Please use this identifier to cite or link to this item:
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/89788
Full metadata record
???org.dspace.app.webui.jsptag.ItemTag.dcfield??? | Value | Language |
---|---|---|
dc.contributor.advisor | 李財坤 | zh_TW |
dc.contributor.advisor | Tsai-Kun Li | en |
dc.contributor.author | 張靖瀅 | zh_TW |
dc.contributor.author | Ching-Ying Chang | en |
dc.date.accessioned | 2023-09-22T16:06:53Z | - |
dc.date.available | 2023-11-10 | - |
dc.date.copyright | 2023-09-22 | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-07-19 | - |
dc.identifier.citation | Abdelrahman, 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 | - |
dc.identifier.uri | http://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.abstract | Drug 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.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2023-09-22T16:06:53Z No. of bitstreams: 0 | en |
dc.description.provenance | Made available in DSpace on 2023-09-22T16:06:53Z (GMT). No. of bitstreams: 0 | en |
dc.description.tableofcontents | Acknowledgment 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 | - |
dc.language.iso | en | - |
dc.title | 藥品可及性的跨大陸比較分析 | zh_TW |
dc.title | A cross-continental comparative analysis of the drug access system | en |
dc.type | Thesis | - |
dc.date.schoolyear | 111-2 | - |
dc.description.degree | 碩士 | - |
dc.contributor.oralexamcommittee | 姜至剛;沈湯龍;周涵怡 | zh_TW |
dc.contributor.oralexamcommittee | Chih-Kang Chiang;Tang-Long Shen;Han-Yi Chou | en |
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.keyword | Drug access delay,market authorization,pricing delays,reimbursement delays, | en |
dc.relation.page | 53 | - |
dc.identifier.doi | 10.6342/NTU202301699 | - |
dc.rights.note | 同意授權(全球公開) | - |
dc.date.accepted | 2023-07-19 | - |
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 | - |
Appears in Collections: | 國際三校農業生技與健康醫療碩士學位學程 |
Files in This Item:
File | Size | Format | |
---|---|---|---|
ntu-111-2.pdf Until 2025-08-15 | 732.76 kB | Adobe PDF |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.