건강보험청구데이터를 이용한 2012-2021년 바이오시밀러 사용량 및 약품비 분석
Trends in Biosimilar Utilization and Expenditure in South Korea: Using Korean National Insurance Claims Data From 2012–2021
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Objectives: This study aimed to investigate the trends in insurance-reimbursed biologics using the Korean National Health Insurance Claims Database (KNHICD) from 2012 to 2021. Methods: We analyzed the utilization, expenditure, and market share of listed biologics, which were classified as original, original line extension, biosimilar, and biosimilar line extension. Utilization was calculated using treatment days (TDs) defined as the dose of the active ingredient of the biologics divided by daily defined dose. Results: Total expenditure of biologics increased approximately doubled from KRW 279.3 billion in 2012 to KRW 533.6 billion in 2021, and utilization increased approximately 2.5 times from 13.4 million TDs in 2012 to 34.3 million TDs in 2021. The expenditures and utilization of originals have decreased since 2017, while those of biosimilars and original line extension have increased. For immunosuppressants, the proportion of original decreased the most, but original line extension filled the gap. For anticancer agents, reimbursement for biosimilars have caused in a decrease in the proportion of original line extension, which had been increasing previously. The market shares of other treatment agents biosimilar was lower than the other treatment group. The utilization of biosimilars varies by treatment agents group, depending on the prescription classifications, medical institution type, medical department. Conclusion: The annual total expenditure and utilization of biologics are increasing gradually. However, the expenditure on originals for most treatment types decreased after biosimilars were included in insurance coverage. These results demonstrate the market substitute effect of biosimilars and the potential financial savings of health insurance due to the increasing proportion of utilization and expenditures for biosimilars accompanied by decreasing utilization and expenditures for original biologics. Meanwhile, original line extensions have been developed to maintain a portion of the market share against biosimilars. Reflecting these findings, appropriate policies are needed to promote the rational use of biologics.
Abstract
Objectives: This study aimed to investigate the trends in insurance-reimbursed biologics using the Korean National Health Insurance Claims Database (KNHICD) from 2012 to 2021. Methods: We analyzed the utilization, expenditure, and market share of listed biologics, which were classified as original, original line extension, biosimilar, and biosimilar line extension. Utilization was calculated using treatment days (TDs) defined as the dose of the active ingredient of the biologics divided by daily defined dose. Results: Total expenditure of biologics increased approximately doubled from KRW 279.3 billion in 2012 to KRW 533.6 billion in 2021, and utilization increased approximately 2.5 times from 13.4 million TDs in 2012 to 34.3 million TDs in 2021. The expenditures and utilization of originals have decreased since 2017, while those of biosimilars and original line extension have increased. For immunosuppressants, the proportion of original decreased the most, but original line extension filled the gap. For anticancer agents, reimbursement for biosimilars have caused in a decrease in the proportion of original line extension, which had been increasing previously. The market shares of other treatment agents biosimilar was lower than the other treatment group. The utilization of biosimilars varies by treatment agents group, depending on the prescription classifications, medical institution type, medical department. Conclusion: The annual total expenditure and utilization of biologics are increasing gradually. However, the expenditure on originals for most treatment types decreased after biosimilars were included in insurance coverage. These results demonstrate the market substitute effect of biosimilars and the potential financial savings of health insurance due to the increasing proportion of utilization and expenditures for biosimilars accompanied by decreasing utilization and expenditures for original biologics. Meanwhile, original line extensions have been developed to maintain a portion of the market share against biosimilars. Reflecting these findings, appropriate policies are needed to promote the rational use of biologics.
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