Cost‐effectiveness of Prostate Health Index for prostate cancer detection

Abstract

Study Type – Diagnostic (cost effectiveness) Level of Evidence 2b What's known on the subject? and What does the study add? The Beckman Coulter prostate health index (phi) was developed as a combination of serum prostate specific antigen (PSA), free PSA and a PSA precursor form [−2]proPSA to calculate the probability of prostate cancer and was used as an aid in distinguishing prostate cancer from benign prostatic conditions for men with PSA test 2–10 ng/mL and non‐suspicious digital rectal examination. Phi has been shown to improve diagnostic accuracy in prostate cancer detection compared with total and free PSA. An earlier 1‐year budget impact analysis revealed it to be a complementary approach to current prostate cancer screening strategies. The current study evaluated the cost‐effectiveness of early prostate cancer detection with phi in combination with a PSA test compared with a PSA test alone from the US societal perspective. The model with over 25 annual screening cycles for men aged 50–75 years indicated that PSA plus phi dominated the PSA test alone in prostate cancer detection and consequent treatment. PSA plus phi may be an important strategy for prostate cancer detection. OBJECTIVE To evaluate the cost‐effectiveness of early prostate cancer detection with the Beckman Coulter Prostate Health Index (phi) (not currently available in the USA) adding to the serum prostate‐specific antigen (PSA) test compared with the PSA test alone from the US societal perspective. PATIENTS AND METHODS Phi was developed as a combination of PSA, free PSA, and a PSA precursor form [−2]proPSA to calculate the probability of prostate cancer and was used as an aid in distinguishing prostate cancer from benign prostatic conditions for men with a borderline PSA test (e.g. PSA 2–10 ng/mL or 4–10 ng/mL) and non‐suspicious digital rectal examination. We constructed a Markov model with probabilistic sensitivity analysis to estimate expected costs and utilities of prostate cancer detection and consequent treatment for the annual prostate cancer screening in the male population aged 50–75 years old. The transition probabilities, health state utilities and prostate cancer treatment costs were derived from the published literature. The diagnostic performance of phi was obtained from a multi‐centre study. Diagnostic related costs were obtained from the 2009 Medicare Fee Schedule. Cost‐effectiveness was compared between the strategies of PSA test alone and PSA plus phi under two PSA thresholds (≥2 ng/mL and ≥4 ng/mL) to recommend a prostate biopsy. RESULTS Over 25 annual screening cycles, the strategy of PSA plus phi dominated the PSA‐only strategy using both thresholds of PSA ≥2 ng/mL and PSA ≥4 ng/mL, and was estimated to save $1199 or $443, with an expected gain of 0.08 or 0.03 quality adjusted life years, respectively. The probabilities of PSA plus phi being cost effective were approximately 77–70% or 78–71% at a range of $0–$200 000 willingness to pay using PSA thresholds ≥2 ng/mL and ≥4 ng/mL, respectively. CONCLUSION The strat...

Prostate health index vs percent free prostate-specific antigen for prostate cancer detection in men with “gray” prostate-specific antigen levels at first biopsy: systematic review and meta-analysis

“…Such an analysis was recently performed, 21 suggesting that PSA plus PHI was a less costly diagnostic strategy to detect PCa compared with the PSA test alone. Taking into account that the cost of %fPSA is clearly higher than PSA alone and PHI can be expected to reduce false negative tests, the use of PHI instead of %fPSA as a reflex test in tPSA range of 2-10 ng/mL may decrease the global costs and disutility related to the prostate biopsy procedure.…”

The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

“…Of these, 2146 references were immediately excluded because they did not include the term 'cost' or 'economic' in either the title or the abstract. The remaining 103 records were assessed for eligibility and 99 were excluded because they did not include the relevant comparators or did not consider an eligible [113][114][115][116] However, none of the four references met the study inclusion criteria and they were, therefore, excluded from the systematic review. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram for the cost-effectiveness review is shown in Figure 4.…”

“…The search carried out by the EAG identified the two studies 114,116 (one considering the PCA3 assay and the other phi) that had been summarised in the NICE scope. 49 One of these studies 116 focused on a screening population and was carried out from a US health-care perspective.…”

“…49 One of these studies 116 focused on a screening population and was carried out from a US health-care perspective. The second study was carried out in France, but only 21.1% of the population had had a prior negative biopsy.…”

Emerging biomarkers in the detection and prognosis of prostate cancer

“…Despite the high cost of the test for determining p2PSA, the use of PHI in the detection of PCa decreases global costs. The additional blood test costs are compensated by the savings on the costs of physician office visits and the avoidance of unnecessary biopsies [47,48]. According to data collected in a meta-analysis that we published in 2013 [37] concerning 12 relevant articles evaluating these tests, the AUCs were between 0.635 and 0.78 for %p2PSA and between 0.703 and 0.77 for PHI.…”