The Value of a New Diagnostic Test for Prostate Cancer: A Cost-Utility Analysis in Early Stage of Development.

backgroundStandard biopsy for prostate cancer diagnosis is an unpleasant and sometimes painful procedure with a detection rate as low as around 50%. Consequently, an accurate blood-based test would be highly desirable to improve the predictive accuracy. However, the clinical value of a new blood test for diagnosing prostate cancer depends on its sensitivity and specificity, in relation to the selected target population.

objectiveThe aim of this analysis was to investigate the health-economic value of introducing a new and more accurate diagnostic blood-based test to identify men in need of a biopsy to diagnose prostate cancer.

methodWe developed a Discrete Event Simulation Model with outputs including number of biopsies, cancer diagnosis, treatments and prostate cancer deaths. The analysis was performed from a health care perspective. It used epidemiologic data, treatment patterns, and health care costs from the Swedish region Skåne (population of 1.3 million). A 90% sensitivity and specificity of the new test was assumed.

resultsAmong 31,250 men, age 50-69 years, 16.4% had a PSA between 3.0 and 9.9 µg/L and 28.9% a PSA of 2.0-9.9 µg/L. Testing men with PSA 3.0-9.9 µg/L, as in current clinical practice, decreased the number of biopsies by 3595, detected 61 more cancers, resulting in and two more fatalities and subsequently a loss of 14 QALYs. Cost offsets could justify a test value of SEK 4996. Testing a larger population, PSA 2.0-9.9 µg/L prevented 6 deaths, added 50 QALYs, and could justify a value of the test of SEK 5165, given a value of health of SEK 500,000 per QALY.

conclusionA new blood-based test for prostate cancer has a significant potential to reduce the number of biopsies needed, resulting in reduced health care costs and improve patient care.