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약제의 신규등재 절차와 급여기준 관리

New Drug Listing Process and Reimbursement Standard Management

  • 배윤경 (건강보험심사평가원 약제관리실) ;
  • 유미영 (건강보험심사평가원 약제관리실)
  • Yoon Kyeong Bai (Department of Pharmaceutical Benefits, Health Insurance Review and Assessment Service) ;
  • Mi-Young You (Department of Pharmaceutical Benefits, Health Insurance Review and Assessment Service)
  • 투고 : 2023.08.11
  • 심사 : 2023.08.17
  • 발행 : 2023.08.20

초록

The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

키워드

참고문헌

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  2. 국민건강보험 요양급여의 기준에 관한 규칙 제10조2. https://www.law.go.kr/LSW/lsSc.do?section=&menuId=1&subMenuId=15&tabMenuId=81&eventGubun=060101&query=국민건강보험+요양급여의+기준에+관한+규칙#undefined (accessed Aug 11, 2023).
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  8. 암환자에게 처방.투약하는 약제에 대한 요양급여의 적용기준 및 방법에 관한 세부사항(심평원장 공고). https://www.hira.or.kr/ebooksc/ebook_702/ebook_702_202210040427096360.pdf (accessed Aug 11, 2023).