As EU HTA evolves under the Joint Clinical Assessment (JCA), the expectations for structured, regulator-ready patient engagement are rising. Yet too many sponsors are working off outdated assumptions.
This post unpacks five common myths, and shows how early access can give you a strategic edge.
“Patient engagement is just a box to tick”
Not anymore. Under the EU HTA Regulation, patient engagement is both a source of evidence and a point of scrutiny.
HTA bodies want to see how patient input is used to shape your development—not just presented as an afterthought.
“Early Access is just about access”
It’s more than that. Early access programmes offer a valuable opportunity to generate real-world patient insights.
In rare diseases especially, this data is critical when trial populations are small.
“We’ll collect patient input later”
That’s too late. The JCA runs in parallel with EMA review—so you need structured insight ready early.
Waiting risks missing your chance to align evidence with regulatory timelines.
“Anecdotes are enough”
They’re not. Stories alone won’t satisfy HTA reviewers.
They expect traceable, methodologically sound patient data that integrates with your clinical and RWE package.
“We’ve got time to align affiliates”
Unfortunately, you don’t. Without early coordination, valuable local insights risk being left out of your JCA submission.
Start alignment early—with a clear playbook.
Turn early access into early advantage.
At swii.ch, we help sponsors go beyond box-ticking and build patient insight into the heart of their evidence strategy.
Contact us to learn how we can help.
#JCA #HTA #RareDisease #EarlyAccess #PatientEngagement #RWE