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艾昆纬:2025精准医疗时代肿瘤治疗可及性:中东及非洲部分国家监管审批与医保报销趋势报告(英文版)(43页).pdf

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1、AUGUST202 5Trends in Regulatory Approval and Reimbursement for Select Countries in the Middle East and AfricaOncology Therapy Access in the Era of Personalized MedicineResearch by the IQVIA Institute in 2024 revealed geographical differences in the availability of oncology novel active substances(NA

2、S)across select EU countries,Australia,Canada,and Brazil,influenced by factors such as country-level variations in clinical data acceptance,health technology assessment(HTA)processes,clinical endpoint priorities,and manufacturer strategies.Building on these insights,trends in overall regulatory appr

3、ovals and reimbursement have been analyzed for oncology therapies indicated in solid tumors and hematological malignancies in two Gulf Cooperation Council(GCC)nations Saudi Arabia and United Arab Emirates(UAE)and three African countries Algeria,Egypt,and South Africa.Important dynamics associated wi

4、th the oncology therapy landscape such as the registration and reimbursement of selected innovative targeted therapies including antibody-drug conjugates(ADCs),bispecific antibodies(bsAbs),cell and gene therapies(CAGTs),and immuno-oncology checkpoint inhibitors have been assessed.The associated comp

5、anion diagnostic requirements to administer some of these therapies are also discussed.This report outlines the underlying factors contributing to the oncology therapy access challenges,examines their implications,and highlights ongoing country level efforts to address them.It concludes with action

6、items aimed at improving oncology therapy access.The findings are intended to support discussions on existing hurdles,showcase on-going initiatives,and guide strategies to enhance access to precision oncology therapies.This report has been developed independently by the IQVIA Institute for Human Dat

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根据文章内容,主要概括如下: 1. 中东和非洲地区肿瘤治疗的可及性存在显著差异。2014-2023年,沙特阿拉伯和阿联酋注册了全球新上市的肿瘤新活性物质(NAS)的31%,而欧盟为52%。在注册的NAS中,沙特阿拉伯55%、阿联酋84%通过公共渠道报销,而德国、意大利、法国分别为98%、88%、72%。 2. 沙特阿拉伯和阿联酋从全球上市到注册的中位数时间分别为27个月和23个月,而从注册到报销的中位数时间分别为23个月和6个月。阿尔及利亚、埃及、南非的注册率较低,分别为5%、17%、17%。 3. 沙特阿拉伯和阿联酋已注册了部分靶向治疗药物,如ADC、双特异性抗体、免疫检查点抑制剂,但CAR-T细胞疗法尚未注册。阿尔及利亚、埃及、南非的注册率较低。 4. 沙特阿拉伯和阿联酋对需要伴随诊断的NAS的报销率分别为50%和78%,而阿尔及利亚、埃及、南非的注册率分别为15%、47%、36%。 5. 沙特阿拉伯和阿联酋正在采取措施改善肿瘤治疗的可及性,包括加强审批途径、建立HTA框架、激活临床试验等。阿尔及利亚、埃及、南非也面临审批和报销延迟等问题。
中东非洲肿瘤治疗现状如何? 肿瘤创新疗法在这些国家普及吗? 如何改善这些国家的肿瘤治疗?
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