Donepezil 경구제(품명: 아리셉트정 등), 패취제(품명: 도네리온패취 등)

기준 내용

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

가. 투여대상

1) 3mg, 5mg, 10mg 경구제 및 87.5mg, 175mg 패취제

가) , 나) 조건을 동시에 충족하는 알츠하이머 형태(뇌혈관 질환을 동반한 알츠하이머 포함)의 경증(mild), 중등도(moderate), 중증(severe) 치매증상

가) 간이정신진단검사(MMSE; Mini Mental State Exam) 26점 이하

나) 치매척도검사

(1) CDR(Clinical Dementia Rating) 1∼3 또는

(2) GDS(Global Deterioration Scale) stage 3∼7

2) 23mg 경구제

가) , 나) 조건을 동시에 충족하는 알츠하이머 형태(뇌혈관 질환을 동반한 알츠하이머 포함)의 중등도·중증 치매증상

가) 간이정신진단검사(MMSE; Mini Mental State Exam) 20이하

나) 치매척도검사

(1) CDR(Clinical Dementia Rating) 2∼3 또는

(2) GDS(Global Deterioration Scale) stage 4∼7

나. 투여용량 및 기간

1) 3mg 경구제

가) 소화기계 이상반응 감소 목적으로 필요 시 초기 용량을 1일 1회 3mg으로 시작할 수 있으나 1~2주를 초과하여 사용하지 않는 것을 원칙으로 함.

나) 저체중(BMI Chapter 19. Cholinesterase Inhibitors

· CURRENT Diagnosis & Treatment: Neurology, 3e, 2019> Chapter 9: Dementia & Memory Loss

· Harrison's Principles of Internal Medicine, 21e, 2022> Chapter 431: Alzheimer’s Disease

· Bradley and Daroff's Neurology in Clinical Practice, 8e, 2022> Chapter 95. Alzheimer Disease and Other Dementias

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· Homma A, et al. Clinical efficacy and safety of donepezil on cognitive and global function in patients with Alzheimer's disease. A 24-week, multicenter, double-blind, placebo-controlled study in Japan. E2020 Study Group. Dement Geriatr Cogn Disord. 2000 Nov-Dec;11(6):299-313.

· Homma A, et al. Donepezil treatment of patients with severe Alzheimer's disease in a Japanese population: results from a 24-week, double-blind, placebo-controlled, randomized trial. Dement Geriatr Cogn Disord. 2008;25(5):399-407.

· Rogers SL, et al. The Efficacy and Safety of Donepezil in Patients with Alzheimer‘s Disease: Results of a US Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Dementia. 1996 Nov-Dec;7(6):293-303.

· Farlow MR, et al. Effectiveness and tolerability of high-dose (23 mg/d) versus standard-dose (10 mg/d) donepezil in moderate to severe Alzheimer's disease: A 24-week, randomized, double-blind study. Clin Ther. 2010 Jul;32(7):1234-51.

· 대한비만학회. 비만 진료지침 2022. 8판.

· World Health Organization. Regional Office for the Western Pacific. (2000). The Asia-Pacific perspective : redefining obesity and its treatment. Sydney : Health Communications Australia.