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KMID : 1142220230180020161
Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 2 p.161 ~ p.169
Multiple Myeloma Treatment Realities: Examining Current Treatments and Exploring Clinical Characteristics Using Population-based Real-World Data
Kim Yei-Jin

Kang Ka-Won
Suh Hae-Sun
Abstract
Multiple myeloma (MM) is a blood cancer characterized by the abnormal proliferation of plasma cells, and its prevalence is increasing in Korea due to an aging population. Although MM shows challenges with frequent relapses, developments in innovative medications have significantly improved survival rates. In 2019, daratumumab was approved for reimbursement as a fourth-line treatment by the Korean National Health Insurance (NHI). This study aimed to examine the current MM drugs covered by NHI benefits and explore the demographic and clinical characteristics of patients receiving fourth-line treatment. We divided the subjects into two groups based on whether they used daratumumab in the fourth line or later using Health Insurance Review and Assessment Service claims data. The final study cohort comprised 601 patients in the daratumumab treatment group (Dara) and 1,141 patients in the non-daratumumab treatment group (Non-dara). There were significant differences between the two groups, including average age at the time of the fourth treatment, comorbidities, and prior treatment drugs. For both groups, bortezomib was the most frequently used drug during the first to third lines of treatment (Dara: 94.34%; Non-dara: 96.49%). Additionally, higher rates of liver disease (Dara: 34.78%; Non-dara: 29.80%) and cardiovascular disease (Dara: 24.46%; Non-dara: 19.54%) were seen in the daratumumab treatment group. The results implied a close relationship between MM treatment in actual settings and reimbursement criteria in Korea. Recognizing the pivotal role of real-world data in regulatory science across pharmaceutical life cycles, our findings contribute valuable insights. This study will serve as foundational data for decision-making about MM, which is becoming more prevalent in Korea.
KEYWORD
Multiple Myeloma, Real-World Data, Treatment Patterns, Reimbursement
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