Presentation (CTI)

OBJECTIVES: Health technology assessment (HTA) submissions for oncology medicines increasingly rely on early or interim clinical evidence, resulting in immature overall survival (OS) data at time of assessment. This raises questions about the impact of immature OS data on reimbursement outcomes. The current analysis examines recent HTA decisions in France and Germany to assess whether OS maturity influences these outcomes and how survival uncertainty is managed.
METHODS: Oncology HTAs published by the German Federal Joint Committee (G-BA) in 2025 were identified from the G-BA website. Corresponding French assessments were retrieved from the Haute Autorité de Santé (HAS) website noting indication, comparator, endpoints, data maturity, and HTA outcomes.
RESULTS: Among G-BA assessments, 9 of 21 (43%) included mature OS data with all receiving a considerable (33%) or minor (66%) added benefit rating. Among assessments with immature OS data (12/21; 57%), outcomes included major (8%), considerable (42%), minor (25%), and not proven or non-quantifiable (25%). 52% of all assessments published in 2025 received a not proven rating, largely due to inappropriate comparator selection or reliance on single-arm studies. For corresponding HAS assessments, 9 of 30 (30%) included mature OS data of which 7 (78%) were reimbursed. Two assessments (29%) achieved a moderate rating (ASMR III), while most (71%) achieved a minor (IV) or no improvement (V) rating. Among assessments with immature OS data, 20/21 (95%) were reimbursed. Six (30%) achieved ASMR III while the remainder (70%) achieved ASMR IV or V.
CONCLUSIONS: Overall, these data show that immature OS data do not necessarily lead to negative HTA outcomes in Germany or France, demonstrating that OS immaturity alone does not preclude recognition of clinical benefit when supported by other robust evidence. Together, the results highlight the importance of the overall strength of the clinical evidence package in HTA decision-making.