原研药危机!谈判药、仿制药纳入地方医保

2018-10-19 遥望 赛柏蓝

昨日(10月17日),天津市社保中心发布关于将替格瑞洛片等国家谈判药品仿制药纳入医保支付范围有关问题的通知 。

▍国家谈判药品仿制药进入地方医保

昨日(10月17日),天津市社保中心发布关于将替格瑞洛片等国家谈判药品仿制药纳入医保支付范围有关问题的通知 。



通知明确,自2018年10月18日起,将替格瑞洛片等3个国家谈判药品的仿制药,纳入天津市基本医疗保险、工伤保险和生育保险支付范围。



此前,2018年8月15日,天津市曾发布关于做好谈判药品仿制药医保支付管理有关问题的通知。

通知提到,目前仿制药支付标准暂按其实际市场销售价格执行,但不得超过相应谈判药品的支付标准。仿制药规格与谈判药品不一致的,支付标准参照《国家发展改革委关于印发药品差比价规则的通知》(发改价格〔2011〕2452号)计算。

▍原研药市场份额或被挤占

拿此次纳入天津市医保支付范围的替格瑞洛片来说,替格瑞洛是阿斯利康研发的一种新型的、具有选择性的小分子抗凝血药,是第一个可逆结合、直接起效、口服给药的新型P2Y12受体拮抗剂。

2011年7月获得美国FDA批准上市,商品名为Brilinta。2012年12月阿斯利康的替格瑞洛进入中国市场。据米内网数据,阿斯利康的替格瑞洛在国内已超过5亿元市场规模。

8月2日晚间,深圳信立泰才发布公告称收到了国家药品监督管理局核准签发的替格瑞洛片《药品注册批件》,拿下替格瑞洛片的国内首仿。

10月18日即被纳入了天津市基本医保支付范围。这对阿斯利康一家独大的替格瑞洛片市场无疑将产生影响。

阿斯利康的替格瑞洛片医保支付标准为90mg/片,8.45元,限急性冠脉综合症患者,支付不超过12个月。

深圳信立泰的替格瑞洛片换算成90mg/片医保支付标准是5.99元,也是限急性冠脉综合症患者,支付不超过12个月。

而根据国办政策要求,仿制药与原研药的医保支付标准将逐渐趋近,这无疑将更有利于仿制药的市场表现。

更不用说,截至目前,国内已经有30多家药企提交了替格瑞洛的注册申请,其中16家与相对应的替格瑞洛片获得批准临床,处于审评状态。

▍支付标准暂按仿制药实际市场销售价执行

除天津市外,2018年7月3日,北京市人力社保局发布通知,36种谈判药品的仿制药纳入北京市基本医疗保险、工伤保险和生育保险药品目录乙类药品范围。

通知要求对于支付标准,仿制药规格与谈判药品一致的,支付标准暂按仿制药实际市场销售价格执行,但不得超过相应谈判药品的支付标准;

仿制药规格与谈判药不一致的,支付标准参照《国家发展改革委关于印发药品差比价规则的通知》(发改价格〔2011〕2452号)计算。如计算后的支付标准高于仿制药实际市场销售价格,以仿制药实际市场销售价格为支付标准。

2018年8月21日,陕西省铜川市也发出通知,将国家谈判药品的仿制药纳入基本医疗保险支付范围,按照《国家药品目录》的乙类药品管理。限定支付内容按照人社部发〔2017〕54号文件同类药品规定执行。

▍仿制药进医保将成常态化

2018年9月30日,天津市人民政府办公厅印发关于改革完善仿制药供应保障及使用政策实施方案的通知。

通知称将建立完善我市医保药品目录动态调整机制,并按规定将符合条件的仿制药纳入医保报销范围。

完善仿制药医保报销政策。根据国家医保药品目录管理政策要求,建立完善本市医保药品目录动态调整机制,及时更新医保药品目录,满足临床用药需求。

对本市医保药品目录中的药品,不限定商品名或生产厂家,按规定将符合条件的仿制药纳入医保报销范围。

合理制定医保药品支付标准,逐步实现与原研药质量和疗效一致的仿制药、原研药按相同标准支付,促进仿制药替代使用。

除天津市外,全国不少省市已经先后发布类似通知,跟进落实2018年3月21日国务院办公厅印发的关于改革完善仿制药供应保障及使用政策的意见。

综合来看,目前北京已经将36个谈判药品的仿制药全部纳入北京市医保目录支付范围,天津目前纳入三个。

根据国办文件的要求,不仅如此,还将逐步实现与原研药质量和疗效一致的仿制药、原研药按相同标准支付。

可见,目前谈判药品的仿制药纳入地方医保目录只是一个开端,随着各项条件的成熟,更多的仿制药将实现与原研药同等的医保支付地位,届时原研药受到的影响还将进一步加剧。

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1704391, encodeId=0d421e043910b, content=<a href='/topic/show?id=3be83e20383' target=_blank style='color:#2F92EE;'>#原研药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37203, encryptionId=3be83e20383, topicName=原研药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b9530733134, createdName=shanyongle, createdTime=Mon Jul 22 19:30:00 CST 2019, time=2019-07-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261450, encodeId=3ebe12614507c, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Sat Oct 20 15:30:00 CST 2018, time=2018-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=349842, encodeId=167a34984238, content=了解一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTLbTp9nZtjwVrSZNxAXbAicnKQWnic2eBdJUQYhxO36XdkstSicr7FVF8p5ReH4omtmsbnLdvZLiaJJ1A/132, createdBy=8bff2327056, createdName=kafei, createdTime=Fri Oct 19 15:18:54 CST 2018, time=2018-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=349804, encodeId=9ab234980447, content=了解一下,谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Fri Oct 19 08:28:58 CST 2018, time=2018-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=349784, encodeId=a309349e844b, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Fri Oct 19 06:54:41 CST 2018, time=2018-10-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=349783, encodeId=190d349e8367, content=学习了,谢谢分享。, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Fri Oct 19 06:47:31 CST 2018, time=2018-10-19, status=1, ipAttribution=)]
    2018-10-20 drwjr
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    2018-10-19 kafei

    了解一下谢谢

    0

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    2018-10-19 天地飞扬

    了解一下,谢谢分享!

    0

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    2018-10-19 深海的鱼

    学习学习学习

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    2018-10-19 惠映实验室

    学习了,谢谢分享。

    0

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