환자중심 의료기술 최적화 연구사업 소개

조송희 대한산부인과학회 2022 대한산부인과학회 학술대회 Vol.108 No.-

연령관련황반변성환자에서 항혈관내피성장인자의 국내 사용 현황

조송희,신상진,서재경,최하진,강민주,양장미,지동현 대한안과학회 2019 대한안과학회지 Vol.60 No.8

Purpose: To evaluate the current use of intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) in patients with age-related macular degeneration (AMD). Methods: We analyzed the number and medical costs of patients with AMD diagnosed by the National Health Insurance Corporation (2007–2016). We also analyzed the number and medical costs of such patients who received anti-VEGF treatment, and analyzed the frequency, period of use, and average medical cost of anti-VEGF use in AMD patients. Finally, we evaluated the use of anti-VEGF injections for new AMD patients. Results: The number of patients with AMD was 236,158 in 2009 and 537,528 in 2016, which represented a 2.3-fold increase over 8 years. Of these, the number of patients undergoing anti-VEGF therapy increased steadily from 9,961 in 2009 to 35,762 in 2016. The mean number of cycles of ranibizumab or aflibercept per patient was 4.87 ± 3.37, and the mean interval between treatments was 2.89 months. On average, 6.2 injections were performed in the first year of diagnosis, and the frequency of use decreased with time, with an average of 1.2 cycles after 4 years of diagnosis. Among all AMD patients in 2016, the total medical cost of those treated with anti-VEGF was 76.9 billion won, and the average medical cost per person was 2,162,145 won. Conclusions: The use of two drugs, ranibizumab and aflibercept, as reflected in public health insurance claims, steadily increased over the study period. Notably, there was a tendency to substitute aflibercept for ranibizumab. 목적: 연령관련황반변성환자에서 항혈관내피성장인자의 유리체내주입술의 국내 사용 현황을 알아보고자 하였다. 대상과 방법: 국민건강보험공단의 청구 자료(2007-2016년)를 이용하여 연령관련황반변성으로 진단받은 환자들을 대상으로 항혈관내피성장인자를 주입받은 환자들의 규모와 의료비를 분석하였다. 연령관련황반변성환자들의 항혈관내피성장인자 주입술의 사용 횟수, 사용 주기, 평균 의료 비용 등을 분석하였다. 또한 신환자의 규모와 항혈관내피성장인자 주입술의 사용 현황을 조사하였다. 결과: 연령관련황반변성 유병환자 수는 2009년 236,158명이었으나 2016년 기준 537,528명으로 7년 사이 2.3배 증가하였다. 이 중에서 항혈관내피성장인자 주입술을 시행받은 환자들의 규모는 2009년 9,961명에서 2016년 35,762명으로 증가하였다. 라니비주맙 또는애플리버셉트의 1인당 평균 사용 횟수는 약 4.87 ± 3.37회로 나타났으며 평균 치료 간격은 2.89개월로 확인되었다. 진단받은 첫 해에 평균 6.2회의 주입술을 받았고, 시간이 흐를수록 사용 횟수가 줄어들어 진단 4년이 지난 뒤에는 평균 1.2회의 사용 횟수를 보였다. 항혈관내피성장인자 치료를 받은 환자의 전체 의료비는 769억 원이었으며, 1인당 평균 의료 비용은 2,162,145원이었다(2016년 기준). 결론: 국민건강보험공단 건강보험 청구자료를 이용하여 급여 약제인 라니비주맙, 애플리버셉트의 사용 현황을 살펴본 결과 두 약제의 사용량은 꾸준히 증가하고 있었다.

의료기술평가와 국제네트워크

조송희 한국보건행정학회 2015 한국보건행정학회 학술대회 논문집 Vol.2015 No.2

당뇨망막병증에서 항혈관내피성장인자의 국내 사용 현황: 국민건강보험공단 자료 분석

조송희,신상진,서재경,최하진,양장미,강민주,지동현 대한안과학회 2019 대한안과학회지 Vol.60 No.7

Purpose: To evaluate the current use of intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) in patients with diabetic retinopathy. Methods: We determined the current number of diabetic retinopathy patients and their medical expenditure using National Health Insurance Service claims data (2007-2016). We also analyzed the medical costs of patients with diabetic retinopathy who received anti-VEGF treatment, including ranibizumab and aflibercept. We then evaluated aspects of the use of anti-VEGF injections, such as frequency and intervals, in newly diagnosed diabetic retinopathy patients who received anti-VEGF treatment, along with their medical costs. Results: The number of patients with diabetic retinopathy was 397,956 in 2009 and 721,310 in 2016, a 1.8-fold increase over 8 years. Of these, the number of patients undergoing anti-VEGF therapy was 4,283 in 2015 and 4,270 in 2016. Of the diabetic retinopathy patients in 2016, the total medical cost of those treated with anti-VEGF was 1.5 billion won, and the average medical cost per person was 3,531,064 won. Conclusions: Based on the National Health Insurance claims data, the use of ranibizumab and aflibercept is increasing. The results of this study suggest that diabetic retinopathy will become an important public health issue. 목적: 당뇨망막병증환자에서 항혈관내피성장인자의 유리체내 주입술의 국내 사용 현황을 알아보고자 하였다. 대상과 방법: 국민건강보험공단의 건강보험 청구자료(2007년-2016년)를 이용하여 당뇨망막병증으로 진단받은 환자들을 대상으로 유병환자의 규모와 의료비를 분석하였다. 또한 당뇨망막병증환자 중 유리체강내 항혈관내피성장인자를 주입술을 받은 환자들의 규모와 의료비를 분석하였다. 또한 당뇨망막병증으로 새로 진단받은 환자 중 유리체강내 항혈관내피성장인자 주입술을 받은 환자의 규모와 항혈관내피성장인자 주입술의 평균 의료비 규모를 확인하였다. 결과: 당뇨망막병증 유병환자 수는 2009년 397,956명이었으나 2016년 기준 721,310명으로 8년 사이 1.8배 증가하였다. 이 중에서 항혈관내피성장인자 주입술을 시행받은 환자들의 규모는 당뇨망막병증환자에서 항혈관내피성장인자 주입술의 보험급여가 적용된 2015년에 4,283명, 2016년에는 4,270명으로 나타났다. 2016년 기준 당뇨망막병증 유병환자 중 항혈관내피성장인자 치료를 받은 환자의 전체 의료비는 약 150억 원이었으며, 1인당 평균 의료비용은 3,531,064원이었다. 당뇨망막병증을 새로 진단받고 항혈관내피성장인자 주입술을 받은 환자는 2015년과 2016년에 각각 1,433명, 1,077명이었다. 결론: 본 연구는 국민건강보험공단 건강보험 청구 자료를 이용하여 급여 약제인 라니비주맙과 애플리버셉트의 사용 현황을 살펴보았으며, 연구 결과 당뇨망막병증에서 두 약제의 사용량은 꾸준히 증가하고 있었다.

패혈증 의심환자에서 프로칼시토닌 검사의 효과

조송희(Song hee Cho),서재경(Jae Kyung Suh),고민정(Min jeong Ko),이상민(Sang min Lee),장보형(Bo hyung Jang),장은진(Eun Jin Jang) 한국보건의료연구원 2016 근거와 가치 Vol.2 No.2

Objectives: This study was to assess clinical effectiveness on determining discontinuation of antibiotics based on procalcitonin levels in sepsis suspected patients. Methods: Existing systematic review search was performed based on the pre-established strategy in various databases including EMBASE, Ovid-Medline, and KoreaMed. Prkno et al. (2013) was selected considering comprehensiveness of literature search, research scope, as well as the Assessment of Multiple Systematic Reviews (AMSTAR) score. Using the search strategy of the selected study, additional systematic search was conducted to identify randomized clinical trials (RCT) that compare the effectiveness of procalcitonin-based antibiotics therapy with standard care. In order to evaluate the quality of studies, the risk of bias assessment tool was used. All database search and quality assessment were conducted by two reviewers independently. Metaanalysis was performed using a random-effect model. Results: A total of 8 RCTs were included. Duration of antibiotic therapy was significantly reduced in procalcitonin-guided therapy group, compared to standard treatment group (mean difference, -2.43; 95% confidence interval, -3.46, -1.40), while 28-day mortality, hospital mortality, and length of stay did not show any significant difference. Conclusion: Procalcitonin-guided therapy shortened duration of antibiotic treatment compared to standard care without any harmful effect on other clinical outcomes such as mortality or length of hospital stay.

e-PSM 시스템의 사용실태와 이행률 향상방안

안윤지,조송희,현유진,신예진,갈원모 대한설비관리학회 2018 대한설비관리학회지 Vol.23 No.4

With the increasing use of chemicals in domestic businesses, the possibility of fire explosion and poisonous material leakage accidents is also increasing. Accordingly, the Korea Occupational Safety and Health Agency(KOSHA) has implemented the process safety management (PSM) system for a long time. However, process safety report submission has been providing and operating e-PSM since 2016 to address these problems as it is difficult to increase budget spending due to the need for professional capabilities and commissioning the report to consulting institutions. Therefore, this study conducts questionnaires on whether e-PSM system that is well utilized in the field, focusing on existing PSM business sites. In order to find out the activation method that can solve the deficiency factors by analyzing various inconveniences and problems accurately, we propose three improvement methods as educational aspect, promotional direction of e-PSM system, and institutional aspect.

당뇨황반부종에서 항혈관내피성장인자 치료의 재정 영향 분석

양장미,신상진,서재경,최하진,조송희,강민주,지동현 대한안과학회 2019 대한안과학회지 Vol.60 No.7

Purpose: This study investigated the optimal strategy to minimize budgetary constraints on National Health Insurance (NHI) services, while maximizing the number of diabetic macular edema (DME) patients who receive anti-vascular endothelial growth factor (anti-VEGF) therapy. Methods: We estimated the potential budget impact of anti-VEGF treatments in DME patients based on perceived upcoming changes in reimbursement fees over the next 5 years (2018-2022). Four scenarios were evaluated: (1) current anti-VEGF treatment patterns, (2) the hypothetical reimbursement fee, (3) the introduction of a new molecule similar to current anti-VEGF treatments, and (4) the prescription of an off-label drug, bevacizumab. The number of patients, anti-VEGF treatments, and medical costs for each scenario were calculated using claims data from the Korean NHI system and anti-VEGF prescription data from a single hospital. Results: The potential budget impact of anti-VEGF injections in patients with DME over the next 5 years was estimated to be about 97.7 billion and 106.2 billion KRW for scenarios 1 and 2, respectively. In scenario 3, in which a biosimilar product to anti- VEGF is used, the estimated budget of the NHI system would be approximately 98.4 billion KRW. If an off-label drug is reimbursed, roughly 79.5 billion KRW will be required for the NHI system’s budget. Conclusions: If the revised fee structure for AMD patients is similarly applied to anti-VEGF injections for DME patients, the NHI fiscal requirements will increase disproportionately over the next 5 years compared to current reimbursement conditions. Given the growth of DME patients in today’s patient population, the use of a biosimilar or off-label drug is a financially viable alternative to reduce the overall burden on the NHI system. 목적: 당뇨황반부종환자를 위한 항혈관내피성장인자 치료에서 가상의 보험급여 조건과 환경의 변화가 건강보험재정에 미치는 영향을 분석하였다. 대상과 방법: 본 연구에서는 4개의 시나리오가 가정되었는데, 첫째는 현재의 급여 기준하의 시나리오로 현재의 급여 기준에서 당뇨황반부종의 항혈관내피성장인자 처방은 평생 14회로 제한되어 있다. 두 번째 시나리오는 14회라는 치료 횟수의 제한을 삭제하는 것이다. 세 번째 시나리오는 2020년부터 항혈관내피성장인자의 바이오시밀러가 시장에 도입되는 것을 가정한 것이다. 마지막으로 네 번째 시나리오는 항혈관내피성장인자의 허가초과의약품, 베바시주맙이 급여화되는 경우를 가정한 것이다. 시나리오 분석을 위해 국민건강보험공단 청구자료 및 의료기관 자료를 바탕으로 향후 5년 동안 예상 진료환자 수, 치료 횟수, 1인당 의료비 등을 추정하였으며, 이를기준으로 재정 부담을 추계하였다. 결과: 각각의 시나리오에 따른 추계된 재정부담은 첫 번째 시나리오에서는 947억 원, 두 번째 시나리오에서는 1,062억 원, 세 번째 시나리오에서는 984억 원, 네 번째 시나리오에서는 795억 원의 보험소요재정이 예상되었다. 결론: 당뇨황반부종환자에 연령관련황반변성환자에 대한 항혈관내피성장인자 급여 기준을 적용할 경우 재정 부담이 증가하는 것을알 수 있다. 따라서 당뇨황반부종 유병환자의 증가를 고려할 때 바이오시밀러 및 베바시주맙 도입 등의 정책적 대안에 대한 고려가필요하다.

습성 나이관련황반변성에서 항혈관내피성장인자의 유효성과 안전성: 네트워크 메타분석

강민주,신상진,서재경,조송희,최하진,양장미,지동현 대한안과학회 2019 대한안과학회지 Vol.60 No.8

Purpose: To compare the efficacy and safety of intravitreal injections of bevacizumab, ranibizumab, and aflibercept for the treatment of new patients with age-related macular degeneration (AMD). Methods: We conducted an update of the most recent and high quality systematic reviews (Canadian Agency for Drug Technology in Health [CADTH] 2016). Three randomized clinical trials were added to 13 trials identified from the CADTH report. The efficacy outcomes were 1) average improvement in visual acuity, 2) proportion of patients who experienced an improvement in vision (an increase in best-corrected visual acuity (BCVA) of ≥ 15 on Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and 3) proportion of patients who experienced worsening of vision (decrease in BCVA of ≥ 15 ETDRS letters). In addition, safety outcomes included systemic adverse events and ocular-related adverse events. To analyze the outcomes of 16 randomized controlled trials, we conducted meta-analyses on the outcome measures. Results: There was no significant difference in efficacy outcomes among anti-vascular endothelial growth factor (anti-VEGF) drugs. The mean difference in BCVA between ranibizumab and bevacizumab was 0.33 (95% confidence interval [CI]: -1.29, 1.95), and the odds ratio (OR) for a vision gain in the BCVA of ≥ 15 ETDRS letters for the ranibizumab versus aflibercept treatment was 1.02 (95% CI: 0.80, 1.30). There was also no significant difference in safety outcomes, except in terms of arterial thromboembolic events (ranibizumab vs. bevacizumab; OR: 2.15; 95% CI: 1.04, 4.41). Conclusions: The efficacy of anti-VEGF drugs for AMD patients was not significantly different. The safety of the drugs was also not significantly different, except in terms of arterial thromboembolic events. 목적: 나이관련황반변성환자의 치료에 쓰이는 베바시주맙, 라니비주맙 및 애플리버셉트의 유리체내 주입술의 유효성과 안전성을 메타분석을 통하여 비교하고자 하였다. 대상과 방법: 연구 목적에 부합하는 최근의 고품질의 체계적인 검토(Canadian Agency for Drug Technology in Health 2016)를 선정하였고, 여기에서 확인된 13건의 임상 시험에 3건의 무작위 임상 시험을 추가하여 메타분석 및 네트워크 메타분석을 시행하였다. 유효성 결과 지표로는 1) 시력의 평균 향상, 2) 시력 개선을 경험한 환자의 비율, 3) 시력이 악화된 환자의 비율을 파악하였고, 안전성 결과에는 전신 이상 반응 및 안구 관련 이상 반응을 분석하였다. 결과: 항혈관내피성장인자 간의 유효성 결과에는 유의한 차이가 없었다. 라니비주맙 대 베바시주맙의 평균 최대교정시력의 차이는 0.33 (95% confidence interval [CI], -1.29, 1.95)이었고 15글자 이상의 시력 증가에서는 라니비주맙 대 애플리버셉트의 위험도(odds ratio, OR)는 1.02 (95% CI, 0.80, 1.30)였다. 또한 동맥 혈전 색전증의 발생을 제외하고는 안전성 결과에 유의한 차이가 없었다(라니비주맙 대 베바시주맙, OR, 2.15; 95% CI, 1.04, 4.41). 결론: 나이관련황반변성에서의 항혈관내피성장인자의 유효성은 유의한 차이를 보이지 않았고, 안전성은 동맥 혈전 색전증 증상을 제외하고는 유의미한 차이가 없었다.

당뇨황반부종에서 항혈관성장인자의 유효성과 안전성: 네트워크 메타분석

최하진,신상진,서재경,조송희,양장미,강민주,지동현 대한안과학회 2019 대한안과학회지 Vol.60 No.2

Purpose: Intravitreal aflibercept, ranibizumab, bevacizumab, and dexamethasone are the most widely used drugs in the treatment of diabetic macular edema (DME). The aim of this study was to compare the efficacy and safety of anti-vascular endothelial growth factors and dexamethasone for the treatment of DME. Methods: There were nine previous systematic reviews on this topic; we updated these high-quality reviews. Seven studies were added to two studies following a literature search. Efficacy outcomes were 1) average improvement in visual acuity, 2) proportion of patients who experienced an improvement in vision (an increase in best-corrected visual acuity (BCVA) of ≥ 15 in the Early Treatment Diabetic Retinopathy Study [ETDRS]), and 3) proportion of patients who experienced worsening vision (a decrease in BCVA of ≥ 15 in the ETDRS). Safety outcomes included systemic adverse events and ocular-related adverse events. Results: The mean difference in the BCVA for ranibizumab versus bevacizumab treatment was 0.16 (95% confidence interval [CI]: -0.02, 0.34), and that for ranibizumab versus aflibercept was -0.08 (95% CI: -0.26, 0.10). The mean difference in the change of BCVA for aflibercept versus ranibizumab was -0.20 (95% CI: -0.40, -0.01), and that for aflibercept versus bevacizumab was -0.34 (95% CI: -0.53, -0.14). Other efficacy outcomes showed similar trends, and there was no significant difference between treatments. There was also no significant difference in both systemic and ocular adverse events rates between the treatments. Conclusions: In DME patients, the efficacy of aflibercept was found to be higher with respect to BCVA changes compared with ranibizumab or bevacizumab. However, there were no significant difference in terms of visual acuity improvement or visual acuity of more than 15 letters, nor in terms of anti-vascular endothelial growth factors (as a safety outcome). 목적: 당뇨황반부종 환자에서 항혈관성장인자의 유리체내주입술의 유효성과 안전성을 알아보고자 하였다. 대상과 방법: 연구목적에 부합하는 최근의 고품질의 체계적인 검토를 선정하였고, 선정된 문헌 고찰에 7건의 최근 수행된 무작위 임상시험을 추가하여 메타분석 및 네트워크 메타분석을 시행하였다. 유효성 결과 지표로는 1) 시력의 평균 향상, 2) 15글자 이상의 최대교정시력 개선을 경험한 환자의 비율, 3) 15글자 이상의 최대교정시력 저하를 경험한 환자의 비율을 파악하였고, 안전성 결과에는 전신이상 반응 및 안구 관련 이상 반응을 분석하였다. 결과: 라니비주맙과 베바시주맙의 교정시력의 평균 차이는 0.16 (95% confidence interval [CI]: -0.02, 0.345)이었고, 라니비주맙 대애플리버셉트의 평균시력 차이는 -0.08 (95% CI: -0.26, 0.10)이었다. 치료 전후의 시력변화를 약제 간의 비교한 최대교정시력 변화지표에서 라니비주맙(-0.20; 95% CI: -0.40, -0.01)과 베바시주맙(-0.34; 95% CI: -0.53, -0.14)이 각각 애플리버셉트에 비해 효과가낮은 것으로 나타났다. 전신 및 안구 부작용에서 약제 간에 유의한 차이가 없었다. 결론: 당뇨황반부종에서 애플리버셉트는 라니비주맙 또는 베바시주맙에 비하여 최대교정시력의 변화에 있어서 보다 효과적인 것으로나타났다. 그러나 15글자 이상의 시력향상이나 시력저하에 있어서는 세 가지 약제에서 유의한 차이를 보이지 않았다. 항혈관성장인자의 안전성은 약제 간에 유의한 차이를 보이지 않았다.

Procalcitonin-Guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients (PRODA): a Multi-Center Randomized Controlled Trial

전경만,서재경,장은진,조송희,류호걸,나성원,홍상범,이현주,김재열,이상민 대한의학회 2019 Journal of Korean medical science Vol.34 No.14

Background: The objective of this study was to establish the efficacy and safety of procalcitonin (PCT)-guided antibiotic discontinuation in critically ill patients with sepsis in a country with a high prevalence of antimicrobial resistance and a national health insurance system. Methods: In a multi-center randomized controlled trial, patients were randomly assigned to a PCT group (stopping antibiotics based on a predefined cut-off range of PCT) or a control group. The primary end-point was antibiotic duration. We also performed a cost- minimization analysis of PCT-guided antibiotic discontinuation. Results: The two groups (23 in the PCT group and 29 in the control group) had similar demographic and clinical characteristics except for need for renal replacement therapy on ICU admission (46% vs. 14%; P = 0.010). In the per-protocol analysis, the median duration of antibiotic treatment for sepsis was 4 days shorter in the PCT group than the control group (8 days; interquartile range [IQR], 6–10 days vs. 14 days; IQR, 12–21 days; P = 0.001). However, main secondary outcomes, such as clinical cure, 28-day mortality, hospital mortality, and ICU and hospital stays were not different between the two groups. In cost evaluation, PCT- guided therapy decreased antibiotic costs by USD 30 (USD 241 in the PCT group vs. USD 270 in the control group). The results of the intention-to-treat analysis were similar to those obtained for the per-protocol analysis.Conclusion: PCT-guided antibiotic discontinuation in critically ill patients with sepsis could reduce the duration of antibiotic use and its costs with no apparent adverse outcomes.