European Market Access Under JCA
Launching in Europe now means planning for JCA from the outset
What is JCA?
The EU Health Technology Assessment Regulation (HTAR), adopted in 2021, entered its first stage in January 2025, bringing oncology medicines and advanced therapy medicinal products (ATMPs) under its scope.
Timeline for implementation of JCA under the EU HTA regulation
New oncology medicinal products and ATMPs
Orphan medicinal products
All new medicinal products
dossier aligned with final assessment scope
meeting
by EMA
How JCA is changing the European HTA landscape
Central to JCA, is the Population, Intervention, Comparator, Outcome (PICO) framework which defines the assessment scope that manufacturers must address in their JCA submissions. Each EU Member State describes its national needs and standards of care through a PICO survey. These requirements are consolidated into a unified assessment scope intended to address the needs of each Member State. The final PICO scope defines the evidence package required for JCA.
The JCA PICOs must address the needs of all countries in scope (27 EU MS, Norway, Liechtenstein and Iceland)
Key JCA challenges
Heterogenous and diverse PICOs
Preparation risk assessment
Limited adaptation time
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