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Patient Accessibility and Budget Impact of Orphan Drugs in South Korea: Long-Term and Real-World Data Analysis (2007–2019)

Author

Listed:
  • Se Hee Lee

    (College of Pharmacy, Sookmyung Women’s University, Seoul 04310, Korea
    These authors contributed equally to this work.)

  • Seung-Lai Yoo

    (Department of Insurance Benefits, National Health Insurance, Wonju 26464, Korea
    These authors contributed equally to this work.)

  • Joon Seok Bang

    (College of Pharmacy, Sookmyung Women’s University, Seoul 04310, Korea)

  • Jong Hyuk Lee

    (Department of Pharmaceutical Engineering, Hoseo University, Asan 32499, Korea)

Abstract

This study aimed to identify orphan drug accessibility and impact on pharmaceutical budgets in South Korea by analyzing the status of orphan drug designation, approval, reimbursement, and pharmaceutical expenditure. We analyzed the dataset on orphan drugs designated, approved, and reimbursed from 2007 to 2019 based on long-term real-world data. The designated and approved orphan drugs were 165 and 156, respectively, and 88 out of 156 approved products were reimbursed. Total expenditure on orphan drugs increased annually to account for about 1.44% of total pharmaceutical expenditure in 2018. Orphan drug expenditure per patient increased on average by 8.7% per year. The average annual cost of orphan drugs was USD 27,000–USD 47,000, with the maximum value of USD 260,000–USD 560,000. As there are a number of orphan drugs that have not yet been reimbursable after approval, a reimbursement policy should be established that considers the characteristics of orphan drugs. Since the rapid increase in orphan drug expenditure can be a potential threat to the insurance budget, budget management should also be considered. In conclusion, it is necessary to take preemptive measures to manage the health insurance budget efficiently while improving patient accessibility to orphan drugs.

Suggested Citation

  • Se Hee Lee & Seung-Lai Yoo & Joon Seok Bang & Jong Hyuk Lee, 2020. "Patient Accessibility and Budget Impact of Orphan Drugs in South Korea: Long-Term and Real-World Data Analysis (2007–2019)," IJERPH, MDPI, vol. 17(9), pages 1-8, April.
    • Handle: RePEc:gam:jijerp:v:17:y:2020:i:9:p:2991-:d:350502
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    References listed on IDEAS

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    1. Todd Gammie & Christine Y Lu & Zaheer Ud-Din Babar, 2015. "Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries," PLOS ONE, Public Library of Science, vol. 10(10), pages 1-24, October.
    2. Bae, Eun-Young & Hong, Ji-Min & Kwon, Hye-Young & Jang, Suhyun & Lee, Hye-Jae & Bae, SeungJin & Yang, Bong-Min, 2016. "Eight-year experience of using HTA in drug reimbursement: South Korea," Health Policy, Elsevier, vol. 120(6), pages 612-620.
    3. Seung-Lai Yoo & Dae-Jung Kim & Seung-Mi Lee & Won-Gu Kang & Sang-Yoon Kim & Jong Hyuk Lee & Dong-Churl Suh, 2019. "Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System," IJERPH, MDPI, vol. 16(2), pages 1-15, January.
    4. Carl Blankart & Tom Stargardt & Jonas Schreyögg, 2011. "Availability of and Access to Orphan Drugs," PharmacoEconomics, Springer, vol. 29(1), pages 63-82, January.
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