제약산업 입장에서 본 우리나라 의약품 등재제도의 문제점

• 영문명: Industry perspective on current HTA system in Korea
• 발행기관: 한국보건사회약료경영학회
• 저자명: 고수경(Su-Kyoung Ko)
• 간행물 정보: 『한국보건사회약료경영학회지』제4권 제1호, 14~22쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2015.11.30

영문 초록

Positive list system was introduced in 2007 as a part of DERP (Drug Expenditure Rationalization Plan) in Korea. The purpose of this system is allocation efficiency based on value for money. Value is evaluated by HTA (Health Technology Assessment) focusing on clinical usefulness and cost-effectiveness with proven evidence at the time of launch. This article is prepared to assess current HTA system from industry perspective considering value-based decision making. It seems that current HTA process has several areas to improve since reimbursement decision is too much dependent on launch time evidence which may not reflect true value. The difficulty of showing superior efficacy does not necessarily mean there isn’t any additional value for society. New treatment option brings value of better treatment mixture. Drugs with unquantifiable benefit also have their own value. The issue is that current HTA often fails to capture these values. Current HTA focusing on statistical significance sometimes fails to find clinically significant value. One of big issues is that uncertain evidence of effect is often interpreted as the evidence of no value. ICER dependent decision making may result in unreasonable decision such as non-reimbursement of highly valuable drug for society. HTA methodology needs to be evolved in accordance with advancement of science. The flexible pricing method such as risk-sharing and holistic approach like MCDA (multiple criteria decision analysis) in decision-making is required for better patient access. This decision should incorporate fair assessment for innovativeness, clinical usefulness and equity not only for cost-effectiveness or budget impact.

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키워드

pricing and reimbursement HTA value-based decision-making