한국임상약학회지제 26 권제 4 호 Korean J Clin Pharm, Vol. 26, No. 4, 2016 Original Article Korean Journal of Clinical Pharmacy Official Journal of Korean College of Clinical Pharmacy Available online at http://www.kccp.or.kr pissn: 1226-6051 환자표본자료를이용한간경변증환자의의료이용특성및의료비용분석 김혜린 1 박재아 2 신지영 2 박승후 2 이의경 2 * 1 삼육대학교약학대학, 2 성균관대학교약학대학 (2016년 8월 28일접수 2016년 10월 21일수정 2016년 10월 24일승인 ) Analysis of Medical Use and Costs Related to the Management of Liver Cirrhosis Using National Patients Sample Data Hye-Lin Kim 1, Jae-A Park 2, JiYoung Sin 2, Seung-Hoo Park 2, and Eui-Kyung Lee 2 * 1 College of Pharmacy, Sahmyook University, Seoul 01795, Republic of Korea 2 School of Pharmacy, Sungkyunkwan University, Gyeonggi-do 03063, Republic of Korea (Received August 28, 2016 Revised October 21, 2016 Accepted October 24, 2016) ABSTRACT Background: Liver cirrhosis causes substantial socio-economic burden and is one of the major severe liver diseases in Korea. Nonetheless, there is only a few studies that analyzes disease burden of liver cirrhosis in Korea. Such study must be carried out due to its increasing need from the invention of new drugs for chronic hepatitis and demand for cost-effectiveness analyses. Methods: Patient sample data with ensured representativeness was analyzed retrospectively to compare the medical costs and uses for patients with compensated cirrhosis and decompensated cirrhosis. Patient claims data that include K74 and K703 from the year of 2014 were selected. Within the selected data, decompensated cirrhosis patient was identified if complications such as ascites (R18), encephalopathy (B190), hepatic failure (K72), peritonitis (K65), or esophageal varices (I85) were included, and they were compared to compensated cirrhosis patients. Results: 6,565 patients were included in the analysis. The average cost per patient was 6,471,020 (SD 8,848,899) KRW and 2,173,203 (4,220,942) KRW for decompensated cirrhosis and compensated cirrhosis, respectively. For inpatients, the average hospitalized days was 38.0 (56.4) days and 27.2 (57.2) days for decompensated cirrhosis and compensated cirrhosis, respectively. For outpatients, the average number of visits was 8.7 (9.1) days and 5.3 (7.5) days for compensated cirrhosis and decompensated cirrhosis, respectively. Conclusion: Compared to compensated cirrhosis patients, decompensated cirrhosis patients had higher costs, especially for hospitalization, injection, examination, and drugs administrated within medical institutions. KEY WORDS: Compensated cirrhosis, decompensated cirrhosis, medical cost, medical utilization 우리나라에서간질환, 특히간경변증의유병률이높으며간경변증은주요사망원의하나로알려져있다. 우리나라간경변증환자에서의주요원인질환은만성B형간염이 64.9% 로가장많고, 알코올 18.6% 이그뒤를따른다. 간경변증이진행되어복수, 식도정맥류출혈, 간성뇌증의합병증이나타나는비대상성간경병증으로이행되면 5년생존율이 20-40% 로예후가매우불량한우리나라의대표적인중증간질환이다. 1,2) 건강보험심사평가원의의료통계 3) 에의하면, 간경변증의의료비용은매년증가하고있다 ( 간의섬유증및경변증 (K74) 2011 년기준요양급여비용총액약 730 억원, 2015 년기준약 800억원 ; 알코올성간경변증 (K703) 2011년기준약 358억원, 2015년기준약 479억원 ). 간경변증은 B형간염, C형간염, 알코올간질환이주원인이며, 간경변을거쳐간암이발생한다. 특히사회경제적으로활동능력이왕성한 40-50대중년남성에게서많이발생하여 3) 직접의료비용과함께생산성손실비용까지감안하면, 사회경제적부담이상당할것임을예상할수있다. 2) 간경변증의질병비용을제시한몇몇국외선행연구가수행 *Correspondence to: Eui-Kyung Lee, School of Pharmacy #530302, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeonggi-do 03063, Republic of Korea Tel: +82-31-290-7786, Fax: +82-31-299-4379 E-mail: ekyung@skku.edu 341
342 / Korean J Clin Pharm, Vol. 26, No. 4, 2016 되었는데, 대부분원인질환인 B형간염또는 C형간염에대한비용연구에서하나의세부건강상태로포함되어있었다. 비용의범주는직접의료비만을포함하거나간접비까지포함하는등다양하였다. 4-9) 그러나국가간의료이용및치료패턴, 가격및비용차이등으로외국에서수행된의료비용연구의결과를국내현실에활용하는것은매우어렵다. 예를들어유럽의많은국가들에서는입원환자의수가는행위별수가제가아닌질병군별포괄수가제로서상환되며, 10) 우리나라의의약품가격과의료수가수준은외국에서와많은차이를보인다. 11-14) 한편간경변증이우리나라에서대표적인중증간질환이고사회적부담이상당함에도불구하고이에대한국내질병비용연구는충분하지못하다. 최근국내 8개대학병원의 C형간염환자의병원자료를이용하여분석한연구가발표되었는데, C형간염의다양한진행경과에따라의료비용과의료이용현황을분석하여제시하였으나 15) 대부분의병원이 3차의료기관으로서국내의료기관전체를대표한다고보기에는다소무리가있다. 한편최근새로운작용기전의 C형간염치료제가출시되면서이들에대한경제성평가의수요가커지고있는데, 간염은만성질환이므로바이러스감염이후간기능이파괴되면서간경변증, 간암, 간이식을요하는단계로진행되기까지장기간에걸쳐발생하는건강상태를반영하게된다. 대부분의만성간염에대한경제성평가선행연구 16-24) 의모델은대상성간경변증과비대상성간경변증건강상태를포함하고있으며, 분석을위해서는이건강상태에서발생하는비용자료가필요하다. 따라서본연구에서는대표성이확보된국내비용자료원을이용하여대상성간경변증과비대상성간경변증환자의비용및의료이용에대한차이를분석하고자한다. 연구방법 대상성간경변증및비대상성간경변증환자의정의대한간학회에서발간한진료가이드라인에의하면간경변증은병리조직학적으로정의되는질환으로임상적으로대상성간경변증과비대상성간경변증으로분류되며비대상성간경변증은복수, 정맥류출혈, 간성뇌증등의합병증이있는경우로정의된다. 1,2,25) 한국표준질병사인분류 (KCD) 상병코드에서는대상성간경변증과비대상성간경변증으로구분되어있지않았다. 따라서일차적으로검색결과와소화기내과임상전문의의자문을통해간경변증으로사용될수있는코드는 K74 ( 간의섬유증및경변증 ) 과 K70.3 ( 알콜성간경변증 ) 으로확정하였다. 그리고간경변증진료가이드라인 1), 선행연구 4) 및임상전문의자문에의하면비대상성간경변증은간경변증이진행되어복수 (R18), 간성혼수 (B190), 간부전 (K72), 복막염 (K65), 식도정맥류 (I85) 와같은합병증이나타나는상태에해당한다. 따라서본연구 에서비대상성간경변증은상기의간경변증상병코드 (K74, K70.3) 와함께 5개합병증증상에해당하는분류코드를갖는환자로, 합병증의분류코드를갖지않는경우대상성간경변증환자로조작적정의하여구분하였다. 분석자료원본연구에서는 2014년건강보험심사평가원환자표본자료 (HIRA-NPS-2014) 를후향적으로분석하였다. 환자표본자료는요양기관의건강보험청구원자료 (raw data) 에서개인및법인에대한정보를제거한후통계학적으로표본추출된 2차자료로 ( 전체환자추출비율 3%, 약 140만명 ), 해당년도요양개시일기준으로 1년간청구된진료내역으로구축된데이터셋이다. 심평원환자표본자료는명세서일반내역 ( 이하 Table 20), 진료내역 ( 이하 Table 30), 수진자상병 ( 이하 Table 40), 원외처방교부상세 ( 이하 Table 53) 로구성되어있다. 각내역별로포함되는주요변수는다음과같다. Table 20은명세서연결코드, 수진자고유번호, 성별, 연령, 서식코드, 내원일수, 수술여부, 심결요양급여비용 ( 총액, 본인부담금, 보험자부담금 ), 요양기관고유번호등을포함하고있다. Table 30에는항코드 ( 진찰료, 입원료, 투약료, 마취료등항목구분 ), 단가, 1회 1일투약량, 총투여일수또는실시횟수, 총사용량또는실시횟수, 금액, 가산적용금액, 일반명코드, 분류코드등의변수를포함한다. Table 40에는상병기호, 상병 청구진료과목코드등을, Table 53에는처방전교부번호, 1회 1일투약량, 총투여일수또는실시횟수, 금액, 일반명코드등을포함한다. 모든내역에는명세서연결코드가있어각내역으로분할되어있는명세서를연결할수있다. 본연구에서는 Table 20, Table 30, Table 40, Table 53을사용하였다. 분석데이터셋구축과정 분석대상데이터셋구축 1 간경변증상병코드를갖는명세서번호추출 : Table 40에서간경변증상병코드 K74 또는 K703을포함하는명세서번호를선택하였다. 2 비대상성간경변증환자추출 : 다음으로는다시 Table 40 에서비대상성간경변증의다섯개합병증코드 (R18, B190, K72, K65, I85) 를갖는명세서를추출하여 1에서추출해둔간경변증명세서데이터셋의환자와비교하여양쪽에모두존재하는환자의수진자고유번호를추출하였다. 3 Table 20에서 1에서추출해둔간경변증명세서번호에해당하는데이터를추출하고, 2에서추출된비대상성간경변증환자를표시하는변수를생성하였다. 4 진료및처방내역추출하여결합 : 간경변증명세서에해당하는진료내역추출 : 상기간경변증상병코드를갖는명세
환자표본자료를이용한간경변증환자의의료이용특성및의료비용분석 / 343 서 (1) 에해당하는진료내역 (Table 30) 및처방내역 (Table 53) 을추출하여연결하였다. 5 2 의 Table 20 데이터셋에서수진자고유번호, 연령, 성별, 수술여부, 의료기관종별, 비대상성변수등분석에필요한변수들을추려 4의데이터셋에연결하여분석에필요한데이터셋을구축하였다. 데이터셋정리상기에서구축된분석데이터셋에다음과같은처리를하였다. Table 20에서심결요양비용이 0인명세서는분석에서제외하였다. 그리고서식번호코드가의과입원, 의과외래가아닌약 0.2% 의명세서를제외하였다. 그리고 Table 30에서일반명약품코드가존재하는경우항코드와관계없이의료기관내투약의약품비로재분류하였다. 비용분석에사용된비용의종류 환자표본자료에는여러비용이제시되고있어관점에따라보험자부담비용, 환자본인부담비용, 전체비용으로분석할수있다. 본연구에서는전체비용으로하되가산적용금액변수를이용하여분석하였다. 통계분석 SAS version 9.4 (SAS Institute, Inc., Cary, NC) 를이용하였으며, 대상성간경변증환자군과비대상성간경변증환자군간의비용및의료이용 ( 내원일수 ) 의유의성을검정하기위해, 분석목적과변수의특성에따라 Student s t-test, Chi-square test를수행하였다. 연구결과 연구대상자특성최종적으로분석에포함된데이터셋에는총 6,565명환자 ( 간경변증환자가 5,415명, 비대상성간경변증환자가 1,150명 ) 의 927,997건의명세서가포함되었다. 간경변증전체환자의평균연령은 58.2세 (SD 12.4) 로나타났는데, 대상성간경변증환자에서 57.8세 (12.2), 비대상성간경변증환자에서 60.0세 (12.9) 로비대상성간경변증환자의연령이다소높았다 (p<0.0001). 성별은남성환자가약 68%, 여성환자가약 32% 를차지하였다. 수술경험이있는환자는비대상성간경변증환자에서 39.5%, 대상성간경변증환자에서 9.7% 로차이를보였고 (p<0.0001), 입원의경험이있는환자역시각각 70.7%, 22.3% 로비대상성간경변증환자에서더높은비율을나타내었다 (p<0.0001) (Table 1). 의료기관종별환자수및내원일수는 Table 2에제시하였다. 입원환자및외래환자에서모두종합병원이상에서진료받은환자가 70% 를상회하고있었다. Table 1. Baseline characteristics. Total N=6,565 CC N=5,415 DC N=1,150 Variables N % N % N % p-value a) Age, yr mean 58.2 57.8 60.0 (±SD) (±12.4) (±12.2) (±12.9) <0.0001 Age group, n <20 24 0.37 21 0.39 3 0.26 20-29 58 0.88 48 0.89 10 0.87 30-39 296 4.51 260 4.80 36 3.13 40-49 1,103 16.8 921 17.01 182 15.83 50-59 2,213 33.71 1,848 34.13 365 31.74 60-69 1,596 24.31 1,332 24.60 264 22.96 70-79 1,002 15.26 782 14.44 220 19.13 >80 273 4.16 203 3.75 70 6.09 Sex, n Male 4,491 68.41 3,699 68.3 792 68.9 0.7270 Female 2,074 31.59 1,716 31.7 358 31.1 Surgery Experience, n yes 978 14.9 524 9.7 454 39.5 <0.0001 Hospitalization Experience, n yes 2,018 30.7 1,205 22.3 813 70.7 <0.0001 Abbreviations: CC (Compensated cirrhosis); DC (Decompensated cirrhosis); SD (Standard Deviation) a) p-values from Student s t-test or Chi-square test as variables characteristics 각환자들은입원과외래진료를이용할수있고, 상급종합병원부터의원까지이용가능하기때문에요양기관종별환자수의합은전체환자수를초과할수있다. 내원일수 ( 외래환자에서는외래진료를위한내원일수, 입원환자에서는입원일수 ) 에서는외래환자의경우 1인당평균 5.9일 (7.9) 의료기관을내원하고, 입원환자는 1인당평균 31.6일 (57.1) 입원하는것으로나타났다. 의료비용분석비대상성간경변증환자의 1 인당평균비용은 6,471,020 원 (8,848,899) 이고, 대상성간경변증환자의 2,173,203원 (4,220, 942) 로서비대상성간경변증환자의의료비용이 4,297,817원 (5,329,718) 더소요되는것으로분석되었으며이차이는통계적으로유의하였다 (p<0.0001) (Table 3). 비용을항코드별로구분하며 1인당평균비용을비교한결과진찰비, 입원료, 투약료, 주사료, 이학요법료, 검사료, 영상진단및방사선치료료, 의료기관내에서투약하는의약품비, 원외처방약품비항목에서대상성간경변증환자와비대상성간경변증환자간통계적으로유의한차이를보였다. 세부적으
344 / Korean J Clin Pharm, Vol. 26, No. 4, 2016 Table 2. Utilization of hospital services per patient. Number of Patients Number of Days Medical institutions Total Inpatient Outpatient Inpatient Outpatient N % N % n % N Mean SD N Mean SD Tertiary general hospital 2,872 38.0 780 33.8 2,663 40.6 780 23.5 37.3 2,663 6.1 7.5 General hospital 2,527 33.5 1001 43.3 2,144 32.7 1,001 29.7 47.4 2,144 6.3 7.7 Hospital 688 9.1 329 14.2 465 7.1 329 38.4 58.1 465 5.8 6.6 Nursing hospital 190 2.5 179 7.7 19 0.3 179 128.6 120.7 19 5.3 5.5 Clinic 1,275 16.9 21 0.9 1,265 19.3 21 52.0 83.4 1,265 7.7 12.3 Public health center 2 0.0 0.0 2 0.0 2 8.0 1.4 Total 6,565 2,018 5,908 2,018 31.6 57.1 5,908 5.9 7.9 The total for each variable does not match due to the number of patients overlapping between medical institution type. 로살펴보면가장큰차이를보이는항목은검사료로서비대상성간경변증환자에서 1,212,159원 (1,564,561), 대상성간경변증환자에서 377,945원 (560,112) 으로비대상성간경변증환자의비용이 834,213원 (844,950) 더크게지출되는것으로나타났다 (p<0.0001). 다음으로는입원료항목이각각 1,883,442 원 (2,297,178), 1,105,817원 (1,658,866) 으로비대상성간경변증환자의비용이 777,625원 (1,945,876) 더소요되었고 (p<0.0001), 의료기관에서투약한의약품비가각각 1,201,479 원 (2,406,869), 585,879원 (2,032,616) 으로비대상성간경변증환자에서 615,600원 (2,131,150) 더높은것으로확인되었다 (p<0.0001). 한편이학요법료의경우대상성간경변증환자가 507,802원 (2,349,490), 비대상성간경변증환자가 116,955원 (232,881) 으로서대상성간경변증환자의비용이 390,848원 (1,877,568) 더높은것으로분석되었으나이는앞서차이를보인다른항목들보다환자수가적고, 대상성간경변증환자군에특이적으로높은비용환자가포함된결과이다. 입원환자의비용을비교한결과비대상성간경변증환자가 7,400,562원 (9,416,889), 대상성간경변증환자가 4,491,776원 (6,436,126) 으로비대상성간경변증환자에서 2,908,786원 (3,651,805) 더많이소요되고 (p<0.0001), 외래환자의경우비 Table 3. Medical cost per patient by decompensation. Compensated Cirrhosis Decompensated Cirrhosis Classification Estimates, KRW Estimates, KRW P-value N Mean SD Median N Mean SD Median Total cost 5,415 2,173,203 4,220,942 851,652 1,150 6,471,020 8,848,899 3,921,508 <.0001 Classified costs by clause code Consultation 5,086 62,608 89,458 41,040 1,139 160,787 166,422 119,370 <.0001 Hospitalization 1,168 1,105,817 1,658,866 547,355 811 1,883,442 2,297,178 1,131,430 <.0001 Administration 1,246 25,561 44,444 13,096 806 42,303 58,062 24,382 <.0001 Injection 1,840 137,753 624,516 20,022 885 610,198 1,603,757 199,122 <.0001 Anesthesia 158 245,152 235,128 169,177 77 261,794 297,824 172,979 0.6683 Physical therapy 175 507,802 2,349,490 38,200 101 116,955 232,881 31,812 0.0304 Psychotherapy 99 427,484 1,015,337 39,988 78 242,769 738,779 26,390 0.1633 Surgery or treatment 896 1,233,668 2,944,700 292,255 717 1,164,186 2,602,901 370,407 0.6155 Examination 4,810 377,945 560,112 230,033 1,111 1,212,159 1,564,561 743,774 <.0001 Imaging or radiotherapy 1,551 212,586 652,838 27,447 850 271,333 609,010 69,589 0.0277 Etc. 2,274 639,186 2,015,839 163,411 856 921,567 2,203,931 312,596 0.0011 Hospital drug 3,069 585,879 2,032,616 85,857 1,007 1,201,479 2,406,869 594,897 <.0001 Pharmacy drug 3,634 882,452 1,263,076 452,142 903 785,133 1,193,396 412,560 0.0304 Costs by inpatient/outpatient Inpatient 1,205 4,491,776 6,436,126 2,411,985 813 7,400,562 9,416,889 4,605,718 <.0001 Outpatient 4,925 639,291 1,852,371 292,269 983 728,530 1,426,638 432,001 0.09 Abbreviations: KRW (Korean won); SD (Standard Deviation)
환자표본자료를이용한간경변증환자의의료이용특성및의료비용분석 / 345 Table 4. Utilization (institution visit days) per patient by decompensation. Classification Compensated Cirrhosis Decompensated Cirrhosis N Mean SD Median N Mean SD Median P-value Utilization by hospital visits, days per patients Hospitalization 1,205 27.2 57.2 10 813 38.0 56.4 19 <.0001 Outpatients visit 4,925 5.3 7.5 4 983 8.7 9.1 7 <.0001 Utilization per patient by medical institution types, days per patients Tertiary general hospital 2,638 10.7 12.4 7 809 26.9 27.3 19 <.0001 General hospital 2,205 14.2 21.8 9 947 34.8 39.9 24 <.0001 Hospital 550 16.3 29.7 8 250 28.8 39 14 <.0001 Nursing hospital 112 119.6 131.7 51.5 86 85.9 100.2 37.5 0.042 Clinic 1,083 10.5 18.3 5 204 12.2 17.4 7.5 0.2274 Public health center 2 6 7.1 6 - - - - - 대상성간경변증환자가 728,530원 (1,426,638), 대상성간경변증환자가 639,291원 (1,852,371) 으로분석되었으나그차이는통계적으로유의하지않았다 (p=0.09). 의료이용 ( 내원일수 ) 분석결과간경변증환자의내원일수를비대상성여부에따라차이를분석한결과는 Table 4와같다. 먼저입원환자에서비대상성간경변증환자의 1인당평균입원일수는 38.0일 (56.4) 이고대상성간경변증환자는 27.2일 (57.2) 로비대상성간경변증환자의입원기간이 10.8일 (56.9) 더길었다 (p<0.0001). 외래환자에서도비대상성간경변증환자의 1인당입원일수는 8.7일 (9.1) 이고대상성간경변증환자는 5.3일 (7.5) 로비대상성간경변증환자의외래진료를위한내원일수가 3.3일 (7.5) 더많은것으로분석되었다 (p<0.0001). 고 본연구는대상성간경변증이진행되어복수, 복막염, 식도정맥류, 간성혼수등의간부전합병증이동반되는경우비대상성간경변증으로정의하여대상성 비대상성여부에따른의료비용과의료이용의차이를대표성있는자료원을이용하여분석한연구이다. 분석결과비용및의료이용은간기능이보다악화된상태인비대상성간경변증환자에서더높은것으로나타났다. 이러한경향은한국인 C형간염환자를대상으로한김도영등의연구 15) 에서대상성간경변증환자보다비대상성간경변증환자에서의비용이높게산출된결과와일치하였다. 그러나본연구의비대상성간경변증환자의비용이대상성간경변증환자의비용보다약 3배정도큰것으로분석되었던것에비해더큰 5배정도의격차를보였다. 앞서언급한것처럼김도영등의연구에서사용한자료원은 8개병원에서수집된환자들의 찰 의료비용이며, 대상성 비대상성간경변증환자가각각 77명, 20명으로상대적으로환자수가작고, 또포함된대부분의병원이규모가큰상급종합병원으로서, 전국의료기관의청구자료에서통계적으로추출된환자표본자료를자료원으로한본연구와는집계된비용의범위나포함된의료기관의성격의차이가있어직접적으로비교하기는어렵다. Abregel 등 (2016), Kieran 등 (2015) 의선행연구 4,5) 역시비대상성간경변증환자의비용이대상상간경변증환자의 3.1-4.6배정도높은것으로나타났다. 한편태국에서수행된또다른 C형간염환자대상비용을분석한 Thongsawat 등 (2014) 의연구 7) 에서는앞서국내연구에서비대상성간경변증환자가대상성간경변증환자보다의료비용이높았던분석결과와는반대로오히려대상성간경변증환자의의료비용이더높은것으로제시되었다. 항바이러스제약품비와검사비를제외한항목의비용은비대상성간경변증환자의비용이더컸으나대상성간경변증환자전체비용의 70% 이상을차지하는항바이러스약품비에서의큰차이에의한결과로해석된다. 이는 Starmeyer 등 (2014) 6) 의연구에서도유사한경향을보였다. 앞서언급한바와같이각국가마다의료이용및치료패턴과비용, 수가체계가다르므로의료비용연구는수행된국가에따라서로다른결과를보일수있고, 연구자가어떤비용을분석대상으로포함했는가에따라달라질수있다. 그러나미국, 유럽, 아시아지역 16개국가의의료비용연구에대한체계적문헌고찰 26) 결과에서제시되는바와같이대체적으로비대상성간경변증환자에서의비용이대상성간경변증환자에비해더큰것으로보인다. 1년간의환자표본자료를이용하여분석한본연구에는몇가지제한점이있다. 먼저환자표본자료에포함된개별환자의자료는 1년간관찰된것이아니기때문에본연구의분석결과는 1인당연간평균비용혹은연간내원일수라고볼수는없다. 그러나분석에포함된대상성 비대상성간경변증환자수가충분히크고, 양쪽군에동일하게작용하기때문에두군의
346 / Korean J Clin Pharm, Vol. 26, No. 4, 2016 차이를비교하는데큰편중은없을것으로사료된다. 추후장기간의코호트자료를이용하여분석을수행하면, 이러한제한점이보완될수있을것으로판단된다. 다음으로, 환자표본자료는보험급여청구를목적으로하는자료의특성상질병코드의누락이나정확성에관한우려를완전히배제할수없다. 27) 유사한맥락에서본연구는질병분류코드를통해비용과의료이용을파악하였기때문에환자에대한정확한임상자료가부족하다. 마지막으로비급여자료에대한정보가없어서사회적관점에서의직접의료비를산출하는데한계가있다. 상기에서의제한점에도불구하고, 본연구에서는우리나라전체인구에대한대표성을확보할수있고국내현실을잘반영한 real-world data를이용하여간질환의진행과정중중요한상태인간경변증환자의비용과의료이용에대해분석하였다. 아울러질병분류코드체계에서대상성 비대상성간경변증을특정하는코드가구분되어있지않으나비대상성간경변증의임상적특징을파악하여조작적으로정의하였다는점에서의미가있다. 본연구의비용분석결과는다양한간염치료제의경제성평가를수행함에있어유용하게활용될수있다. B형간염과 C형간염의치료비용이매년증가하고있고, 28) 특히만성C형간염은최근새로운기전의고가약제들이개발되어출시되면서학계와산업계에서는이약제들의경제성평가가활발히수행되고있다. 29-31) 대부분의만성간염의경제성평가모델은바이러스에감염된이후만성간염자연경과단계와간경변증으로이행되어간기능이악화되는단계가결합되는형태를보인다. 즉약제투여로바이러스성만성감염의자연사단계에서나타난효능이장기간에걸쳐간경변증, 간세포암등으로이행되는성과를평가하게되는데, 대상성간경변증과비대상성간경변증건강상태를포함한다. B형간염바이러스, C형간염바이러스, 혹은알코올에의한간질환에관계없이간세포가파괴되면서간기능이저하되는대상성 비대상성간경변증건강상태를포함하기때문에본연구의비용분석결과는다양한간염치료제의비용효과성평가에적용될수있을것으로기대한다. 또한의료비등의질병비용연구는특정질환이나건강행동에대한경제적부담을평가하여정책의우선순위를결정하거나프로그램의정당성을확인하는목적으로활용될수있다. 27) 본연구에서는간경변증환자의직접의료비만을분석하였으나, 간질환으로인한조기사망비용및생산성손실에의한간접비비중이간질환환자비용의약 80% 를차지한다는국내선행연구결과를감안하여 32) 간질환중에서도상대적으로중증인간경변증으로인한사회경제적영향을추정하는것이가능하다. 아울러추후배포되는환자표본자료로본연구와동일한분석을하여시간의경과에따른결과를비교하거나혹은다른질환에서의비용과비교하여의료비용에영향을미치는보건의료정책에대한평가에도활용할수있을것으로사료된다. 결 대표성이확보되는 real-world 데이터인환자표본자료를이용하여대상성간경변증과비대상성간경변증환자의의료비용을비교한결과, 비대상성간경변증환자에서의비용이크게나타났으며, 특히입원비, 주사료, 검사료, 의료기관내투약의약품비에서의차이가컸다. 의료이용측면에서도비대상성간경변증환자의입원일수및외래내원일수가대상성간경변증환자보다더컸다. 론 감사의글 본연구는보건복지부보건의료연구개발사업의지원에의하여이루어졌습니다 ( 과제고유번호 : HC15C3380). 참고문헌 1. The Korean Association for the Study of the Liver and liver cirrhosis clinical research center. Clinical Practice Guideline for Liver Cirrhosis, Update. Seoul: Jin-corp, 2011; 1-83. http://www.kasl.org/ bbs/index.html?code=guide&category=&gubun=&idx=&page =1&number=48&mode=view&order=&sort=&keyfield=&key 2. The Korean Association for the Study of the Liver, White Paper on Liver Diseases in Korea, Seoul: The Korean Association for the Study of the Liver, 2013. 3. HIRA. Healthcare Bigdata Hub. Available from http://opendata. hira.or.kr/op/opc/olap3thdsinfo.do. Accessed July 14, 2016. 4. Abergel A, Rotily M, Branchoux S, et al. Chronic hepatitis C: Burden of disease and cost associated with hospitalisations in France in 2012 (The HEPC-LONE study). Clin Res Hepatol Gastroenterol 2016; 40(3): 340-8. 5. Kieran JA, Norris S, O'Leary A, et al. Hepatitis C in the era of directacting antivirals: real-world costs of untreated chronic hepatitis C; a cross-sectional study. BMC infect Dis 2015;15:471. 6. Stahmeyer JT, Rossol S, Bert F, et al. Cost of treating hepatitis C in Germany: a retrospective multicenter analysis. Eur J Gastroenterol Hepatol 2014;26(11):1278-85. 7. Thongsawat S, Piratvisuth T, Pramoolsinsap C, et al. Resource Utilization and Direct Medical Costs of Chronic Hepatitis C in Thailand: A Heavy but Manageable Economic Burden. Clin Res Hepatol Gastroenterol 2014;3:12-8. 8. Zhang S, Ma Q, Liang S, et al. Annual economic burden of hepatitis B virus-related diseases among hospitalized patients in twelve cities in China. J Viral Hepat 2016;23(3):202-10. 9. Lu J, Xu A, Wang J, et al. Direct economic burden of hepatitis B virus related diseases: evidence from Shandong, China. BMC Health Serv Res 2013;13:37. 10. Lim SJ, Jo JH, Kim SH, Status of health insurance system and reform trend in major foreign countries, Seoul: National Health Insurance Service, 2014;1-126. 11. Lee H, Shin E, Lee C, et al. Medical price levels of OECD countries: A Comparative Study. Research Institute for Healthcare Policy. 2012;11:1-62. 12. Kwon S, Kim S, Kim T, et al. Comparison of domestic and foreign
환자표본자료를이용한간경변증환자의의료이용특성및의료비용분석 / 347 generic drug prices. National Health Insurance Service?Health Insurance Review and Assessment Service. 2010. 13. Kim S. Pharmaceutical pricing policies in a global market. OECD health policy studies. 2011. 14. Lee E, Kim H, Kim B et al. Comparative analysis of drug price level in Korea compared to OECD countries. Sungkyunkwan University? Korean Research-based Pharma Industry Association. 2014. 15. Kim do Y, Yoon KT, Kim W, et al. Estimation of direct medical cost related to the management of chronic hepatitis C and its complications in South Korea. Medicine 2016;95(30):e3896. 16. Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014; 370(16):1483-93. 17. Leleu H, Blachier M, Rosa I. Cost-effectiveness of sofosbuvir in the treatment of patients with hepatitis C. J Viral Hepat 2015; 22(4):376-83. 18. Linas BP, Barter DM, Morgan JR, et al. The cost-effectiveness of sofosbuvir-based regimens for treatment of hepatitis C virus genotype 2 or 3 infection. Ann Intern Med 2015;162(9):619-29. 19. Petta S, Cabibbo G, Enea M, et al. Cost-effectiveness of sofosbuvirbased triple therapy for untreated patients with genotype 1 chronic hepatitis C. Hepatology 2014;59(5):1692-705. 20. Pfeil AM, Reich O, Guerra IM, et al. Cost-effectiveness analysis of sofosbuvir compared to current standard treatment in swiss patients with chronic hepatitis C. PloS one 2015;10(5):e0126984. 21. San Miguel R, Gimeno-Ballester V, Blazquez A, et al. Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C. Gut 2014. 22. Shepherd J, Jones J, Hartwell D, et al. Interferon alpha (pegylated and non-pegylated) and ribavirin for the treatment of mild chronic hepatitis C: a systematic review and economic evaluation. Health Technol Assess 2007;11(11):1-205, iii. 23. Siebert U and Sroczynski G. Effectiveness and cost-effectiveness of initial combination therapy with interferon/peginterferon plus ribavirin in patients with chronic hepatitis C in Germany: a health technology assessment commissioned by the German Federal Ministry of Health and Social Security. Int J Technol Assess Health Care 2005;21(1):55-65. 24. Wright M, Grieve R, Roberts J, et al. Health benefits of antiviral therapy for mild chronic hepatitis C: randomised controlled trial and economic evaluation. Health Technol Assess 2006;10(21):1-113, iii. 25. The Korean Association for the Study of the Liver. Chronic Hepatitis Clinical Practice Guideline. 2015. 26. El Khoury AC, Wallace C, Klimack WK, et al. Economic burden of hepatitis C-associated diseases: Europe, Asia Pacific, and the Americas. J Med Econ 2012;15(5):887-96. 27. Kim Y, Shin S, Park J, et al. Costing methods in Healthcare. National Evidence-based Healthcare Collaborating Agency 2013. 28. Shon C, Choi HY, Shim JJ, et al. The Economic Burden of Hepatitis A, B, and C in South Korea. Jpn J Infect Dis 2016;69(1): 18-27. 29. Chen GF, Wei L, Chen J, et al. Will Sofosbuvir/Ledipasvir (Harvoni) Be Cost-Effective and Affordable for Chinese Patients Infected with Hepatitis C Virus? An Economic Analysis Using Real-World Data. PloS one 2016;11(6):e0155934. 30. Chhatwal J, He T, Hur C, et al. Direct-acting antiviral agents for patients with hepatitis C virus genotype 1 infection are cost saving. Clin Gastroenterol Hepatol 2016. 31. Virabhak S, Yasui K, Yamazaki K, et al. Cost-effectiveness of directacting antiviral regimen ombitasvir/paritaprevir/ritonavir in treatmentnaive and treatment-experienced patients infected with chronic hepatitis C virus genotype 1b in Japan. J Med Econ 2016;19(12):1144-56. 32. Lee S, Chung W, Hyun KR. Socioeconomic costs of liver disease in Korea. Korean J Hepatol 2011;17(4):274-91.