A Real-World Analysis of Patientswith Triple Class Exposed Multiple Myeloma in Italy: Epidemiology Estimates, Treatment Pattern and Economic Burden

ABSTRACT
OBJECTIVES: This research aimed to provide updated epidemiological estimates of multiple myeloma (MM) in Italy and
to characterize the clinical journey, treatment patterns, and economic burden focusing specifically on the subset of patients
who have been exposed to all three major therapeutic classes: proteasome inhibitors, immunomodulatory drugs, and anti-
CD38 monoclonal antibodies (triple-class exposed, TCE).
METHODS: A retrospective analysis was conducted using Italian healthcare administrative databases covering 12 million
individuals. The research included (i) an epidemiological analysis of MM prevalence and incidence, and (ii) a longitudinal
analysis of TCE patients identified between January 2017 and June 2023. Inclusion criteria required exposure to the three
major MM drug classes. Healthcare resource utilization (HCRU) and direct costs from the Italian National Health Service
perspective were assessed at one-year follow-up.
RESULTS: As of August 2022, MM incidence was 9/100,000 and prevalence 40.9/100,000; TCE prevalence was estimated
at 4.1/100,000, projecting to 2,557 TCE patients in Italy. From 6,102 MM patients, 894 were identified as TCE; 887 had
sufficient follow-up for inclusion. TCE patients had a mean age of 67 years and a mild comorbidity burden (Charlson Index
= 0.7). Among 309 recent TCE cases (2022–2023), 35.6% became TCE in first-line therapy and 46.5% in second-line.
HCRU analysis (n=461) showed high service use, with annual per-patient costs averaging €119,899—88% attributable to
MM-related drugs.
CONCLUSIONS: This real-world analysis highlights a growing population of TCE MM patients in Italy, with increasing
exposure to combination therapies earlier in treatment. The findings underscore the substantial clinical and economic
burden posed by this population, reinforcing the need for novel therapeutic options to improve outcomes and manage costs
within the healthcare system.