Affiliation:
1. Fundación Centro de Tratamiento en Investigación sobre Cáncer Luis Carlos Sarmiento Angulo (CTIC)
2. Institut d´Investigació Biomédica Sant Pau (IIB SANT PAU)
3. Pontificia Universidad Javeriana
4. Baxter International
5. Foundation for Clinical and Applied Cancer Research-FICMAC
Abstract
Abstract
Background: In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy.
Methods: This study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Inputs were obtained from national unit cost tariffs, published literature, and clinical trial database. The study population comprised women with hormone-receptor-positive (HR+), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were discounted incremental cost-utility ratio (ICUR; 2021 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB).Probabilistic (PSA) and deterministic sensitivity analysis (DSA) were performed.
Results: ODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2,374 and $554 compared with the standard strategy, respectively, and were cost-saving in cost-utility plane. NMB for ODX was $2,203 and for MMP was $416. Both tests dominate the standard strategy. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-utility in 95.5% of the cases compared with 70.2% cases involving MMP.DSA showed that the variable with significant influence was the monthly cost of adjuvant chemotherapy. PSA revealed that ODX was a consistently superior strategy.
Conclusions: Genomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR+ and HER2− EBC is a cost-utility strategy that allows Colombian NHS to maintain budget.
Publisher
Research Square Platform LLC