The European journal of health economics : HEPAC : health economics in prevention and care · 2026
Budget impact analysis of Oncotype DX® multigenic prognostic test in patients with early breast cancer in Italy.
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Ciani Oriana, Federici Carlo, Generali Daniele, Zambelli Alberto
Аннотация
OBJECTIVE: This study investigates the mid-term budget impact of using the Oncotype DX® multigene prognostic test (MPT) in estrogen receptor (ER)+/ human epidermal growth factor receptor 2 (HER2)- early breast cancer (EBC) patients with 0 to 3 positive lymph nodes, following its recent reimbursement approval in Italy.
METHODS: A budget impact analysis was conducted from the perspective of the Italian National Health Service (SSN) over a 5-year time horizon. The analysis compared a strategy using MPT to inform chemotherapy (CT) decisions versus standard clinical practice. A hybrid decision-tree and cohort state-transition model was employed, utilizing data primarily from the Italian BONDx study. Sensitivity analyses, including probabilistic and univariate analyses, were performed to assess the robustness of the results and to determine the test price required to offset the budget impact over a five-year time horizon.
RESULTS: In the base-case scenario where all ER+/HER2- EBC patients receive the test, MPT use led to a 40.2% reduction in CT prescription. However, the overall budget impact was positive, with an additional cost of €106.1 million (95%CrI 98.5 to 113.6) over five years (approximately €21 million per year), mainly due to the acquisition costs of the MPTs. The maximum cost of the test to have a null budget impact in this scenario was estimated at €560. A scenario where MPTs were only applied to patients with a pre-test CT recommendation based on clinical-pathological criteria showed instead potential annual savings of €5.6 million (-€28.1 million in total, 95%CrI - 36.5 to -19.7).
CONCLUSION: Implementing MPTs in ER+/HER2- EBC management in Italy significantly affects CT prescription rates and healthcare expenditures. While MPTs reduce unnecessary CT and related adverse events, their high upfront cost necessitates strategic policy measures to ensure cost-effective implementation. Targeted MPT strategies, focusing on patients with a pre-test chemotherapy recommendation, demonstrate greater efficiency and potential savings for the Italian NHS.
METHODS: A budget impact analysis was conducted from the perspective of the Italian National Health Service (SSN) over a 5-year time horizon. The analysis compared a strategy using MPT to inform chemotherapy (CT) decisions versus standard clinical practice. A hybrid decision-tree and cohort state-transition model was employed, utilizing data primarily from the Italian BONDx study. Sensitivity analyses, including probabilistic and univariate analyses, were performed to assess the robustness of the results and to determine the test price required to offset the budget impact over a five-year time horizon.
RESULTS: In the base-case scenario where all ER+/HER2- EBC patients receive the test, MPT use led to a 40.2% reduction in CT prescription. However, the overall budget impact was positive, with an additional cost of €106.1 million (95%CrI 98.5 to 113.6) over five years (approximately €21 million per year), mainly due to the acquisition costs of the MPTs. The maximum cost of the test to have a null budget impact in this scenario was estimated at €560. A scenario where MPTs were only applied to patients with a pre-test CT recommendation based on clinical-pathological criteria showed instead potential annual savings of €5.6 million (-€28.1 million in total, 95%CrI - 36.5 to -19.7).
CONCLUSION: Implementing MPTs in ER+/HER2- EBC management in Italy significantly affects CT prescription rates and healthcare expenditures. While MPTs reduce unnecessary CT and related adverse events, their high upfront cost necessitates strategic policy measures to ensure cost-effective implementation. Targeted MPT strategies, focusing on patients with a pre-test chemotherapy recommendation, demonstrate greater efficiency and potential savings for the Italian NHS.