Presentation (CTI)

OBJECTIVES: The purpose of this study is to examine the relationship between HTA bodies and conditional marketing (CMA) or accelerated approved (AA) medications, if these drugs benefit from reimbursement decisions, and the way approval criteria were applied to HTA submissions.
METHODS: For this research we have selected the drugs that are approved via conditional marketing authorization or accelerated drug approval in EU and US irrespective of disease condition and from year 2016-2024. We captured the i) accelerated approved (AA) drugs and their indication pair in HTA websites ii) assessed their clinical, economical and humanistic outcomes to give HTA recommendations iii) Durational gap between AA and HTA approvals iv) Evidence and recommendation difference.
RESULTS: 72% of AA/CMA drugs (n=58/81) received HTA reimbursement, but with high variability in approval delays (median 8.2 months, range: 1-36 months). HTA recommendations varied significantly: 45% positive, 32% restricted, 23% negative—despite similar clinical/economic submissions. RWE utilization: Only 28% of HTAs incorporated RWE to support AA drugs, highlighting a gap discussed. Cancer drugs benefited from special funding schemes in 60% of EU5 countries, expediting access despite limited evidence.
CONCLUSIONS: Different procedures are probably the cause of the significant variation in the time it takes for a reimbursement decision to be made by nation. To fully understand how these delays affect patient outcomes and access to care, more study is required. Coverage, early market access, and HTA are not always guaranteed by expedited regulatory approval.