Tested against three published EU JCA reports, the platform anticipated 10 of 11 JCA comparators and every core outcome in under an hour per product, starting from only the population and intervention
VIENNA, Nov. 9, 2026 /PRNewswire-PRWeb/ -- MadeAi today launched MadeAi-JCA, the first AI-enabled platform built for the European Union's Joint Clinical Assessment (JCA), at ISPOR Europe 2026. MadeAi-JCA anticipates the JCA scope, comparators, outcomes, and PICO sets that all 27 EU member states will request, before the official scope is issued. Every output is linked to its source.
The launch is backed by a validation study against three published EU JCA reports. Given only each product's population and intervention, the platform captured 10 of 11 JCA-defined comparators (91%). It also identified every core outcome and correctly structured the PICO sets for all three products, in under one hour per product.
27 countries, 100 days, one shot
Under the EU HTA Regulation, new oncology medicines and advanced therapy medicinal products have required a Joint Clinical Assessment since January 2025, with orphan medicines following in 2028. Each assessment consolidates the population, intervention, comparator, and outcome (PICO) requirements of 27 member states into a single scope.
Once that scope is set, manufacturers have roughly 100 days to deliver a dossier, and there is no second attempt. Anticipating the scope today means cross-referencing HTA reports, clinical guidelines and drug registries across 27 member states by hand. That typically takes five weeks or more of specialist HEOR effort per product. MadeAi-JCA does this work in a single automated run. Teams get a reviewer-ready anticipated scope in under an hour, over 200 times faster than manual work, so evidence generation and dossier planning can start weeks sooner.
Validated against three published EU JCA reports
MadeAi used three published EU JCA assessments, all publicly available, as ground truth:
- Tovorafenib (Ojemda) in BRAF-altered paediatric low-grade glioma
- Lurbinectedin (Zepzelca) as first-line maintenance in extensive-stage small cell lung cancer
- Tarlatamab (Imdylltra) in extensive-stage small cell lung cancer after platinum-based chemotherapy
The platform received only the population and intervention. That is the information a manufacturer has before the official scope is issued, with no prior HTA data and no trial results. Outputs were judged on whether they were complete enough for dossier preparation. The results:
- 91% comparator accuracy: 10 of 11 unique JCA comparators captured across the three products
- 100% core outcome coverage: overall survival, progression-free survival, objective response rate, safety and health-related quality of life identified for every product
- 100% PICO set structure: correctly captured, including complex cases with several sub-populations
- 100% source traceability: every comparator, outcome and PICO set linked to its source document, with rationale
Under one hour per product, over 200 times faster than manual cross-referencing across 27 member states
The anticipated PICO set for lurbinectedin matched the published JCA scope exactly. For tovorafenib, the platform correctly structured eight PICOs across three BRAF sub-populations. For tarlatamab, it structured seven PICOs across four sub-populations, separating platinum-sensitive and platinum-resistant patients.
The one comparator not surfaced, everolimus for tovorafenib, applies only to a tumor type outside the BRAF-altered indication. The platform also flagged mechanism-specific safety outcomes, such as cytokine release syndrome and neurotoxicity (ICANS) for tarlatamab, a bispecific T-cell engager.
Built for transparent, accountable AI in HTA
The study follows the HTA Coordination Group's AI principles published in July 2026. MadeAi-JCA gives expert teams a structured starting point. They review, finalize and own every scope decision before it enters the dossier. Each output carries its source and rationale, giving teams a full audit trail, and the study itself provides the performance evidence needed to disclose AI-assisted scoping in a dossier.
"Almost all of the conversation about JCA is about process. We looked hard for a platform built for this problem, found none, and built one," said Gaugarin Oliver, Chief Executive Officer at MadeAi. "Getting the scope right early is what makes 100 days workable. Our validation shows that from just the population and intervention, MadeAi-JCA can anticipate the comparators and every core outcome in under an hour, with a source behind every answer."
See MadeAi-JCA at ISPOR Europe 2026
MadeAi will demonstrate MadeAi-JCA at ISPOR Europe 2026 in Vienna, Austria, starting November 9, at Booth #1022. To book a demo, visit us at www.madeai.com or contact info@madeai.com.
About MadeAi
MadeAi builds AI-enabled technology for health technology assessment and market access. MadeAi-JCA, is the first AI-enabled platform for EU Joint Clinical Assessment. It covers the work from anticipated PICO scoping through systematic literature review, data extraction, and evidence synthesis in one platform. The MadeAi platform supports commercial life sciences teams across a range of evidence synthesis needs by leveraging AI to streamline onerous workflows, dense research analysis, and rigorous report generation in a transparent, accurate, traceable, repeatable, and compliant manner. Learn more at www.madeai.com and follow MadeAi on LinkedIn.
Media Contact
Meghan Oates-Zalesky, MadeAi, 1 617-435-2470, Meghan.oates@madeai.com, http://www.madeai.com
SOURCE MadeAi
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