Why RAREready was created
RAREready exists to do one specific thing: help rare disease and ATMP teams bring JCA thinking into the decisions being made on their programmes now – well before formal scope begins.
For rare disease, mandatory JCA scope opens in 2028. But the decisions that will most shape how a programme is eventually assessed – comparator selection, endpoint hierarchy, population definition, patient evidence framing – are being made today, in protocol meetings and global development conversations.
Teams know JCA is coming. Many have access to the methodology, the guidance, sometimes an internal task force already in place. What’s harder is the application – making sure JCA thinking is visible, owned and consistently applied in the decisions being shaped now, when there is still room to move.
What RAREready does
RAREready is an upstream readiness and alignment framework for rare disease and ATMP teams preparing for EU Joint Clinical Assessment. It sits earlier than HTA and methodology work — in the decisions and conversations that determine whether that later work is built on the right foundations.
It focuses on three things:
Behavioural and structural alignment. Drawing on expertise in behavioural science, organisational design and rare disease patient insight, we create the internal conditions that allow JCA thinking to be applied consistently in practice – across functions, geographies and asset lifecycles. This is where the gap between knowing JCA and acting on JCA actually closes.
Organisational readiness. Making sure JCA thinking is visible, clearly owned and consistently considered at asset level – across functions and between global and EU teams – at the moments when decisions are actually being shaped. Without clear ownership at asset level, JCA thinking has nowhere to live between decision points.
Interpretation clarity. Helping teams understand how their existing evidence, outcomes and patient insight may be viewed once a joint, multi-country assessment lens is applied – and where it may be worth building further clarity before assessment timelines begin.
Who delivers RAREready
RAREready is led by Rob Wyer and delivered through swii.ch health – a specialist rare disease consultancy with expertise across patient insight, behavioural science, digital innovation and evidence organisation.
For specialist input on market access and HEOR, we draw on a curated network of senior collaborators brought in per engagement. This keeps the work senior and focused, without layering in capability that isn’t needed for the question in front of us.
Our work complements existing HEOR, regulatory and market access relationships – sitting upstream of where specialist partners operate, and focused on the organisational and interpretive groundwork that supports their work downstream.