본문 바로가기
KERD
논문KCI 등재

환자의 신약 접근성 강화 정책 제안

Policy Suggestions to Improve Patient Access to New Drugs in Korea

2

조회

0

다운로드

1

인용

0

참고문헌

키워드

주제분류약학

초록

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

Abstract

Objective: This study aimed to overview and assess the effectiveness of the policies and regulations that have governed new drug access in Korea, and to propose policies to enhance patient access to drugs, particularly for new innovative medicines. Methods: We approached drug access issues in two perspectives: approval lag (or availability) and reimbursement lag (or affordability). The issues were identified and evaluated through the review of literature, public documents, reports published by the government agencies and private organizations, and news articles. Results: To shorten approval lag, it is recommended to hire and train more reviewers at the Ministry of Food and Drug Safety. Increasing user fees to a realistic level can facilitate this process. To reduce reimbursement lag, flexible incremental cost-effectiveness ratio threshold, alternative cost-effectiveness evaluation, and establishment of funding source other than the national health insurance are identified as the areas to be improved. Conclusion: The current policies and regulations had to be supplemented by new systems to drastically promote patient accessibility to new drugs, consequently in order to promote national public health.

참고문헌 (50)

  1. 이태진, "의약품 보험 급여 및 가격 결정과 경제성 평가의 활용", 예방의학회지, 41(2), pp.69~73 (2008), 대한예방의학회
  2. Yoo SL, "Improving patient access to new drugs in South Korea : Evaluation of the national drug formulary system", Int J Environ Res Public Health, 16(2), pp.288~ (2019)
  3. Ha D, "A comparative analysis of the impact of a positive list system on new chemical entity drugs and incrementally modified drugs in South Korea", Clin Ther, 33(7), pp.926~932 (2011)
  4. Hogerzeil HV, "The concept of essential medicines : lessons for rich countries", BMJ, 329(7475), pp.1169~1172 (2004)
  5. Wiedenmayer K, "Managing Pharmaceuticals in International Health", pp.19~31 (2004), Birkhäuser
  6. "Monitoring the building blocks of health systems: A handbook of indicators and their measurement strategies"[URL]
  7. Kwon HY, "Availability and affordability of drugs with a conditional approval by the European Medicines Agency; comparison of Korea with other countries and the implications", Front Pharmacol, 9, pp.938~ (2018)
  8. Frank R. Lichtenberg, "The Health Impact of, and access to, New Drugs in Korea", East Asian Economic Review, 24(2), pp.127~164 (2020), 대외경제정책연구원[DOI]
  9. Kim ES, "The effect of policies for improving the access to new medicine: A retrospective analysis in 2007-2016", Ph.D, pp.2016
  10. "The United States vs. Other Countries: Availability of New Medicines Varies"[URL]
  11. "The United States vs. Other Countries: Availability of Cancer Medicines Varies"[URL]
  12. 김유진, "의약품 접근성 향상을 위한 방안 고찰", 한국임상약학회지, 28(1), pp.40~50 (2018), 한국임상약학회[DOI]
  13. Andersson F, "The Drug Lag Issue : The debate seen from an international perspective", Int J Health Serv, 22(1), pp.53~72 (1992)
  14. Okabayashi S, "Drug lag for inflammatory bowel disease treatments in the East and West", Inflamm Intest Dis, 3(1), pp.25~31 (2018)
  15. Lee SW, "Notable differences in drug lag between Korea and Japan of new drugs between 2009 and 2017", Ther Innov Regul Sci, 54(2), pp.418~423 (2020)
  16. "Step 4: FDA Drug Review"[URL]
  17. "CDER Approval Times for Priority and Standard NDAs and BLAs Calendar Years 1993 – 2015"[URL]
  18. "Increase user fee, planning to recruit '87+a' drug approval review personnel"[URL]
  19. "Review report on the 2020 budget plan revenue and expenditure under the jurisdiction of the Ministry of Food and Drug Safety"[URL]
  20. "2018 Drug Approval Report"[URL]
  21. "A Study on the Improvement of the Legal System for the Development of Advanced Biopharmaceuticals Regulatory System"[URL]
  22. 최혜영, "한국의 신약 허가기간에 대한 조사 연구(2011~2017년)", 약 학 회 지, 64(1), pp.47~53 (2020), 대한약학회[DOI]
  23. "Future Prospect of Pharmaceuticals and Medium to Long-Term Strategy of Health Policy and Governance"[URL]
  24. Cameron D, "On what basis are medical costeffectiveness thresholds set? Clashing opinions and an absence of data : a systematic review", Glob Health Action, 11(1), pp.1447828~ (2018)
  25. Kaitin KI, "Deconstructing the drug development process : the new face of innovation", Clin Pharmacol Ther, 87(3), pp.356~361 (2010)
  26. "Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs (amendment)"[URL]
  27. "Health insurance coverage for high-priced drugs such as targeted cancer drugs is expanded"[URL]
  28. "The new drug registration system, ‘RSA’, why is it not working?"[URL]
  29. Campbell SM, "Defining quality of care", Soc Sci Med, 51(11), pp.1611~1625 (2000)
  30. "Pre-announcement of new drug evaluation regulations to enhance patient access to rare disease medicines, etc"[URL]
  31. "Results of the Evaluation Committee on the Listing of Drugs"[URL]
  32. "Opinion inquiry for “Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs”"[URL]
  33. "A study of post-list management for indispensable drugs of Korean National Health Insurance"[URL]
  34. "Standards on Designation, Implementation, etc. of Differential Coverage"[URL]
  35. "Notice No. 2020-181 (2020.8.24) of “Drug reimbursement list and reimbursed price cap table”"[URL]
  36. "No. 2020-107,108, The Second Recruitment Notice for Medical Product Sector Reviewers (new, alternative)"[URL]
  37. "Ministry of Food and Drug Safety and its affiliated organizations"[URL]
  38. "Prescription Drug User Fee Amendments"[URL]
  39. "Regulations on fees for licensing medicines, etc"[URL]
  40. "Fees payable to the European Medicines Agency"[URL]
  41. "Fees for regulatory review and face-to-face consultation"[URL]
  42. 김수진, "희귀질환 약제, 항암제 별도 기금 도입에 대한 약제급여 결정 전문가와 이해관계자 시각", 한국임상약학회지, 30(3), pp.177~184 (2020), 한국임상약학회[DOI]
  43. "Moon Jae-in care (Health Insurance Coverage Enhancement, Moon Jae-in Care Plus)"[URL]
  44. "Status and Future Plans for Strengthening Health Insurance Coverage"[URL]
  45. "A Study on the Improvement of Access to Medicines for Four Major Severe Diseases - Focusing on the Financing of Rare Disease Therapy and Anti-cancer Drugs"[URL]
  46. "Generics 360-Generic drugs in Canada, 2018"[URL]
  47. Yoon YK, "Trends of antibiotic consumption in Korea according to national reimbursement data (2008-2012): A population-based epidemiologic study", Medicine (Baltimore), 94(46), pp.e2100~ (2015)
  48. "Announcement of a pilot project to re-evaluate the appropriateness of health insurance policies"[URL]
  49. "Disclosure of the results of deliberation by the 6th Drug Reimbursement Evaluation Committee in 2020"[URL]
  50. Holtorf A-P, "External reference pricing for pharmaceuticals-a survey and literature review to describe best practices for countries with expanding healthcare coverage", Value Health Reg Issues, 19, pp.122~131 (2019)

관련 논문AI추천

이 간행물의 다른 논문 (7건)