從創新到給付：醫療器材生命周期評估在健保制度下的利害關係人分析

Abstract

研究背景與目的：隨著全球醫療科技之快速演進，醫療器材展現出高度迭代性與操作者依賴性等有別於傳統藥品之動態特質。然而現行臺灣全民健康保險體系之醫療科技評估（Health Technology Assessment, HTA）多侷限於上市前之單點靜態審查，難以如實反映創新醫材於真實臨床應用中的長期價值。為此本研究奠基於「醫療器材全生命週期（Total Product Life Cycle, TPLC）」與「利害關係人理論」之雙重視角，旨在剖析臺灣健保制度下，創新醫材從市場准入至給付核定過程中，所面臨之結構性制度障礙與多元權力網絡間之博弈動態 。 研究方法：本研究採行質性訪談設計，並建構一涵蓋生命週期醫療科技評估（Life Cycle Health Technology Assessment, LC-HTA）、NASSS 框架、利害關係人顯著性模型以及價值照護導向(Value-Based Healthcare, VBHC)之多維度理論整合框架。並採取立意抽樣與滾雪球抽樣法則，針對 11 位隸屬於產、官、學、醫界之核心利害關係人（涵蓋政策執行者、臨床醫師、醫材業者及專家學者）進行半結構式深度訪談。蒐集之訪談逐字稿文本，再嚴謹遵循「框架分析法」之五個標準化階段，透過主題矩進行跨群體之觀點對照與系統化詮釋，以確保研究結果之信實度。 研究結果：實證分析指出臺灣醫材給付生態系面臨三大結構性矛盾。首先，在行政路徑層面，術式碼掛鉤限制與自費代碼（Z 碼）之銜接落差，導致創新醫材平均需等待 856.7 天方能完成市場准入，影響跨國科技公司對臺灣市場之資源配置優先順序。在價值評估層面，受限於單一支付者之預算控管邏輯，審查程序呈現藥物化偏誤，使得醫材之增量迭代價值與減輕照護負擔等社會效益，於靜態核價框架中被邊緣化。而於臨床機構擴散層面，技術導入之學習曲線與醫療風險高度集中於醫師與醫療機構，迫使臨床端在總額框架下傾向採取風險規避措施，影響具高社會價值技術之臨床滲透率。在此權力動態中，健保署作為決定型利害關係人，在以預算控管優先之決策框架下，產業界與病患群體於共擬會議中之實參與度與決策影響力相對受限。 結論：綜合上述發現，本研究主張臺灣醫材給付政策極需由傳統之「技術理性」向「程序正義」與「動態規管」邁進。在具體政策優化藍圖上，建議主管機關應法制化「監理沙盒」與「綠色通道」機制，打破現行單一之准入路徑。同時應積極佈建獨立於總額外之「醫療科技專款基金」，並全面導入「前瞻性掃描」預警機制，期能於資源稀缺之挑戰下，為臺灣擘畫出一個兼顧財務永續、產業創新與健康平權之動態醫療科技生態系 。

Background and Objective: With the rapid evolution of global medical technology, medical devices demonstrate dynamic characteristics, such as high iterability and operator dependency, that distinguish them from traditional pharmaceuticals. However, the current Health Technology Assessment (HTA) framework under the Taiwan National Health Insurance (NHI) system remains largely confined to single-point, static reviews prior to market entry. This approach fails to capture the evolving, long-term clinical value of innovative devices. Grounded in the dual perspectives of the Total Product Life Cycle (TPLC) and Stakeholder Theory, this study systematically analyzes the structural institutional barriers and the power dynamics among multiple stakeholders during the transition of innovative medical devices from market access to reimbursement approval in Taiwan. Methods: This study adopts a qualitative research design, constructing a multi-dimensional conceptual framework that integrates Life Cycle Health Technology Assessment (LC-HTA), the NASSS framework, the Stakeholder Salience Model, and Value-Based Healthcare (VBHC). Utilizing purposive and snowball sampling techniques, semi-structured interviews were conducted with 11 core stakeholders across the public, private, academic, and clinical sectors (including policymakers, clinicians, medical device industry executives, and academic experts). The interview transcripts were analyzed using the "Framework Method" via thematic matrices to cross-examine multi-stakeholder perspectives and ensure the credibility and depth of the findings. Results: Empirical analysis reveals three structural contradictions within Taiwan’s medical device reimbursement ecosystem. At the institutional pathway level, the decoupling of novel procedures from fee schedules and the regulatory alignment gap self-pay codes (Z-codes) result in an average post-approval lag of 856.7 days, significantly hindering multinational medical technology companies from prioritizing the Taiwanese market. Then, as for the value assessment level, driven by the single-payer's financial defense logic, the HTA process exhibits a distinct "pharmaceutical bias" systematically compressing the incremental iterative value of medical devices and their broader social benefits, such as reducing caregiver burdens. Third, at the clinical diffusion level, the sunk costs of learning curves and clinical risks associated with technology adoption are heavily concentrated on frontline physicians and healthcare institutions. Under the global budget cap, this induces risk-aversive behaviors and severely limits the clinical penetration of high-value innovations. Within the dynamics, the National Health Insurance Administration acts as the dominant stakeholder; under its budget-control-first framework, the substantive participation and decision-making leverage of both the industry and patient groups remain constrained. Conclusion: Based on these findings, this study contends that Taiwan’s medical de- vice reimbursement policy must undergo a paradigm shift, transitioning from traditional "technical assessment" toward "procedural justice" and "dynamic regulation." In terms of the policy optimization blueprint, it is recommended that authorities insti- tutionalize "Regulatory Sandbox" and "Expedited Pathway" mechanisms to diversify the current rigid access routes. Concurrently, a "Strategic Dedicated Fund" independent of the global budget should be established, alongside the implementation of a "Horizon Scanning" early-warning mechanism. This study aims to delineate a dynamic medical technology ecosystem for Taiwan that harmonizes financial sustainability, industrial innovation, and health equity amid severe resource scarcity.