진입 신약의 유형이 질환별 의약품 상한금액 및 의료이용에 미치는 영향
Effect of new drug entry type on drug list price and healthcare expenditure by disease
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신의료기술의 진입이 보건의료분야가 직면하는 중요한 현상 중 하나로 주목받고 신약의 진입에 대해 긍정적인 평가와 부정적인 평가가 모두 제기되는 현 시점에서 새롭게 보험급여 적용되는 신약의 유형에 따른 보건의료적 영향을 고찰해볼 필요가 있다. 본 연구에서는 질환별로 신약 진입의 영향을 분석하기 위해 2011년 이후 약제급여목록에 진입한 신약을 혁신성의유형에 따라 임상적 유용성 개선된 계열최초성분, 임상적 유용성 개선 없는 계열최초성분, 임상적 유용성 개선된 계열후속성분, 임상적 유용성 개선 없는 계열후속성분으로 구분하고, 필수성의 유형에 따라 필수약제, 비필수약제로 구분하여 2011년 이후 신약이 진입한 질환 별로 혁신성 유형 및 필수성 여부에 따른 선발약제 상한금액 인하율, 1인당 요양급여비용, 1인당 내원일수에 미치는 영향을 분석하였다. 연구결과, 혁신적 약제 중 임상적 유용성 개선된 계열최초성분 진입 시 1인당 요양급여비용 13.2%의 증가와 임상적 유용성 개선된 계열후속성분 진입시 선발약제 상한금액 1.29%의 인하, 1인당 요양급여비용 20.3%의 감소 및 1인당 내원일수6.94%의 감소를 보였다. 또한, 필수 약제 진입 시 선발약제 상한금액 3.04%의 인하, 1인당 요양급여비용 18.5%의 감소 및 1인당 내원일수 6.94%의 감소를 보였다. 본 연구의 분석 결과는의약품의 혁신성 유형 및 필수성 여부에 따라 약품비, 요양급여비용 및 내원일수에 미치는 영향이 상이할 수 있음을 함의하며, 약품비를 증가시키지 않고 의료이용에 긍정적인 영향을 주는 유형의 신약의 진입이 있을 수 있음을 시사한다.
Abstract
As the entry of new medical technology is noted as one of the important phenomena in the healthcare sector, the impact of new drugs on healthcare sector needs to be assessed according to their types. In this study, in order to analyze the impact of entry of new drugs by disease, new drugs that have entered the list of the reimbursed drugs since 2011 are classified by their types of innovation: first-in-class ingredient with improved clinical benefit, first-in-class ingredient without improved clinical benefit, later-in-class ingredient with improved clinical benefit and later-in-class ingredient without improved clinical benefit and by necessity; essential drugs and non-essential drugs. And we performed analysis to evaluate the effect of new drugs entry on the frontier drug's list price, per capita health expenditures and per capita days of outpatient visits or hospitalization. The result indicates that entry of the first-in-class ingredient with improved clinical benefit causes per capita health expenditures to increase by 13.2% while entry of the later-in-class ingredient with improved clinical benefit reduces the frontier drug's list price by 1.29%, per capita health expenditures by 20.3%, and per capita days of outpatient visits or hospitalizations by 6.94%. And the result also indicates that entry of the essential drug reduces the frontier drug's list price by 3.04%, per capita health expenditures by 18.5% and per capita days of outpatient visits or hospitalization by 6.94%. The finding of this study implies that the effect on the drug list price, health expenditures and number of days of outpatient visits or hospitalization could be different depending on the new drug's type of innovation and necessity. This suggests that we could identify the types of new drugs that wouldn't increase pharmaceutical costs and have a positive effect on healthcare sector.
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