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    中国已上市罕见病药物70余种“孤儿药”步入上市快车道

    时间:2021-11-08 21:18:44 来源:昆山尚驰机电设备工程有限公司 作者:周彦宏
    原标题:中国已上市罕见病药物70余种“孤儿药”步入上市快车道记者19日获悉,到目前为止,基于《第一批罕见病目录》,中国已上市罕见病相关药物70余种,涉及60余种罕见病。这些罕见病患者已实现“有药可医”。同时,罕见病高值药(“孤儿药”)也步入了上市的快车道。由全国罕见病学术团体主委联席会议、上海市罕见病防治基金会和上海市医学会罕见病专科分会联合主办的尿素循环障碍防控多学科专家研讨会19日在此间举行。中国各地的罕见病学术组织负责人、相关临床医学、药学、法学、政策研究及卫生经济学等领域专家和企业界人士共同直面罕见病用药保障机制的机遇和挑战,并建言献策。据悉,全世界已经发现的罕见病在7000种左右,80%为遗传性疾病,罕见病患者中儿童约占一半,1岁以下婴儿死亡原因中,约35%是由罕见病引起的。专家回答记者提问。陈静摄据了解,近年来,中国先后出台了一系列政策,推动了罕见病防治与保障的发展。同时,随着国家医药卫生体制改革发展,药品审评审批流程不断优化,2019年、2020年分别有多种高值药获批中国,使罕见病患者及家庭看到了希望。近年来,罕见病药物进入中国、纳入国家医保目录的步伐逐年加大。采访中,记者了解到,伴随相关治疗药物在中国获批上市,尿素循环障碍患者的长期治疗和生活质量的提高有了新的保障。据悉,尿素循环障碍(UCD)是常染色体隐形遗传性疾病。新生儿早期发病,致死率高;迟发性疾病可导致智力障碍和死亡。研讨会上,记者获悉,上海、青岛和浙江、佛山等多地纷纷探索罕见病用药保障机制。各地通过将罕见病纳入大病医保、建立专项基金制度、推行政府型商保、鼓励参与医疗救助、倡导慈善帮扶、企业捐赠、个人一定比例自付等方式,为患者带来福音。采访中,记者了解到,各地的探索仍然存在许多局限,比如:个人自付比例地方差异大;罕见病患者人数少,药价谈判空间有限;政策性商保在快速发展中产品设计不够成熟,难以形成长效机制等等。上海市罕见病防治基金会理事长李定国对记者表示,罕见病不仅是医学问题更是社会问题。罕见病由于发病率低、治疗手段有限、社会对罕见病认知度低而被忽视。发现难、治疗难、用不上药,用不起药,一直是困扰罕见病患者及家庭的重要原因之一。他认为,推动罕见病防治是由社会文明进步的一个象征。北京大学第一医院儿科教授杨艳玲教授表示,对于罕见病和遗传病来说,应做到能防尽防,能治尽治。这位专家坦言,80%的罕见病是遗传代谢病,遗传病大多数是隐性遗传,从防控来说,难度非常大,因此必须能治尽治。复旦大学附属儿科医院院长黄国英坦言,探索罕见病用药保障机制是循序渐进的过程,也是随着国家经济社会发展不断充实,提升的过程。他希望产学研医结合起来,企业主动跟医疗机构合作,共同研发罕见病的诊疗药物和器械方法。全国罕见病学术团体主委联席会议秘书长王琳则对记者表示,罕见病的防治和优生优育、提升中华民族整体素质是一致的。王琳认为,罕见病药物应尽量多地纳入医保目录,为罕见病家庭分担经济压力,这是值得探讨的问题。她认为,建立政府主导的罕见病用药多方共付机制尤为迫切,要破解罕见病立法难题,同时建立罕见病中国数据库。据了解,近年来,中国罕见病事业的发展,给药品企业带来了机遇,也使其面临挑战。药品审评审批流程的优化和改革,大大缩短了罕见病药物上市的窗口期。企业的努力提高了罕见病患者的用药保障。采访中,多位专家均表示,企业在谋发展过程中,要坚持经济效益和社会效益并重。据悉,多数罕见病高值药依赖进口,价格昂贵。企业要合理降低患者用药成本,才能提高药物在罕见病患者中的可及性,加大罕见病药物自主研发。(苏亦瑜)

    (责任编辑:安谷)

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