Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system

Abstract Introduction The 21-gene platform Oncotype DX helps clinicians identify women with early- stage estrogen receptor (ER)-positive breast cancer who will not benefit from adjuvant chemotherapy. However, it is too expensive to be implemented by the Brazilian public health system (SUS). Therefor...

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Main Authors: Daniel de Iracema Gomes Cubero, Fernando Luiz Affonso Fonseca, Beatriz da Costa Aguiar Alves Reis, Luiz Vinicius de Alcantara Sousa, Jean Henri Maselli-Schoueri, Auro da Giglio
Format: Article
Language:English
Published: BMC 2025-08-01
Series:BMC Health Services Research
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Online Access:https://doi.org/10.1186/s12913-025-13230-6
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author Daniel de Iracema Gomes Cubero
Fernando Luiz Affonso Fonseca
Beatriz da Costa Aguiar Alves Reis
Luiz Vinicius de Alcantara Sousa
Jean Henri Maselli-Schoueri
Auro da Giglio
author_facet Daniel de Iracema Gomes Cubero
Fernando Luiz Affonso Fonseca
Beatriz da Costa Aguiar Alves Reis
Luiz Vinicius de Alcantara Sousa
Jean Henri Maselli-Schoueri
Auro da Giglio
author_sort Daniel de Iracema Gomes Cubero
collection DOAJ
description Abstract Introduction The 21-gene platform Oncotype DX helps clinicians identify women with early- stage estrogen receptor (ER)-positive breast cancer who will not benefit from adjuvant chemotherapy. However, it is too expensive to be implemented by the Brazilian public health system (SUS). Therefore, the aim of this study was to assess the cost-effectiveness of a new 21- gene platform for guiding treatment decisions in these patients. Methods Cost-effectiveness analysis, conducted over a 6-month period, based on standard values payable by the SUS for adjuvant hormone therapy and chemotherapy. Effectiveness was measured in quality-adjusted life years, and sensitivity analyses for different hypothetical costs of the 21-gene platform were performed. Results When all patients were considered, decision tree analysis revealed a benefit of standard clinical risk factor-based approach alone over the use of the 21-gene platform for making treatment decisions. However, for patients classified as high risk according to clinical factors, the 21-gene platform was less expensive than the standard clinical risk factor-based approach, with a platform cost of up to USD 294.75. The incremental cost-effectiveness ratio (ICER) for the platform was lower than that of the 2022 Brazilian gross domestic product per capita (used as the willingness to pay) up to a 21-gene platform cost of USD 1,505.46. Conclusion The use of the 21-gene platform can be cost effective for guiding treatment decisions in early ER- positive breast cancer treated by the SUS for patients classified at high risk on the basis of clinical factors if a cost limit of US$ 1,505.46 per test is considered.
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spelling doaj-art-8418bc0bae2c4534b85ac92f5d6a05332025-08-20T03:46:03ZengBMCBMC Health Services Research1472-69632025-08-012511810.1186/s12913-025-13230-6Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health systemDaniel de Iracema Gomes Cubero0Fernando Luiz Affonso Fonseca1Beatriz da Costa Aguiar Alves Reis2Luiz Vinicius de Alcantara Sousa3Jean Henri Maselli-Schoueri4Auro da Giglio5Disciplina de Oncologia e Hematologia do Centro Universitário FMABCCentro de Estudos e Pesquisas de Hematologia e Oncologia do Centro Universitário FMABC. Santo AndréCentro de Estudos e Pesquisas de Hematologia e Oncologia do Centro Universitário FMABC. Santo AndréCentro de Estudos e Pesquisas de Hematologia e Oncologia do Centro Universitário FMABC. Santo AndréCentro de Estudos e Pesquisas de Hematologia e Oncologia do Centro Universitário FMABC. Santo AndréCentro de Estudos e Pesquisas de Hematologia e Oncologia do Centro Universitário FMABC. Santo AndréAbstract Introduction The 21-gene platform Oncotype DX helps clinicians identify women with early- stage estrogen receptor (ER)-positive breast cancer who will not benefit from adjuvant chemotherapy. However, it is too expensive to be implemented by the Brazilian public health system (SUS). Therefore, the aim of this study was to assess the cost-effectiveness of a new 21- gene platform for guiding treatment decisions in these patients. Methods Cost-effectiveness analysis, conducted over a 6-month period, based on standard values payable by the SUS for adjuvant hormone therapy and chemotherapy. Effectiveness was measured in quality-adjusted life years, and sensitivity analyses for different hypothetical costs of the 21-gene platform were performed. Results When all patients were considered, decision tree analysis revealed a benefit of standard clinical risk factor-based approach alone over the use of the 21-gene platform for making treatment decisions. However, for patients classified as high risk according to clinical factors, the 21-gene platform was less expensive than the standard clinical risk factor-based approach, with a platform cost of up to USD 294.75. The incremental cost-effectiveness ratio (ICER) for the platform was lower than that of the 2022 Brazilian gross domestic product per capita (used as the willingness to pay) up to a 21-gene platform cost of USD 1,505.46. Conclusion The use of the 21-gene platform can be cost effective for guiding treatment decisions in early ER- positive breast cancer treated by the SUS for patients classified at high risk on the basis of clinical factors if a cost limit of US$ 1,505.46 per test is considered.https://doi.org/10.1186/s12913-025-13230-6Cost-effectiveness analysis21-gene platformEarly hormone positive breast cancerBrazilian public health systemRisk factor stratificationDecision-making
spellingShingle Daniel de Iracema Gomes Cubero
Fernando Luiz Affonso Fonseca
Beatriz da Costa Aguiar Alves Reis
Luiz Vinicius de Alcantara Sousa
Jean Henri Maselli-Schoueri
Auro da Giglio
Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
BMC Health Services Research
Cost-effectiveness analysis
21-gene platform
Early hormone positive breast cancer
Brazilian public health system
Risk factor stratification
Decision-making
title Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
title_full Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
title_fullStr Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
title_full_unstemmed Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
title_short Cost-Effectiveness analysis of the 21-Gene platform for guiding treatment decisions for early Hormone-Positive breast cancer: the perspective of the Brazilian public health system
title_sort cost effectiveness analysis of the 21 gene platform for guiding treatment decisions for early hormone positive breast cancer the perspective of the brazilian public health system
topic Cost-effectiveness analysis
21-gene platform
Early hormone positive breast cancer
Brazilian public health system
Risk factor stratification
Decision-making
url https://doi.org/10.1186/s12913-025-13230-6
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