신약 진입에 의한 미충족의료 해소가 약제비 변화에 미치는 영향
Effects of unmet medical needs satisfaction by new drug entry on pharmaceutical expenditures
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신약의 진입 및 혁신으로 인한 비용 상승이 지속됨에도 여전히 많은 질환의 필요가 충족되지 않고 있는 현상을 고려하여 새로운 성분 진입에 의해 미충족의료가 해소되는 방식이 약제비 변화에 미치는 영향에 대한 평가가 필요하다. 본 연구에서는 질환별로 신약 진입에 의한 미충족의료 해소의 약제비 변화에 대한 영향을 분석하기 위해 최초해소, 실패해소, 부분해소라는 미충족의료 해소 유형별로 국민관심질환, 희귀·난치성 질환, 2008년-2021년 사이 신약 진입 질환을 대상으로 소요비용, 환자수, 구성비와 약제비에 대한 영향 및 대체효과·확장효과를 분석하면서 약제 계열, 환자군 분화 정도도 함께 고려하였다. 연구결과, 최초해소로 소요비용 88.0% 상승, 환자수 8.0% 증가하지만 구성비가 57.0% 감소하여 약제비가 39.0% 상승하고 (+)31.0%의 대체효과, (+)8.0%의 확장효과가 발생했다. 실패해소로 확장효과가 발생하지 않았고, 소요비용 상승폭과 유사한 정도로 구성비가 감소하여 약제비 변화 현상 및 대체효과도 발생하지 않았다. 부분해소의 경우, 계열분화 미고려시 나타났던 유의한 소요비용 상승, 환자수 증가, 구성비 감소가 계열분화 고려시 발생하지 않았고 약제비가 9.5% 증가하며 (+)5.4%의 대체효과가 나타났다. 또한 계열분화로도 소요비용 76.9% 상승, 구성비 81.3% 감소가 발생했다. 본 연구의 분석결과는 최초해소가 가장 크게 약제비를 상승시키고 대체효과·확장효과를 일으키며, 최초해소와 부분해소가 갖는 약제비 세부요소에 대한 영향 및 대체효과, 확장효과로 인한 약제비 증가 현상이 치료제들간 계열의 활발한 분화를 통해 완화될 수 있음을 시사한다.
Abstract
The aim of this study is to investigate the impact of the medical unmet needs satisfaction on pharmaceutical expenditures by their type; first satisfaction, satisfaction for treatment failure; satisfaction for selective patients. We analyze the impact of unmet medical needs satisfaction by new drug entry on drug expenditures, treatment substitution and expansion effect considering the differentiation degree of drug classes and patients' group for public concern diseases, rare and intractable diseases, and diseases with new drug entry between 2008 and 2021. And growth of drug expenditures is decomposed into 3 parts; cost, patients' number, drug mix. The result indicates that first satisfaction causes cost to increase by 88.0%, patients' number to increase by 8.0%, drug mix to decrease by 57.0% and overall drug expenditures to increase by 39.0%, (+)31.0% substitution effect, (+)8.0% expansion effect. Satisfaction for treatment failure neither gives rise to significant expansion effects nor causes significant change in drug expenditures, substitution effect due to cost increase being offset by the decrease of drug mix. Satisfaction for selective patients causes drug expenditures to increase by 9.5%, (+)5.4% substitution effect and the significance of increase in cost, patients' number and decrease in drug mix is lost when considering differentiation of drugs' classes. Classes differentiation itself results in 76.9% increase in cost and 81.3% decrease in drug mix. The finding of this study implies the degree of increase in drug expenditures, substitution and expansion effect of the first satisfaction is the largest. And it suggests the impact on the decomposed part of pharmaceutical expenditures and the increase in drug expenditures due to the substitution and expansion effect can be mitigated through active differentiation of drug classes in relation to first satisfaction and satisfaction for selective patients.
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