중증질환 치료제의 접근성 강화: 개별환자접근방식과 별도기금 도입의 필요성

• 영문명: Enhancing Access to Medicines through the Named Patient Approach and Dedicated Funding: Insights from France, Scotland, and Australia
• 발행기관: 한국사회약학회 (구.한국보건사회약료경영학회)
• 저자명: 권혜영(Hye-Young Kwon)
• 간행물 정보: 『한국보건사회약료경영학회지』제13권 제1호, 1~14쪽, 전체 14쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.05.31

국문 초록

This study aims to explore solutions to address access to medicines (A2M) for cancer or severe disease patients, particularly focusing on the challenges of coverage gaps and non-listed medicines in South Korea. To achieve this, the life cycle-based A2M frameworks of France, Scotland, and Australia were analyzed. The findings revealed that these countries maintained the principles of drug reimbursement while enhancing access to anticancer and orphan drugs through the Named-Patient Approach (NPA) and Dedicated Funds. To ensure access during the coverage gap period, each country operated specific programs: AAP in France, IPTR and PACS Tier 2 in Scotland, and IPU in Australia. Additionally, for non-listed but high-cost drugs such as ultra-orphan drugs, mechanisms such as Liste en Sus (France), PACS Tier 1 (Scotland), and LSDP and HST Addendum (Australia) were implemented, commonly supported through dedicated funding to ensure continued patient access. The NPA complemented collective reimbursement systems by providing a more tailored and inclusive A2M framework. In contrast, South Korea lacks these structures, leading to efforts to expedite the drug evaluation process or introduce bypass mechanisms to increase drug listing. Additionally, policies such as “Use first, Assess later” have been proposed, which risk undermining the principles of evidence-based drug evaluation and cost-effectiveness assessment. To enhance A2M in South Korea, two key recommendations were proposed in this study. First, introducing the NPA to accommodate individual patients needs. Second, establishing a dedicated fund supported by pharmaceutical manufacturers’ contributions to enable financial support during the coverage gaps and for non-listed drugs. This approach might preserve the principles of the Positive List System while ensuring a more comprehensive and equitable A2M framework. Moreover, formalizing pharmaceutical manufacturers’ patient assistance programs through a structured approach would enhance equity by shifting the focus from product-based assistance to needs-based support. Ultimately, broad societal consensus—through stakeholder engagement, policy discussions, and public awareness—will be essential for implementing these policy changes.

목차

서 론

우리나라 항암 및 희귀의약품 접근성 보장과 한계

외국의 의약품 생애주기별 접근성 보장제도

시사점: 개별환자접근방식과 별도기금의 도입

결론 및 고찰

참고문헌

키워드

Access to medicines ultra-orphan drugs positive listing named patient approach dedicated fund