Why RAREready was created
EU Joint Clinical Assessment began in 2025. The first assessments — covering oncology and ATMP products – are still early, and the process itself continues to evolve. For rare disease programmes, mandatory scope does not begin until 2028. But the signals from those first assessments are already informative, and the organisations best placed when their programmes reach JCA will be those who have started preparing their internal thinking now.
What the early assessments have made clear is that JCA is not simply a more complex version of national HTA. It brings multiple Member States into a single, simultaneous evaluation – surfacing differences in how evidence, outcomes and patient insight are interpreted across borders in ways that internal review does not always anticipate. For rare disease programmes, where data is limited and clinical expectations can vary significantly, those differences are likely to surface early and require careful preparation.
They have also highlighted how genuinely complex it is to embed JCA thinking consistently across cross-functional, globally distributed asset teams – particularly when ownership of JCA is still being defined, when EU and global functions are still finding how best to connect around it, and when the boundary between JCA and HTA thinking is not always straightforward to hold in practice.
RAREready was created to support teams at exactly this stage – providing practical, upstream readiness that complements existing internal capability and external partnerships, and helps organisations prepare with confidence before timelines tighten.
What RAREready is
RAREready is an upstream readiness and alignment framework for rare disease and ATMP teams preparing for EU Joint Clinical Assessment.
It is not an HTA framework. It does not sit alongside dossier preparation or evidence strategy – it sits before those things, in the decisions and conversations that determine whether that later work is built on the right foundations.
RAREready focuses on three things:
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.
Organisational readiness Supporting teams to ensure 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.
Behavioural and structural alignment Drawing on expertise in behavioural science and rare disease patient insight to support the internal conditions that allow new ways of thinking to be applied consistently in practice – across teams, geographies and asset lifecycles.
How we work
We work with a small cross-functional group over a defined period, focused on live assets and real decisions.
Depending on what is most useful, this may involve structured working sessions with US and EU colleagues, a review of existing materials through a JCA lens, development of a concise decision tool for use at key milestones, or a broader asset-level playbook that teams can draw on as the programme evolves.
The approach is intentionally practical and lightweight. We work alongside established processes rather than adding to them – and we are clear throughout about what sits within our scope and what belongs with specialist HTA, HEOR and access partners.
Who delivers RAREready
RAREready is delivered by swii.ch health – a specialist rare disease consultancy with deep expertise across patient insight, behavioural science, digital innovation and evidence organisation.
That combination is deliberate. Preparing cross-functional, geographically distributed asset teams to act consistently on JCA requires more than content expertise. It requires understanding how decisions are made in practice, how to connect new thinking to existing workflows, and how patient insight can be structured to withstand joint assessment scrutiny.
We do not design PICOs, advise on dossier content, provide economic modelling, or replace HEOR, market access or regulatory partners.
Our work complements those relationships – sitting upstream of where specialist HTA and evidence partners operate, and focused on the organisational and interpretive groundwork that supports their work downstream.