비급여 「인체조직유래 2차 가공뼈」 급여전환 적정성 평가

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demineralized bone matrixbone graftbone substitutesspinal surgeryhealth benefit appropriateness
In 2017, Korean government announced plans to expand coverage of the National Health Insurance and has gradually included uncovered medical services into the benefit package. Prior to coverage inclusion decision, Health Insurance Review and Assessment Service conducts benefit appropriateness review on items expected to be used in large
For over a decade, demineralized bone matrix (hereafter DBM) has been commonly used in Korea as bone graft material to treat bone defect, and has not been covered by the National Health Insurance. DBM contains glycerol, the carrier to help fix bone graft. DBM is an osteoinductive material that removes calcium phosphate in human bone, and is known to be mainly used in spinal fusions.
DBM was decided not to be covered by the National Health Insurance due to its relatively higher price than artificial bone and unclear evidence to prove its cost-effectiveness. Since the decision, DBM has not been re-assessed for coverage. As such, this study would like to attempt to evaluate benefit appropriateness of DBM.

This study aims to collect and analyze DBM's traits and relevant regulations, safety and efficacy, and use cases from home and abroad in order to assess benefit appropriateness of DBM and suggest a theme for discussion.

Safety and efficacy assessment was conducted based on literature review and expert advice. Usage status in Korea was analyzed based on auto insurance and health insurance claims data, factual survey of national health insurance medical bill, production/import/export sales report of medical devices, and released expenditure data of NHI uncovered services. Usage status of overseas was analyzed based on price data of public and private insurance web sites.

Criteria to decide benefit appropriateness and co-payment rate include safety and efficacy, substitutability, cost-effectiveness, and social needs20).
Safety of DBM was not discussed in this study as DBM manufacturers are required to get approval from the tissue bank according to the Human Tissue Act.
Spinal fusion was one of the most common use case in literature review for efficacy. When we limited the material to those with control group, there were 25 studies of spinal fusion, which was around 60% of all eligible papers. In most spinal fusion studies, DMB was used in autogenous bone graft or allogenic bone graft. Many studies compared spinal fusion cases against autogenous bone graft, and most conclusions showed no significant differences between two groups. Studies of other surgeries were
insufficient in number and were mostly retrospective case control studies of low quality.
Similar conclusions were observed in three systematic reviews.
In America, private insurer Aetna and Cigna stated that DBM has osteoinductive qualities (unlike allogenic bone) and can serve as a useful medical device for spinal fusion. Also, DBM was used in France, Japan, Taiwan, and Australia. In particular, Japan and Australia provides public insurance to DBM use.
As to substitutability, DBM is similar with other bone replacement in that it can be used as bone extender, but is different because it has osteoinductive qualities, which is clinically beneficial. Other medical device with osteoinductive qualities allowed for orthopedic operation is rhBMP-2 (Announcement No. 2020-100, effective from May 25, 2020)
However, as the application of rhBMP-2 is limited to lumbar spinal fusion and traumatic acute fracture of limbs, it cannot fully replace DBM.
Cost-effectiveness analysis should compare DBM with the most similar medical materials. Such examples of bone replacement would be 100% DBM (without carrier) with osteoinduction which is being covered, and rhBMP-2 that has not been determined for coverage. However, the substitutability is available only in some applications of the two. For reference, the price of uncovered DBM 1cc is KRW 520,000. In the benefit list of medical materials, the ceiling price of 100% DBM is KRW 119,360 (less than 1-2 cc). The price cap of alloplastic bone is KRW 55,080 (fine grained, 1g or more and less than 2g). For bone chip, the cap is KRW 70,300 (coarse/crush/cube, less than 1~2cc) These examples reaffirm that DBM is 4 to 9 times more expensive.
Regarding social needs, 65% of spinal fusion patients are age 60 or older. Because DBM is mainly used for musculoskeletal operations not directly related to death, it is not one of the medical materials with high medical importance. The number of spinal fusion patients went up by 8.7% from 2015 to 2019. On the auto claim statement, based on a
surgery unit, the lowest bill of DBM was KRW 440,000 and highest bill was KRW 4.5 million.

Considering benefit assessment standards and usage examples from Korea and abroad, DMB can be included in the National Health Insurance Package. However, the consumption volume should be controled by benefit criteria because DBM is expensive. The target of use can be limited by benefit standards because evidence of efficacy has not been fully proved for certain operations. There are factors to be considered when DBM is decided to be covered.
First, current bone replacement benefit criteria do not grant joint use of different bone replacement materials. However, there was literature evidence that DBM showed good clinical outcome when used with other bone replacement material. As such, benefit criteria need to be re-reviewed on the joint use.
Second, the ceiling price for 100% DBM need to be discussed alongside. The most important raw material of DBM product is human bone. The difference of the two is carriers, so when we discuss DBM, we also need to review price cap for DBM without carriers.
Third, the ceiling price should be decided at an adequate level. When set too low, the quality of imported bone or production process could be negatively affected.
Forth, the announcement name needs to change. Current Korean announcement name is too generic and does not specify DBM. Considering that DBM is the most commonly used name, we need to set up a clear set of names for DBM with and without carriers to differentiate the two.
Fifth, if DBM was decided for preliminary coverage, assessment indicators for coverage inclusion need to be selected in advance, and data collection and assessment plan should be reviewed simultaneously. As mentioned above, there are many types of DBM and insufficient amount of studies except for spinal fusion. Efficacy could vary upon the types of spinal surgery, and there is not enough clinical evidence. Therefore, reassessment planing and monitoring is needed.
In addition, there are concerns over the potential use of DBM even when autogenous bone graft is available from spinal surgery. Such cases need to be monitored after coverage inclusion.
Additionally, there is a need for research on the medical material selection standards of physicians. Although the number of physicians who participated in this study was limited, it seems that physicians did not have much information about medical materials. Most of them said that they chose based on their own experience or opted for widely used ones. Such answers suggest that we need to examine the selection standards for medical materials and attempt to encourage rational purchasing by providing a solid foundation.
Alternative Title
National Health Insurance Coverage Inclusion Assessment of Demineralized Bone Matrix with Carriers
Table Of Contents
요 약 ---------------------------------- ⅰ

제1장 서론 ---------------------------------- 1
1. 연구배경 ---------------------------------- 1
2. 연구목적 ---------------------------------- 2
3. 연구내용 및 방법 ---------------------------------- 2

제2장 골 이식용 치료재료 ---------------------------------- 5
1. 개요 ---------------------------------- 5
가. 골 이식 ---------------------------------- 5
나. 골 이식재 종류 ---------------------------------- 5
다. 국내 인체조직 관련 규정 ---------------------------------- 8
라. 건강보험 및 비급여 등재 현황 ---------------------------------- 10
마. 급여기준 및 심사지침 ---------------------------------- 13
2. 인체조직유래 2차 가공뼈 개요 ---------------------------------- 17
가. 개요 ---------------------------------- 17
나. 식품의약품안전처 허가 ---------------------------------- 20
다. 가이드라인 ---------------------------------- 22
라. 판매업체 조사 ---------------------------------- 24
3. 소결 ---------------------------------- 40

제3장 국내 사용현황 분석 ---------------------------------- 43
1. 자료원 개요 ---------------------------------- 43
가. 자동차보험 진료비 청구자료 ---------------------------------- 44
나. 건강보험환자 진료비 실태조사 자료 ---------------------------------- 47
다. 비급여 진료비용 정보공개 자료 ---------------------------------- 49
라. 의료기기 생산 및 수출·수입·수리실적 보고 자료 ---------------------------------- 52
2. 적응증이 유사한 급여 골이식재 사용 현황 ---------------------------------- 55
가. 분석대상 ---------------------------------- 55
나. 급여 골이식재 사용현황 ---------------------------------- 59
3. 비급여 인체조직유래 2차 가공뼈 사용 현황 ---------------------------------- 68
가. 분석대상 ---------------------------------- 68
나. 일반현황 ---------------------------------- 71
다. 가격 현황 ---------------------------------- 78
라. 사용량 현황 ---------------------------------- 88
마. 환자규모 및 특성 ---------------------------------- 91
바. 병용사용 현황 ---------------------------------- 94
4. 비급여 인체조직유래 2차 가공뼈 시장규모 ---------------------------------- 96
5. 소결 ---------------------------------- 100

제4장 유효성 문헌고찰 ---------------------------------- 105
1. 문헌검색 개요 ---------------------------------- 105
2. 문헌검색 계획 ---------------------------------- 106
가. 핵심질문(PICO) ---------------------------------- 106
나. 문헌 선택 및 배제기준 ---------------------------------- 106
3. 국외 데이터베이스 검색 및 문헌고찰 결과 ---------------------------------- 107
가. 국외 데이터베이스 검색결과 ---------------------------------- 107
나. 문헌고찰 결과 ---------------------------------- 108
4. 국내 데이터베이스 검색 및 문헌고찰 결과 ---------------------------------- 135
가. 국내 데이터베이스 검색결과 ---------------------------------- 135
나. 문헌고찰 결과 ---------------------------------- 135
5. 소결 ---------------------------------- 155

제5장 임상 전문가 자문 및 업체 인터뷰 ---------------------------------- 158
1. 전문가 자문회의 ---------------------------------- 158
가. 개요 ---------------------------------- 158
나. 1차 회의 결과 ---------------------------------- 158
다. 2차 회의 결과 ---------------------------------- 160
2. 업체 인터뷰 ---------------------------------- 163
가. 개요 ---------------------------------- 163
나. 수입업체 인터뷰 결과 ---------------------------------- 163
다. 제조업체 인터뷰 결과 ---------------------------------- 165
3. 소결 ---------------------------------- 167

제6장 국외 보험적용 현황 ---------------------------------- 170
1. 일본 ---------------------------------- 170
2. 대만 ---------------------------------- 173
3. 호주 ---------------------------------- 176
4. 미국 ---------------------------------- 179
5. 프랑스 ---------------------------------- 184
6. 각국별 Grafton DBM 가격비교 ---------------------------------- 187
7. 소결 ---------------------------------- 188

제7장 결론 및 제언 ---------------------------------- 190

참고문헌 ---------------------------------- 196
ABSTRACT ---------------------------------- 202
부 록 ---------------------------------- 208
김소희 et al. (202012). 비급여 「인체조직유래 2차 가공뼈」 급여전환 적정성 평가.
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