分子腫瘤委員會制度之研究：精準醫療實踐下的挑戰、機會與未來發展

Abstract

本研究聚焦於分子腫瘤委員會（molecular tumor board, MTB）在精準醫療時代下的治理樣貌與永續發展，旨在釐清其制度設計關鍵與最佳實踐模式。研究採用比較個案研究法與文件分析法，選取美國、歐盟（以荷蘭為代表）與韓國三大國家作為典範案例，從政策架構、產業參與與臨床實務等層面進行制度比較，並進一步映射至臺灣情境，探討其借鏡價值與制度移植的可行性。 分析結果顯示，三國分別發展出「市場導向生態系」（美國）、「公私協力網絡」（荷蘭）與「國家戰略競速」（韓國）三種差異化制度模式，反映出各自政治經濟背景與治理邏輯。然而，無論模式為何，皆面臨變異詮釋標準不一、藥物可近性不均與品質監管缺口等共通挑戰。對照國際經驗，臺灣具備全民健保、高品質醫療體系與國家級生醫資料平台等制度優勢，卻同時面臨「診斷-治療斷鏈」、跨域人才短缺與法規真空等結構性障礙，導致分子腫瘤委員會制度難以發揮其應有效能。 為回應上述挑戰，本研究提出「混合型策略」作為臺灣未來發展分子腫瘤委員會制度之優化途徑：一方面應建立國家級數據治理中心與條件式給付機制，以縮減實證與給付間之落差；另一方面，透過病患倡議與產業創新導入更多治療選項，提升制度彈性與臨床可行性。同時，建議推動分子腫瘤委員會品質指標與責任階梯化模型之制定，形塑問責明確、透明治理的永續制度設計。 本研究認為，分子腫瘤委員會的成功關鍵不僅在於技術導入，更取決於制度設計的完整性與治理機制的韌性。本研究對臨床實務端提供跨領域人才培育與流程優化之參考建議，對政策制定端則勾勒出監管強化與財務永續並行的改革藍圖，期盼能為臺灣乃至其他全民健保國家推動精準腫瘤醫學發展提供具體借鏡與策略參考。

This study focuses on the governance and sustainability of molecular tumor boards (MTBs) in the era of precision medicine, aiming to identify the institutional design elements and best practices critical to their success. Employing a comparative case study methodology and documentary analysis, the research examines three representative national models-the market-driven ecosystem of the United States, the public-private collaborative network of the Netherlands, and South Korea’s state-led strategic initiative-analyzing their policy frameworks, industrial dynamics, and clinical implementation. These international insights are then mapped onto the Taiwanese context to assess the feasibility of institutional transfer and adaptation. Findings reveal that each country has developed a distinct governance model reflecting its unique sociopolitical and healthcare systems. However, common challenges persist across all cases, including inconsistent standards for variant interpretation, unequal access to targeted therapies, and a lack of quality oversight mechanisms. In comparison, Taiwan benefits from strong institutional foundations, such as a universal health insurance system, high-quality healthcare services, and a national biomedical data infrastructure. Nonetheless, it faces structural barriers-most notably the diagnostic–therapeutic gap, shortages in cross-disciplinary expertise, and regulatory ambiguity-which hinder the full functionality of its MTB framework. In response, this study proposes a hybrid strategy as the optimal pathway for advancing MTB governance in Taiwan. Key recommendations include establishing a centralized data governance hub and implementing conditional reimbursement policies to bridge the evidence–reimbursement divide; encouraging patient advocacy and fostering industry-driven innovation to diversify treatment access; and developing standardized quality metrics and a tiered accountability model to promote transparent and sustainable institutional design. The study concludes that the effectiveness of MTBs depends not only on technological capabilities but, more importantly, on coherent system architecture, adequate resource allocation, and the establishment of a learning-oriented healthcare framework. It provides practical recommendations for healthcare institutions regarding talent development and process optimization, while outlining a policy roadmap that balances regulatory robustness with financial sustainability. The findings aim to serve as a strategic reference for Taiwan and other countries with single-payer systems seeking to advance precision oncology.