糖尿病腎病變自費新藥的市場導入策略：旅程觀點

Abstract

糖尿病腎病變（Diabetic Kidney Disease, DKD）為全球糖尿病病人的主要併發症，影響約30-40%的病人，並導致末期腎病變與高昂的醫療負擔。台灣糖尿病盛行率達11.8%，約為230萬人，且透析發生率居全球之冠，年醫療支出高達533億新台幣。儘管現行標準治療能延緩疾病進展，但仍無法完全阻止腎功能惡化與心血管風險，凸顯臨床需求未被充分滿足亟待突破。新一代自費藥物F藥，具備降低23%腎臟風險及心腎雙重保護之潛力，獲得國際與台灣學會1A級最高推薦，為DKD治療帶來突破性希望。本研究以「自費新藥導入的旅程觀點」出發，深入分析F藥在台灣市場的導入困境，聚焦於藥廠、醫師與病人三端角色的互動與挑戰。研究採用深度訪談法，針對心臟科、腎臟科與新陳代謝科醫師，了解其對藥物價值、推廣策略與病人接受度的認知與行為反應。結果發現，制度性錨定（如參照價格）造成價格與價值的偏差，科別文化分化導致跨科合作困難，醫病信任斷層進一步阻礙新藥推廣。為突破這些結構性障礙，研究提出「院內三端點旅程地圖」與「系統化推廣策略」，強調在藥廠端調整價值傳遞策略、在醫師端建立跨科合作與認知整合機制、在病人端運用SDM醫病共享決策(Shared Decision Making)衛教與經濟支持方案，來共同促進新藥的市場落地與長期依從。本研究不僅豐富台灣慢性病藥物創新的理論架構，也提供具體政策建議，協助建立公平、創新且永續的醫療體系，為「健康台灣」與「三高防治888計畫」的長遠目標提供實務範例，推動價值醫療的轉型與長期臨床效益。

Diabetic Kidney Disease (DKD) is a major complication affecting approximately 30-40% of diabetic patients globally, leading to end-stage renal disease and substantial healthcare burdens. In Taiwan, diabetes prevalence reaches 11.8%, with the highest dialysis incidence worldwide and annual medical expenditures exceeding NT$53.3 billion. While current standard treatments slow disease progression, they fail to fully halt renal deterioration and cardiovascular risks, underscoring unmet clinical needs. The novel self-pay Drug F, demonstrating 23% renal risk reduction and dual cardiorenal protection potential, has received top-tier 1A recommendations from international and Taiwanese medical societies, offering breakthrough hope for DKD management. This study adopts a "journey perspective of new self-pay drug adoption" to analyze Drug F's market-entry challenges in Taiwan, focusing on interactions among pharmaceutical companies, physicians, and patients. Using in-depth interviews with cardiologists, nephrologists, and endocrinologists, the research examines perceptions of drug value, promotion strategies, and patient acceptance. Findings reveal that institutional anchoring (e.g., reference pricing) creates price-value misalignment, departmental cultural divides hinder cross-specialty collaboration, and physician-patient trust gaps impede drug adoption. To overcome these structural barriers, the study proposes a "Hospital Three-Endpoint Journey Map" and systematic promotion strategy, emphasizing: Pharmaceutical companies: Adjusted value-delivery strategies Physicians: Cross-departmental collaboration and cognitive integration mechanisms Patients: Shared Decision Making (SDM) education and financial support programs This framework aims to facilitate drug accessibility and long-term adherence. The research not only enriches Taiwan's chronic disease drug innovation theory but provides actionable policy recommendations to establish an equitable, innovative, and sustainable healthcare system. It offers practical models for "Healthy Taiwan" and the "Three-High Prevention 888 Plan," advancing value-based healthcare transformation and long-term clinical benefits.