EARLY ECONOMIC AND PATHWAY IMPACT OF INCORPORATING NOVEL MASS SPECTROMETRY-BASED TESTING INTO TREATMENT RESPONSE ASSESSMENT FOR MULTIPLE MYELOMA
Author(s)
Teofilo Borunda Duque, PharmD, MS1, Nick Paciaroni, PhD1, Gregory Price, MPH1, Stefan Leichtl, PhD2, Christian Suharlim, MPH, MD1.
1Thermo Fisher Scientific, Waltham, MA, USA, 2Thermo Fisher Scientific (BRAHMS GmbH), Hennigsdorf, Germany.
1Thermo Fisher Scientific, Waltham, MA, USA, 2Thermo Fisher Scientific (BRAHMS GmbH), Hennigsdorf, Germany.
OBJECTIVES: In multiple myeloma (MM), response assessment includes conventional monoclonal protein testing with immunofixation electrophoresis (IFE); bone marrow evaluation is performed in IFE-negative patients to confirm deep response, such as complete or stringent complete response (CR/sCR). However, bone marrow biopsy imposes patient, caregiver, and healthcare burden. Novel MALDI-TOF mass spectrometry (MS)-based testing can detect monoclonal protein below IFE threshold and may optimize biopsy timing. This study evaluated the pathway and economic impact of incorporating MS into CR/sCR confirmation following contemporary MM therapy.
METHODS: A decision-tree model compared three response assessment pathways: conventional IFE-guided biopsy, reflex MS testing after negative IFE, and an additional MS-only sensitivity analysis. In the reflex and MS-only pathways, biopsy was performed for MS-negative patients with suspected CR/sCR and deferred for MS-positive patients. Clinical inputs were obtained from global trials and real-world studies (CEPHEUS, MAIA, IMROZ, GEM2012MENOS65). Scenario analyses varied response rates, biopsy costs, and the proportion of deferred biopsies ultimately avoided. US CPT Medicare reimbursement rates were used to estimate cost-neutral MS prices in headroom analyses across biopsy-avoidance scenarios.
RESULTS: Overall, 73.4% achieved IFE negativity. Per 1,000 IFE-negative patients scheduled for biopsy, the reflex MS-based pathway identified 16.5% as MS-positive and deferred 165 biopsies. Across biopsy-avoidance scenarios, this translated to 99 avoided biopsies per 1,000 biopsy-scheduled patients [range 83-132]. US payer cost-neutral headroom is $294 [range: $245-$392], although this estimate may be conservative because not all cost offsets were captured. Findings remained directionally consistent across alternative pathways, response rates, and country-specific cost assumptions.
CONCLUSIONS: Results suggest that incorporating MS in MM response assessment may improve efficiency by reducing premature bone marrow evaluations, lowering healthcare resource utilization, and decreasing biopsy-related burden for patients and caregivers. MS testing appears feasible when the expected test price remains below modeled payer cost-neutrality thresholds. Prospective studies are needed to confirm these findings in real-world practice.
METHODS: A decision-tree model compared three response assessment pathways: conventional IFE-guided biopsy, reflex MS testing after negative IFE, and an additional MS-only sensitivity analysis. In the reflex and MS-only pathways, biopsy was performed for MS-negative patients with suspected CR/sCR and deferred for MS-positive patients. Clinical inputs were obtained from global trials and real-world studies (CEPHEUS, MAIA, IMROZ, GEM2012MENOS65). Scenario analyses varied response rates, biopsy costs, and the proportion of deferred biopsies ultimately avoided. US CPT Medicare reimbursement rates were used to estimate cost-neutral MS prices in headroom analyses across biopsy-avoidance scenarios.
RESULTS: Overall, 73.4% achieved IFE negativity. Per 1,000 IFE-negative patients scheduled for biopsy, the reflex MS-based pathway identified 16.5% as MS-positive and deferred 165 biopsies. Across biopsy-avoidance scenarios, this translated to 99 avoided biopsies per 1,000 biopsy-scheduled patients [range 83-132]. US payer cost-neutral headroom is $294 [range: $245-$392], although this estimate may be conservative because not all cost offsets were captured. Findings remained directionally consistent across alternative pathways, response rates, and country-specific cost assumptions.
CONCLUSIONS: Results suggest that incorporating MS in MM response assessment may improve efficiency by reducing premature bone marrow evaluations, lowering healthcare resource utilization, and decreasing biopsy-related burden for patients and caregivers. MS testing appears feasible when the expected test price remains below modeled payer cost-neutrality thresholds. Prospective studies are needed to confirm these findings in real-world practice.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE240
Topic
Economic Evaluation
Topic Subcategory
Thresholds & Opportunity Cost
Disease
Oncology