의료기술평가를 통한 급여결정의 한계와 극복방안: 기등재의약품목록정비 사업에 대한 평가를 중심으로
Challenges in drug re-evaluation system based on health technology assessment
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초록
2010년 7월 정부는 3년 이상을 진행해오던 기등재의약품목록정비 사업을 크게 축소하는 방향의 정책변경 안을 건강보험정책심의위원회에 상정하였다. 평가대상 약들의 임상적 유용성만 검토하지 비용-효과성은 평가하지 않겠다는 것이 주요 골자이다. 대신 개별 제품의 약가가 성분별 최고가 대비 80% 이상인 경우 가격을 일괄 인하하는 안을 제시하였다. 본 연구는 이러한 정책 변경이 그간의 사업에 대한 체계적 평가 위에서 전개되지 않은 점을 우려하며, 이미 평가가 완료된 시범사업에 대한 다각적인 평가를 통해 의료기술평가를 급여결정에 활용하는 바람직한 방안을 모색해본다. 우선 시범사업 과정에서 제기된 이슈들을 항목별로 하나씩 검토해보고 절차적 공정성을 어느 정도 확보하였는지 기존 이론을 토대로 평가한 결과, 과학적 근거의 불확실성을 보완하는 가치 판단의 과정이 보강될 필요가 있음을 확인하였으며, 절차적 공정성을 확보하기 위해 더 많은 노력이 필요함도 확인하였다. 아울러 제외국의 경험과의 비교를 통해 과학적 평가와 이를 근거로 한 판단의 과정은 분리되어야 하며 이 과정에서 고려하는 여러 기준은 사전에 충분히 공유될 필요가 있다는 점도 확인하였다.
Abstract
Korea is among the countries which have experienced rapidly increasing drug expenditures. According to OECD health data, the annual growth rate of Korean drug expenditure was around 10% from 2001 to 2006. To control and keep this increase rate within sustainable levels, and attain the efficiency within the system, the Korean government announced the introduction of a positive list system in May 2006. Under the positive list system, only drugs which have established their value in terms of clinical efficacy and cost-effectiveness can be listed. In addition to new drugs, listed drugs have also been scheduled to have their value re-evaluated during the period from 2007 to 2012. Based on the evaluation results, existing drugs with low added value will be de-listed. The Health Insurance Review and Assessment Service(HIRA) has a mandate to review all listed drugs, and it reviewed migraine and hyperlipidemia drugs as a pilot project in 2007. Since HIRA opened its assessment reports and the preliminary decisions of the committee, there has been a debate over the assessment methodology and decisions made by the committee. This study will discuss the issues which have been raised in Korea during the re-evaluation of two therapeutics groups. These issues are: the relation between scientific assessment and decision making, the use of cost-effectiveness data in the determination of ceiling price, and the way social values are reflected in reimbursement decisions.
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