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      한국, 호주, 캐나다, 영국의 항암제 및 희귀의약품의 접근성에 대한 고찰 = Review of reimbursement recommendations of the oncology and the orphan drug in Korea, Australia, Canada and Britain

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      https://www.riss.kr/link?id=A100051941

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      다국어 초록 (Multilingual Abstract)

      Oncology drugs and orphan drugs are usually very costly, while their clinical benefits are marginal or uncertain, resulting in high incremental cost-effectiveness ratios(ICER) and unfavorable reimbursement recommendations. This study sought to compare the reimbursement criteria and recommendations of the oncology and the orphan drugs in Korea (Drug Reimbursement Evaluation Committee) with Australia (Pharmaceutical Benefit Advisory Committee), Canada (pCODR (the pan-Canadian Oncology Drug Review) and Common Drug Review) and Britain (National Institute for Health and Clinical Excellence), where economic evaluation process has been formally considered as part of the drug reimbursement decision process, by referring to publicly available information. Criteria for life saving drugs, as well as drugs that are categorized as life saving drugs and recommended to be reimbursed regardless of the economic evaluation, were identified; Criteria for life saving drugs are similar across four countries, which includes the availability of the alternative treatment, the number of patients, the severity of diseases, and the clinical improvements of the drug. Of those 14 drugs which were reimbursed under the special criteria, all of them were reimbursed in Korea, 9 of which were reimbursed under the special criteria, whereas 3 of them were reimbursed under rule of rescue in Australia and 3 of them were covered under the End of Life program in Britain. Of those 14 drugs, 8 of them were considered and 6 of which were reimbursed in the Britain and 12 of them were considered and all of them were reimbursed in Australia. Korea does not have a separate funding program such as life saving drug program in Australia, yet most of the drugs that were reimbursed under the special funding program in Australia and Britain were already reimbursed in Korean National Health Insurance Program. In conclusion, there were insufficient evidence to conclude that oncology drugs and orphan drugs are less likely to be reimbursed in Korea compared with other agencies where economic evaluation has been formally implemented.
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      Oncology drugs and orphan drugs are usually very costly, while their clinical benefits are marginal or uncertain, resulting in high incremental cost-effectiveness ratios(ICER) and unfavorable reimbursement recommendations. This study sought to compare...

      Oncology drugs and orphan drugs are usually very costly, while their clinical benefits are marginal or uncertain, resulting in high incremental cost-effectiveness ratios(ICER) and unfavorable reimbursement recommendations. This study sought to compare the reimbursement criteria and recommendations of the oncology and the orphan drugs in Korea (Drug Reimbursement Evaluation Committee) with Australia (Pharmaceutical Benefit Advisory Committee), Canada (pCODR (the pan-Canadian Oncology Drug Review) and Common Drug Review) and Britain (National Institute for Health and Clinical Excellence), where economic evaluation process has been formally considered as part of the drug reimbursement decision process, by referring to publicly available information. Criteria for life saving drugs, as well as drugs that are categorized as life saving drugs and recommended to be reimbursed regardless of the economic evaluation, were identified; Criteria for life saving drugs are similar across four countries, which includes the availability of the alternative treatment, the number of patients, the severity of diseases, and the clinical improvements of the drug. Of those 14 drugs which were reimbursed under the special criteria, all of them were reimbursed in Korea, 9 of which were reimbursed under the special criteria, whereas 3 of them were reimbursed under rule of rescue in Australia and 3 of them were covered under the End of Life program in Britain. Of those 14 drugs, 8 of them were considered and 6 of which were reimbursed in the Britain and 12 of them were considered and all of them were reimbursed in Australia. Korea does not have a separate funding program such as life saving drug program in Australia, yet most of the drugs that were reimbursed under the special funding program in Australia and Britain were already reimbursed in Korean National Health Insurance Program. In conclusion, there were insufficient evidence to conclude that oncology drugs and orphan drugs are less likely to be reimbursed in Korea compared with other agencies where economic evaluation has been formally implemented.

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      참고문헌 (Reference)

      1 권혜영, "희귀의약품 보험약가결정: 문제점과 시사점" 한국보건경제정책학회 16 (16): 17-37, 2010

      2 박실비아, "희귀의약품 급여에 관한 국가별 동향과 시사점" 82 : 1-8, 2011

      3 박실비아, "희귀난치성 질환자의 의약품 접근성 제고 방안" 한국보건사회연구원 2010

      4 배은영, "한국, 호주, 캐나다의 의약품 급여평가결과 비교" 한국보건경제정책학회 17 (17): 1-21, 2011

      5 허정헌, "한국, 고가항암제 건보 적용 주먹구구, 투명성 꼴찌" 한국일보

      6 김정주, "위험분담 적용범위 확대평가 대폭완화 요구 봇물" 데일리팜

      7 건강보험심사평가원, "약제의 요양급여대상여부 등의 평가기준 및 절차 등에 관한 규정(규정 제230호, 2013.12.31.)"

      8 박실비아, "약제비 지출의 효율화를 위한 고비용 의약품 관리방안" 한국보건사회연구원 2011

      9 건강보험심사평가원, "약제급여평가위원회 평가결과"

      10 김경훈, "암환자의 약제처방 형태 분석 보고" 건강보험심사평가원 2010

      1 권혜영, "희귀의약품 보험약가결정: 문제점과 시사점" 한국보건경제정책학회 16 (16): 17-37, 2010

      2 박실비아, "희귀의약품 급여에 관한 국가별 동향과 시사점" 82 : 1-8, 2011

      3 박실비아, "희귀난치성 질환자의 의약품 접근성 제고 방안" 한국보건사회연구원 2010

      4 배은영, "한국, 호주, 캐나다의 의약품 급여평가결과 비교" 한국보건경제정책학회 17 (17): 1-21, 2011

      5 허정헌, "한국, 고가항암제 건보 적용 주먹구구, 투명성 꼴찌" 한국일보

      6 김정주, "위험분담 적용범위 확대평가 대폭완화 요구 봇물" 데일리팜

      7 건강보험심사평가원, "약제의 요양급여대상여부 등의 평가기준 및 절차 등에 관한 규정(규정 제230호, 2013.12.31.)"

      8 박실비아, "약제비 지출의 효율화를 위한 고비용 의약품 관리방안" 한국보건사회연구원 2011

      9 건강보험심사평가원, "약제급여평가위원회 평가결과"

      10 김경훈, "암환자의 약제처방 형태 분석 보고" 건강보험심사평가원 2010

      11 배승진, "신약 적정가치 평가 연구" 건강보험심사평가원 2012

      12 김성지, "기준 요건 완화 ‘준필수의약품’ 지정 확대를" 국민일보 쿠키뉴스

      13 이혜선, "국민들, ‘고가 항암제’ 보험적용 원해" 약업신문

      14 환자단체연합회, "[성명] 급평위는 말기 대장암 표적치료제에 대한 건강보험 급여결정을 하기 바란다"

      15 환자단체연합회, "[논평] 정부의 위험분담제 시행에 관한 환자단체의 입장"

      16 Viera, Anthony J., "Understanding interobserver agreement: the kappa statistic" 37 (37): 360-363, 2005

      17 Neumann, Peter J., "Therapies for advanced cancerspose a special challenge for health technology assessment organizations in many countries" 31 (31): 700-708, 2012

      18 Desser, A. S., "Societal views on orphan drugs: cross sectional survey of Norwegians aged 40 to 67" 341 : 2010

      19 Hughes D, "Rationing of drugs for rare diseases" 24 (24): 315-316, 2006

      20 Dolan P, "QALY maximisation and people's preferences: a methodological review of the literature" 14 (14): 197-208, 2005

      21 NICE, "Published technology appraisals"

      22 NICE, "Published technology appraisals"

      23 Cookson, R., "Public healthcare resource allocation and the Rule of Rescue" 34 (34): 540-544, 2008

      24 Mason, A., "Public funding of new cancer drugs: Is NICE getting nastier?" 45 (45): 1188-1192, 2009

      25 PBS, "Public Summary Documents by Product"

      26 NICE, "Patient access schemes liaison unit"

      27 "Pan Canadian Oncology Drug Review"

      28 Miller, K., "Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer" 357 : 2666-2676, 2007

      29 "PBAC Guidelinds, F.3 Other relevant factors, Basis for any claim for the ‘rule of rescue’"

      30 McCabe, C., "Orphan drugs and the NHS: should we value rarity?" 331 (331): 1016-, 2005

      31 Cancer Care Ontario, "New Drug Funding Program (NDFP)"

      32 Raftery, James, "NICE and the challenge of cancer drugs" 338 : 271-, 2009

      33 Raftery, James, "Multiple sclerosis risk sharing scheme: a costly failure" 340 : c1672-, 2010

      34 "Multi-Criteria Decision Analysis in Health Technology Assessments of Orphan Drugs"

      35 "McArthur, Ontario public drug program(OPDP) evaluation framework for drugs for rare disease(DRDs)"

      36 "List of technologies with approved Patient Access Schemes, recommended by NICE for use in the NHS"

      37 "Life Saving Drugs Program"

      38 Georges J, "Key findings from a fivecountry survey of public attitudes about Alzheimer’s disease" 2011

      39 "End of Life care for adults, Quality Standards, QS13 - Issued"

      40 Hillner, B. E., "Efficacy does not necessarily translate to cost effectiveness: a case study in the challenges associated with 21st-century cancer drug pricing" 27 (27): 2111-2113, 2009

      41 Jaroslawski, S., "Design of patient access schemes in the UK: influence of health technology assessment by the National Institute for Health and Clinical Excellence" 9 (9): 209-215, 2011

      42 "Common Drug Review"

      43 Ravi Singh, "Canada’s patchwork of ‘orphan’ drug policies, pharmaphorum"

      44 Sunstein C., "Bad deaths" 14 (14): 259-282, 1997

      45 Peter J. Neumann, "Assessment Organizations In Many Countries Therapies For Advanced CancersPose A Special Challenge For Health Technology" 31 (31): 700-708, 2012

      46 "Appraising orphan drugs" NICE

      47 "Advisory Group for National Specialised Services (AGNSS)"

      48 Williamson, Steve, "A report into the uptake of patient access schemes in the NHS" 2009

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      학술지 이력

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      연월일 이력구분 이력상세 등재구분
      2027 평가예정 재인증평가 신청대상 (재인증)
      2021-01-01 평가 등재학술지 유지 (재인증) KCI등재
      2018-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2015-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2011-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2008-01-01 평가 등재학술지 선정 (등재후보2차) KCI등재
      2007-01-01 평가 등재후보 1차 PASS (등재후보1차) KCI등재후보
      2006-09-15 학회명변경 영문명 : The Korean Association of Health Economics Policy -> The Korean Association of Health Economics and Policy KCI등재후보
      2005-01-01 평가 등재후보학술지 선정 (신규평가) KCI등재후보
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      기준연도 WOS-KCI 통합IF(2년) KCIF(2년) KCIF(3년)
      2016 0.66 0.66 0.76
      KCIF(4년) KCIF(5년) 중심성지수(3년) 즉시성지수
      0.74 0.68 1.153 0.64
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