한국보건의료기술평가학회
 
 
 

 Original Article


다운로드 #1 : 0602014006_김성주.pdf (1 MB)


Methods on Improvement of Accessibility for Rare Disease Treatments: Providers’ Perspective
공급자 시각에서의 희귀질환 치료제 접근성 개선방안

Ji Yeon Lee1, Yeong Mi Cho1, Sung Tae Kim2, and Sung Ju Kim1
이지연1·조영미1·김성태2·김성주1
1Regulatory Affairs & Market Access, Genzyme Korea, Seoul, Korea 2KIM & CHANG, Seoul, Korea
(주)젠자임코리아1, 김 장 법률사무소2


Corresponding Author: Sung Ju Kim ,Tel: +82-2-2136-9313, Fax: +82-2-2136-9399, Email: kim.sungju@gmail.com
 
 Abstract

Objectives: Studies for policy proposal on orphan drug accessibility in Korea have been performed mainly in payers’ perspectives so far. This study aimed to propose an improvement plan of orphan drug accessibility by considering current status and issues of orphan drug reimbursement in providers’ perspectives. Methods: We investigated publications on the distinctive features of orphan drug and the assessment process of orphan drug in other countries. For current reimbursement status and issues in Korea, Health Insurance Review & Assessment Service assessment documents were reviewed. Results: The most distinctive characteristics of orphan drugs are rarity, disease severity, absence of alternatives and preference for equity rather than financial efficiency. In other countries, the assessment of orphan drugs tends to be more flexible than other drugs and the consideration of societal preference is emphasized in reimbursement decision. The reimbursement probability of orphan drugs is lower than other drugs in Korea and the main reason of rejection was uncertainty in cost-effectiveness. For improvement of orphan drug accessibility, maintaining consistency in drug assessment, mitigation of essential drug criteria, introduction of other assessment methods and special funding can be considered as solutions in current situation. Conclusion: Recently Korean government also makes efforts to improve accessibility of orphan drugs by flexible assessment of drug cost-effectiveness considering disease severity. But in providers’ perspectives, the barrier is still quite high and consideration of various institutional methods is essential to accelerate patient access to orphan drugs.

Key Words Orphan drug · Rare disease · Accessibility.
 
 


 
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