicines from 2030.
Read those dates carefully. They are when JCA applies at launch, but the evidence is designed years earlier, in the trials running now. Every clinical programme beyond Phase 1 today is already affected. The time to build evidence that meets these expectations is now, not at submission.
Why is this urgent?
JCA does not lower the evidence bar - it shortens the time you have to meet it:
- One shot at Europe. A single EU-wide clinical assessment - no repositioning country by country.
- You don’t pick the comparator. The EU panel does - and asks roughly eight versions of the question per medicine, each a defined PICO (Population, Intervention, Comparator, Outcome), often against comparators your trial never studied.
- About 100 days. That is the window from receiving the PICO scope to filing the dossier. Gaps cannot be closed in 100 days.
- Consequences cascade. A weak EU report is read across reference-pricing markets - lower pricing, months later, in several markets at once.
You cannot retro-fit comparator data or patient-relevant outcomes you did not design in. The first JCA report, published in June 2026 on tovorafenib (Ojemda), already shows the pattern: a broad set of PICOs the developer could only partly answer, and an indirect comparison the assessors judged highly uncertain. Assessors reward evidence that is comparative, relevant to the populations in scope, and measured with instruments they trust.
Regulatory approval is not HTA acceptability
This is the distinction most programmes underestimate. A measure can be qualified by regulators and still fall short at the HTA table, because HTA bodies assess clinical meaningfulness and cost-effectiveness, not qualification alone. SV95C in Duchenne muscular dystrophy is EMA-qualified as a primary endpoint and FDA-accepted as a secondary one - yet it still needs HTA-specific evidence linking it to quality of life (QALYs, EQ-5D). The scope of a JCA is set through PICO, and digital measures bear most directly on the Outcome. A measure that is validated, fit-for-purpose and sensitive to change can supply a patient-relevant outcome that holds up across many PICOs, rather than one that answers a single national question. That is where evidence either survives joint assessment or falls apart.
What DEEP has already proven
This is not a someday-pilot. DEEP has already shown, with a regulator, that it can turn this kind of policy shift into executable practice. Our EMA proof of concept - convened with eight pharmaceutical companies, EFPIA and the EMA – is published in Scientific Reports (2026), validating the Stack model for regulatory review, evidence reuse and lifecycle management. The NICE work extends the same approach to the HTA and market-access side.
Stage 1 of that work is complete: months of scoping with NICE, culminating in a deep working session in April 2026 across worked SV95C (Duchenne) and sleep cases. It validated that mapping DEEP’s Stack model to HTA and PICO requirements is sound and aligned with NICE’s thinking. We intend to extend the same exercise to other HTA bodies. The foundation is endorsed; Stage 2 pressure-tests it with real cases. New members join now, at the high-value stage, where the planning risk is absorbed and the insights are ahead.
The mission, and how members benefit
The heart of it: members bring their own real cases and burning questions and pressure-test them against the model, working with DEEP to select a use case and see how the device-agnostic Target Solution Profile supports their chosen HTA framework and surfaces evidence gaps, and how the Stack model enables standardised, reusable evidence for both regulatory and HTA acceptance. It is a two-way exchange - members get answers that matter to their programmes; DEEP sharpens the model. Members also shape the case study, take part in the authority interactions directly, and get the learnings far earlier than the eventual publication.
HTA bodies are sovereign, and no one can promise acceptance. What a mission seat de-risks is your preparation - surfacing evidence gaps and designing patient-relevant, multi-market evidence before your 100-day assessment clock starts.
Bring your case to the table
If you have a lead EU-in-scope asset, the most concrete place to start is its likely PICOs: have they been simulated, and has the evidence been stress-tested against them?
Contact us if you are interested in finding out more about joining DEEP and other sponsors in taking the right steps towards successful HTA interactions.
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