台灣生物相似性藥品進入醫院市場的契機初探

Abstract

生物藥品從1982年重组人類胰島素上市迄今已近三十年，不僅為許多慢性疾病或罕見疾病提供了良好的治療效果，更讓癌症等嚴重疾病帶來更多曙光，生物技術的不斷演進，逐步應用到藥品開發，至今已近兩百種生物藥品可提供病人治療選擇。藥品市場逐年快速成長，生物藥品因為其較高的單價及新產品不斷推出，生物藥品成為全球製藥產業中成長最快速的一環。根據IQVIA的統計，全球西藥市場規模高達近2,700億美元，較2018年成長13.6%，2015~2019年複合年成長率（Compound Annual Growth Rate，CAGR）達12.6%，其中全球十大用藥有8個是生物藥品，甚至全球銷售金額百大的藥物中，生物藥品已經超過1/3以上。預期到2025年生物藥品將佔整體處方藥品市場35%以上。 隨者許多生物藥品陸續專利到期，針對原開發生物藥品生產的生物相似性藥品也漸漸進入市場，相關議題從臨床前的開發、專利、臨床試驗到進入市場的法規、核價及臨床使用都有不同議題的討論。生物藥品不像化學小分子藥物能夠做到完全一樣，只能證實相似，這樣的特質如何讓生物相似性藥品進入臨床使用，嘉惠需要的病人及減輕醫療財務負擔都是各國引頸期盼的。截至2020年底我國已經有12種生物相似性藥品（共17個品項）獲得核准，其中11種生物相似性藥品（共15個品項）已有健保給付；然而根據IQVIA 2020年9月的市場調查報告顯示，生物相似性藥品對比原開發藥品市場的佔有率小於0.4%。 藥品的使用延遲有許多可能，從研發核准的創新延遲、不同市場的上市延遲、保險給付的延遲及臨床使用擴散延遲。本研究試圖從生物相似性藥品在台灣醫院市場的現況及擴散延遲的潛在原因來切入，針對醫院藥品進用人員進行問卷調查了解潛在進用的考量因素，最後再引用動態競爭的架構來提出生物相似性藥品在廠商間的競爭策略。 本研究透過文獻探討統整六大潛在醫院通路擴散的構面，透過問卷調查分析後，針對有進用跟尚未進用兩組來做分析，發現尚未進用的醫院主要考量在「產品（生物相似性藥）本身及顧客需求相關」、「藥廠/製造廠本身因素」，而有進用的主要考量在「供貨通路及顧客方便性因素」及「產品價格因素及顧客成本相關」。此外僅有約23%受訪服務的醫院有生物相似性藥品的進用規範，這部分也是潛在造成醫院市場擴散延遲的原因。生物相似性藥品的名詞知曉度夠高，但是在相關關鍵的認知及法規管理政策上有近半受訪者仍不清楚。此外從創新擴散關鍵因素來分析，尚未進用的醫院對於生物相似性藥品的「對比利益性」較為在乎，而已經進用的醫院則是「相容性」及「可感知性」。 生物相似性藥品市場才剛開起我國大門，從動態競爭的分析下，在這極度寡占且高度市場重疊且資源相似的競爭，當生物相似性藥品進入醫院後，廠商間的競合策略在不同進入階段需要確保有動態的競爭態勢，如何從「察覺-動機-能力」的分析來制定行動策略非常的關鍵。期盼本研究相關結果能作為未來主管機關及相關產業同好在生物相似性藥品的管理及進用之參考，未來生物相似性藥品的使用能在日漸高漲的健保費用壓力下分攤藥費支出壓力、嘉惠病人用要可近性並持續造就生物藥品市場及產業的發展。

Biologics have been introduced to the pharmaceutical market since 1982 with recombinant human insulin. Not only have they provided treatment benefits for many chronic diseases or rare diseases, biologics have also advanced management of serious diseases like cancers. With continuous evolution of biotechnology that is being applied to drug development, there are nearly two hundred kinds of biologics available worldwide. The pharmaceutical market is rapidly growing annually, and biologics have become the fastest growing sector with their higher unit prices and continuous new product launches. According to IQVIA’s report, the global prescription medicine market has reached nearly US$270 billion, an increase of 13.6% compared to 2018, and the compound annual growth rate (CAGR) from 2015 to 2019 has reached 12.6%. Eight of the top ten best-selling drugs in the world belong to biologics, with greater than one-third of the global top hundred medicines also being biologics. It is expected that by 2025, biologics will account for more than 35% of the overall prescription medicine market. With the patent expirations of many biologics, biosimilars have gradually entered the market. Several topics related to biosimilars, including preclinical development method, patent linkage, regulatory requirement for clinical trials, pricing, and clinical use consideration, are being widely discussed. Unlike chemical drugs where identical structures can be manufactured, biologics can only manufacture similar structure. All the countries are looking forward to adopting biosimilar drugs in clinical setting to benefit patients in need and reducing medical financial burdens. As of the end of 2020, 12 biosimilar drugs (out of a total of 17 items) have been approved in Taiwan, and 11 biosimilar drugs (out of a total of 15 items) have been reimbursed by the national health insurance. However, according to IQVIA's September 2020 market survey report, the market share of biosimilar drugs is less than 0.4% compared to the biologic originators. There are many possibilities for the delay in drug adoption, from the delay in approval of research and license, delay in launches in different markets, delay in reimbursement approval, and delay in clinical use. This study attempts to develop the potential strategy for the introduction of biosimilar drugs in Taiwan’s hospital market by leveraging the framework of innovaiotn diffusion and dynamic competition. Our methodologies involve reviewing the current hospital market situation of biosimilar drugs and analyzing the potential factors for the delay in hospital market penetration, as well as conducting an attitudinal survey of biosimilar purchase with the drug procurement staff and pharmacists. We integrate six potential dimensions of the drug diffusion in hospitals channels through the literature review. After analyzing the survey result, it is found that the “Product (biosimilar medicine) characteristics which is related to customer needs', and “Pharmacetical company characteristics” which are the key influencial factors for those hospital without biosimilar products. 'Price-related factors which is related to customers’ cost', and 'Channel (place) activities which is related to customer convenience' are the key influential factors associated with those hospital with introducing biosimilar drugs. In addition, only 23% of the hospitals possess the regulation for the introduction of biosimilar drugs, which is also the potential cause of delay in their penetration within the hospital market. Although the awareness of biosimilar drugs is high, nearly half of the respondents are still unclear with the key concepts and regulatory policies related to biosimilars. Furthermore, we observed that for those hospital without introducing biosimilars, the 'relatice advantage” is the key consideration among all the key factors of innovaiotn diffusion. For those hospitals with introducing biosimilars, the “Compatibility” and “Observability” are the key innovation diffusion factors. The biosimilar market has just taken off in Taiwan. In the extremely oligopolistic, highly overlapping market segment vying for similar resource, the ability of manufacturers to maintain a dynamically competitive profiles at different entry stages with various competition and cooperation strategies among themselves becomes quite critical. Thus, applying the analytical framework of 'perception-motivation-ability' in both strategy and action plan is crucial. The relevant results of this study could serve as a reference for the management and promotion of biosimilar drugs by the government authorities and industries in the future, with the hope that biosimilars can eventually contribute towards sharing the pressure of drug prices amidst the rising health insurance costs, benefiting patients' drug accessibility, and growing the biopharmaceutical market and industry.