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  1. NTU Theses and Dissertations Repository
  2. 醫學院
  3. 國際三校農業生技與健康醫療碩士學位學程
請用此 Handle URI 來引用此文件: http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89788
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dc.contributor.advisor李財坤zh_TW
dc.contributor.advisorTsai-Kun Lien
dc.contributor.author張靖瀅zh_TW
dc.contributor.authorChing-Ying Changen
dc.date.accessioned2023-09-22T16:06:53Z-
dc.date.available2023-11-10-
dc.date.copyright2023-09-22-
dc.date.issued2023-
dc.date.submitted2023-07-19-
dc.identifier.citationAbdelrahman, A. A., Saad, A. A., Sabry, N. A., & Farid, S. F. (2016). Perceptions of Egyptian physicians about drug shortage during political disturbances: Survey in Greater Cairo. Bulletin of Faculty of Pharmacy, Cairo University, 54(2), 191–196. https://doi.org/10.1016/j.bfopcu.2016.05.004
Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. (2018). Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, 68(6), 394–424.
Bujar, M., McAuslane, N., & Liberti, L. (2021). The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions. Pharmaceutical Medicine, 35(2), 113–122. https://doi.org/10.1007/s40290-020-00372-7
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125477Orig1s000 SUMMARY REVIEW. (n.d.). FDA. Retrieved May 9, 2023, from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125477Orig1s000Sum R.pdf
Center for Drug Evaluation, Taiwan. (n.d.). Www.cde.org.tw. Retrieved May 20,2023, from https://www.cde.org.tw/eng/drugs/med_explain?id=39.
Chen, G.-T., Chang, S.-C., & Chang, C.-J. (2018). New Drug Reimbursement and
Pricing Policy in Taiwan. Value in Health Regional Issues, 15, 127–132.
https://doi.org/10.1016/j.vhri.2018.03.004
Cyramza. (2018, September 17). European Medicines Agency.
https://www.ema.europa.eu/en/medicines/human/EPAR/cyramza#overview-
section
CYRAMZA (ramucirumab). (n.d.). Haute Autorité de Santé. Retrieved May 9,
2023, from https://webzine.has-sante.fr/jcms/p_3186709/fr/cyramza-ramucirumab
Cyramza (Ramucirumab). (n.d.). Ameli. Retrieved May 9, 2023, from
http://www.codage.ext.cnamts.fr/codif/bdm_it/fiche/index_fic_medisoc.php?p_cod
e_cip=3400955000273&p_site=AMELI
Cyramza (Ramucirumab). List of New Drug Items Listed in the National Health
Insurance. (n.d.). National Health Insurance administration. Retrieved May 9, 2023, from https://www.nhi.gov.tw/Law_Detail.aspx?n=5597495EEC8219A1&sms=36A0BB 334ECB4011&s=BE7DE5572470A38E
Cyramza (Ramucirumab). Online query service for health care medicines. (n.d.). National Health Insurance administration. Retrieved May 9, 2023, fromhttps://www.nhi.gov.tw/QueryN_New/QueryN/Query1
Cyramza (Ramucirumab). Proposal for drugs to be included in the national health
insurance benefit list. (n.d.). Center For Drug Evaluation. Retrieved May 9, 2023, from https://www.cde.org.tw/Content/Files/HTA/%E8%97%A5%E5%93%81/2016%E5 %B9%B4/50_30700_1_%E8%A8%8E%E8%AB%96%E6%A1%889_Cyrmaza% 20HTA.pdf
CYRAMZA injection. market authorization information. (2015, December 24). Taiwan Food and Drug Administration. https://info.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=60000999
CYRAMZA(RAMUCIRUMAB). (n.d.). Drugs@FDA: FDA-Approved Drugs; U.S. Food and Drug Administration. Retrieved May 9, 2023, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.pro cess
EU Pricing & Reimbursement. (2014). Hogan Lovells. https://www.hoganlovells.com/~/media/hogan-lovells/pdf/publication/eu-pricing-- reimbursement-newsletter--november-2014_pdf.pdf
Health spending (indicator). (2023). OECD Data; OECD.
https://data.oecd.org/chart/76Hn
Honig, P. K. (2014). Recent Trends and Success Factors in Reducing the Lag Time to Approval of New Drugs in Japan. Clinical Pharmacology & Therapeutics, 95(5), 467–469. https://doi.org/10.1038/clpt.2013.256
Interview form of Cyramuza. (2022, August). Eli Lilly and Company. https://www.lillymedical.jp/assets/vaultpdf/jp/ja/9d9e7d7fd155e49ab7b1753d7d0b 2bce28de6ed3d499cb44be9404ea54d2b429/%E3%82%B5%E3%82%A4%E3%83 %A9%E3%83%A0%E3%82%B6%EF%BC%88%E3%83%A9%E3%83%A0%E3 %82%B7%E3%83%AB%E3%83%9E%E3%83%96%EF%BC%89%E3%82%A4 %E3%83%B3%E3%82%BF%E3%83%93%E3%83%A5%E3%83%BC%E3%83 %95%E3%82%A9%E3%83%BC%E3%83%A0%20%7C%20%E5%8C%BB%E7 %99%82%E9%96%A2%E4%BF%82%E8%80%85%E5%90%91%E3%81%91% 20%E2%80%93%20%E6%97%A5%E6%9C%AC%E3%82%A4%E3%83%BC% E3%83%A9%E3%82%A4%E3%83%AA%E3%83%AA%E3%83%BC%E6%A0 %AA%E5%BC%8F%E4%BC%9A%E7%A4%BE
Interview form of Zejula. (n.d.). Takeda Pharmaceutical Company Limited. Retrieved May 9, 2023, from https://www.takedamed.com/mcm/medicine/download.jsp?id=1238&type=INTER VIEW_FORM
Jacquet, E., Kerouani-Lafaye, G., Grude, F., Goncalves, S., Lorence, A., Turcry,F., Brunel, L., Belgodere, L., Monard, A., Guyader, G., Boudali, L., & Albin, N. (2021). Comparative study on anticancer drug access times between FDA, EMA and the French temporary authorisation for use program over 13 years. European Journal of Cancer, 149, 82–90. https://doi.org/10.1016/j.ejca.2021.03.008
Kamae, I., Thwaites, R., Hamada, A., & Fernandez, J. L. (2020). Health technology assessment in Japan: a work in progress. Journal of Medical Economics, 23(4), 317–322. https://doi.org/10.1080/13696998.2020.1716775
Launch of ZEJULA® Tablets for the Treatment of Ovarian Cancer. (n.d.). Retrieved May 9, 2023, from https://www.takeda.com/ja- jp/announcements/ZEJULA
Lythgoe, M. P., Desai, A., Gyawali, B., Savage, P., Krell, J., Warner, J. L., & Khaki, A. R. (2022). Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019. JAMA Network Open, 5(6), e2216183. https://doi.org/10.1001/jamanetworkopen.2022.16183
McLaughlin, M., Kotis, D., Thomson, K., Harrison, M., Fennessy, G., Postelnick, M., & Scheetz, M. H. (2013). Effects on patient care caused by drug shortages: A Survey. Journal of Managed Care Pharmacy, 19(9), 783–788. https://doi.org/10.18553/jmcp.2013.19.9.783
National health insurance annual statistical report. (n.d.). National Health Insurance Administration, Ministry of Health and Welfare. Retrieved April 10, 2023, from https://www.nhi.gov.tw/Content_List.aspx?n=BC0498EE81BDCBB6&topn=23C6 60CAACAA159D
New chemical entity(NCE) Assessment Report - Registration - Drugs - Food and Drug Administration, Department of Health. (n.d.). Taiwan Food and Drug Administration. Retrieved May 9, 2023, from https://www.fda.gov.tw/ENG/SiteList.aspx?sid=10664&
NHI price list and information on generic drugs. (2023, April 1). Ministry of Health, labour and Welfare. https://www.mhlw.go.jp/topics/2023/04/tp20230401- 01.html
Okabayashi, S., Kobayashi, T., & Hibi, T. (2018). Drug Lag for Inflammatory Bowel Disease Treatments in the East and West. Inflammatory Intestinal Diseases, 3(1), 25–31. https://doi.org/10.1159/000491878
Pauwels, K., Simoens, S., Casteels, M., & Huys, I. (2015). Insights into European drug shortages: A survey of hospital pharmacists. PLoS ONE, 10(3), e0119322. https://doi.org/10.1371/journal.pone.0119322
R&D Briefing 85: New drug approvals in six major authorities 2012–2021: Focuson Facilitated Regulatory Pathways and internationalisation. (2022). Centre for Innovation in Regulatory Science (CIRS). https://cirsci.org/wp- content/uploads/dlm_uploads/2022/06/CIRS-RD-Briefing-85-6-agencies-v2.3.pdf
Rawla, P., & Barsouk, A. (2019). Epidemiology of gastric cancer: global trends, risk factors and prevention. Gastroenterology Review, 14(1), 26–38. https://doi.org/10.5114/pg.2018.80001
Rémuzat, C., Toumi, M., Jørgensen, J., & Kefalas, P. (2015). Market access pathways for cell therapies in France. Journal of Market Access & Health Policy, 3(1), 29094. https://doi.org/10.3402/jmahp.v3.29094
Sabine, V. (2020). PPRI Pharma Brief: France 2020. Gesundheit Österreich GmbH (GÖG / Austrian National Public Health Institute). https://jasmin.goeg.at/1686/1/PPRI_Pharma_Brief_FR_2020_final_Oct2020.pdf
Shih, Y., Liao, K., Chen, Y., Lin, F., & Hsiao, F. (2020). Reimbursement Lag of New Drugs under Taiwan’s National Health Insurance System compared to United Kingdom, Canada, Australia, Japan, and South Korea. Clinical and Translational Science, 13. https://doi.org/10.1111/cts.12778
Shitara, K., & Ohtsu, A. (2014). Ramucirumab for gastric cancer. Expert Review of Gastroenterology & Hepatology, 9(2), 133–139. https://doi.org/10.1586/17474124.2015.987754
Shortening the WAIT - Patient Access to Medicines in Europe. (n.d.). Www.efpia.eu; EFPIA Homepage. Retrieved May 20, 2023, from https://www.efpia.eu/media/677311/efpia-patient-wait-indicator.pdf.
Stewart, C., Ralyea, C., & Lockwood, S. (2019). Ovarian Cancer: An Integrated Review. Seminars in Oncology Nursing, 35(2), 151–156. https://doi.org/10.1016/j.soncn.2019.02.001
Takayama, A., & Narukawa, M. (2017). Comparison of New Drug Accessibility and Price Between Japan and Major European Countries. Therapeutic Innovation & Regulatory Science, 51(5), 604–611. https://doi.org/10.1177/2168479017706716
Wang, T., Cao, X., He, Y., & Chen, X. (2022). Innovation drug approvals based on a bridging study: from concept to practice. Translational Breast Cancer Research, 3, 2–2. https://doi.org/10.21037/tbcr-21-43
Zejula (Niraparib).List of New Items Covered by National Health Insurance. (2022, December 14). National Health Insurance Administration, MOHW. https://www.nhi.gov.tw/BBS_Detail.aspx?n=73CEDFC921268679&sms=D6D536 7550F18590&s=BE7386A284B2F2FC
Zejula - European Medicines Agency. (2018, September 17). European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/zejula
ZEJULA(niraparib). (n.d.). Drugs@FDA: FDA-Approved Drugs; U.S. Food and Drug Administration. Retrieved May 9, 2023, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.proces s&ApplNo=208447
Zejula(Niraparib). (n.d.). Ameli. Retrieved May 9, 2023, from http://www.codage.ext.cnamts.fr/codif/bdm_it//fiche/index_fic_medisoc.php?p_co de_cip=3400930126684&p_site=AMELI
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dc.identifier.urihttp://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89788-
dc.description.abstract藥品可及性延遲是藥證取得、藥品定價、藥品納入健保延遲所得到的結果,這 會對個人的健康和財政狀況造成負面影響。本文利用各國衛生主管機關公開的資 料,比較分析北美、歐洲、亞洲等不同大陸間的藥品可及性、新藥申請、藥品定 價等過程及系統,並透過 Cyramza (Ramucirumab) 和 Zejula (Niraparib)這兩個藥 品的案例分析,來強化論述。此分析總結出藥證取得延遲通常各國相似,但是藥 品納入健保卻因為各國投入健保的預算及當地未滿足醫療需求不同,而造成相當 大的延遲差異,總體來說,這個比較分析報告提供了不同大陸間製藥產業的法規 和定價系統有價值的洞見,以期待能增加藥品可及性。zh_TW
dc.description.abstractDrug access delays, including market authorization, pricing, and reimbursement delays, can significantly impact individuals' health and wealth. The study analyzes drug access, new drug approval processes, and pricing systems in several continents, including North America, Europe, and Asia, based on data disclosed by their regulatory authorities. The analysis relies on two case studies (Cyramza (Ramucirumab) and Zejula (Niraparib)) to strengthen the finding. This report finds that the market authorization waiting time is usually similar within countries. However, reimbursement delays can vary significantly because of the healthcare budget and national unmet medical needs differences. Overall, the comparative analysis provides valuable insights into the pharmaceutical industry's regulatory frameworks and pricing mechanisms in different regions, emphasizing the need for ongoing policy development to improve drug access and affordability globally.en
dc.description.provenanceSubmitted by admin ntu (admin@lib.ntu.edu.tw) on 2023-09-22T16:06:53Z
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dc.description.provenanceMade available in DSpace on 2023-09-22T16:06:53Z (GMT). No. of bitstreams: 0en
dc.description.tableofcontentsAcknowledgment 1
摘要 2
Abstract 3
Introduction 5
Market authorization 7
Drug Pricing 13
Reimbursement 18
Objective 27
Method 27
Case study 29
Cyramza (Ramucirumab) in gastric cancer 29
Zejula (Niraparib) in ovarian cancer 34
Discussion 38
Conclusion 41
Reference 43
Abbreviation list 52
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dc.language.isoen-
dc.subject藥品納入健保延遲zh_TW
dc.subject藥品定價zh_TW
dc.subject藥品可及性延遲zh_TW
dc.subjectpricing delaysen
dc.subjectreimbursement delaysen
dc.subjectDrug access delayen
dc.subjectmarket authorizationen
dc.title藥品可及性的跨大陸比較分析zh_TW
dc.titleA cross-continental comparative analysis of the drug access systemen
dc.typeThesis-
dc.date.schoolyear111-2-
dc.description.degree碩士-
dc.contributor.oralexamcommittee姜至剛;沈湯龍;周涵怡zh_TW
dc.contributor.oralexamcommitteeChih-Kang Chiang;Tang-Long Shen;Han-Yi Chouen
dc.subject.keyword藥品可及性延遲,藥品定價,藥品納入健保延遲,zh_TW
dc.subject.keywordDrug access delay,market authorization,pricing delays,reimbursement delays,en
dc.relation.page53-
dc.identifier.doi10.6342/NTU202301699-
dc.rights.note同意授權(全球公開)-
dc.date.accepted2023-07-19-
dc.contributor.author-college醫學院-
dc.contributor.author-dept國際三校農業生技與健康醫療碩士學位學程-
dc.date.embargo-lift2025-08-15-
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