国家集采设置“隐藏关”:分适应症报量采购,政策执行精细化

2022-06-28 烟酰胺 健识局

按不同适应症来进行部分集采,是第七批集采的一大亮点,也是进行“科学集采”的一种尝试,国家集采就此开启了一个新阶段。

第七批国家集采,行业嗅到了一丝不一样的气味。

根据6月20日国家联采办发布的公告,第七批集采涉及59个品种、208个品规,奥美拉唑注射剂、头孢美唑、伊利替康等多个亿元份额产品位列其中。

今年2月,集采启动前,国家医保局陈金甫副局长就曾在政策吹风会上表示,要针对特定品种以及竞争格局来设置药品带量采购竞价规则,比如竞价规则、带量比例、协议期多少,“谁来报量、谁来选量,都要针对品种进行精细化设计。”

这番表述已然落地。健识局发现,第七批集采中已经出现了针对“特定品种”的“精细化”报量和采购设计。

健识局独家获得一份文件显示,今年2月,国家组织药品联采办曾发布通知,要求针对吗替麦考酚酯这个品种组织按适应症报量。而在实际的第七批集采中,这一品种的拟采购量,已经体现出了“按适应症集采”的指导原则。

这是一个从0到1的创新:全国集采第一次按照“科学报量、科学选定采购量”的原则选择品种,未来很有可能在更多品种上进行推广。

图片

分适应症报量

国家集采自从2018年11月启动试点以来,企业参与积极,各项规则日趋完善。尤其是普通常见药集采逐步完成后,集采的重点开始转向专科、特殊用药,遇到的问题也就会更多。

第七批集采中选原则的最大变化是,除了满足“最低价1.8倍”、降幅50%以上等条件之外,还增加了一条非常复杂的原则,简单来说就是:最高价的6个品种,即使符合降价条件,也不再纳入集采范围。

这一原则非常直接地表明:国家集采正在试图平衡各品种之间的价差,尽量给各省份价格较接近的药。

此前,集采完成后,各品种按照分配到的省份供货,导致各省之间药品品牌不同,价格会有差异。从规则来看,价差最大可能达到1.8倍。这显然不符合公平性的原则。

第七批集采对这一不公平现象作了修正,“贴着线”降价的品种可能就不能参与集采了。

在尽量压低价格、平衡各省支付的情况下,集采也给一些品种留有了空间。

今年2月份,一份由国家组织药品联合采购办公室发出的名为《关于报送吗替麦考酚酯相关采购数据的通知》的文件在业内流传。联采办表示“系统已退回提交采购需求的医疗机构数据”,要求各机构按照新要求重新报量。

这在集采历史上是很罕见的、针对单品发出的重新报量通知。

吗替麦考酚酯是第七批集采的拟采购品种,联采办在1月份时候就已经让各地上报该药0.25g和0.5g两种规格的采购量。但在2月份,却另外下文重报数据,其中另有玄机。

吗替麦考酚酯是一种免疫抑制剂,常被用于器官移植排异,同时还可作为糖皮质激素助减剂,用于治疗免疫性疾病,如系统性红斑狼疮等。两类用药的对象和数量完全不同,据行业相关人士透露:国内的吗替麦考酚酯大概80%用于器官移植患者,剩下20%用于其他疾病患者。

重报数据后,联采办要求按器官移植和非器官移植两类用途分别报量。当时业界就判断:医保局此举可能是为了区分不同适应症的用药,进行“定向集采”。

最终披露的吗替麦考酚酯拟采购量显示:医保局在第七批集采中首次尝试了“按适应症”集采的新模式。

 

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只采全国总量20%-25%

吗替麦考酚酯首度尝试差异化报量,和药物背后患者群体特殊性有关。

据米内网数据,2019年时,中国公立医疗机构终端售出的吗替麦考酚酯超30亿元。罗氏和中美华东制药两大玩家抢占了大份额市场,其中罗氏的份额为60.7%,中美华东制药占比约34.4%。

大部分器官移植患者依靠吗替麦考酚酯抵御排异反应,可能需要终身服药。而且,这款药有个非常特殊的地方:FDA、欧洲移植协会、加拿大Drug bank、上海医药行业协会等行业知名机构都将吗替麦考酚酯都被列入“窄治疗指数药物”。

窄治疗指数,是指用药剂量或血药浓度一旦出现小的差异,就可能导致严重治疗失败或严重不良反应。2018年,日本进行了试验,5例器官移植患者在身体机能平稳后,用仿制的吗替麦考酚酯替代原研药,结果4例发生了血药浓度水平不稳定的现象。

国内企业中,海正、中美华东、先声等企业都有吗替麦考酚酯的仿制品种,且通过了一致性评价。但国际移植协会等多个权威指南都明确:不宜进行不同品牌药物的转换。也就是说,患者不能轻易换药。

类似的状况其实在以前批次的集采中也发生过。如阿卡波糖、氯吡格雷等慢性病用药在纳入集采范围后,原研药物有落选,有的只在部分省份供货,不少慢性病患者都反映遭遇换药后不适应的问题。

但是,“窄治疗指数药物”吗替麦考酚酯如果换药,后果可能不止是“不舒服”。

因此,第七批集采虽然纳入了吗替麦考酚酯,但国家医保局通过区分适应症科学报量,更贴合市场实际使用情况。

图片

大致推算,集采涉及的市场份额在7亿元左右。这一金额正是吗替麦考酚酯市场总额的20%-25%,对应的正是免疫性疾病的非移植用药部分。

医保局考虑的,正是患者的换药风险,也实践了陈金甫提出的“针对品种进行精细化设计”的集采原则。

按不同适应症来进行部分集采,是第七批集采的一大亮点,也是进行“科学集采”的一种尝试,国家集采就此开启了一个新阶段。

撰稿|烟酰胺

辑|江芸 贾亭

运营 | 莫羽汐

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    2022-10-16 xsm929
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1971255, encodeId=da8619e125528, content=<a href='/topic/show?id=3f2ce6594e4' target=_blank style='color:#2F92EE;'>#精细化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76594, encryptionId=3f2ce6594e4, topicName=精细化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ffd5416, createdName=bettycmoon, createdTime=Sat Feb 11 16:30:06 CST 2023, time=2023-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1735561, encodeId=b9d71e3556188, content=<a href='/topic/show?id=6fe998e4074' target=_blank style='color:#2F92EE;'>#集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98740, encryptionId=6fe998e4074, topicName=集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=969d33912216, createdName=xsm929, createdTime=Sun Oct 16 01:30:06 CST 2022, time=2022-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1634874, encodeId=849f16348e439, content=<a href='/topic/show?id=1bcf40995d8' target=_blank style='color:#2F92EE;'>#国家集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40995, encryptionId=1bcf40995d8, topicName=国家集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a3222313809, createdName=751943081_32627956, createdTime=Thu Feb 23 13:30:06 CST 2023, time=2023-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1260528, encodeId=de6c126052869, content=<a href='/topic/show?id=1ed65e476b8' target=_blank style='color:#2F92EE;'>#政策#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57476, encryptionId=1ed65e476b8, topicName=政策)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=322359, createdName=bioon3, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336879, encodeId=650a13368e9d1, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532941, encodeId=1735153294133, content=<a href='/topic/show?id=88f395665de' target=_blank style='color:#2F92EE;'>#采购#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95665, encryptionId=88f395665de, topicName=采购)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9bb312387914, createdName=wolongzxh, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1229416, encodeId=ef2b122941677, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1aa5476355, createdName=ms8000000287906505, createdTime=Wed Jun 29 11:14:30 CST 2022, time=2022-06-29, status=1, ipAttribution=)]
    2022-06-30 bioon3
  5. [GetPortalCommentsPageByObjectIdResponse(id=1971255, encodeId=da8619e125528, content=<a href='/topic/show?id=3f2ce6594e4' target=_blank style='color:#2F92EE;'>#精细化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76594, encryptionId=3f2ce6594e4, topicName=精细化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ffd5416, createdName=bettycmoon, createdTime=Sat Feb 11 16:30:06 CST 2023, time=2023-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1735561, encodeId=b9d71e3556188, content=<a href='/topic/show?id=6fe998e4074' target=_blank style='color:#2F92EE;'>#集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98740, encryptionId=6fe998e4074, topicName=集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=969d33912216, createdName=xsm929, createdTime=Sun Oct 16 01:30:06 CST 2022, time=2022-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1634874, encodeId=849f16348e439, content=<a href='/topic/show?id=1bcf40995d8' target=_blank style='color:#2F92EE;'>#国家集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40995, encryptionId=1bcf40995d8, topicName=国家集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a3222313809, createdName=751943081_32627956, createdTime=Thu Feb 23 13:30:06 CST 2023, time=2023-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1260528, encodeId=de6c126052869, content=<a href='/topic/show?id=1ed65e476b8' target=_blank style='color:#2F92EE;'>#政策#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57476, encryptionId=1ed65e476b8, topicName=政策)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=322359, createdName=bioon3, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336879, encodeId=650a13368e9d1, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532941, encodeId=1735153294133, content=<a href='/topic/show?id=88f395665de' target=_blank style='color:#2F92EE;'>#采购#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95665, encryptionId=88f395665de, topicName=采购)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9bb312387914, createdName=wolongzxh, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1229416, encodeId=ef2b122941677, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1aa5476355, createdName=ms8000000287906505, createdTime=Wed Jun 29 11:14:30 CST 2022, time=2022-06-29, status=1, ipAttribution=)]
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    2022-06-30 wolongzxh
  7. [GetPortalCommentsPageByObjectIdResponse(id=1971255, encodeId=da8619e125528, content=<a href='/topic/show?id=3f2ce6594e4' target=_blank style='color:#2F92EE;'>#精细化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76594, encryptionId=3f2ce6594e4, topicName=精细化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ffd5416, createdName=bettycmoon, createdTime=Sat Feb 11 16:30:06 CST 2023, time=2023-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1735561, encodeId=b9d71e3556188, content=<a href='/topic/show?id=6fe998e4074' target=_blank style='color:#2F92EE;'>#集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98740, encryptionId=6fe998e4074, topicName=集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=969d33912216, createdName=xsm929, createdTime=Sun Oct 16 01:30:06 CST 2022, time=2022-10-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1634874, encodeId=849f16348e439, content=<a href='/topic/show?id=1bcf40995d8' target=_blank style='color:#2F92EE;'>#国家集采#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40995, encryptionId=1bcf40995d8, topicName=国家集采)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a3222313809, createdName=751943081_32627956, createdTime=Thu Feb 23 13:30:06 CST 2023, time=2023-02-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1260528, encodeId=de6c126052869, content=<a href='/topic/show?id=1ed65e476b8' target=_blank style='color:#2F92EE;'>#政策#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=57476, encryptionId=1ed65e476b8, topicName=政策)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=322359, createdName=bioon3, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336879, encodeId=650a13368e9d1, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1532941, encodeId=1735153294133, content=<a href='/topic/show?id=88f395665de' target=_blank style='color:#2F92EE;'>#采购#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95665, encryptionId=88f395665de, topicName=采购)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9bb312387914, createdName=wolongzxh, createdTime=Thu Jun 30 02:30:06 CST 2022, time=2022-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1229416, encodeId=ef2b122941677, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1aa5476355, createdName=ms8000000287906505, createdTime=Wed Jun 29 11:14:30 CST 2022, time=2022-06-29, status=1, ipAttribution=)]
    2022-06-29 ms8000000287906505

    学习了

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