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Cost-Effectiveness of a Biopsy-Based 8-Protein Prostate Cancer Prognostic Assay to Optimize Treatment Decision Making in Gleason 3 + 3 and 3 + 4 Early Stage Prostate Cancer.

BACKGROUND
Many patients with Gleason 3 + 3 and 3 + 4 early stage prostate cancer receive invasive treatment but likely derive little or no benefit. A novel 8-protein prognostic assay generates a risk score at time of biopsy that is predictive of prostate cancer aggressiveness and can inform treatment decisions. The objective of this study was to evaluate the cost-effectiveness of using the assay to inform treatment decisions compared with usual care.


PATIENTS AND METHODS
We developed a simulation model to estimate quality-adjusted life-year (QALY) and cost outcomes for the 8-protein assay and usual care strategies. Risk classification outcomes, treatment distributions, costs, health state utilities, and mortality rates were derived from the assay's validation study and the peer-reviewed literature. Outcomes included incremental QALYs, costs, and cost-effectiveness ratios. We conducted one-way and probabilistic sensitivity analyses to evaluate the most influential inputs and to explore joint uncertainty in outcomes, respectively.


RESULTS
The 8-protein assay strategy resulted in 0.04 more QALY and $700 less in costs compared with usual care (and thus was "dominant"). The cost-effectiveness of the assay strategy was most sensitive to the assay cost, the active surveillance health state utility, and the proportion of low-risk patients receiving active surveillance (vs. treatment) in usual care. In the probabilistic sensitivity analyses, the assay strategy decreased cost and increased QALYs in 86.9% and 58.3% of simulations, respectively.


CONCLUSION
Assuming that ongoing prospective studies support the results of retrospective validation studies, the 8-protein prognostic assay strategy for prostate cancer is likely to be a cost-effective alternative to usual guideline-based care in biopsy Gleason 3 + 3 and 3 + 4 early stage prostate cancer.