Presentation (CTI)

OBJECTIVES: In EU5 markets, national health technology assessment (HTA) processes delay patient access to novel cancer therapies relative to the United States. During this window, patients may receive less effective treatments or lose eligibility for the most novel, life-saving therapies. We quantify the survival benefit associated with faster access across three high-burden oncology indications, providing a modeled evidence base for policy discussions on the mortality consequences of HTA reimbursement delays.
METHODS: We developed patient-level microsimulations for multiple myeloma (MM), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC), each simulating 180,000 patients over 20-years. Disease progression and mortality were modelled in monthly cycles via parametric survival distributions calibrated to pivotal-trial medians and scaled by patient-specific hazard modifiers. Paired US and EU5-equivalent delay scenarios were run under common random numbers, isolating the incremental survival impact of timely drug access. Early-access switchers, are patients who accessed superior therapy under US timelines that would have been unavailable under EU5-equivalent delays.
RESULTS: Relative to the EU5 delay scenario, switchers survived an average of 20 additional months with MM, 8 months with NSCLC, and 4.4 months with CRC. Population-level impact was substantial: NSCLC alone preserves approximately 39,000 life-years annually. The access benefit was consistent, with survival gains across age, frailty, and functional status subgroups. In MM, the sickest patients benefited most - stage IV patients gained 27.7 months, reflecting the time-sensitive value of CAR-T and bispecific antibodies before T-cell fitness degrades. In CRC, dMMR/MSI-H patients gained 9.5 months; for this subgroup, an 8-month EU delay represents near-complete loss of the immunotherapy survival advantage.
CONCLUSIONS: US patients who accessed novel therapies ahead of EU5-equivalent timelines gained between 4.4 and 20 months of additional survival, on average. This margin compounds with every subsequent innovation a patient survives to receive.