Presentation (CTI)

OBJECTIVES: Precision medicine has revolutionised oncology by tailoring treatment based on patients’ genomics. Companion diagnostics (CDx), defined as in vitro diagnostics developed alongside targeted therapies, identify patients most likely to benefit and support personalised strategies. This study examines the impact of CDx on health technology assessment (HTA) and reimbursement outcomes for breast cancer and non-small cell lung cancer (NSCLC) therapies (excluding generics) approved by the EMA between 2019 and 2024.
METHODS: We analysed HTA appraisals and reimbursement decisions in Germany, France, Italy and Spain for 30 approved indications across 19 drugs.
RESULTS: The majority of indications (83%) required a CDx, as specified in the EMA label. However, HTA decisions for CDx-associated indications varied significantly between countries. In NSCLC, French HTA resulted in mixed reimbursement outcomes for CDx-associated indications, with the sole non-CDx indication receiving a higher ASMR rating than the CDx-linked indications. In Germany, all NSCLC indications, including the non-CDx indications, were assessed with a no added benefit rating or had decisions still pending. Italy approved only CDx-linked indications, whereas Spain issued mainly positive recommendations for all NSCLC indications. For breast cancer, France showed similar reimbursement outcomes for both CDx and non-CDx indications. Germany favoured non-CDx indications, while Italy’s decisions were largely consistent regardless of CDx status. Spain recommended most breast cancer drugs positively.
CONCLUSIONS: In conclusion, reimbursement patterns for CDx-linked therapies varied across countries within this limited sample. This variability, combined with national regulations on CDx reimbursement, complicates decision-making. Consequently, reimbursement for CDx-requiring therapies remains unpredictable and is likely to be influenced by evolving European and country-specific precision medicine policies.