The challenge isn’t awareness. It’s making JCA thinking usable in real decisions.
In April 2026, the first endorsed EU Joint Clinical Assessment was issued – on an orphan-designated paediatric oncology product – is published on the Europa portal. The rules are being written now, on assets that look like the ones rare disease teams are preparing for 2028. The scope expansion to orphan medicinal products in January 2028 fixes when external scrutiny formally opens. It does not fix when the upstream conversation needs to happen.
Most rare disease teams already understand JCA is coming. The harder task is applying that knowledge to live programme decisions: which assumptions are still open, which are already locked, and whether the reasoning behind them can be explained consistently across functions and markets.
This guide is written for the people who feel that responsibility already – particularly access leads – and are looking for a practical way to start.
20–25 minute read · Free · No subscription required
Updated May 2026
Three questions worth sitting with
- Where do the comparator, endpoint and population decisions in your programme currently live – in shared understanding, or mainly with the teams who made them?
- If those decisions were discussed across Development, Medical, Access and affiliates today, would they be described in the same way, or would some differences begin to emerge?
- At this stage of the programme, is there a clear moment where these perspectives are brought together and worked through, or is alignment expected to form over time?
If these questions land, the guide is written for you.
What you’ll find inside
Six sections, written for people who already understand JCA and are looking for practical ways to anchor it inside live programme decisions:
- What JCA actually changes – and what it doesn’t
- The three decisions worth examining now: comparator, endpoint hierarchy, population definition
- The access lead’s distinctive positionThe window before reasoning becomes fixed
- What first-wave JCA experience is already showingWhat the upstream conversation actually does
Including a practical framework of five upstream stages – from choices taking shape through to assessment begins – and what work remains possible inside each.
With contributions from
Sara Aswegan – Rare Disease Executive, Advisor, Board Member – Foreword
Dr Caroline Tolley, PhD – Medical Affairs Leader, Rare Disease Field perspective – What JCA looks like from the field
Note: The guide is not an HTA methodology review, a dossier gap analysis or a substitute for your HEOR shop or submission partner. This is upstream work and it is most valuable before any of those things have engaged.
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Frequently asked questions
Who is this guide for? It’s written for access leads and programme leads in rare disease and ATMP teams preparing for EU Joint Clinical Assessment. The substance is most directly useful to people who already understand JCA is coming and are looking for practical ways to anchor that thinking inside live programme decisions. Medical, HEOR, Development and affiliate colleagues working on the same assets will also find it relevant.
What does it cover? Six sections across what JCA actually changes, the three decisions worth examining now (comparator, endpoint hierarchy, population definition), the access lead’s distinctive position, the window before reasoning becomes fixed, what first-wave JCA experience is already showing, and what the upstream conversation actually does. Around 20–25 minutes of reading.
Who wrote it? Rob Wyer, Managing Partner of RAREready and swii.ch health, with a foreword by Sara Aswegan (rare disease executive, advisor, board member) and a field perspective from Dr Caroline Tolley, PhD (medical affairs leader, rare disease).
Will I be added to an email sequence? No. You’ll receive the guide directly. We don’t enrol you in an automated follow-up sequence. If you want to talk, you can book a readiness conversation at any point – but the decision sits with you.