Presentation (CTI)

OBJECTIVES: The European Union Joint Clinical Assessment (JCA), implemented in January 2025, requires a single assessment scope that incorporates comparator requirements across member states. This study evaluated comparator alignment between manufacturers and national HTA bodies, its association with HTA outcomes, and cross-country variability in preferred comparators.
METHODS: Using our proprietary AI-enabled analytics platform (OMNIA), we analyzed publicly available HTA assessments for innovative therapies in France (FR), Germany (DE), Italy (IT), and Spain (ES) (2020-2024). We assessed whether manufacturers' comparators matched HTA-preferred comparators, examined associations with HTA outcomes, and quantified the number of distinct preferred comparators across countries for each indication.
RESULTS: Of 2,326 reports (FR 1,042; DE 619; IT 222; ES 443), the manufacturer's comparator aligned with the body's preference in 64.9%, 95.5%, 68.0% and 56.9% in FR, DE, IT, ES respectively; Germany's near-universal alignment reflects G-BA's binding prospective comparator. Alignment predicted the outcome: the positive rate when aligned versus divergent was 49.0% vs 21.2% (FR), 57.8% vs 42.1% (DE), 68.2% vs 39.2% (IT), and 85.9% vs 67.1% (ES). Across 345 molecule-indications assessed in two or more countries, the pooled preferred-comparator set had a median of 6, rising to 9 in oncology.
CONCLUSIONS: Comparator heterogeneity remains a key challenge under EU JCA. These findings suggest that comparator strategy should be treated as a drug development decision, not solely an HTA consideration, to ensure evidence generation aligns with evolving European assessment and access requirements.