EU JCA Patient Playbook for a Mid-Size Biotech
A modular cross-functional reference for EU JCA readiness – built to prepare affiliate teams ahead of formal scope, and designed to be used at the point of need rather than filed away.
At a glance
A mid-size biotech, preparing its first specialty asset for EU launch, wanted to build organisational readiness for EU Joint Clinical Assessment ahead of formal scope — particularly for the small affiliate teams who would feel the pressure most when JCA arrived. We worked with the Market Access Director and a cross-functional task force to design a modular playbook, then helped roll it out across central and affiliate teams so it actually got picked up when it mattered.
The challenge
JCA began in 2025 for oncology and ATMP, with orphan medicines entering scope in 2028 and all centrally authorised medicines from 2030. The team had been watching the early oncology and ATMP assessments carefully. Their conclusion: JCA surfaces questions about patient input, evidence framing and scope earlier than national HTA has typically demanded — and answers are much harder to develop once formal timelines are running.
But the pressure won’t fall evenly. Affiliates sit at the end of the JCA chain — translating central thinking into national implementation under tight timelines, often as small teams with no specialist JCA expertise. The Market Access Director recognised that without upstream preparation, JCA would expose affiliates to expectations they had no realistic way to meet in time.
Three issues sat behind the decision to act early:
- Patient-related inputs were the least standardised part of their evidence work – and the early JCA assessments had elevated their importance
- Affiliates were beginning to ask central teams about JCA, but answers depended on individual judgement and informal iteration
- Past internal playbooks tend to launch well then sit unread – and small affiliate teams under pressure are the least likely to reach for one
What we did
We approach playbook design as behavioural design. The point is not to document a process; it is to shift what people do at the moments where decisions are actually made.
Three design choices made this a working tool rather than a reference artefact:
Designed for the decision moment. Each module followed the same internal shape – purpose, ownership, key actions, risks, and a short step-by-step guide of what to do first, next, and last. The repeated structure made it fast to navigate – particularly for non-specialist affiliate teams who needed clarity quickly, not a deep dive into JCA theory.
Ownership made explicit, not implied. Cross-functional decisions tend to drift when responsibility is shared. Every module named who owned each call, removing the ambiguity that usually lets things slip between Medical, Market Access and Commercial – and between central and affiliate teams.
Rolled out, not handed over. We ran working sessions with central and affiliate teams to walk the playbook through live assets, surface real questions, and embed it into existing workflows. Familiarity was built before the moment of need – so when affiliate teams later faced JCA pressure, the playbook would be something they had already used, not a document they had to remember existed.
What the playbook was designed to change
The playbook targeted specific behavioural shifts.
For affiliates: moving from open-ended clarification (“what should we do here?”) toward more specific, decision-quality engagement (“we’re considering X, does that fit?”) – enabling small teams to contribute at the appropriate depth despite limited JCA exposure.
For the central team: reducing reactive triage and the drift of patient-related decisions between Medical, Market Access and Commercial – freeing capacity for strategic input as readiness work scaled across assets.
Governance was kept deliberately simple. The core structure stays stable across assets, with updates incorporated as JCA guidance evolves – not as rework.