scholarly journals 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

2015 ◽  
Vol 19 (87) ◽  
pp. 1-192 ◽  
Author(s):  
Amanda Nicholson ◽  
James Mahon ◽  
Angela Boland ◽  
Sophie Beale ◽  
Kerry Dwan ◽  
...  

BackgroundThere is no single definitive test to identify prostate cancer in men. Biopsies are commonly used to obtain samples of prostate tissue for histopathological examination. However, this approach frequently misses cases of cancer, meaning that repeat biopsies may be necessary to obtain a diagnosis. The PROGENSA®prostate cancer antigen 3 (PCA3) assay (Hologic Gen-Probe, Marlborough, MA, USA) and the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) are two new tests (a urine test and a blood test, respectively) that are designed to be used to help clinicians decide whether or not to recommend a repeat biopsy.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of the PCA3 assay and the phi in the diagnosis of prostate cancer.Data sourcesMultiple publication databases and trial registers were searched in May 2014 (from 2000 to May 2014), including MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science, Medion, Aggressive Research Intelligence Facility database, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number Register and World Health Organization International Clinical Trials Registry Platform.Review methodsThe assessment of clinical effectiveness involved three separate systematic reviews, namely reviews of the analytical validity, the clinical validity of these tests and the clinical utility of these tests. The assessment of cost-effectiveness comprised a systematic review of full economic evaluations and the development of a de novo economic model.SettingThe perspective of the evaluation was the NHS in England and Wales.ParticipantsMen suspected of having prostate cancer for whom the results of an initial prostate biopsy were negative or equivocal.InterventionsThe use of the PCA3 score or phi in combination with existing tests (including histopathology results, prostate-specific antigen level and digital rectal examination), multiparametric magnetic resonance imaging and clinical judgement.ResultsIn addition to documents published by the manufacturers, six studies were identified for inclusion in the analytical validity review. The review identified issues concerning the precision of the PCA3 assay measurements. It also highlighted issues relating to the storage requirements and stability of samples intended for analysis using the phi assay. Fifteen studies met the inclusion criteria for the clinical validity review. These studies reported results for 10 different clinical comparisons. There was insufficient evidence to enable the identification of appropriate test threshold values for use in a clinical setting. In addition, the implications of adding either the PCA3 assay or the phi to clinical assessment were not clear. Furthermore, the addition of the PCA3 assay or the phi to clinical assessment plus magnetic resonance imaging was not found to improve discrimination. No published papers met the inclusion criteria for either the clinical utility review or the cost-effectiveness review. The results from the cost-effectiveness analyses indicated that using either the PCA3 assay or the phi in the NHS was not cost-effective.LimitationsThe main limitations of the systematic review of clinical validity are that the review conclusions are over-reliant on findings from one study, the descriptions of clinical assessment vary widely within reviewed studies and many of the reported results for the clinical validity outcomes do not include either standard errors or confidence intervals.ConclusionsThe clinical benefit of using the PCA3 assay or the phi in combination with existing tests, scans and clinical judgement has not yet been confirmed. The results from the cost-effectiveness analyses indicate that the use of these tests in the NHS would not be cost-effective.Study registrationThis study is registered as PROSPERO CRD42014009595.FundingThe National Institute for Health Research Health Technology Assessment programme.

2020 ◽  
Vol 23 (4) ◽  
pp. 615-621 ◽  
Author(s):  
Jeremy Yuen-Chun Teoh ◽  
Chi-Ho Leung ◽  
Maggie Haitian Wang ◽  
Peter Ka-Fung Chiu ◽  
Chi-Hang Yee ◽  
...  

2016 ◽  
Vol 19 (2) ◽  
pp. 153-157 ◽  
Author(s):  
Eveline A.M. Heijnsdijk ◽  
Dwight Denham ◽  
Harry J. de Koning

2020 ◽  
Author(s):  
Edna Keeney ◽  
Howard Thom ◽  
Emma Turner ◽  
Richard M Martin ◽  
Josie Morley ◽  
...  

Abstract Background There is currently no formal prostate cancer screening programme in the UK. Early detection using age-based prostate-specific antigen (PSA) testing is unlikely to be cost-effective due to limited mortality benefit and harms associated with overdetection. However, the discovery of new prostate cancer specific biomarkers and more accurate diagnostic strategies (e.g. magnetic resonance imaging (MRI)) could improve the outcomes of screening. A systematic review was conducted to assess the evidence base on cost-effectiveness of such innovations and areas for further development. Methods To identify model-based economic evaluations of screening and diagnostic tests for prostate cancer, a systematic review of the literature using the NHS Economic Evaluation Database, Medline, EMBASE, HTA databases, NICE guidelines, and UK National Screening Committee guidance was carried out, between 2009 and 2019. Relevant data were extracted on study type, model inputs, modelling methods and cost-effectiveness conclusions and the results narratively synthesized. Results Sixteen studies were included in the review. Seven studies compared the cost-effectiveness of new urinary or blood biomarkers compared to each other or the PSA test and found the biomarkers e.g. the Prostate Health Index (PHI) and SelectMDx, to be the most cost-effective. Seven studies compared newer prostate biopsy methods, including MRI-guided, to TRUS guided biopsy and found MRI-guided methods to be most cost-effective. The newer detection methods showed a reduction in unnecessary biopsies and overtreatment. However, there was uncertainty around the most cost-effective pathway of follow-up strategies (MRI/biomarkers) in men who have a negative initial biopsy. Many studies did not model stage or grade of cancer, cancer progression or the entire testing, screening and treatment pathway. Very few studies fully accounted for uncertainty in their analysis. Conclusions This review brings together the cost-effectiveness literature for novel screening and testing methods used in the diagnosis of prostate cancer. Several limitations of the published models were identified. The models generally either compared new biomarkers or new imaging techniques which highlights the importance of future work in this area, as biomarkers and imaging are likely to be used in combination.


2016 ◽  
Vol 20 (24) ◽  
pp. 1-486 ◽  
Author(s):  
Elizabeth Thurgar ◽  
Samantha Barton ◽  
Charlotta Karner ◽  
Steven J Edwards

BackgroundTypically occurring on the external genitalia, anogenital warts (AGWs) are benign epithelial skin lesions caused by human papillomavirus infection. AGWs are usually painless but can be unsightly and physically uncomfortable, and affected people might experience psychological distress. The evidence base on the clinical effectiveness and cost-effectiveness of treatments for AGWs is limited.ObjectivesTo systematically review the evidence on the clinical effectiveness of medical and surgical treatments for AGWs and to develop an economic model to estimate the cost-effectiveness of the treatments.Data sourcesElectronic databases (MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library databases and Web of Science) were searched from inception (or January 2000 for Web of Science) to September 2014. Bibliographies of relevant systematic reviews were hand-searched to identify potentially relevant studies. The World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov were searched for ongoing and planned studies.Review methodsA systematic review of the clinical effectiveness literature was carried out according to standard methods and a mixed-treatment comparison (MTC) undertaken. The model implemented for each outcome was that with the lowest deviance information criterion. A de novo economic model was developed to assess cost-effectiveness from the perspective of the UK NHS. The model structure was informed through a systematic review of the economic literature and in consultation with clinical experts. Effectiveness data were obtained from the MTC. Costs were obtained from the literature and standard UK sources.ResultsOf 4232 titles and abstracts screened for inclusion in the review of clinical effectiveness, 60 randomised controlled trials (RCTs) evaluating 19 interventions were included. Analysis by MTC indicated that ablative techniques were typically more effective than topical interventions at completely clearing AGWs at the end of treatment. Podophyllotoxin 0.5% solution (Condyline®, Takeda Pharmaceutical Company Ltd; Warticon®solution, Stiefel Laboratories Ltd) was found to be the most effective topical treatment evaluated. Networks for other outcomes included fewer treatments, which restrict conclusions on the comparative effectiveness of interventions. In total, 84 treatment strategies were assessed using the economic model. Podophyllotoxin 0.5% solution first line followed by carbon dioxide (CO2) laser therapy second line if AGWs did not clear was most likely to be considered a cost-effective use of resources at a willingness to pay of £20,000–30,000 per additional quality-adjusted life-year gained. The result was robust to most sensitivity analyses conducted.LimitationsLimited reporting in identified studies of baseline characteristics for the enrolled population generates uncertainty around the comparability of the study populations and therefore the generalisability of the results to clinical practice. Subgroup analyses were planned based on type, number and size of AGWs, all of which are factors thought to influence treatment effect. Lack of data on clinical effectiveness based on these characteristics precluded analysis of the differential effects of treatments in the subgroups of interest. Despite identification of 60 studies, most comparisons in the MTC are informed by only one RCT. Additionally, lack of head-to-head RCTs comparing key treatments, together with minimal reporting of results in some studies, precluded comprehensive analysis of all treatments for AGWs.ConclusionsThe results generated by the MTC are in agreement with consensus opinion that ablative techniques are clinically more effective at completely clearing AGWs after treatment. However, the evidence base informing the MTC is limited. A head-to-head RCT that evaluates the comparative effectiveness of interventions used in clinical practice would help to discern the potential advantages and disadvantages of the individual treatments. The results of the economic analysis suggest that podophyllotoxin 0.5% solution is likely to represent a cost-effective first-line treatment option. More expensive effective treatments, such as CO2laser therapy or surgery, may represent cost-effective second-line treatment options. No treatment and podophyllin are unlikely to be considered cost-effective treatment options. There is uncertainty around the cost-effectiveness of treatment with imiquimod, trichloroacetic acid and cryotherapy.Study registrationThis study is registered as PROSPERO CRD42013005457.FundingThe National Institute for Health Research Health Technology Assessment programme.


2020 ◽  
Vol 10 ◽  
Author(s):  
Da Huang ◽  
Xiaoqun Yang ◽  
Yishuo Wu ◽  
Xiaoling Lin ◽  
Danfeng Xu ◽  
...  

BackgroundClinical studies have suggested that prostate health index (phi) outperforms prostate-specific antigen (PSA) tests in prostate cancer detection. The cost-effectiveness of phi with different cutoffs is poorly understood in the context of decision making for prostate biopsy.MethodsIn a multicenter cohort, 3,348 men with elevated total PSA (tPSA) underwent initial prostate biopsy from August 2013 to May 2019. We constructed a decision model to evaluate the incremental cost-effectiveness ratios of different phi cutoffs. Total costs and reimbursement payments were based on the fee schedule of Shanghai Basic Medical Insurance and converted into United States dollars ($). Two willingness-to-pay thresholds were estimated as one or three times the average gross domestic product per capita of China ($7,760 or $23,279, respectively).ResultsThe total costs of prostate biopsy and PSA tests were estimated at $315 and $19, respectively. The cost of phi test varied between $72 to $130 in different medical centers. Under different phi cutoffs (from 23 to 35), phi test predicted reductions of 420 (21.7%) to 972 (50.2%) in unnecessary biopsies, with a total gain of 23.77–57.58 quality adjusted life-years compared to PSA tests. All the cutoffs would be cost-effective for patients with tPSA levels of 2–10 ng/ml. Applying 27 as the cutoff was cost-effective for each tPSA range, with missing positive cases ranging from 11 (3.4%) to 33 (11.5%).ConclusionsUsing phi test was cost-effective in the decision-making process for initial prostate biopsy, especially for patients with tPSA values between 2–10 ng/ml. The phi cutoff of 27 was cost-effective regardless of tPSA ranges and should be recommended from a health-economic perspective.


2018 ◽  
Vol 44 (5) ◽  
pp. E2 ◽  
Author(s):  
Won Hyung A. Ryu ◽  
Michael M. H. Yang ◽  
Sandeep Muram ◽  
W. Bradley Jacobs ◽  
Steven Casha ◽  
...  

OBJECTIVEAs the cost of health care continues to increase, there is a growing emphasis on evaluating the relative economic value of treatment options to guide resource allocation. The objective of this systematic review was to evaluate the current evidence regarding the cost-effectiveness of cranial neurosurgery procedures.METHODSThe authors performed a systematic review of the literature using PubMed, EMBASE, and the Cochrane Library, focusing on themes of economic evaluation and cranial neurosurgery following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Included studies were publications of cost-effectiveness analysis or cost-utility analysis between 1995 and 2017 in which health utility outcomes in life years (LYs), quality-adjusted life years (QALYs), or disability-adjusted life years (DALYs) were used. Three independent reviewers conducted the study appraisal, data abstraction, and quality assessment, with differences resolved by consensus discussion.RESULTSIn total, 3485 citations were reviewed, with 53 studies meeting the inclusion criteria. Of those, 34 studies were published in the last 5 years. The most common subspecialty focus was cerebrovascular (32%), followed by neurooncology (26%) and functional neurosurgery (24%). Twenty-eight (53%) studies, using a willingness to pay threshold of US$50,000 per QALY or LY, found a specific surgical treatment to be cost-effective. In addition, there were 11 (21%) studies that found a specific surgical option to be economically dominant (both cost saving and having superior outcome), including endovascular thrombectomy for acute ischemic stroke, epilepsy surgery for drug-refractory epilepsy, and endoscopic pituitary tumor resection.CONCLUSIONSThere is an increasing number of cost-effectiveness studies in cranial neurosurgery, especially within the last 5 years. Although there are numerous procedures, such as endovascular thrombectomy for acute ischemic stroke, that have been conclusively proven to be cost-effective, there remain promising interventions in current practice that have yet to meet cost-effectiveness thresholds.


2014 ◽  
Vol 30 (3) ◽  
pp. 273-281 ◽  
Author(s):  
Davide Minniti ◽  
Ottavio Davini ◽  
Maria Rosaria Gualano ◽  
Maria Michela Gianino

Objectives:The study question was whether dual-energy X-ray absorptiometry (DXA) alone is more cost-effective for identifying postmenopausal women with osteoporosis than a two-step procedure with quantitative ultrasound sonography (QUS) plus DXA. To answer this question, a systematic review was performed.Methods:Electronic databases (PubMed, INAHTA, Health Evidence Network, NIHR, the Health Technology Assessment program, the NHS Economic Evaluation Database, Research Papers in Economics, Web of Science, Scopus, and EconLit) were searched for cost-effectiveness publications. Two independent reviewers selected eligible publications based on the inclusion/exclusion criteria. Quality assessment of economic evaluations was undertaken using the Drummond checklist.Results:Seven journal articles and four reports were reviewed. The cost per true positive case diagnosed by DXA was found to be higher than that for diagnosis by QUS+DXA in two articles. In one article it was found to be lower. In three studies, the results were not conclusive. These articles were characterized by the differences in the types of devices, parameters and thresholds on the QUS and DXA tests and the unit costs of the DXA and QUS tests as well as by variability in the sensitivity and specificity of the techniques and the prevalence of osteoporosis.Conclusions:The publications reviewed did not provide clear-cut evidence for drawing conclusions about which screening test may be more cost-effective for identifying postmenopausal women with osteoporosis.


2013 ◽  
Vol 29 (3) ◽  
pp. 227-233 ◽  
Author(s):  
Tim Mathes ◽  
Dawid Pieper ◽  
Sunya-Lee Antoine ◽  
Michaela Eikermann

Objectives: The objective of this systematic review was to evaluate the cost-effectiveness of interventions aiming to increase the adherence to highly active antiretroviral therapy (HAART) in HIV-infected patients in developed countries (WHO stratum A).Methods: A systematic search for comparative health economic studies was conducted in the following databases: EMBASE, MEDLINE, NHS Economic Evaluation Database, CINAHL, HEED, and EconLit. The identified publications were selected by two reviewers independently according to predefined inclusion and exclusion criteria. Furthermore, these were evaluated according to a standardized checklist and finally extracted, analyzed, and summarized.Results: After reviewing the abstracts and full texts four relevant studies were identified. Different educational programs were compared as well as the Directly Observed Therapy (DOT). A critical aspect to be considered in particular was the poor transparency of the cost data. In three cost-utility analyses the costs per quality-adjusted life-year (QALY) in the baseline scenario were each under USD 15,000. The sensitivity analyses with a presumed maximum threshold of USD 50,000/QALY showed a predominantly cost-effective result. In one study that examined DOT the costs add up to over USD 150,000/QALY.Conclusions: It seems that adherence interventions for HAART in HIV-infected patients can be cost-effective. Nevertheless, the quality of the included studies is deficient and only a few of the possible adherence interventions are taken into consideration. A final assessment of the cost-effectiveness of adherence interventions in general is, therefore, not possible.


2020 ◽  
Vol 3 ◽  
pp. 23
Author(s):  
James F. O'Mahony

Callender et al. recently published a model-based cost-effectiveness analysis of a risk-tailored approach to prostate cancer screening. It considers the costs and effects of prostate cancer screening offered to all men aged 55-69 without any risk selection and, alternatively, over a range of risk-tailored strategies in which screen eligibility is determined by a varying threshold of disease risk. The analysis finds that the strategy of screening men once they reach a 10-year absolute risk of disease of 5% or more is cost-effective in a UK context. I believe there are several problems with the study, mostly stemming from an incorrect interpretation of the cost-effectiveness estimates. I show that one reinterpretation of their results indicates that screening is much less cost-effective than the original analysis suggests, indicating that screening should be restricted to a much smaller group of higher risk men. More broadly, I explain the challenges of attempting to meaningfully reinterpret the originally published results due to the simulation of non-mutually exclusive intervention strategies. Finally, I consider the relevance of considering sufficient alternative screening intensities. This critique highlights the need for appropriate interpretation of cost-effectiveness results for policymakers, especially as risk stratification within screening becomes increasingly feasible.


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