허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. 투여대상: 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(RRMS)에서 만 18세 이상 성인 중
1) 1년에 1회 이상의 재발이 있는 환자
2) 최소 1년에 1회 이상 주기적인 MRI 검사에서 새로운 조영증강 병변 혹은 새로 발생하거나 크기가 증가한 T2 영상 병변이 있는 환자
3) 1차 치료제(인터페론 베타 등) 투여 후 치료 실패 또는 불내성을 나타내며 외래통원이 가능한(걸을 수 있는) 환자
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)
· 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)