보험인정기준 상세내용

■ 고시 개정 전체내용

각 약제별 허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.



- 아 래 -



가. 투여 대상

1) McDonald(`17) 진단기준(시간파종(Dissemination in time, DIT)과 공간파종(Dissemination in space, DIS)을 충족)에 부합하면서 다른 유사질환에 의한 발생을 배제할 수 있는 재발완화형 다발경화증 환자

2) 이차 진행성 다발경화증 환자

3) 다른 질환으로 설명되지 않는 탈수초성 Brain MRI 소견이 있고 뇌 또는 척수에 2개 이상의 lesion을 가진 경우로서, 다발경화증으로 진행될 확률이 높은 CIS 환자(Clinically isolated syndrome, 임상적으로 단발성 병변이 있는 증후군)



나. 투여중지 기준

1) 신경과전문의가 진찰하여 12개월 이내에 2회의 심한 손상이 유발되는 재발이 있는 경우(Two disabling relapses, as defined by the examining neurologist, within a 12 month period)

2) 6개월에 걸쳐 관찰할 수 있는 손상이 증가하는 이차적인 진행 상태(Secondary progression with an increase in disability observable over 6 months)

3) 6개월간 지속적으로 보행 능력이 나빠져 걸을 수 없을 때(Loss of ability to walk, with or without assistance, persistent for at least 6 months)



다. 중지기준에 해당하지 않는 경우에는 투여기간의 제한 없이 계속 투여를 인정함.



■ 고시 개정 고시번호(시행일자)

고시 제2021-26호(2021.2.1.)



■ 고시 개정 사유

교과서, 가이드라인, 임상문헌, 제외국 보험기준, 학회의견 등 참조하여, 각 약제별 허가사항 범위 내에서투여대상을 McDonald 진단기준을 충족하는 재발완화형 환자로 확대 및 CIS 진단 요건 문구를 명확히 함.



■ 관련문헌 등

· Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria, Lancet Neurol 2018; 17: 162？73

· 손은희 등, 다발경화증의 진단: 2017 맥도널드진단기준, J Korean Neurol Assoc 36(4):273-279, 2018

· Harrison's Principles of Internal Medicine, 20e>Chapter 436: Multiple Sclerosis

· Goldman-Cecil Medicine 26th ed(2020)>CHAPTER 383 MULTIPLE SCLEROSIS AND DEMYELINATING CONDITIONS>Types of Multiple Sclerosis

· Conn's Current Therapy 2020>？ MULTIPLE SCLEROSIS

· NICE guideline; Multiple sclerosis in adults:management_Clinical guideline(Published: 8 October 2014)

· B. Yamout, et al., Consensus recommendations for the diagnosis and treatment of multiple sclerosis: 2019 revisions to the MENACTRIMS guidelines, Multiple Sclerosis and Related Disorders 37 (2020) 101459

· Defining the clinical course of multiple sclerosis; The 2013 revisions, Neurology® 2014;83:278？286

· National Multiple Sclerosis Society_Multiple Sclerosis

· Scolding N, et al. Association of British Neurologists :revised (2015) guidelines forprescribing disease-modifying treatments in multiple sclerosis, Pract Neurol 2015;15:273？279

· O’Connor et al, Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis, N Engl J Med 2011;365:1293-303.

· Confavreux et al, Oral terifl unomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebocontrolled, phase 3 trial, Lancet Neurol 2014; 13: 247？56

· Vermersch P et al, Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial, Multiple Sclerosis Journal 2014, Vol. 20(6) 705？716 (TENERE)

· Confavreux et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years, Multiple Sclerosis Journal 2012 18(9) 1278？89

· The IFNB Multiple Sclerosis Study Group, Interferon beta-lb is effective in relapsing-remitting - multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial, NEUROLOGY 1993;43:655-661

· Gold R et al, Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis, N Engl J Med 2012;367:1098-107

· Fox et al. Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis. N Engl J Med 2012;367:1087-97

· Hutchinson M et al. Curr Med Res Opin. Efficacy and safety of BG-12(dimethyl fumarate) and other disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis: a systematic review and mixed treatment comparison. 2014 Apr;30(4):613-27.

· J-W Hyun, W Kim et al. Application of the 2017 McDonald diagnostic criteria for multiple sclerosis in Korean patients with clinically isolated syndrome, Multiple Sclerosis Journal 2019, Vol. 25(11) 1488？1495

· 민주홍 등, 다발성경화증 시장 이해에 관한 연구, Journal of Multiple Sclerosis 8(2):19-23, 2017

· NICE guideline: Teriflflunomide for treating relapsing？remitting multiple sclerosis (Published: 22 January 2014), Beta interferons and glatiramer acetate for treating multiple sclerosis (Published: 27 June 2018), Fingolimod for the treatment of highly active relapsing？remitting multiple sclerosis (Published: 25 April 2012), Dimethyl fumarate for treating relapsing-remitting multiple sclerosis (Published: 27 August 2014)

· Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria, Lancet Neurol 2018; 17: 162？73

· 손은희 등, 다발경화증의 진단: 2017 맥도널드진단기준, J Korean Neurol Assoc 36(4):273-279, 2018

· Harrison's Principles of Internal Medicine, 20e>Chapter 436: Multiple Sclerosis

· Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis-Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology, Neurology® 2018;90:777-788.

· ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis, Multiple Sclerosis Journal 2018, Vol. 24(2) 96？120

· B. Yamout, et al., Consensus recommendations for the diagnosis and treatment of multiple sclerosis: 2019 revisions to the MENACTRIMS guidelines, Multiple Sclerosis and Related Disorders 37 (2020) 101459

· Scolding N, et al. Association of British Neurologists :revised (2015) guidelines forprescribing disease-modifying treatments in multiple sclerosis, Pract Neurol 2015;15:273？279

· 김수현 등, 다발성경화증의 조기 진단 및 치료, Journal of Multiple Sclerosis 1(2):44-51, 2010

· 임상적단독증후군의 임상진료지침: 1부. 평가와 진단 ; Journal of Multiple Sclerosis 7(2):29-39, 2016

· 임상적단독증후군의 임상진료지침: 2부. 관리와 추적 ; Journal of Multiple Sclerosis 7(2):40-48, 2016

· L. Kappos et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes (BENEFIT), Neurology 2006;67;1242-1249

· J Kuhle, G Disanto et al. Conversion from clinically isolated syndrome to multiple sclerosis: A large multicentre study, 2015 Mult Scler;21:1013-1024

· 민주홍 등, 다발성경화증 시장 이해에 관한 연구, Journal of Multiple Sclerosis 8(2):19-23, 2017



■ 변경 전 고시번호(시행일자)

고시 제2017-35호(2017.3.1.)3-2