The cost-effectiveness of PC screening using the Stockholm3 test

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Abstract

Objectives
The European Randomized Study of Screening for Prostate Cancer found that prostate-specific antigen (PSA) screening reduced prostate cancer mortality, however, the costs and harms from screening may outweigh any mortality reduction. Compared with screening using the PSA test alone, using the Stockholm3 Model (S3M) as a reflex test for PSA ≥ 1 ng/mL has the same sensitivity for Gleason score ≥ 7 cancers while the relative positive fractions for Gleason score 6 cancers and no cancer were 0.83 and 0.56, respectively. The cost-effectiveness of the S3M test has not previously been assessed.

Methods We undertook a cost-effectiveness analysis from a lifetime societal perspective. Using a microsimulation model, we simulated for: (i) no prostate cancer screening; (ii) screening using the PSA test; and (iii) screening using the S3M test as a reflex test for PSA values ≥ 1, 1.5, and 2 ng/mL. Screening strategies included quadrennial re-testing for ages 55–69 years performed by a general practitioner. Discounted costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated.

Results Comparing S3M with a reflex threshold of 2 ng/mL with screening using the PSA test, S3M had increased effectiveness, reduced lifetime biopsies by 30%, and increased societal costs by 0.4%. Relative to the PSA test, the S3M reflex thresholds of 1, 1.5, and 2 ng/mL had ICERs of 170,000, 60,000, and 6,000 EUR/QALY, respectively. The S3M test was more cost-effective at higher biopsy costs.

Conclusions Prostate cancer screening using the S3M test for men with an initial PSA ≥ of 2.0 ng/mL was cost-effective compared with screening using the PSA test alone




Introduction

Prostate cancer is the most common male cancer diagnosed, the third most common cause of male cancer death, and the fourth-highest cost by cancer site in Europe [1, 2]. The European Randomized Study of Screening for Prostate Cancer (ERSPC; ISRCTN49127736) found that four-yearly screening for prostate cancer, using the prostate-specific antigen (PSA) test, for ages 55–69 years increased incidence by 41% and reduced mortality by 20% over 16 years [3]. The PSA test is inexpensive but has diagnostic limitations that lead to unnecessary biopsies, over-diagnosis, over-treatment, and increased costs [3–6]. We use the term “screening” in a manner that includes both organized screening and opportunistic testing.

Some commentators take the view that the costs and harms of prostate cancer screening outweigh the health benefits from early detection. A contrasting view is that prostate cancer screening has become so widely accepted that we should consider harm and cost reduction strategies for prostate cancer screening. Reflecting these two views, the US Preventive Services Task Force recommended against PSA screening in 2012 [7], which was followed by a limited decline in PSA screening in the United States, and then the Task Force changed their recommendation to shared decision-making in 2018 [8]. One consequence of this debate is that few healthcare systems have organized prostate cancer screening.

To reduce the downstream costs and potential harms associated with PSA screening, a number of new screening tests and risk calculators have been developed, including the 4K score, the Prostate Health Index, PCA3 (a urine-based test), and the ERSPC risk calculators [9], however, there have been comparatively few economic evaluations [10–12].




Conclusions

Compared with quadrennial PSA screening, the use of the S3M as a reflex test at PSA ≥ 2.0 ng/ mL was predicted to result in a low cost per QALY gained in Sweden. However, the use of the S3M test at reflex PSA thresholds of 1 and 1.5 ng/mL was predicted to result in very high and high costs per QALY gained, respectively. Lower S3M test costs would further improve the cost-effectiveness of the S3M test. S3M is a cost-effective reflex test that can reduce harms due to prostate cancer screening while maintaining the health benefits from early detection.
 
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