국내 폐암환자 전수 자료를 활용한 진행성 비소세포폐암 환자에서 EGFR 유전자변이에 따른 일차약으로서 개별맞춤형치료의 비용효과성 평가
Cost-Effectiveness of Personalized Medicine as First-Line Therapy According to EGFR Mutation Status for Advanced Non-small Cell Lung Cancer Using Real-World Data: the Entire Patients data in South Korea
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초록
연구배경개별맞춤형치료의 비용효과성 평가는 모형의 특이성으로 인해 임상시험에서 얻은 결 과를 적용하는데 제한점이 존재하고, 이는 비용효과성 결과의 불확실성을 초래한다. 본 연구는 임상문헌에 근거하여 비소세포폐암에서 EGFR 유전자변이에 대한 표적항암제인 tyrosine kinase inhibitors (TKIs)의 일차약으로서 개별맞춤형치료의 비용효과성을 평가한 선행연구 결 과를 검증하기 위한 하나의 보완적 연구로서, real-world data를 활용하여 개별맞춤형치료의 비용효과성을 평가하였다. 연구방법일차 치료로 항암제를 사용하는 3b, 4기의 진행성 비소세 포폐암 환자를 대상으로 일차약으로 유전자변이 검사 없이 전체 환자에게 표준항암화학요법 (cisplatin+pemetrexed)을 투여하는 치료법과 비교하여 EGFR 유전자변이 검사 결과에 따른 개 별맞춤형치료의 비용효과성을 평가하였다. 분석관점은 비급여를 제외한 직접의료비용만을 포 함한 보험자관점에서 분석하였다. 분석모형은 분석주기 1개월, 분석기간 60개월로 하는 마콥 모형을 구축하였다. 자료원은 국민건강보험공단의 “‘국민건강보험자료 공유서비스”의 “맞춤형 DB”를 이용하여 2006년 1월 1일부터 2014년 12월 31일까지 국내 폐암환자 전수 자료에 대한자료를 사용하였다. 비용은 2015년 기준으로 제시하였다. 연구결과기본분석 결과, 표준항암화 학요법군과 개별맞춤형치료군의 비용은 각각 38,163,912원, 39,516,972원이고, 효과(QALY)는 각 각 0.8718, 0.9683으로, ICER가 14,019,081원/QALY로 개별맞춤형치료가 비용효과적이었다. 일 원민감도분석에 의하면 의료비용에 가장 민감한 것으로 나타났다. 결론본 연구 결과는 임상 문헌에 근거한 선행연구에서 나타난 개별맞춤형치료의 비용효과성 결과를 강하게 지지하였다.
Abstract
Backgrounds Personalized medicine as first-line therapy according to EGFR mutation status was cost-effective compared to the standard chemotherapy in non-small cell lung cancer (NSCLC) patients, but some limitations have been found related to the application of clinical efficacy data based on clinical trials. This study aims to evaluate the cost-effectiveness as a supplementary study to confirm the results from previous studies using real-world data. Methods Personalized medicine as first-line therapy according to EGFR mutation status was compared with the standard chemotherapy (cisplatin+pemetrexed) in patients with stage 3b or 4 NSCLC. The study was conducted from the national healthcare system perspective. A Markov model was constructed with one month cycle and 60-month time horizon. The data was obtained from National Health Insurance data Sharing Service (NHISS), including the entire patient data of lung cancer during January 1, 2006 to December 31, 2014 in South Korea. Results In the base case analysis, the personalized medicine was cost-effective compared to the standard chemotherapy, with KRW 14,019,081 per QALY gained. One-way sensitivity analyses that the results were most sensitive to medical costs. Conclusions The results strongly support the results of the personalized medicine evaluated based on clinical trials.
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