One European clinical assessment, twenty-seven national decisions — plan for both
The EU HTA Regulation has moved the clinical assessment of new medicines to a single Joint Clinical Assessment (JCA) — starting with oncology and advanced therapies and expanding to all new active substances. The evidence question is now set centrally through PICOs, but pricing and reimbursement still happen nationally. We help teams anticipate the PICOs, build one dossier that survives many comparators, and land the national adaptations that follow.
Strategic advisory
Before any deliverable is scoped, our consultants work with your leadership to answer the questions that determine whether the evidence will change a decision.
- JCA readiness diagnostics: timeline mapping against EMA submission, evidence-gap analysis and governance set-up
- PICO anticipation — modelling the populations, comparators and outcomes member states are likely to request, and what each implies for your evidence
- Joint Scientific Consultation (JSC) strategy and preparation with the HTA Coordination Group
- National adaptation strategy: how the JCA report will play into AMNOG (G-BA/IQWiG), HAS, AIFA, Spanish and Nordic appraisals — and NICE outside the EU
Evidence generation capabilities
JCA Dossier Development
Full clinical dossier authoring to the HTA Coordination Group template, including multiple-PICO evidence presentation.
Indirect Treatment Comparisons for Multiple PICOs
Feasibility assessment, NMAs, MAICs and STCs to address every requested comparator with defensible methods.
Systematic Literature Reviews
SLRs designed for JCA scope — broad enough for anticipated PICOs, rigorous enough for assessor scrutiny.
National HTA Adaptations
Country-specific value dossiers and economic models building on the JCA report for Germany, France, Italy, Spain and beyond.
JSC & Early Dialogue Support
Briefing books, question strategy and evidence-plan documentation for joint scientific consultations.
EU HTA Policy Monitoring
Tracking of HTAR implementing acts, HTACG guidance and member-state uptake with implications briefs.
AI-assisted strategic analysis
Not every project needs it. For the engagements below, our consultants draw on in-house AI tools to analyse faster and more consistently — and you receive the insight as a strategic report with recommendations.
JCA readiness assessment
For assets entering JCA scope, we benchmark the evidence package against anticipated PICOs and assessor expectations — using in-house AI tools to structure the gap analysis and prioritise what to generate first.
PICO anticipation modelling
For scoping preparation, we model the populations, comparators and outcomes each member state is likely to request — drawing on national HTA precedents and guideline landscapes — and translate the likely PICO set into ITC feasibility and evidence-generation implications.
Questions clients ask about EU HTA & Joint Clinical Assessment
JCA preparation draws heavily on our HEOR & Global Market Access Strategy, Advanced Analytics and Scientific Communications capabilities.
Which products are in scope of the EU Joint Clinical Assessment?+
Oncology medicines and advanced therapy medicinal products since January 2025, orphan medicines from 2028 and all new active substances from 2030, plus selected high-risk medical devices.
What is a PICO in the JCA context?+
The Population, Intervention, Comparator and Outcomes each member state requests for the assessment. A single JCA can involve many PICOs, so the evidence package must anticipate multiple comparators.
Does the JCA replace national HTA?+
No — it centralises the clinical assessment, but pricing and reimbursement decisions remain national. The JCA report must be adapted for AMNOG, HAS, AIFA, Spanish and Nordic appraisals.
How early should JCA preparation start?+
At least 18–24 months before EMA submission, to allow PICO anticipation, evidence-gap closure and joint scientific consultation where available.
Scope a EU HTA & Joint Clinical Assessment engagement
Share your objectives, timelines and target markets. We respond within one business day with next steps.