Presentation (CTI)

OBJECTIVES: Under Germany’s AMNOG framework, demonstrating additional benefit versus an appropriate comparator is critical for pricing and reimbursement. EU Joint Clinical Assessment (JCA) in 2025 aims to harmonize evaluations of relative clinical effectiveness across member states. This study evaluates whether recent G‑BA decisions would have differed under a JCA framework and assesses whether such outcomes reflect unavoidable evidence limitations or preventable gaps in evidence planning.
METHODS: A structured review of publicly available G‑BA resolutions (Beschlüsse) and rationales was conducted (January 2024-June 2026). Cases with conclusions of “additional benefit not proven” were included. Each case was assessed against key evidentiary criteria, including comparator alignment, comparative evidence, and population relevance. Identified gaps were mapped against JCA methodological expectations, including multi-PICO scoping and requirements for comparative analyses.
RESULTS: Seven G‑BA assessments were identified (oncology: 28.6%; non-oncology: 71.4%), all concluding no additional benefit. Key drivers included: (1) comparator misalignment (57.1%; e.g., placebo/BSC vs active comparator), (2) reliance on non-comparative designs (42.9%; e.g., single-arm studies), (3) weak or absent indirect comparisons (42.9%), and (4) population misalignment (14.3%; e.g., mismatch with indicated/HTA-relevant populations). Most submissions (85.7%) had multiple issues (mean: 2-3), indicating systemic rather than isolated gaps. These deficiencies align with JCA evidentiary expectations; however, presence of multiple concurrent limitations suggests that, even where certain elements may be acceptable under JCA, overall evidence base may still lead to uncertain conclusions and may not fully align with G‑BA requirements.
CONCLUSIONS: JCA is unlikely to substantially reduce “additional benefit not proven” outcomes in Germany, as many gaps reflect upstream evidence generation and design limitations. Findings highlight a disconnect between HTA expectations and manufacturer evidence strategies. Without improved evidence planning, similar challenges may persist across both JCA and national level. Manufacturers should adopt proactive evidence strategies—head‑to‑head feasibility, early NMA/ITC, and multi‑stakeholder validation—to improve outcomes across JCA, G‑BA, and pricing.