보험인정기준 상세내용

■ 고시 신설 전체내용

1. 허가사항 범위 내에서 투여 시 요양급여 함을 원칙으로 함.



2. 허가사항 범위를 초과하여 성인 및 소아의 백반증에 아래와 같은 기준으로 투여 시 요양급여를 인정함.

- 아 래 -

가. 투여부위 : 얼굴, 목, 손 등 노출부위에 발생한 백반증



나. 투여방법 : 각 약제의 식약처 허가사항(용법·용량)에 따름 (단, 전신흡수를 촉진시킬 수 있는 밀봉요법은 피함)



다. 대상약제 : alclometasone dipropionate, amcinonide, betamethasone valerate, budesonide, clobetasol propionate, clobetasone butyrate, desonide, desoxymethasone, dexamethasone propionate, diflorasone diacetate, diflucortolone valerate, diflupredinate, fluocinonide, fluticasone propionate, halcinonide, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone valerate, methylprednisolone aceponate, mometasone furoate, prednicarbate, prednisolone valeroacetate, triamcinolone acetonide 성분의 액제, 크림제, 연고제, 로션제, 겔제인 코르티코스테로이드 피부 도포제



- 단, 점막 부위 투여를 위한 제형의 약제(안연고, 구강용 연고 등)와 코르티코스테로이드 성분 외의 성분(예: gentamicin sulfate, isoconazole nitrate 등)과의 복합제는 제외함.



※ 각 약제의 허가사항 중 ‘용법·용량’(연속 투여 가능 기간 및 기간 당 사용 가능한 약제의 총량)과 ‘사용상 주의사항’(‘1.다음 환자(부위)에는 투여하지 말 것’ 항 및 ‘이상 반응’ 항 등)을 반드시 참고하여 투여토록 함.



■ 고시 신설 고시번호(시행일자)

고시 제2019-57호(2019.4.1.)



■ 고시 신설 사유

백반증이 현행 ‘사33 피부과적 자외선 치료’ 및 ‘백반 또는 백납에 대한 치료의 급여 여부’ 고시에서 얼굴과 목, 손 등 노출부위에 한해 급여 인정되고 있는 점, 교과서 및 가이드라인에서 스테로이드 외용제 투여의 임상적 유용성이 확인되는 점 등 참고하여 얼굴과 목, 손 등 노출부위에 요양급여를 인정하고, 부작용 발생의 우려가 높은 약제라는 특수성을 고려하여 각 약제의 허가사항 중 ‘사용상의 주의사항’의 ‘다음 환자에는 투여하지 말 것’ 항 및 ‘이상 반응’ 항 등 관련 내용을 반드시 참고하여 투여토록 명시함.

■ 관련문헌 등

· Harrison's Principles of Internal Medicine, 20e > Chapter 54: Skin Manifestations of Internal Disease > HYPOPIGMENTATION

· Fitzpatrick's Dermatology in General Medicine, 8e 2012 > Chapter 74. Vitiligo > Treatment

· Clinical Dermatology Sixth Edition 2016 > Chapter 19. Light-related diseases and disorders of pigmentation > DISORDERS OF HYPOPIGMENTATION >　Vitiligo

· A. Taieb, et al. Guidelines for the Management of Vitiligo. The European Dermatology Forum Consensus, 2012 British Association of Dermatologists 2013 168, pp5？19

· Naoki OISO, et al. Guidelines for the diagnosis and treatment of vitiligo in Japan, Journal of Dermatology 2013; 40: 344？354.

· A. Wollenberg, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I, JEADV 2018, 32, 657？3682.

· Ichiro Katayama, et al. Japanese guidelines for atopic dermatitis 2017*, Allergology International 66 (2017) 230e247

· Bae JM, et al. The efficacy of 308-nm excimer laser/light (EL) and topical agent combination therapy versus EL monotherapy for vitiligo: A systematic review and meta-analysis of randomized controlled trials (RCTs). J Am Acad Dermatol. 2016 May;74(5):907-15.

· Bapur Erduran F, et al. Comparison of the efficacy of 308-nm excimer lamp monotherapy with topical tacrolimus or clobetasol 17-propionate combination therapies in localized vitiligo. Photodermatol Photoimmunol Photomed. 2016 Sep;32(5-6):247-253.

· Sisti A, et al. Effectiveness and safety of topical tacrolimus monotherapy for repigmentation in vitiligo: a comprehensive literature review. An Bras Dermatol. 2016 Apr;91(2):187-95.

· Park OJ, et al. A combination of excimer laser treatment and topical tacrolimus is more effective in treating vitiligo than either therapy alone for the initial 6 months, but not thereafter. Clin Exp Dermatol. 2016 Apr;41(3):236-41.

· Cavalie M, et al. Maintenance therapy of adult vitiligo with 0.1% tacrolimus ointment: a randomized, double blind, placebo-controlled study. J Invest Dermatol. 2015 Apr;135(4):970-4.

· Ho N, et al. A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0·1% vs. clobetasol propionate 0·05% in childhood vitiligo. Br J Dermatol. 2011 Sep;165(3):626-32.

· Majid I, et al. Does topical tacrolimus ointment enhance the efficacy of narrowband ultraviolet B therapy in vitiligo? A left-right comparison study. Photodermatol Photoimmunol Photomed. 2010 Oct;26(5):230-4.

· de Menezes AF, et al. Pharmacologic Treatment of Vitiligo in Children and Adolescents: A Systematic Review. Pediatr Dermatol. 2017 Jan;34(1):13-24.

· Dang YP, et al. Effect of topical calcineurin inhibitors as monotherapy or combined with phototherapy for vitiligo treatment: a meta-analysis. Dermatol Ther. 2016 Mar-Apr;29(2):126-33.

· Roy P, et al. Effectiveness of Topical Corticosteroid, Topical Calcineurin Inhibitors and Combination of Them in the Treatment of Vitiligo. Mymensingh Med J. 2016 Oct;25(4):620-627.

· Dayal S, et al. Treatment of Childhood Vitiligo Using Tacrolimus Ointment with Narrowband Ultraviolet B Phototherapy. Pediatr Dermatol. 2016 Nov;33(6):646-651.

· Njoo MD, et al. Nonsurgical repigmentation therapies in vitiligo. Meta-analysis of the literature. Arch Dermatol. 1998 Dec;134(12):1532-40.

· Lepe V, et al. A double-blind randomized trial of 0.1% tacrolimus vs 0.05% clobetasol for the treatment of childhood vitiligo. Arch Dermatol. 2003 May;139(5):581-5.

· Farajzadeh S, et al. The efficacy of pimecrolimus 1% cream combined with microdermabrasion in the treatment of nonsegmental childhood vitiligo: a randomized placebo-controlled study. Pediatr Dermatol. 2009 May-Jun;26(3):286-91.

· Shim WH, et al. A pilot study of 1% pimecrolimus cream for the treatment of childhood segmental vitiligo. Ann Dermatol. 2013 May;25(2):168-72.

· Kose O, et al. Mometasone cream versus pimecrolimus cream for the treatment of childhood localized vitiligo. J Dermatolog Treat. 2010 May;21(3):133-9.

· Dawid M, et al. Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: results of a randomized, double-blind, vehicle-controlled study. J Dtsch Dermatol Ges. 2006 Nov;4(11):942-6.

· Kumaran MS, et al. Effect of topical calcipotriol, betamethasone dipropionate and their combination in the treatment of localized vitiligo. J Eur Acad Dermatol Venereol. 2006 Mar;20(3):269-73.

· Esfandiarpour I, et al. The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: a double-blind, placebo-controlled clinical trial. J Dermatolog Treat. 2009;20(1):14-8.

· Kathuria S, et al. Segmental vitiligo: a randomized controlled trial to evaluate efficacy and safety of 0.1% tacrolimus ointment vs 0.05% fluticasone propionate cream. Indian J Dermatol Venereol Leprol. 2012 Jan-Feb;78(1):68-73.

· Westerhof W, et al. Left-right comparison study of the combination of fluticasone propionate and UV-A vs. either fluticasone propionate or UV-A alone for the long-term treatment of vitiligo. Arch Dermatol. 1999 Sep;135(9):1061-6.

· Coskun B, et al. Topical 0.05% clobetasol propionate versus 1% pimecrolimus ointment in vitiligo. Eur J Dermatol. 2005 Mar-Apr;15(2):88-91.

· Jordi Castellsague, et al. A cohort study on the risk of lymphoma and skin cancer in users of topical tacrolimus, pimecrolimus, and corticosteroids (Joint European Longitudinal Lymphoma and Skin Cancer Evaluation ？ JOELLE study). Clinical Epidemiology 2018:10 299？310.

· David J, et al. Association Between Malignancy and Topical Use of Pimecrolimus. JAMA Dermatology Published online February 18, 2015.

· S. C. S. Cai, et al. Topical calcineurin inhibitors in eczema and cancer association: A cohort study. JOURNAL OF DERMATOLOGICAL TREATMENT, 2016.