Cost-effectiveness analysis of Oncotype DX from a Brazilian private medicine perspective: A GBECAM multicenter retrospective study.
Authors: Oliveira Leandro Carvalho , Megid Thais Baccili Cury , Rosa Daniela Dornelles , Magliano Carlos Alberto da Silva , Suzuki Daniele Assad , Argolo Daniel F. , Sanches Solange Moraes , Testa Laura , Bines Jose , Kaliks Rafael Alioska , Caleffi Maira , Gagliato Debora De Melo , Sahade Marina , Barroso-Sousa Romualdo , Correa Tatiana Strava , Shimada Andrea , Katz Artur , Mano Max S. 
Published: June 2022

e18822

Background: Oncotype DX (ODX) is a validated tool for the prediction of risk of recurrence and benefit of chemotherapy (CH) in both node negative (N0) and positive (N1), hormone receptor positive (HR+), HER2 negative (HER2-) early breast cancer (eBC). Due to limited access to novel genomic assays in Brazil, treatment decisions remain largely driven by traditional clinicopathologic risk factors. ODX has been reported to be cost-effective, but limited data is available considering the reality of middle-income countries such as Brazil. We aim to evaluate the cost-effectiveness of ODX across strata of clinical risk groups using data from a large dataset of patients from various Brazilian institutions. Methods: Clinicopathologic and ODX information were analyzed for patients with T1-T3, N0-N1, HR+/HER2- eBC who had an ODX performed between 2005 and 2020. Projections of CH indication by clinicopathologic criteria were based on binary clinical risk categorization based on the Adjuvant! algorithm, as used in the MINDACT study. The ODX score was correlated with the indication of CH according to TAILORx and RxPONDER data. Two decision-tree models were developed. In the first model, low and high clinical risk patients were included the model. In the second model, only high clinical risk patients were included. The cost for ODX and CH (U$2,846 and U$14,464, respectively) were based on the Brazilian private medicine perspective. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Results: Six hundred and forty-five patients were analyzed. 411 patients (63.7%) had low clinical risk and 234 patients (36.3%) had high clinical risk disease. The ODX indicated low (< 11), intermediate (11-25) and high (> 25) risk in 119 (18.4%), 415 (64.3%) and 111 (17.2%) patients, respectively. Among 645 patients analyzed in the first model, 234 (36.2%) had clinical and 198 (30.6%) had genomic indication for CH, respectively. In this model, ODX was modestly effective (5.6% reduction in CH indication) though with an incremental cost of US$ 2,040 per patient. Among 234 patients analyzed in the second model (high clinical risk only), 99 (42.3%) patients had genomic indication of CH. In this model, ODX led to a 57.7% reduction in CH indication and reduced costs by US$5,491 per patient (table). The results remained robust in the 1,000 probabilistic simulations. Conclusions: Our study suggests that ODX is cost-saving for patients with high clinical risk HR+/HER2- eBC in the perspective of the Brazilian private health system. Its incorporation into routine practice should be strongly considered by health care providers.[Table: see text]