Christian Siegfried, Miyuru Amarapala, Xavier Leleu, Lauren Fusfeld
{"title":"Using QIP-MS to Guide the Timing of MRD Testing in Patients With Multiple Myeloma: A Budget Impact Analysis From the French Payer Perspective.","authors":"Christian Siegfried, Miyuru Amarapala, Xavier Leleu, Lauren Fusfeld","doi":"10.2147/CEOR.S498848","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Serum or urine protein electrophoresis (SPEP or UPEP) and immunofixation electrophoresis (SIFE or UIFE) are routinely used to detect M-proteins in MM patients. However, SPEP and SIFE are not sensitive enough to measure M-protein levels that are low but still clinically significant. This study aimed to evaluate the potential cost savings associated with using the EXENT GAM Assay, a serum-based quantitative-immunoprecipitation mass spectrometry (QIP-MS) diagnostic test instead of SIFE to guide the timing of minimal residual disease (MRD) testing for patients with multiple myeloma (MM).</p><p><strong>Patients and methods: </strong>A simple 2-year budget impact model was created in Excel using data from MM clinical trials and fee schedules. Patients are tested with either QIP-MS or SIFE at predetermined timepoints. If patients test negative, they will receive MRD testing. The result of the MRD test will determine if the preceding serum-based test was a true negative result (MRD test is negative) or a false negative result (MRD test is positive). Patients receiving autologous stem cell transplant (henceforth referred to as transplant) and those not receiving transplant are both eligible for one MRD test per year. MRD testing for transplant-eligible patients occurs prior to transplant and one year following transplant.</p><p><strong>Results: </strong>Across a hypothetical population of 5154 mm patients receiving 1<sup>st</sup>-line treatment in France, using QIP-MS instead of SIFE prior to MRD testing leads to 1973 fewer false negative results and 744 more false positive results (due, in part, to the detection of residual IgG). Net savings per QIP-MS test would be €260 or total savings of €2,481,832.</p><p><strong>Conclusion: </strong>This study suggests that the use of QIP-MS prior to MRD testing may be cost-saving for testing French patients with MM.</p>","PeriodicalId":47313,"journal":{"name":"ClinicoEconomics and Outcomes Research","volume":"17 ","pages":"107-114"},"PeriodicalIF":2.1000,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11849414/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ClinicoEconomics and Outcomes Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/CEOR.S498848","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: Serum or urine protein electrophoresis (SPEP or UPEP) and immunofixation electrophoresis (SIFE or UIFE) are routinely used to detect M-proteins in MM patients. However, SPEP and SIFE are not sensitive enough to measure M-protein levels that are low but still clinically significant. This study aimed to evaluate the potential cost savings associated with using the EXENT GAM Assay, a serum-based quantitative-immunoprecipitation mass spectrometry (QIP-MS) diagnostic test instead of SIFE to guide the timing of minimal residual disease (MRD) testing for patients with multiple myeloma (MM).
Patients and methods: A simple 2-year budget impact model was created in Excel using data from MM clinical trials and fee schedules. Patients are tested with either QIP-MS or SIFE at predetermined timepoints. If patients test negative, they will receive MRD testing. The result of the MRD test will determine if the preceding serum-based test was a true negative result (MRD test is negative) or a false negative result (MRD test is positive). Patients receiving autologous stem cell transplant (henceforth referred to as transplant) and those not receiving transplant are both eligible for one MRD test per year. MRD testing for transplant-eligible patients occurs prior to transplant and one year following transplant.
Results: Across a hypothetical population of 5154 mm patients receiving 1st-line treatment in France, using QIP-MS instead of SIFE prior to MRD testing leads to 1973 fewer false negative results and 744 more false positive results (due, in part, to the detection of residual IgG). Net savings per QIP-MS test would be €260 or total savings of €2,481,832.
Conclusion: This study suggests that the use of QIP-MS prior to MRD testing may be cost-saving for testing French patients with MM.