Diverging Relative Clinical Benefit Assessment Across HAS and G-BA: A Forecast for EU HTA in Oncology Drugs

OBJECTIVES: This study examines the level of harmonisation in added clinical benefit assessments of oncology drugs between the French Haute Autorité de Santé (HAS) and the German Gemeinsamer Bundesausschuss (G-BA). In doing so, it aims to forecast challenges and opportunities for the upcoming EU joint clinical assessment (JCA) regulation.

METHODS: The G-BA website was screened to identify all G-BA added benefit assessments of oncology drug-indication pairs. A matching sample of HAS evaluations for oncology drug-indication pairs was identified. Data was extracted on the added benefit (G-BA), ASMR (HAS), clinical evidence considered, and clinical contextual factors (unmet need, disease severity and disease rarity). Interagency agreement was assed using Cohen-kappa scores. When outcomes diverged, clinical evidence in each submission was analysed to understand if discrepancies were due to differences in the evidence considered or in the interpretation of evidence.

RESULTS: Preliminary analysis on 107 matched outcomes revealed “poor” interagency agreement (k = 0.193) between HAS and G-BA on the added benefit, despite similar overall distributions of benefit ratings. Within the G-BA, 51% of outcomes were no-added benefit, 31% non-quantifiable or minor added benefit, and 18% considerable/major added benefit. Within HAS 50% of outcomes received were ASMR V, 28% ASMR IV, and 22% ASMR III or higher. Differences in nominated comparators, acceptance of indirect treatment comparisons, and interpretation of evidence contributed to divergences in benefit rating across the two agencies.

CONCLUSIONS: There is limited alignment across Germany and France in their assessment of relative clinical benefit for oncology products raising questions about how JCA will be operationalised at EU level. In the absence of clear and consistent best practices in relative clinical benefit assessment, the validity and level of acceptance of JCA outputs will be limited.