Julia Simoes Correa-Galendi1, Maria Del Pilar Estevez Diz2, Stephanie Stock3, Dirk Müller3. 1. Institute for Health Economics and Clinical Epidemiology, The University Hospital of Cologne (AöR), Sao Paulo, SP, Brazil. julia.simoes-correa-galendi@uk-koeln.de. 2. Insituto Do Cancer Do Estado de Sao Paulo, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. 3. Institute for Health Economics and Clinical Epidemiology, The University Hospital of Cologne (AöR), Sao Paulo, SP, Brazil.
Abstract
BACKGROUND: Clinical evidence supports the use of genetic counselling and BRCA1/2 testing for women at risk for hereditary breast and ovarian cancer. Currently, screen-and-treat strategies are not reimbursed in the Brazilian Unified Healthcare System (SUS). The aim of this modelling study was to evaluate the cost effectiveness of a gene-based screen-and-treat strategy for BRCA1/2 in women with a high familial risk followed by preventive interventions compared with no screening. METHODS: Adopting the SUS perspective, a Markov model with a lifelong time horizon was developed for a cohort of healthy women aged 30 years that fulfilled the criteria for BRCA1/2 testing according to the National Comprehensive Cancer Network (NCCN) guideline. For women who tested positive, preventive options included intensified surveillance, risk-reducing bilateral mastectomy and bilateral salpingo-oophorectomy. The Markov model comprised the health states 'well', 'breast cancer', 'death' and two post-cancer states. Outcomes were the incremental costs per quality-adjusted life-year (QALY) and the incremental costs per life-year gained (LYG). Data were mainly obtained by a literature review. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the results. RESULTS: In the base case, the screen-and-treat strategy resulted in additional costs of 3515 Brazilian reais (R$) (US$1698) and a gain of 0.145 QALYs, compared with no screening. The incremental cost-effectiveness ratio (ICER) was R$24,263 (US$21,724) per QALY and R$27,258 (US$24,405) per LYG. Applying deterministic sensitivity analyses, the ICER was most sensitive to the probability of a positive test result and the discount rate. In the probabilistic sensitivity analysis, a willingness to pay of R$25,000 per QALY gained for the screen-and-treat strategy resulted in a probability of cost effectiveness of 80%. CONCLUSION: Although there is no rigorous cost-effectiveness threshold in Brazil, the result of this cost-effectiveness analysis may support the inclusion of BRCA1/2 testing for women at high-risk of cancer in the SUS. The ICER calculated for the provision of genetic testing for BRCA1/2 approximates the cost-effectiveness threshold proposed by the World Health Organization (WHO) for low- and middle-income countries.
BACKGROUND: Clinical evidence supports the use of genetic counselling and BRCA1/2 testing for women at risk for hereditary breast and ovarian cancer. Currently, screen-and-treat strategies are not reimbursed in the Brazilian Unified Healthcare System (SUS). The aim of this modelling study was to evaluate the cost effectiveness of a gene-based screen-and-treat strategy for BRCA1/2 in women with a high familial risk followed by preventive interventions compared with no screening. METHODS: Adopting the SUS perspective, a Markov model with a lifelong time horizon was developed for a cohort of healthy women aged 30 years that fulfilled the criteria for BRCA1/2 testing according to the National Comprehensive Cancer Network (NCCN) guideline. For women who tested positive, preventive options included intensified surveillance, risk-reducing bilateral mastectomy and bilateral salpingo-oophorectomy. The Markov model comprised the health states 'well', 'breast cancer', 'death' and two post-cancer states. Outcomes were the incremental costs per quality-adjusted life-year (QALY) and the incremental costs per life-year gained (LYG). Data were mainly obtained by a literature review. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the results. RESULTS: In the base case, the screen-and-treat strategy resulted in additional costs of 3515 Brazilian reais (R$) (US$1698) and a gain of 0.145 QALYs, compared with no screening. The incremental cost-effectiveness ratio (ICER) was R$24,263 (US$21,724) per QALY and R$27,258 (US$24,405) per LYG. Applying deterministic sensitivity analyses, the ICER was most sensitive to the probability of a positive test result and the discount rate. In the probabilistic sensitivity analysis, a willingness to pay of R$25,000 per QALY gained for the screen-and-treat strategy resulted in a probability of cost effectiveness of 80%. CONCLUSION: Although there is no rigorous cost-effectiveness threshold in Brazil, the result of this cost-effectiveness analysis may support the inclusion of BRCA1/2 testing for women at high-risk of cancer in the SUS. The ICER calculated for the provision of genetic testing for BRCA1/2 approximates the cost-effectiveness threshold proposed by the World Health Organization (WHO) for low- and middle-income countries.