Sperm-structure-integrating nanodecorated microrobots have shown promise in medicine delivery and infertility treatment.A variety of spermbots use cutting-edge nanomaterials and 3D printing technology to enhance their...Sperm-structure-integrating nanodecorated microrobots have shown promise in medicine delivery and infertility treatment.A variety of spermbots use cutting-edge nanomaterials and 3D printing technology to enhance their functioning,such as biomimetic sperms and flagellate microorganisms.The success rates of assisted reproductive technology techniques like in vitro fertilisation(IVF)and intracytoplasmic sperm injection(ICSI)may increase as a result of these developments.Furthermore,the incorporation of artificial intelligence(AI)into spermbots has the potential to optimize reproductive therapies by reducing inherited illnesses through genetic screening and editing.However,before the widespread implementation of spermbots in clinical practice,several critical aspects must be addressed.Thorough investigations into biocompatibility,ethical considerations,and long-term safety are necessary to ensure that these technologies are safe and effective for in vivo applications.展开更多
目的探讨欧洲五国(Europe Union Five Countries,EU5)对嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T细胞)治疗产品的卫生技术评估(health technology assessment,HTA)、报销政策的差异及对我国的启示。方法检索EU5国家(...目的探讨欧洲五国(Europe Union Five Countries,EU5)对嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T细胞)治疗产品的卫生技术评估(health technology assessment,HTA)、报销政策的差异及对我国的启示。方法检索EU5国家(英国、法国、德国、意大利、西班牙)HTA机构、报销决策机构及支付方等的官方文件,结合欧洲药品管理局和英国药品和健康产品管理局的数据,分析欧洲主要市场获批的CAR-T细胞治疗产品的HTA评估报告、医保报销决策及定价机制等的差异。结果截至2025年4月,5个国家共有6款CAR-T细胞治疗产品上市,各国在HTA周期和评估结论、报销决策等方面存在差异。英国的初始HTA评估周期最短,平均为9.2个月,通过覆盖与证据开发(coverage with evidence development,CED)机制,利用肿瘤药物基金(Cancer Drug Fund,CDF)为不符合常规准入标准的产品提供临时报销;其二次评估过程基于真实世界证据,周期较长。法国采用患者早期访问政策,HTA周期较短,平均为10.7个月,其HTA结果直接决定CAR-T细胞治疗产品的报销比例及定价策略,并通过CED机制报销;二次评估频率较高,从初次评估到二次评估的时间间隔较短。意大利、西班牙和德国支付体系呈现分散化的特征,且HTA评估与报销决策流程不连续。3个国家均采用按疗效付费(pay for performance,P4P)模式,但在报销触发节点的制定、疗效评价指标的选择、支付机制的设计等方面存在差异,德国实施基于患者生存结局的无效返款模式,而意大利和西班牙采用分期见效付款模式。结论CED与P4P均可有效应对CAR-T细胞治疗产品的高价值与高不确定性。CED通过临时报销同步开展上市后研究,P4P在常规准入中依据疗效节点进行风险分担,二者均以真实世界证据为核心。建议将CED与P4P整合纳入医保准入框架,以动态证据降低决策的不确定性。展开更多
文摘Sperm-structure-integrating nanodecorated microrobots have shown promise in medicine delivery and infertility treatment.A variety of spermbots use cutting-edge nanomaterials and 3D printing technology to enhance their functioning,such as biomimetic sperms and flagellate microorganisms.The success rates of assisted reproductive technology techniques like in vitro fertilisation(IVF)and intracytoplasmic sperm injection(ICSI)may increase as a result of these developments.Furthermore,the incorporation of artificial intelligence(AI)into spermbots has the potential to optimize reproductive therapies by reducing inherited illnesses through genetic screening and editing.However,before the widespread implementation of spermbots in clinical practice,several critical aspects must be addressed.Thorough investigations into biocompatibility,ethical considerations,and long-term safety are necessary to ensure that these technologies are safe and effective for in vivo applications.
文摘目的探讨欧洲五国(Europe Union Five Countries,EU5)对嵌合抗原受体T细胞(chimeric antigen receptor T cell,CAR-T细胞)治疗产品的卫生技术评估(health technology assessment,HTA)、报销政策的差异及对我国的启示。方法检索EU5国家(英国、法国、德国、意大利、西班牙)HTA机构、报销决策机构及支付方等的官方文件,结合欧洲药品管理局和英国药品和健康产品管理局的数据,分析欧洲主要市场获批的CAR-T细胞治疗产品的HTA评估报告、医保报销决策及定价机制等的差异。结果截至2025年4月,5个国家共有6款CAR-T细胞治疗产品上市,各国在HTA周期和评估结论、报销决策等方面存在差异。英国的初始HTA评估周期最短,平均为9.2个月,通过覆盖与证据开发(coverage with evidence development,CED)机制,利用肿瘤药物基金(Cancer Drug Fund,CDF)为不符合常规准入标准的产品提供临时报销;其二次评估过程基于真实世界证据,周期较长。法国采用患者早期访问政策,HTA周期较短,平均为10.7个月,其HTA结果直接决定CAR-T细胞治疗产品的报销比例及定价策略,并通过CED机制报销;二次评估频率较高,从初次评估到二次评估的时间间隔较短。意大利、西班牙和德国支付体系呈现分散化的特征,且HTA评估与报销决策流程不连续。3个国家均采用按疗效付费(pay for performance,P4P)模式,但在报销触发节点的制定、疗效评价指标的选择、支付机制的设计等方面存在差异,德国实施基于患者生存结局的无效返款模式,而意大利和西班牙采用分期见效付款模式。结论CED与P4P均可有效应对CAR-T细胞治疗产品的高价值与高不确定性。CED通过临时报销同步开展上市后研究,P4P在常规准入中依据疗效节点进行风险分担,二者均以真实世界证据为核心。建议将CED与P4P整合纳入医保准入框架,以动态证据降低决策的不确定性。
