Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis

To evaluate the cost-effectiveness of utilizing supplemental optoacoustic ultrasound (OA/US) versus gray-scale ultrasound (US) alone to differentiate benign and malignant breast masses in a diagnostic setting.

We created a decision-tree model to compare the cost-effectiveness of OA/US and US from the perspective of the US healthcare system. We utilized diagnostic test performance parameters from the PIONEER-01(NCT01943916) clinical trial and cost parameters (USD) from the Truven Health MarketScan Databases. Utility (quality adjusted life year, QALY) values were determined following published patient-reported outcomes. Cost-effectiveness was calculated through incremental cost-effectiveness ratio (USD/QALY, ICER) and net monetary benefit (NMB) in a Markov chain model. Deterministic and probabilistic sensitivity analyses were performed to determine the significance of variation in input parameters. A willingness-to-pay (WTP) threshold of $100,000/QALY was used for the study.

OA/US had an estimated cumulative cost of $16,617.36 and the outcome of 16.85 QALYs in the 25-year period. The incremental NMB for OA/US was $1495.36, and the ICER was -$31,715.82/QALY, indicating that supplemental use of OA/US was more cost-effective than US alone. In the deterministic sensitivity analysis, when the cost of OA/US exceeded $1030.61 or the sensitivity of OA/US fell below 79.7%, or the specificity fell below 30.5%, the US alone strategy yielded higher NMB values compared to supplemental OA/US. According to probabilistic sensitivity analysis, OA/US was the better strategy in 98.69% of 10,000 iterations.

OA/US is more cost-effective than US to differentiate benign or malignant breast masses in the diagnostic setting. It can reduce costs while improving patients' quality of life, primarily by reducing false-positive results with consequent benign biopsies.