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.


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.


CONCLUSIONS
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.
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, USA Department of Pharmacy, University of Washington, Seattle, Washington, USA.
Joshua A
JA
Roth
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, USA Department of Pharmacy, University of Washington, Seattle, Washington, USA.
Scott D
SD
Ramsey
Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington, USA Department of Pharmacy, University of Washington, Seattle, Washington, USA carlsojj@u.washington.edu.
Josh J
JJ
Carlson
D014408:Biomarkers, Tumor / Q000032:analysis*; D001706:Biopsy / Q000191:economics* / Q000379:methods; D003362:Cost-Benefit Analysis; D003657:Decision Making; D006801:Humans; D008297:Male; D015233:Models, Statistical; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000191:economics* / Q000378:metabolism / Q000473:pathology* / Q000628:therapy; D011506:Proteins / Q000032:analysis*; D019057:Quality-Adjusted Life Years; D012307:Risk Factors
D014408:Biomarkers, Tumor; D011506:Proteins
Assay; Cost-effectiveness; Economic; Prostate cancer; Proteomics