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  1. NTU Theses and Dissertations Repository
  2. 公共衛生學院
  3. 健康政策與管理研究所
請用此 Handle URI 來引用此文件: http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/96865
完整後設資料紀錄
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dc.contributor.advisor鄭守夏zh_TW
dc.contributor.advisorShou-Hsia Chengen
dc.contributor.author任楚瑜zh_TW
dc.contributor.authorChu-Yu Jenen
dc.date.accessioned2025-02-24T16:19:08Z-
dc.date.available2025-02-25-
dc.date.copyright2025-02-24-
dc.date.issued2025-
dc.date.submitted2025-02-12-
dc.identifier.citation1 台灣藥物法規資訊網 (10年11月02日)。衛授食字第1101406631號「新藥及生物藥品(含生物相似性藥品)查驗登記退件機制(Refuse to File;RTF)查檢表」公告修正。https://regulation.cde.org.tw/doc_data_display?sid=3157&doctype2=
2 衛生福利部食品藥物管理署(2024-12-09)。生物相似性藥品專區。https://www.fda.gov.tw/TC/siteContent.aspx?sid=11262
3 饒秀珍 (2019年10月15日)。解讀生物相似性藥品的好消息與壞消息 財訊591期https://www.wealth.com.tw/articles/26f9985a-b936-449c-a1b9-8ec9b8291cba
4 勤業眾信(2015年12月15日)。生物相似性藥品商機觀察從全球發展看台灣機會Deloitte global研究報告 “Winning with biosimilars Opportunities in global markets”
5 衛生福利部中央健康保險署(2022年4月28日)。我國生物相似性藥品健保給付政策現況與願景報告
6 資誠聯合會計師事務所 (2021年4月28日)。資誠生醫透視PwC BIO Insights全球生技製藥趨勢:不斷成長的生物相似性藥品市場報告
7 衛生福利部中央健康保險署醫審及藥材組 戴雪詠前組長(2022年4月28日)。我國生物相似性藥品健保給付政策現況與願景報告,我國生物相似性藥品發展願景研討會8 WHO (2024, May 23)."All for Health, Health for All" sets the stage for the Seventy-seventh World Health Assembly https://www.who.int/news/item/23-05-2024-all-for-health--health-for-all--sets-the-stage-for-the-seventy-seventh-world-health-assembly
9吳麗珍, 黃惠滿 and 李浩銑 (2014)。護理雜誌,2014 Vol. 61 Issue 3 Pages 105-111,DOI: 10.6224/jn.61.3.105
10 Patton,M.Q.(2002).Qualitative research & evaluation methods / by Michael QuinnPatton. (3rd ed.). Thousand Oaks,CA:Sage.
11 萬文隆(2004)。深度訪談在質性研究中的應用。生活科技教育,37(4),17-23。https://doi.org/10.6232/LTE.2004.37(4).4
12 Anfara, V. A., Brown, K. M., & Mangione, T. L. (2002). Qualitative Analysis on Stage: Making the Research Process More Public. Educational Researcher, 31(7), 28–38. http://www.jstor.org/stable/3594403
13 林金定、嚴嘉楓、陳美花(2005)。質性研究方法:訪談模式與實施步驟分析。身心障礙研究季刊,3(2),122-136。https://doi.org/10.30072/JDR.200506.0005
14 Organisation for Economic Co-operation and Development (OECD) (2023, Nov 07). Health at a Glance 2023: OECD Indicators https://www.oecd.org/content/dam/oecd/en/publications/reports/2023/11/health-at-a-glance-2023_e04f8239/7a7afb35-en.pdf
15 湯澡薰、莊博雅、巢杏悠(2009年06月01日至2009年12月31日)。各國藥品支付制度及藥價政策分析及評估,行政院衛生署中央健康保險局九十八年度委託研究計畫,台北醫學大學
16 全民健康保險藥物給付項目及支付標準§32-1-全國法規資料庫。
17 Nice (2015, Nov). Patient Access Schemes – A Who, What, Why, When and How Macaulay, R et al.Value in Health, Volume 18, Issue 7, A552
18 Australia Government Department of Health and Aged Care (2025, Jan 01). About the PBS. https://www.pbs.gov.au/info/about-the-pbs
19 Australia Government Department of Health and Aged Care.Biosimilar Uptake Drivers https://m.pbs.gov.au/general/biosimilars/biosimilar-uptake-drivers-q-and-a.docx
20 Government of Canada (2024, Dec 19).Patented Medicine Prices Review Board https://www.canada.ca/en/patented-medicine-prices-review.html
21 British Columbia Government (2019, May 27). B.C. expands use of biosimilars to offer coverage for more treatment options https://news.gov.bc.ca/releases/2019HLTH0080-001072#assets
22 Japan Pharmaceutical Manufacturers Association (2011, March 02).Pharmaceutical Administration and Regulations in Japan https://www.nihs.go.jp/mhlw/yakuji/yakuji-e_20110502-02.pdf
23 Ministry of Health, Labour and Welfare (2017, Dec 30).Update of Drug Pricing System in Japan https://www.pmda.go.jp/files/000221888.pdf
24 厚生労働省/こうせいろうどうしょう(2024, Aug 21).後発医薬品のある先発医薬品(長期収載品)の選定療養についてhttps://www.mhlw.go.jp/stf/newpage_39830.html
25 Japan Pharmaceutical Manufacturers Association (2011, March 02).Pharmaceutical Administration and Regulations in Japan https://www.nihs.go.jp/mhlw/yakuji/yakuji-e_20110502-02.pdf
26 全民健康保險法§第48條。27 United Kingdom National Health Service (NHS) (2023, Nov 23).NHS prescription charges https://www.nhs.uk/nhs-services/prescriptions/nhs-prescription-charges/
28 施如亮、周浩宇(2010年1月29日)。澳洲藥品給付及管理政策報告,行政院衛生署中央健康保險局
29 OECD Directorate for Employment, Labour and Social Affairs (2006, Dec).Paris V, Docteur E. Pharmaceutical Pricing and Reimbursement Policies in Canada. https://www.oecd.org/content/dam/oecd/en/publications/reports/2006/12/pharmaceutical-pricing-and-reimbursement-policies-in-canada_g17a191c/346071162287.pdf
30 厚生労働省/こうせいろうどうしょう(2024, Aug 21).後発医薬品のある先発医薬品(長期収載品)の選定療養についてhttps://www.mhlw.go.jp/stf/newpage_39830.html
31 衛生福利部中央健康保險署醫審及藥材組 戴雪詠前組長(2022年4月28日)。我國生物相似性藥品健保給付政策現況與願景報告,我國生物相似性藥品發展願景研討會
32 衛生福利部中央健康保險署(2024年6月14日)。使用生物相似性藥品之鼓勵試辦計畫 https://www.nhi.gov.tw/ch/cp-15234-3f6cd-2523-1.html
33 衛生福利部中央健康保險署李伯璋前署長(2022年5月6日)。擴增適應症策略之思考與現況,台灣醫藥品法規學會「導入生物相似性藥品,創造市場競爭機制-生物相似性藥品健保策略」座談會
34 Government of United Kingdom Medicines & Healthcare products Regulatory Agency (2024, Dec 20). Guidance on the licensing of biosimilar products https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products
35 Tracey Roberts (2021, May 27).Education drive can boost UK biosimilar market. Pinsent Masons law firm https://www.pinsentmasons.com/out-law/analysis/education-drive-can-boost-uk-biosimilar-market
36 United Kingdom National Health Service (NHS) (2017, Sep 12).Commissioning framework for biological medicines.https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.pdf
37 Driving down the cost of biologics: lessons from a nationalized health-care system Russell, Mark D et al.The Lancet, Volume 404, Issue 10464, 1723 – 1724 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02151-2/fulltext
38 United Kingdom National Health Service (NHS) (2018, Mar).Commissioning for Quality and Innovation (CQUIN) Guidance for 2017-2019 https://www.england.nhs.uk/wp-content/uploads/2018/04/cquin-guidance-2018-19.pdf
39 Tim Wilsdon, Michele Pistollato, Kirsty Ross-Stewart, Rowan Saada, Pablo Barquin, George Tambassis (2022, Sep).Unlocking the Potential of Biosimilars A Roadmap for Biosimilar Policy Sustainability, Charles River Associates https://www.organon.com/australia/wp-content/uploads/sites/16/2022/09/CRA-Organon-Biosimilars-Country-Landscape-and-Sustainability-Assessment-AUS-vSTC-FINAL.pdf
40 Ben Miller, Stephen Rohl, Jenny Wong (2023, May 23).Biosimilars in Australia, Maddocks https://www.maddocks.com.au/insights/biosimilars-in-australia
41 Australia Government Department of Health and Aged Care (2021, Apr 01). Pharmaceutical Benefits Scheme – Biosimilar Adalimumab https://www.health.gov.au/sites/default/files/2024-10/biosimilar-medicine-fact-sheet-adalimumab.pdf
42 Generic and Biosimilar Medicines Association (GBMA) (2024, Nov 20).Australians to benefit from a potential $1 billion biosimilar medicines’ funding windfall https://gbma.com.au/australians-to-benefit-from-a-potential-1-billion-biosimilar-medicines-funding-windfall/
43 Government of Canada (2022, Aug 26).Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs-1.html
44 Canada's Drug Agency (CDA-AMC) (2020, Jan 21).Utilization of Innovator Biologics and Biosimilars for Chronic Inflammatory Diseases in Canada: A Provincial Perspective https://www.cda-amc.ca/utilization-innovator-biologics-and-biosimilars-chronic-inflammatory-diseases-canada-provincial
45 Government of Canada (2024, May 17).Biosimilar biologic drugs https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html
46 British Columbia Government (2024, Nov 26). Biosimilars Initiative for patients https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/biosimilars-initiative-patients
47 CADTH (2019, Apr).Biosimilars in Canada: Current Environment and Future Opportunity https://www.cda-amc.ca/sites/default/files/symp-2019/presentations/april15-2019/B3-presentation-elungu.pdf
48 T. Gomes, D. McCormack, S. A. Kitchen, J. M. Paterson, M. M. Mamdani, L. Proulx, et al. CMAJ Open 2021 Vol. 9 Issue 4 Pages E1055-E1062 DOI: 10.9778/cmajo. 20210091 Projected impact of biosimilar substitution policies on drug use and costs in Ontario, Canada: a cross-sectional time series analysis https://www.cmajopen.ca/content/9/4/E1055
49 厚生労働省(2024-2025).バイオ医薬品・バイオシミラー講習会https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000132762_00005.htm.l
49 Pharmaceuticals and Medical Devices Agency (PMDA) (2023, Aug 31).Biosimilar Regulation and Guidelines in Japan https://www.pmda.go.jp/files/000267474.pdf
50 厚生労働省(2023, Jun 05).後発医薬品(ジェネリック医薬品)及びバイオ後続品(バイオシミラー)の使用促進についてhttps://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/kouhatu-iyaku/index.html
51 Pharma Japan (2020, Feb 10).Chuikyo Issues Recommendation for 2020 Reimbursement Reform; Biosimilar Premium Set at 1,500 Yen per Month https://pj.jiho.jp/article/241502
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dc.identifier.urihttp://tdr.lib.ntu.edu.tw/jspui/handle/123456789/96865-
dc.description.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。
zh_TW
dc.description.abstractBackground: 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.
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dc.description.provenanceSubmitted by admin ntu (admin@lib.ntu.edu.tw) on 2025-02-24T16:19:08Z
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dc.description.tableofcontents口試委員會審定書 I
誌謝 II
中文摘要 III
ABSTRACT IV
第一章 緒論 1
第一節、 研究背景 1
第二節、 研究動機 5
第三節、 研究目的 5
第四節、 研究方法 6
第二章 政策與數據分析 10
第一節、 國際政策分析 10
第二節、 各國藥品支付制度比較 13
第三節、 各國生物相似性藥品鼓勵政策分析 18
第四節、 各國生物相似性藥品銷售分析 38
第五節、 台灣生物相似性藥品健保給付狀況分析 47
第三章 利害關係人分析 52
第一節、 受訪單位及受訪者背景 52
第二節、 利害關係人需求分析 53
第三節、 生物相似性藥品推廣障礙 57
第四節、 生物相似性藥品推廣助力 61
第五節、 利害關係人需求之政策建議 64
第四章 結論 68
第一節、 研究結果 68
第二節、 研究限制 70
第三節、 政策建議 71
附錄 73
參考文獻 84
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dc.language.isozh_TW-
dc.title生物相似性藥品市場推廣之障礙分析以及政策建議zh_TW
dc.titleAnalysis of barriers and policy recommendations to the market access of biosimilar drugs.en
dc.typeThesis-
dc.date.schoolyear113-1-
dc.description.degree碩士-
dc.contributor.oralexamcommittee石崇良;姜紹青zh_TW
dc.contributor.oralexamcommitteeChung-Liang Shih;Shao-Chin Chiangen
dc.subject.keyword生物相似性藥品,健保鼓勵政策,藥品轉換替代,處方鼓勵,健保永續,zh_TW
dc.subject.keywordbiosimilar medicines,health insurance incentive programs,therapeutic substitution,prescription encouragement,health insurance sustainability,en
dc.relation.page91-
dc.identifier.doi10.6342/NTU202500614-
dc.rights.note同意授權(全球公開)-
dc.date.accepted2025-02-12-
dc.contributor.author-college公共衛生學院-
dc.contributor.author-dept健康政策與管理研究所-
dc.date.embargo-lift2025-02-25-
顯示於系所單位:健康政策與管理研究所

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