On 18 May 2026, the Member State Coordination Group on Health Technology Assessment (HTACG) released significant updates to the Questions and Answers documents on Joint Clinical Assessments (JCAs). These updates reflect lessons from the first wave of JCAs (mainly oncology and ATMPs) and provide much-needed clarity as the system scales up in 2026, with expectations of ~50 JCAs for new medicines this year.
Most Meaningful Updates from the 18 May 2026 Q&As
- PICO Development and Handling Multiple PICOs
The updated guidance strengthens expectations around the scoping process. Sponsors are now expected to anticipate and prepare for multiple PICOs (Population, Intervention, Comparator, Outcome) early in development.
Insight: HTA bodies may request several comparators or subgroups. The Q&As emphasise the need for robust indirect treatment comparisons (ITCs) and network meta-analyses when head-to-head data is limited. This is particularly challenging for rare diseases and ATMPs. - Evidence Synthesis and Subgroup Analyses
Clearer rules on the acceptability of post-hoc and subgroup analyses. Sponsors must provide strong methodological justification for any deviations from the pre-specified analysis plan.
Insight: This raises the bar for statistical rigor. Poorly justified subgroups are likely to be down-weighted or excluded in the final JCA report. - Data Transparency and Publication of JCA Reports
A new dedicated FAQ clarifies what will be published, when, and how commercially confidential information (CCI) will be handled.
Insight: JCAs will be published shortly after the CHMP opinion. Sponsors must proactively identify and justify CCI redactions. Late or weak justifications risk unwanted disclosure, affecting future global filings and competitive positioning. - Interaction Between JCA and National HTA Processes
Confirmation that JCA reports are not legally binding but must be “taken into account” by Member States, with justification required for any divergence.
Insight: Countries with strong national HTA traditions (e.g., Germany, France) are still expected to build on the JCA rather than duplicate it.
Practical Recommendations for Small and Mid-Sized Biotechs
- Start Early with Joint Scientific Consultation (JSC): Engage via the HTA IT Platform as soon as your Phase 2/3 design is stable. Early JSC feedback on PICO and evidence requirements can significantly reduce later rework.
- Design Clinical Programs with JCA in Mind:
- Prioritise head-to-head trials where feasible.
- Build strong real-world evidence (RWE) and indirect comparison strategies from the outset.
- Plan for multiple subgroups and comparators in statistical analysis plans.
- Strengthen Cross-Functional Alignment: Regulatory, HEOR/Market Access, and Clinical teams must work together much earlier. Parallel development of the MAA dossier and JCA-ready evidence package is now essential.
- Prepare for Transparency: Conduct an early CCI assessment on your clinical data packages. Assume most information will eventually be public.
- Resource Planning: Allocate dedicated HEOR and statistical support for JCA dossier preparation. For SMEs, this often means bringing in specialist external support.
How Pharma Design Limited Can Support You
At Pharma Design Limited, we help small and mid-sized biotechs integrate regulatory strategy with HTA requirements from an early stage. Our services include:
- Preparation for Joint Scientific Consultations (JSC)
- Alignment of clinical development plans with anticipated PICO requirements
- Development of robust value propositions and economic models
- Parallel preparation of MAA and JCA-ready dossiers
These updates reinforce a clear trend: successful market access in Europe now requires integrated regulatory + HTA planning from Phase 2 onwards. Companies that treat JCA as an afterthought risk delays, additional evidence requests, or unfavourable national outcomes.