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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본 연구에서는 경제성평가를 급여 결정에 고려하는 한국, 호주, 캐나다, 영국의 항암제 및 희귀의약품의 접근성 제고를 위해 적용되는 제도와 그 적용에 따른 급여 평가 결과를 비교하였다. 경제성평가 결과와 관계없이 예외적으로 급여를 고려하는 기준, 즉 질병의 위중도에 근거하여 급여를 권고하는 기준을 국가별로 비교한 결과, 우리나라의 진료상필수약제, 호주의 Rule of Rescue, 영국의 End of Life 의 경우 대체약제 여부, 질병의 중증도, 임상적 개선, 환자 수 등의 기준에 근거하여 평가하고 있으며 그 기준들은 대체적으로 유사하였다. 캐나다는 주 별로 평가 기준이 다르지만 온타리오 주의 평가기준의 경우 영국, 호주, 한국과 유사하였다. 각 국에서 예외적인 급여권고 기준에 근거하여 급여된 품목들 (한국 9개, 호주 3개, 영국 3개, 겹치는 품목 제외 총 14개)중 외국에서 예외 기준으로 급여가 된 품목들은 우리나라에서 모두 급여 되고 있었다. 2013년 현재 호주(life saving drug program, LSDP) 또는 영국(Patient Access Scheme, PAS)과 같이 희귀/고가 의약품의 접근성 제고를 위한 제도는 2013년 현재 없었으나, LSDP 와 PAS에 의하여 급여되는 품목 12개 중 한국에서 건강보험에 급여가 신청된 10개 품목은 모두 건강보험에서 급여되고 있었다. 본 연구 결과, 한국의 항암제 및 희귀의약품의 급여 권고 수준은 비교국 대비 비슷하거나 더 높아, 우리나라의 항암제 및 희귀의약품의 접근성이 비교국 대비 떨어진다는 근거를 발견하지 못하였다.
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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