허가사항 범위 내에서 아래와 같은 기준으로 투여 시 요양급여를 인정하며, 동 인정기준 이외에는 약값 전액을 환자가 부담토록 함.
- 아 래 -
가. 투여 대상: 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(RRMS) 환자로서 1차 치료제(인터페론 베타 등) 투여 후 치료 실패 또는 불내성인 환자이며 외래통원이 가능한(걸을 수 있는) 만 18세 이상의 성인
나. 투여 기간: 허가사항 용법·용량의 두 번째 치료과정까지 인정. 단, 두 번째 치료과정 이후에도 다음 중 어느 하나에 해당하는 경우에는 허가사항 용법·용량의 세 번째 치료과정까지 인정
- 다 음 -
1) 1회 이상의 재발이 있는 환자
2) 뇌 또는 척수 MRI 검사에서 새로 발생한 T2병변, 크기가 증가한 T2병변 또는 Gadolinium-조영증강 병변 중 2개 이상이 확인되는 환자
· 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)