Cost-Effectiveness of Prostate Cancer Detection in Biopsy-Naïve Men: Ultrasound Shear Wave Elastography vs. Multiparametric Diagnostic Magnetic Resonance Imaging (original) (raw)
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European Urology, 2013
E U R O P E A N U R O L O G Y X X X ( 2 0 1 3 ) X X X -X X X a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m j o u r n a l h o m e p a g e : w w w . e u r o p e a n u r o l o g y . c o m Abstract Background: The current diagnostic strategy using transrectal ultrasound-guided biopsy (TRUSGB) raises concerns regarding overdiagnosis and overtreatment of prostate cancer (PCa). Interest in integrating multiparametric magnetic resonance imaging (MRI) and magnetic resonance-guided biopsy (MRGB) into the diagnostic pathway to reduce overdiagnosis and improve grading is gaining ground, but it remains uncertain whether this image-based strategy is cost-effective. Objective: To determine the cost-effectiveness of multiparametric MRI and MRGB compared with TRUSGB. Design, setting, and participants: A combined decision tree and Markov model for men with elevated prostate-specific antigen (>4 ng/ml) was developed. Input data were derived from systematic literature searches, meta-analyses, and expert opinion. Outcome measurements and statistical analysis: Quality-adjusted life years (QALYs) and health care costs of both strategies were modelled over 10 yr after initial suspicion of PCa. Probabilistic and threshold analyses were performed to assess uncertainty. Results and limitations: Despite uncertainty around the presented cost-effectiveness estimates, our results suggest that the MRI strategy is cost-effective compared with the standard of care. Expected costs per patient were s2423 for the MRI strategy and s2392 for the TRUSGB strategy. Corresponding QALYs were higher for the MRI strategy (7.00 versus 6.90), resulting in an incremental cost-effectiveness ratio of s323 per QALY. Threshold analysis revealed that MRI is cost-effective when sensitivity of MRGB is !20%. The probability that the MRI strategy is cost-effective is around 80% at willingness to pay thresholds higher than s2000 per QALY. Conclusions: Total costs of the MRI strategy are almost equal with the standard of care, while reduction of overdiagnosis and overtreatment with the MRI strategy leads to an improvement in quality of life. Patient summary: We compared costs and quality of life (QoL) of the standard ''blind'' diagnostic technique with an image-based technique for men with suspicion of prostate cancer. Our results suggest that costs were comparable, with higher QoL for the image-based technique.
European Urology
Background: The current recommendation of using transrectal ultrasound-guided biopsy (TRUSB) to diagnose prostate cancer misses clinically significant (CS) cancers. More sensitive biopsies (eg, template prostate mapping biopsy [TPMB]) are too resource intensive for routine use, and there is little evidence on multiparametric magnetic resonance imaging (MPMRI). Objective: To identify the most effective and cost-effective way of using these tests to detect CS prostate cancer. Design, setting, and participants: Cost-effectiveness modelling of health outcomes and costs of men referred to secondary care with a suspicion of prostate cancer prior to any biopsy in the UK National Health Service using information from the diagnostic Prostate MR Imaging Study (PROMIS). Intervention: Combinations of MPMRI, TRUSB, and TPMB, using different definitions and diagnostic cutoffs for CS cancer. Outcome measurements and statistical analysis: Strategies that detect the most CS cancers given testing costs, and incremental cost-effectiveness ratios (ICERs) in qualityadjusted life years (QALYs) given long-term costs. Results and limitations: The use of MPMRI first and then up to two MRI-targeted TRUSBs detects more CS cancers per pound spent than a strategy using TRUSB first (sensitivity = 0.95 [95% confidence interval {CI} 0.92-0.98] vs 0.91 [95% CI 0.86-0.94]) and is cost effective (ICER = £7,076 [s8350/QALY gained]). The limitations stem from the evidence base in the accuracy of MRI-targeted biopsy and the long-term outcomes of men with CS prostate cancer. Conclusions: An MPMRI-first strategy is effective and cost effective for the diagnosis of CS prostate cancer. These findings are sensitive to the test costs, sensitivity of MRItargeted TRUSB, and long-term outcomes of men with cancer, which warrant more empirical research. This analysis can inform the development of clinical guidelines.
Anticancer research, 2018
To evaluate the cost-effectiveness of multiparametric magnetic imaging resonance (mpMRI) in men submitted to repeat saturation prostate biopsy (SPBx). From January 2011 to June 2017, 800 men underwent repeat SPBx; the cost-effectiveness of mpMRI if used as a 'triage test' to avoid unnecessary repeat prostate biopsy was retrospectively calculated using the Italian Public National Health System Day Service. SPBx vs. MRI fusion targeted biopsy diagnosed 215 (89.5%) vs. 184 (76.6%) out of 240, respectively. The overall cost of the 800 prostate biopsies was 138,221 €; the use of mpMRI as triage test would have spared 364/800 procedures, equivalent to 60,905 € (44% of the entire cost), whilst missing 15/205 (7.3%) cases of clinically significant cancer. mpMRI used as a triage test could reduce the need for prostate biopsies by about 45%, thereby improving cost-effectiveness, however, patients should be informed of the false-negative rate associated with mpMRI.
Cost-effectiveness of MRI targeted biopsy strategies for diagnosing prostate cancer in Singapore
BMC Health Services Research, 2021
Background To evaluate the cost-effectiveness of six diagnostic strategies involving magnetic resonance imaging (MRI) targeted biopsy for diagnosing prostate cancer in initial and repeat biopsy settings from the Singapore healthcare system perspective. Methods A combined decision tree and Markov model was developed. The starting model population was men with mean age of 65 years referred for a first prostate biopsy due to clinical suspicion of prostate cancer. The six diagnostic strategies were selected for their relevance to local clinical practice. They comprised MRI targeted biopsy following a positive pre-biopsy multiparametric MRI (mpMRI) [Prostate Imaging – Reporting and Data System (PI-RADS) score ≥ 3], systematic biopsy, or saturation biopsy employed in different testing combinations and sequences. Deterministic base case analyses with sensitivity analyses were performed using costs from the healthcare system perspective and quality-adjusted life years (QALY) gained as the o...
Health technology assessment (Winchester, England), 2018
Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy. To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway. A validating paired-cohort study and an economic evaluation using a decision-analytic model. Eleven NHS hospitals in England. Men at risk of prostate cancer undergoing a first prostate biopsy. Participants underwent three tests: (1) mpMRI (the index test), (2) TRUS-guided biopsy (the current standard) and (3) template ...
BJU international, 2017
To assess the cost-effectiveness of a new urinary biomarker-based risk score (SelectMDx; MDxHealth, Inc., Irvine, CA, USA) to identify patients for transrectal ultrasonography (TRUS)-guided biopsy and to compare this with the current standard of care (SOC), using only prostate-specific antigen (PSA) to select for TRUS-guided biopsy. A decision tree and Markov model were developed to evaluate the cost-effectiveness of SelectMDx as a reflex test vs SOC in men with a PSA level of >3 ng/mL. Transition probabilities, utilities and costs were derived from the literature and expert opinion. Cost-effectiveness was expressed in quality-adjusted life years (QALYs) and healthcare costs of both diagnostic strategies, simulating the course of patients over a time horizon representing 18 years. Deterministic sensitivity analyses were performed to address uncertainty in assumptions. A diagnostic strategy including SelectMDx with a cut-off chosen at a sensitivity of 95.7% for high-grade prostate...
BMJ open, 2014
To compare the diagnostic outcomes of the current approach of transrectal ultrasound (TRUS)-guided biopsy in men with suspected prostate cancer to an alternative approach using multiparametric MRI (mpMRI), followed by MRI-targeted biopsy if positive. Clinical decision analysis was used to synthesise data from recently emerging evidence in a format that is relevant for clinical decision making. A hypothetical cohort of 1000 men with suspected prostate cancer. mpMRI and, if positive, MRI-targeted biopsy compared with TRUS-guided biopsy in all men. We report the number of men expected to undergo a biopsy as well as the numbers of correctly identified patients with or without prostate cancer. A probabilistic sensitivity analysis was carried out using Monte Carlo simulation to explore the impact of statistical uncertainty in the diagnostic parameters. In 1000 men, mpMRI followed by MRI-targeted biopsy 'clinically dominates' TRUS-guided biopsy as it results in fewer expected biops...
The Journal of Urology, 2018
INTRODUCTION AND OBJECTIVES: Due to the growing concerns of over-diagnosis and limitations of conventional transrectal ultrasound guided (TRUS) biopsy, multi-parametric magnetic resonance imaging of the prostate (MP-MRI prostate) may improve the accuracy in detecting clinically significant prostate cancer. With the national trends in MP-MRI prostate utilization poorly described, we sought to elucidate its adoption among patients undergoing a prostate cancer screening and subsequent diagnosis of elevated prostate specific antigen (PSA) in a large privately insured population-based cohort. METHODS: From a large private health insurance database (OptumLabs), we identified men age 40-80 years screened for prostate cancer through PSA testing from January 2010 to December 2016. In addition, the men had to have a diagnosis of enlarged prostate or elevated PSA within 14 days after the screening date. Use of MP-MRI of the prostate and biopsies within the 30 days post diagnosis were collected. Unadjusted, age-specific and age-adjusted annual rates of MRIs over time were analyzed for trends using regression models (trend analysis). RESULTS: We identified 1,018,558 screenings for prostate cancer performed on men age 40-80 years from 2010 to 2016 with a subsequent diagnosis of elevated PSA within 14 days of the PSA test. Overall mean (standard deviation) age was 64.3 (9.5) years. The majority were white (53%); however, 31% were documented as race-unknown. A small proportion went on to have a prostate biopsy (3.9%). Unadjusted annual rates of MRI among those with biopsy significantly increased over time from 5.2 per 1,000 biopsies in 2010 to 13.5 in 2016 (p¼0.0075 for trend). Similarly, annual age-adjusted rates of MRI significantly increased from 5.5 per 1,000 biopsies in 2010 to 13.5 in 2016 (p¼0.0083 for trend). Age-specific rates also increased for all age groups (40-49, 50-59, 60-65, 66-75 and 75þ). The largest and only significant increase was in the age 60-65 group which increased from 4.4 in 2010 to 16.0 in 2016 (p¼0.005 for trend). CONCLUSIONS: Contemporary trends of MP-MRI prostate at the time of biopsy has increased markedly among privately insured patients in the U.S.
European Urology Oncology, 2018
Background: Transrectal ultrasound-guided biopsy (TRUS-Bx) is recommended by the European Urology Association (EAU) as the first diagnostic modality for men at risk of prostate cancer (PCa). Current EAU guidelines reserve the use of multiparametric MRI to target or guide any repeat biopsy (mpMRI-Bx). It remains uncertain if TRUS-Bx is effective as a first strategy in terms of costs, diagnostic performance, time to diagnosis, and triage for individualised therapy. Objective: To determine the diagnostic and treatment costs and the effectiveness of pathways incorporating mpMRI-Bx compared to TRUS-Bx in men at high risk of PCa. Design, setting, and participants: A cost and time analysis was performed using data from a randomised single-centre study of 1140 patients (prostate-specific antigen >4 ng/ml) divided into two groups: 570 patients underwent an initial TRUS-Bx and 570 underwent 3-T mpMRI-Bx. Outcome measurements and statistical analysis: Budget analyses were used to compare the diagnostic strategies using reimbursement data from the Italian National Health Security system. Analyses of reimbursable diagnostic and treatment costs were undertaken separately. Histologic outcomes, pathway diagnostic accuracy, therapy choices, and time to diagnosis were compared. Results and limitations: The cumulative diagnosis costs were 14.6% greater for the mpMRI-Bx pathway than for the TRUS strategy, and 5.2-6.0% higher for therapy. Diagnostic costs were s228 946 for mpMRI-Bx and s199 750 for TRUS-Bx, and the corresponding therapy costs were s1 912 000 and s1 802 800. The mpMRI-Bx strategy was highly effective in excluding clinically significant disease (Gleason !7; sensitivity and negative predictive value both 100%, 95% confidence interval 98-100%). The time to diagnosis was significantly shorter for the mpMRI-Bx (median 4.0 mo interquartile range [IQR] 3-6) than for the TRUS-Bx strategy (median 6 mo, IQR 4-12; p < 0.001). Limitations include the lack of data on costs associated with treatmentrelated complications and follow-up data. Conclusions: The mpMRI-Bx strategy is effective for diagnosing patients with a clinical suspicion of PCa and provides more accurate diagnosis, with combined diagnosis and therapy costs only moderately higher than for the standard strategy. Patient summary: It is a matter of debate whether a diagnostic pathway that incorporates multiparametric magnetic resonance imaging (MRI) as the first-line test before performing any type of biopsy in men suspected of having prostate cancer (PCa) is cost-effective. Our analysis of the costs for men suspected of harbouring PCa revealed higher diagnostic costs for the MRI approach, with the benefits of greater diagnostic accuracy. Moreover, the combined diagnostic and treatment costs are only modestly higher whenever the same treatment for all patients is considered.
European Urology, 2018
Background: The Rotterdam European Randomized Study of Screening for Prostate Cancer risk calculators (ERSPC-RCs) help to avoid unnecessary transrectal ultrasound-guided systematic biopsies (TRUS-Bx). Multivariable risk stratification could also avoid unnecessary biopsies following multiparametric magnetic resonance imaging (mpMRI). Objective: To construct MRI-ERSPC-RCs for the prediction of any-and high-grade (Gleason score !3 + 4) prostate cancer (PCa) in 12-core TRUS-Bx AE MRI-targeted biopsy (MRI-TBx) by adding Prostate Imaging Reporting and Data System (PI-RADS) and age as parameters to the ERSPC-RC3 (biopsy-naïve men) and ERSPC-RC4 (previously biopsied men). Design, setting, and participants: A total of 961 men received mpMRI and 12-core TRUS-Bx AE MRI-TBx (in case of PI-RADS !3) in five institutions. Data of 504 biopsy-naïve and 457 previously biopsied men were used to adjust the ERSPC-RC3 and ERSPC-RC4. Outcome measurements and statistical analysis: Logistic regression models were constructed. The areas under the curve (AUCs) of the original ERSPC-RCs and MRI-ERSPC-RCs (including PI-RADS and age) for any-and high-grade PCa were compared. Decision curve analysis was performed to assess the clinical utility of the MRI-ERSPC-RCs. Results and limitations: MRI-ERSPC-RC3 had a significantly higher AUC for high-grade PCa compared with the ERSPC-RC3: 0.84 (95% confidence interval [CI] 0.81-0.88) versus 0.76 (95% CI 0.71-0.80, p < 0.01). Similarly, MRI-ERSPC-RC4 had a higher AUC for highgrade PCa compared with the ERSPC-RC4: 0.85 (95% CI 0.81-0.89) versus 0.74 (95% CI 0.69-0.79, p < 0.01). Unlike for the MRI-ERSPC-RC3, decision curve analysis showed clear net benefit of the MRI-ERSPC-RC4 at a high-grade PCa risk threshold of !5%. Using a !10% high-grade PCa risk threshold to biopsy for the MRI-ERSPC-RC4, 36% biopsies are saved, missing low-and high-grade PCa, respectively, in 15% and 4% of men who are not biopsied.