CLINICAL AND ECONOMIC VALUE OF THE ONCOTYPE DX BREAST RECURRENCE SCORE TEST IN BRAZIL'S PUBLIC HEALTH SYSTEM: A COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS
Author(s)
Carlos Magliano, Sr., PhD.
PhD, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil.
PhD, Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil.
OBJECTIVES: To evaluate the cost-effectiveness and budget impact of the Oncotype DX test for guiding adjuvant chemotherapy decisions in hormone receptor-positive (HR+), HER2-negative (HER2-) early-stage breast cancer (EBC) within the Brazilian Public Health System (SUS).
METHODS: A hybrid decision tree and Markov model compared clinicopathological risk-based standard care versus Oncotype DX-guided treatment from the SUS perspective. Cost-utility and budget impact analyses were conducted over lifetime and five-year horizons, respectively. The cohort comprised women with HR+/HER2- EBC (N0 and N1 postmenopausal). Costs were estimated in 2025 Brazilian Reais (USD; BRL 5:1), and outcomes were expressed as quality-adjusted life years (QALYs). The price of Oncotype DX® used in the model was based on the current private-sector acquisition price in Brazil. Deterministic and probabilistic sensitivity analyses (PSA; 5,000 Monte Carlo simulations) assessed uncertainty.
RESULTS: In the base case, Oncotype DX was cost-effective (ICER: US$14,120.73/QALY), below Brazilian willingness-to-pay thresholds (US$8,000-24,000/QALY), yielding 0.07 incremental QALYs at an additional cost of US$963.13. Subgroup analyses showed heterogeneous results. N0 high clinical risk patients aged >50 years were dominant (more effective and cost-saving; BI: US$45.1M), while N0 low clinical risk patients aged >50 years remained cost-effective (ICER: US$4,320.18/QALY; BI: US$95.9M). Cost-effectiveness thresholds were exceeded in N0 low clinical risk ≤50 years, N0 high clinical risk ≤50 years, and N1 postmenopausal patients. PSA confirmed a high probability of cost-effectiveness in the overall eligible population. The five-year cumulative budget impact was approximately US$271 million, partially offset by reduced chemotherapy utilization.
CONCLUSIONS: Oncotype DX is cost-effective within the Brazilian SUS, particularly for N0 high clinical risk EBC patients aged >50 years. Risk-stratified implementation may optimize affordability and maximize value for money. As the analysis was based on the current private-sector acquisition price, future price reductions through public-sector procurement or incorporation negotiations could further improve cost-effectiveness and reduce budget impact.
METHODS: A hybrid decision tree and Markov model compared clinicopathological risk-based standard care versus Oncotype DX-guided treatment from the SUS perspective. Cost-utility and budget impact analyses were conducted over lifetime and five-year horizons, respectively. The cohort comprised women with HR+/HER2- EBC (N0 and N1 postmenopausal). Costs were estimated in 2025 Brazilian Reais (USD; BRL 5:1), and outcomes were expressed as quality-adjusted life years (QALYs). The price of Oncotype DX® used in the model was based on the current private-sector acquisition price in Brazil. Deterministic and probabilistic sensitivity analyses (PSA; 5,000 Monte Carlo simulations) assessed uncertainty.
RESULTS: In the base case, Oncotype DX was cost-effective (ICER: US$14,120.73/QALY), below Brazilian willingness-to-pay thresholds (US$8,000-24,000/QALY), yielding 0.07 incremental QALYs at an additional cost of US$963.13. Subgroup analyses showed heterogeneous results. N0 high clinical risk patients aged >50 years were dominant (more effective and cost-saving; BI: US$45.1M), while N0 low clinical risk patients aged >50 years remained cost-effective (ICER: US$4,320.18/QALY; BI: US$95.9M). Cost-effectiveness thresholds were exceeded in N0 low clinical risk ≤50 years, N0 high clinical risk ≤50 years, and N1 postmenopausal patients. PSA confirmed a high probability of cost-effectiveness in the overall eligible population. The five-year cumulative budget impact was approximately US$271 million, partially offset by reduced chemotherapy utilization.
CONCLUSIONS: Oncotype DX is cost-effective within the Brazilian SUS, particularly for N0 high clinical risk EBC patients aged >50 years. Risk-stratified implementation may optimize affordability and maximize value for money. As the analysis was based on the current private-sector acquisition price, future price reductions through public-sector procurement or incorporation negotiations could further improve cost-effectiveness and reduce budget impact.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE214
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Topic Subcategory
Budget Impact Analysis
Disease
Oncology