生物相似性藥品市場推廣之障礙分析以及政策建議

Abstract

背景:台灣健保2021年在生物製劑支出約400億元，占總藥費的18%，且年增長率達8-12%。然而，截至2022年4月，生物相似性藥品僅占生物製劑健保總支出的0.25%，明顯低於國際水準。推估若生物相似性藥品市占率達30%，每年可節省約5.1億元藥費，並隨著更多原開發廠藥品專利到期而將釋放更大的財務節約潛力。

目的:基於低價格和高可及性，推廣生物相似性藥品有助於減輕健保財政負擔並提升患者用藥可近性。由於進入市場的障礙，台灣使用率偏低，需分析主要阻礙因素並且借鑑國際成功經驗，提出有效政策建議，以促進生物相似性藥品的發展，進一步提升藥品可近性並實現健保財政規劃的長期目標。

方法:本研究透過政策比較分析、藥品資料庫分析及利害關係人深度訪談，探討生物相似性藥品的推廣障礙以及有效策略。

結果:患者與醫療提供者首重療效與安全性，若生物相似性藥品能提供與原開發廠藥品療效和安全性相當的臨床實證，將顯著提高接受度。健保署則在有限資源下需平衡財政壓力以及各方利害關係人之需求，生物相似性藥品的低價格為其提供其有效解決方案。國際經驗顯示，英國透過獎懲機制與利潤共享，澳洲以教育推廣增強信心，加拿大實施藥品轉換與處方獎勵政策，日本設定高使用率目標並實施差額負擔，這些策略均成功促進生物相似性藥品的普及。

結論:政策建議包括「擴大健保給付範圍優先推廣生物相似性藥品，並採差額負擔模式」；「逐步將原開發廠藥品處方量的25%轉為生物相似性藥品，提升市場占有率至37%」；「生物相似性藥品上市後，適度調降原開發廠藥品價格7-10%」。整合國際經驗與台灣現況，透過政策目標設定、處方誘因、及教育推廣等策略，將有助於提升生物相似性藥品使用率，減輕健保財政負擔，並促進健保體系的永續發展。

Background: In 2021, Taiwan's National Health Insurance (NHI) allocated approximately NT$40 billion to biologics, accounting for 18% of total drug expenditures, with an annual growth rate of 8–12%. However, as of April 2022, biosimilars comprised only 0.25% of total biologics spending under the NHI, significantly lower than international benchmarks. It is estimated that if biosimilars achieved a 30% market share, annual drug expenditures could be reduced by approximately NT$510 million, with even greater financial savings anticipated as more originator drug patents expire. Objective: Promoting biosimilars, given their lower cost and high accessibility, can alleviate NHI's financial burden while improving patient access to medications. However, due to market entry barriers, Taiwan’s adoption rate of biosimilars remains low. This study aims to analyze key obstacles, draw on successful international experiences, and propose effective policy recommendations to promote biosimilar development, enhance accessibility, and achieve NHI’s long-term financial sustainability goals. Methods: This study employs policy comparative analysis, pharmaceutical database analysis, and in-depth stakeholder interviews to identify barriers to biosimilar adoption and explore effective strategies for their promotion. Results: Patients and healthcare providers prioritize therapeutic efficacy and safety. If biosimilars can provide clinical evidence demonstrating comparable efficacy and safety to originator drugs, acceptance rates are expected to increase significantly. For the NHI, balancing fiscal pressures with the needs of stakeholders is critical, and the lower cost of biosimilars offers an effective solution. Internationally, the United Kingdom has adopted incentive mechanisms and profit-sharing models; Australia has focused on educational campaigns to build confidence in biosimilars; Canada has implemented drug substitution and prescription incentive policies; and Japan has set high conversion rate targets and introduced copayment differentials. These strategies have successfully increased biosimilar utilization. Conclusion: Policy recommendations include: (1) expanding NHI coverage for patients by utilizing biosimilars and implementing a copayment differential model; (2) gradually converting 25% of originator drug prescriptions to biosimilars, increasing their market share to 37%; and (3) moderately reducing the price of originator drugs by 7–10% following the introduction of biosimilars. By integrating international best practices with Taiwan's local context, strategies such as setting policy targets, providing prescribing incentives, and conducting educational campaigns can effectively enhance biosimilar adoption, reduce the financial burden on the NHI, and promote the sustainable development of the healthcare system.