Abstract

ABSTRACT New diagnostics and therapies have been made available to breast cancer patients in the last ten years, however they came with an important economic impact on the NHS. Study objective was to assess the long-term cost-effectiveness of using the 21-gene breast cancer assay (Oncotype DX) in the French clinical practice from the perspective of the NHS. A Markov model was developed to evaluate the long-term costs and clinical outcomes associated with the introduction of Oncotype DX to inform decisions on adjuvant chemotherapy for patients with ER + , node negative early-stage breast cancer in France. The model projected life expectancy, and costs, based on recurrence rates for low, intermediate and high-risk patients (NSABP 20 study) as well as French mortality data. Annual cycles were modeled across three health states: recurrence-free (in which all patients start the simulation), recurrence (following a distant recurrence event) and dead (following a mortality event). In the absence of French specific decision impact data, the model compared the assignment of adjuvant chemotherapy based on the conventional approach or based on the Oncotype DX Recurrence Score using data from a meta-analysis of nine decision impact studies. Costs associated with chemotherapy were collected through a retrospective study at Tenon hospital. Costs associated with long term recurrence were collected from the literature. According to French pharmaco-economic guidelines, costs and outcomes were discounted at 5% per annum. One-way sensitivity analyses were conducted to test the robustness of key parameters. When compared to the current clinical practice, using Oncotype DX is expected to decrease chemotherapy cost (- 630 euros per patient) through patients who are spared unnecessary chemotherapy, and to increase outcomes (0.13 life years gained per patient) through patients reclassified towards chemotherapy following the availability of the Recurrence Score. Oncotype DX is therefore expected to be cost-saving in the French clinical practice. Details of one-way sensitivity analyses will be presented in details. Disclosure R. Rouzier: Consultant Roche, GSK, Genomic Health, Sanofi. E. Chereau: Consultant: Roche, travel expense: Genomic Health. J. Gligorov: Consultant Roche, Genomic Health, Sanofi Pasteur. All other authors have declared no conflicts of interest.

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