Journal of Korean Society for Clinical Pharmacology and Therapeutics (임상약리학회지)

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Cost-effectiveness of Early Use of Etanercept in the Treatment of Rheumatoid Arthritis

류마티스관절염 치료에 있어 Etanercept의 조기사용전략에 대한 비용효과분석

  • Lee, Eui-Kyung (Graduate School of Clinical Pharmacy, Sookmyung Women's University) ;
  • Ko, Suk-Ja (Department of Health Research, Korea Institute for Health and Social Affairs) ;
  • Bae, Sang-Cheol (Division of Rheumatology, Department of Internal Medicine, Hanyang University College of Medicine and the Hospital for Rheumatic Diseases, Hanyang University) ;
  • Sung, Yoon-Kyoung (Division of Rheumatology, Department of Internal Medicine, Hanyang University College of Medicine and the Hospital for Rheumatic Diseases, Hanyang University)
  • 이의경 (숙명여자대학교 임상약학대학원) ;
  • 고숙자 (한국보건사회연구원 보건의료연구실) ;
  • 배상철 (한양대학교 의과대학 내과학교실 류마티스내과, 한양대학교 류마티스병원) ;
  • 성윤경 (한양대학교 의과대학 내과학교실 류마티스내과, 한양대학교 류마티스병원)
  • Received : 2009.05.29
  • Accepted : 2009.06.11
  • Published : 2009.06.30

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Abstract

Objective: To compare the long-term cost-effectiveness of a sequential treatment strategy involving the early use of etanercept (ETN) with that for the conventional late use of ETN in Korean RA patients Methods: A cost-effectiveness analysis was performed to compare two treatment sequences using etanercept with methotrexate: early versus late start to the rheumatoid arthritis (RA) patients in Korea. Decision analysis and Markov cohort simulation were used to extrapolate short-term clinical trial results to a long-term time horizon. The outcome was quantified as the quality-adjusted life years (QALYs). The 6-monthly trends in Health Assessment Questionnaire disability scores were simulated for 1,000 patients for 5and converted into QALYs. Direct medical costs including drugs and monitoring were estimated based on the Korean National Health Insurance reimbursement schedule. Results: The incremental cost-effectiveness ratio for the early versus late use strategy was 78,101 thousand won per QALY gained, but this reduced to 30,012 thousand won, 6,620 thousand won, and -.10,054 per QALY gained when the treatment period was changed to 10, 15, and 30years, respectively. Conclusions: These results show that a sequential treatment strategy with early use of ETN in RA may not represent a cost-effective alternative to the conventional late use of ETN over a 5-year time horizon. However, scenario analyses showed that both the inclusion of indirect costs and long-term use might further improve the cost-effectiveness outcomes for the early use of ETN.

류마티스관절염의 치료전략으로는 항류마티스약제를 이용한 단계적 치료가 일반적이다. 최근에 개발되어 류마티스관절염의 중요한 치료제로 자리매김한 종양괴사인자억제제는 관절염의 증상 감소 외에도 질환의 진행을 억제하는데 매우 효과적인 것으로 알려져 있다. 이러한 우수한 효과로 인해 종양괴사인자억제제의 조기사용의 필요성이 강조되고 있으나 높은 의약품비는 이를 초기치료약물로 사용하는데 있어 제한점으로 지적되고 있다. 목적: 대표적인 종양괴사인자억제제인 etanercept (ETN)을 포함한 한국인 류마티스관절염 환자의 치료전략에 있어서, ETN을 초기약물치료로서 사용하는 치료전략을 현재 일반적으로 시행되고 있는 타약제에 저항성을 보일 경우에 ETN을 사용하는 후기사용전략에 대한 비용-효과를 판단하고자 하였다. 방법: 한국인 류마티스관절염 환자에서 MTX단독요법 후에 MTX와 leflunomide (LFN)병합요법에 저항성을 보일 경우 ETN와methotrexate (MTX)병합요법을 사용하는 후기사용전략에 대하여 초기부터 ETM와 MTX를 사용하는 조기사용전략의 비용효과분석을 시행하였다. 단기간의 임상시험 결과들에 대해 Markov cohort simulation을 시행하였으며, 6개월간의 Health Assessment Questionnaire disability score의 경향을 1,000명에 대해 5년간의 변화를 시뮬레이션하였으며, 이를 성과지표로서 질보정수명 (quality-adjusted life year: QALY)으로 환산하였다. 의약품 및 검사비와 같은 직접의료비용은 한국의 국민건강보험수가를 기준으로 하여 계산하였다. 결과: 5년간의 시뮬레이션에서 ETN의 조기사용전략에 있어서 후기사용전략에 대한 점증적 비용효과비(Incremental cost-effectiveness ratio: ICER)는 1QALY당 78,101(천원)로 계산되었다. 이를 10년, 15년, 30년으로 연장한 감도분석에서 ICER는 1QALY당 30,012(천원), 6,620(천원), -10,054(천원)로 계산되었다. 결론: 5년을 기준으로 하여 한국인 류마티스관절염 환자에 있어 ETN의 조기사용전략은 현재의 일반적인 후기사용전략에 비해 비용효과비가 좋다고 할 수는 없는 것으로 나타났다. 그러나, 간접비용을 포함하거나 장기간의 사용이 필요할 경우에는 ETN의 조기사용전략의 비용효과비가 개선될 수 있을 것으로 판단된다.

Keywords

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