Portfolio · Project 08 · EU HTA · October 2026
How a JCA PICO gets built
Since January 2025, every new cancer medicine seeking EU marketing authorisation also goes through a Joint Clinical Assessment. Before the company writes a word of its dossier, member states say what they need to see: which Patients, compared with which Comparators, on which Outcomes. Their requests are merged into a set of PICOs, and that set decides how much evidence the company must produce and how much of it can come from its own trial.
What each member state asks for
For each country, pick whether treatment differs by marker M status, then tick the comparators used there today. Targeted drug C is only used in marker M-positive disease, so it can only be asked for in that population.
The case: Drug Z in advanced Tumour X
Drug Z is a new oral medicine for adults with advanced Tumour X that has progressed after one prior therapy. Its pivotal trial, ZEN-1, randomised patients to Drug Z or Chemo A. About 40% of patients were marker M-positive; marker status was a stratification factor, but the trial was not powered for subgroups.
Two other published trials exist: B-301 (Immunotherapy B vs Chemo A, all patients, with marker M subgroups reported) and C-201 (Targeted drug C vs Chemo A, marker M-positive patients only). No trial includes best supportive care.
Every PICO is assessed on the same outcomes: overall survival, progression-free survival, health-related quality of life and serious adverse events.
What the requests add up to
The consolidated PICO set
Two clocks, one medicine
EMA days are active assessment days: list of questions at day 120, outstanding issues at day 180, opinion at day 210 (accelerated: 90, 120 and 150). The European Commission usually decides within 67 days of the opinion. The JCA deadlines come from Implementing Regulation (EU) 2024/1381; real procedures can differ, for example when an accelerated assessment reverts to the standard timetable.
Who is in scope, and when
New active substances in oncology, and all advanced therapy medicinal products.
Selected high-risk medical devices begin to be assessed.
Medicines designated for rare diseases join.
Every new medicine authorised through the EU centralised procedure.
What a JCA report does, and what it does not
It describes, it does not judge
The report sets out the relative effects of the new medicine against each PICO’s comparator and how certain those effects are. By law it contains no value judgement or conclusion on the medicine’s overall added clinical value.
Countries still decide
Member states must give the report due consideration in their own assessments, then draw their own conclusions and handle pricing, reimbursement and cost-effectiveness nationally. This is why each country’s comparator matters.
Gaps are reported, not filled
When there is no robust evidence for a PICO, the report says so. Comparators without a shared link to the trial often fall back on indirect comparisons, which Project 09 explains.
Sources
- Regulation (EU) 2021/2282 on health technology assessment. EUR-Lex
- Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 on joint clinical assessments of medicinal products. EUR-Lex
- Cencora. HTAQ Summer 2024: the first six implementing acts (scope finalised at latest 10 days after the CHMP list of questions; dossier within 100 days of the request, 60 days in accelerated procedures; report endorsed no later than 30 days after the Commission decision). cencora.com
- Baker McKenzie. The first implementing act of the EU HTA Regulation on joint clinical assessment, 29 May 2024. bakermckenzie.com
- Cuatrecasas. EU Regulation 2021/2282, applicable as of January 12, 2025 (phase-in dates; reports contain no value judgements). cuatrecasas.com
- EUnetHTA 21. D4.2 Practical guideline on the scoping process, 2023. eunethta.eu
- EFPIA. From guidance to implementation: EFPIA’s reflections on EU HTA scoping PICO exercises. efpia.eu
- European Medicines Agency. The evaluation of medicines, step by step. ema.europa.eu; EUPATI. Accelerated assessment. eupati.eu
- HTA Coordination Group. Methodological guideline for quantitative evidence synthesis: direct and indirect comparisons, adopted 8 March 2024. health.ec.europa.eu
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DisclaimerPersonal project, not sponsored by or affiliated with any employer (current or former) or any university I attended; views are my own. Developed with AI assistance, so errors or outdated details may exist. All medicines, trials, member state requests and dates in the simulation are hypothetical. The rules described reflect the cited sources as of October 2026. Not regulatory, legal or market access advice. Full disclaimer