Abstract

Background

Low specificity of prostate-specific antigen results in a considerable number of unnecessary prostate biopsies in current practice. SelectMDx® predicts significant prostate cancer upon biopsy and is used to reduce the number of unnecessary initial prostate biopsies. Furthermore, potential overtreatment of insignificant prostate cancer can be reduced. Besides the diagnostic accuracy of the test, also the context in a specific country determines the potential health benefit and cost-effectiveness. Therefore, the health benefit and cost-effectiveness of SelectMDx were assessed in France, Germany, Italy, and Spain.

Subject and methods

A decision model was used to compare the current standard of care in which men undergo initial prostate biopsy in case of an elevated prostate-specific antigen, to a strategy in which SelectMDx was used to select men for biopsy. Model inputs most relevant to each of the four countries were obtained. With use of the model long-term quality-adjusted life years (QALYs) and healthcare costs were calculated for both strategies.

Results

In all four countries, the SelectMDx resulted in QALY gain and cost savings compared with the current standard of care. In France, SelectMDx resulted in 0.022 QALYs gained and cost savings of €1217 per patient. For Germany, the model showed a QALY gain of 0.016 and a cost saving of €442. In Italy, the QALY gain and cost savings were 0.031 and €762. In Spain 0.020 QALYs were gained and €250 costs were saved.

Conclusions

The results of the model showed that with SelectMDx, QALYs could be gained while saving healthcare costs in the initial diagnosis of prostate cancer. The significant presence of overtreatment in the current standard of care in all four countries was the main factor that resulted in the beneficial outcomes with SelectMDx.

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References

  1. 1.

    Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, et al. 10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med. 2016;375:1415–24.

  2. 2.

    Catalona WJ, Smith DS, Ratliff TL, Dodds KM, Coplen DE, Yuan JJ, et al. Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med. 1991;324:1156–61.

  3. 3.

    Elabbady AA, Khedr MM. Extended 12-core prostate biopsy increases both the detection of prostate cancer and the accuracy of Gleason score. Eur Urol. 2006;49:49–53.

  4. 4.

    Nam RK, Saskin R, Lee Y, Liu Y, Law C, Klotz LH, et al. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol. 2013;189:S12–7.

  5. 5.

    Draisma G, Etzioni R, Tsodikov A, Mariotto A, Wever E, Gulati R, et al. Lead time and overdiagnosis in prostate-specific antigen screening: importance of methods and context. J Natl Cancer Inst. 2009;101:374–83.

  6. 6.

    Telesca D, Etzioni R, Gulati R. Estimating lead time and overdiagnosis associated with PSA screening from prostate cancer incidence trends. Biometrics. 2008;64:10–9.

  7. 7.

    Heijnsdijk EA, Wever EM, Auvinen A, Hugosson J, Ciatto S, Nelen V, et al. Quality-of-life effects of prostate-specific antigen screening. N Engl J Med. 2012;367:595–605.

  8. 8.

    Van Neste L, Hendriks RJ, Dijkstra S, Trooskens G, Cornel EB, Jannink SA, et al. Detection of high-grade prostate cancer using a urinary molecular biomarker-based risk score. Eur Urol. 2016;70:740–8.

  9. 9.

    Dijkstra S, Govers TM, Hendriks RJ, Schalken JA, Van Criekinge W, Van Neste L, et al. Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostics—a decision analytical model. BJU Int. 2017;120:659–65.

  10. 10.

    Mottet N, Bellmunt J, Briers E, Bolla M, Cornford P, de Santis M, et al. EAU-ESTRO-SIOG guidelines on prostate cancer. 2016;71:618–29.

  11. 11.

    Leitlinienprogramm Onkologie: Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der ver-schiedenen Stadien des Prostatakarzinoms. 2016.

  12. 12.

    FRED Economic Research: Consumer PRice Index of All Items in France. https://fred.stlouisfed.org/series/FRACPIALLMINMEI.

  13. 13.

    DE STATIS: Statistisches Bundesamt: Verbraucherpreise. https://www.destatis.de/DE/ZahlenFakten/GesamtwirtschaftUmwelt/Preise/Verbraucherpreisindizes/Tabellen_/VerbraucherpreiseKategorien.html;jsessionid=6BFE9D955963B22A8B555C5F0485BC77.cae1?cms_gtp=145110_slot%253D2&https=1.

  14. 14.

    The World Bank: Consumer Price Index Italy. http://data.worldbank.org/indicator/FP.CPI.TOTL?locations=IT.

  15. 15.

    The World Bank: Consumer Price Index Spain. https://data.worldbank.org/indicator/FP.CPI.TOTL?locations=ES.

  16. 16.

    Collège des économistes de la santé: French Guidelines for the economic evaluation of health care technologies. 2004.

  17. 17.

    Institut für Qualität und Wirschaftlichkeit im Gesundheidswesen: Institute for Quality and Efficiency in Health Care: General Methods for the Assessment of the Relation of Benefits to Costs. 2009.

  18. 18.

    Capri S, Ceci A, Terranova L, Merlo F, Mantovani L. Guidelines for economic evaluationjs in Italy: Recommendations from the Italian group of the pharmacoeconomic studies. Drug Inf J. 2001;35:189–201.

  19. 19.

    ISPOR: Pharmacoeconomic Guidelines Around the World. Published PE Recommendations Key Features: Spain. https://www.ispor.org/PEguidelines/countrydet.asp?c=20&t=4.

  20. 20.

    Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, et al. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014;370:932–42.

  21. 21.

    Johnstone PA, Rossi PJ, Jani AB, Master V. ‘Insignificant’ prostate cancer on biopsy: pathologic results from subsequent radical prostatectomy. Prostate Cancer Prostatic Dis. 2007;10:237–41.

  22. 22.

    DE STATIS: Statistisches Bundesamt: Life table: Germany, years, sex, completed age. https://www-genesis.destatis.de/genesis/online/logon?sequenz=tabelleErgebnis&selectionname=12621-0001&sachmerkmal=GES&sachschluessel=GESM&language=en.

  23. 23.

    Insitut National D'Études Démographiques. Mortality rates by sex and age. http://www.ined.fr/en/everything_about_population/data/france/deaths-causes-mortality/mortality-rates-sex-age/.

  24. 24.

    I.Stat: Italian Statistics. http://dati.istat.it/Index.aspx.

  25. 25.

    National Statistics Institute. Mortality Tables for the population of Spain 2013. http://www.ine.es/jaxi/tabla.do?path=/t20/p319a/serie/p01/l1/&file=01001.px&type=pcaxis&L=1.

  26. 26.

    Watts S, Leydon G, Eyles C, Moore CM, Richardson A, Birch B, et al. A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance. BMJ Open. 2015;5:e006674.

  27. 27.

    Bellardita L, Valdagni R, van den Bergh R, Randsdorp H, Repetto C, Venderbos LDF, et al. How does active surveillance for prostate cancer affect quality of life? a systematic review. Eur Urol. 2015;67:637–45.

  28. 28.

    Bokhorst LP, Valdagni R, Rannikko A, Kakehi Y, Pickles T, Bangma CH, et al. A decade of active surveillance in the prias study: an update and evaluation of the criteria used to recommend a switch to active treatment. Eur Urol. 2016;70:954–60.

  29. 29.

    Tosoian JJ, Carter HB, Lepor A, Loeb S. Active surveillance for prostate cancer: current evidence and contemporary state of practice. Nat Rev Urol. 2016;13:205.

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Author information

Author notes

  1. These authors contributed equally: Tim M. Govers and Daphne Hessels.

Affiliations

  1. MedValue, Nijmegen, The Netherlands

    • Tim M. Govers
  2. MDxHealth BV, Nijmegen, The Netherlands

    • Daphne Hessels
  3. Medical Unit of Molecular Oncology and Transfer, Department of Biochemistry and Molecular Biology, University Hospital of Lyon-Sud, Hospices Civils of Lyon, Lyon, France

    • Virginie Vlaeminck-Guillem
  4. Cancer Research Centre of Lyon, U1052 INSERM, CNRS 5286, Léon Bérard Centre, Lyon I University, Lyon, France

    • Virginie Vlaeminck-Guillem
  5. BSD: Urologie24, Nuremberg and Dept. of Urology, Friedrich-Alexander University, Erlangen, Germany

    • Bernd J. Schmitz-Dräger
  6. Department of Urology, Ludwig Maximilians-Universität München, Munich, Germany

    • Christian G. Stief
  7. Urology department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain

    • Claudio Martinez-Ballesteros
  8. Division of Urology, European Institute of Oncology, Milan, Italy

    • Matteo Ferro
  9. Department of Urology, Hospital Universitatio Miguel Servet, IIS-Aragón, Zaragoza, Spain

    • Angel Borque-Fernando
  10. Department of Urology, Fundación instituto Valenciano, de oncología, Valencia, Spain

    • Jose Rubio-Briones
  11. Department of Urology, Radboudumc, Nijmegen, The Netherlands

    • J. P. Michiel Sedelaar
  12. Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium

    • Wim van Criekinge
  13. Department of Urology, Radboudumc, Nijmegen, The Netherlands

    • Jack A. Schalken

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Funding

MDxHealth financially supported this study. Tim Govers performs consultancy work for MDxHealth. Daphne Hessels, Wim van Criekinge, and Jack Schalken are employees or advisors to MDxhealth and may have stock options.

Corresponding author

Correspondence to Tim M. Govers.

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DOI

https://doi.org/10.1038/s41391-018-0076-3