Tim M Govers1, Daphne Hessels2, Virginie Vlaeminck-Guillem3,4, Bernd J Schmitz-Dräger5, Christian G Stief6, Claudio Martinez-Ballesteros7, Matteo Ferro8, Angel Borque-Fernando9, Jose Rubio-Briones10, J P Michiel Sedelaar11, Wim van Criekinge12, Jack A Schalken11. 1. MedValue, Nijmegen, The Netherlands. Tim.Govers@radboudumc.nl. 2. MDxHealth BV, Nijmegen, The Netherlands. 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. 4. Cancer Research Centre of Lyon, U1052 INSERM, CNRS 5286, Léon Bérard Centre, Lyon I University, Lyon, France. 5. BSD: Urologie24, Nuremberg and Dept. of Urology, Friedrich-Alexander University, Erlangen, Germany. 6. Department of Urology, Ludwig Maximilians-Universität München, Munich, Germany. 7. Urology department, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain. 8. Division of Urology, European Institute of Oncology, Milan, Italy. 9. Department of Urology, Hospital Universitatio Miguel Servet, IIS-Aragón, Zaragoza, Spain. 10. Department of Urology, Fundación instituto Valenciano, de oncología, Valencia, Spain. 11. Department of Urology, Radboudumc, Nijmegen, The Netherlands. 12. Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium.
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.
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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