▶식약청장이 인정한 범위 내에서 환자의 증상 등에 따라 필요ㆍ적절하게 투여 시 요양급여를 인정함.(고시 제2012-19호)
※ 식약청장이 인정한 범위: 다음에 해당하는 류마티스(자가염증질환) 증상의 경감
- CINCA 증후군(Chronic Infantile Neurologic Cutaneous and Articular Syndrome)으로 확정된 환자
* 시행일: 2012.2.10.
* 신설사유: 미허가 긴급도입의약품으로 교과서, 관련 학회의견 및 임상논문 등을 참조하여 식품의약품안전청장이 인정한 범위 내에서 투여 시 요양급여를 인정함
* 관련근거: ㆍFirestein: Kelley's Textbook of Rheumatology, 8th ed.
ㆍKliegman: Nelson Textbook of Pediatrics, 19th ed.
ㆍGoldman: Goldman's Cecil Medicine, 24th ed.
ㆍHarrison's Principles of Internal medicine, 18th ed.
ㆍAmerican College of Rheumatology, 2011.
ㆍAboin-Gonzalez S, et al. Exacerbation of skin lesions during fever in a patient with chronic infantile neurologic cutaneous articular (CINCA) syndrome. Actas Dermosifiliogr. 2008 Jul-Aug;99(6):481-4.
ㆍGoldbach-Mansky R, et. al. Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition. N Engl J Med. 2006 Aug 10;355(6):581-92.
ㆍLovell DJ, Interleukin-1 blockade by anakinra improves clinical symptoms in patients with neonatal-onset multisystem inflammatory disease. Arthritis Rheum. 2005 Apr;52(4):1283-6.
ㆍNeven B, et al. Long-term efficacy of the interleukin-1 receptor antagonist anakinra in ten patients with neonatal-onset multisystem inflammatory disease/chronic infantile neurologic, cutaneous, articular syndrome. Arthritis Rheum. 2010 Jan;62(1):258-67.
ㆍMiyamae T, et al. Effect of anakinra on arthropathy in CINCA/NOMID syndrome. Pediatr Rheumatol Online J. 2010 Mar 16;8:9.
ㆍCaroli F, et al. Clinical and genetic characterization of Italian patients affected by CINCA syndrome. Rheumatology (Oxford). 2007 Mar;46(3):473-8. Epub 2006 Aug 18.
ㆍMadan V, et al. Muckle-Wells syndrome/neonatal-onset multisystem inflammatory disease overlap associated with myelodysplasia and cerebrovascular accident. Clin Exp Dermatol. 2010 Oct;35(7):752-5.
ㆍRigante D, et al. Hydrocephalus in CINCA syndrome treated with anakinra. Childs Nerv Syst. 2006 Apr;22(4):334-7.
ㆍKhemani C, et al. CINCA Syndrome. Indian Pediatrics. 2007. Dec;17(44):933-936.
ㆍHawkins PN, Bybee A, Aganna E et al. Response to anakinra in a de novo case of neonatal-onset multisystem inflammatory disease. Arthritis Rheum 2004;50:2708.9.
ㆍBoschan C, et al. Neonatal-onset multisystem inflammatory disease (NOMID) due to a novel S331R mutation of the CIAS1 gene and response to interleukin-1 receptor antagonist treatment. Am J Med Genet A. 2006 Apr 15;140(8):883-6.
▶식품의약품안전처장이 인정한 범위 내에서 투여 시 요양급여를 인정함.(고시 제2013-127호)
※ 식품의약품안전처장이 인정한 범위: 다음에 해당하는 류마티스(자가염증질환) 증상의 경감
○ 만성 유아 신경 피부 및 관절 증후군(CINCA; Chronic Infantile Neurologic Cutaneous and Articular Syndrome)으로 확정된 환자
* 시행일: 2013.9.1.
* 종전고시: 고시 제2012-19호(2012.2.10.)
* 변경사유: 용어정비