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비용-효과 분석의 불확실성: 평가와 대응전략

Uncertainties in cost-effectiveness analysis

배은영
한국보건경제정책학회 (The Korean Association of Health Economics and Policy)|2021.12|보건경제와 정책연구 (The Korean Journal of Health Economics and Policy)|제27권 제4호|pp. 131-152

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위험분담불확실성uncertaintyrisk sharingcost-effectiveness analysis정보의 가치비용-효과 분석value of information
주제분류사회과학일반

초록

최근 시장에 진입하였거나 진입을 앞둔 초고가 신약 중에는 비용-효과성을 둘러싼 불확실성이 큰 경우가 많다. 이들 약에 대한 사회적 관심사나 건강보험 재정 부담 등을 고려하였을 때이들 약이 가진 불확실성을 어떻게 평가하고, 어떻게 관리할 것인지는 향후 중요한 정책적 관심사가 될 것으로 보인다. 이글에서는 문헌 고찰을 통해 비용-효과분석의 불확실성을 평가하는방법론들과 불확실성을 효과적으로 관리하기 위한 정책적 대안들을 살펴보았다. 비용-효과분석을 둘러싼 불확실성은 확률적, 모수적, 구조적 불확실성과 이질성으로 분류되는데, 이 중 모수적 불확실성은 주로 민감도 분석을 통해 평가되며, 구조적 불확실성의 평가에는 시나리오 분석이나, 모형 선택, 모형 평균화, 매개변수화 하는 방법 등이 사용되고 있다. 최근에는 정보의 가치 분석을 통해 추가 자료수집의 가치를 평가하는 노력이 이어지고 있으며, 불확실성에 대한정보를 효과적으로 소통하는 방법에 대한 관심도 증가하고 있다. 한편 불확실성을 관리하기 위한 전략으로는 급여결정을 미루거나 재정기반 혹은 성과기반 위험분담제를 적용하는 방법이주로 활용되고 있다. 이 중 성과기반 위험분담제는 불확실성 해소를 목적으로 한 전향적 자료수집 계획을 포함하는데, 불확실성 평가나 의사결정 과정과 연계되지 않은 추가 자료수집은 연구자원의 낭비로 이어질 수 있으므로 주의가 필요하다.

Abstract

There are many uncertainties on cost-effectiveness among high-priced new drugs that have recently entered the market. Considering the social concerns about these drugs and the financial burden of national health insurance, evaluating and managing the uncertainty is expected to become a significant policy concern in the future. Uncertainties surrounding incremental cost-effectiveness ratio are divided into stochastic, structural, and parametric uncertainties and heterogeneity. Among them, parametric uncertainty is mainly evaluated through sensitivity analysis, and efforts are being made to evaluate the value of securing additional evidence through the value of information analysis. Structural uncertainty is overlooked compared to parametric uncertainty despite its significant impact on the results. Scenario analysis, model selection, model averaging, and parameterization have been proposed to analyze it. The performance-based risk-sharing scheme, particularly coverage with evidence development, has been proposed as a risk management plan. However, suppose the data collection plan is not based on uncertainty assessment and is not liked to the decision-making stage. In that case, additional data may have little impact on the final decisions.

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