JCA-Ready Evidence Package.

Why this exists

From 12 January 2025, patient input is a mandatory input into the EU Joint Clinical Assessment. Not a nice-to-have. Sponsors who cannot produce it inside the 100-day dossier window lose scope-defining PICOs.

A single product entering JCA can face up to 67 PICOs across 16 sub-populations. All of them must be addressed. Producing that file from scratch, especially the patient-input dimension, is what makes the 100-day window impossible for most sponsors.

The Equity Engine solves this by starting from a pre-existing UK panel that is already SDoH-profiled at sign-up. We do not recruit for you. We use the panel that is already there.

What is included

• Up to 67 PICO patient-input datasets, formatted to the EUnetHTA 21 template
• One full subgroup analysis across the eight social factors (age, ethnicity, first language, income, geography, disability, caring responsibilities, health literacy)
• Dual formatting: NICE reference case and G-BA reappraisal template
• Lived-experience narrative artefacts for the sub-populations that most affect PICO scoring
• Written justification file that maps every subgroup claim to primary evidence
• One HTA-body review response cycle included
• Assigned lead analyst plus a project sponsor from the Unwritten Health leadership team

What is not included

• Translation into non-UK/EU regulatory formats, those are scoped separately under our SaMD or PMCF engagements
• Bespoke primary-market recruitment. This package uses the pre-existing UK panel
• Full HTA-body defence beyond one response cycle, scoped separately

How it works

Weeks 1 to 3. Kickoff, PICO landscape, exposure mapping. We work with your HTA team to identify the 12 to 67 PICOs that carry the most weight.

Weeks 4 to 12. Panel deployment, data capture, subgroup analysis. Longitudinal surveys, focus groups and patient council queries run in parallel, drawing on the community-partner sampling frame.

Weeks 13 to 18. File assembly, dual-formatting, internal QC, review response cycle. Handover to your HTA team ahead of the dossier submission.

Why it is worth doing at all

The Tufts Center for the Study of Drug Development estimates that every day of HTA and market-access delay after regulatory approval costs a pharma sponsor around $800,000 in unrealised prescription-drug sales, roughly $24 million per month, $144 million for a six-month delay. Sponsors typically budget this against roughly 12 days of post-approval market-access delay exposure. Fix earlier, at fixed scope, versus fix later, at variable and much larger cost.