4+7大降价,药品如何保证质量和供应?国家医保局和企业都回应了

2018-12-13 佚名 赛柏蓝

12月9日晚间,央视财经频道详细报道了国家组织药品集中采购。报道中,医保局相关领导对药品降价相关情况及企业的盈利空间作出回应。

12月9日晚间,央视财经频道详细报道了国家组织药品集中采购。报道中,医保局相关领导对药品降价相关情况及企业的盈利空间作出回应。

药品降价,空间足够大

据央视财经报道,试点的11个城市带量采购有25个药品拟中选,与这些试点城市去年同种药品的最低采购价格相比,拟中选价格平均降幅达到52%,最高的降幅更是在96%左右。

据了解,此次将11个试点城市公立医疗机构分散的药品采购量集中起来,形成规模团购效应,以量换价,明显降低药价,切实减轻患者药费负担,也有利于减少企业的跨区域市场推广成本。

国家医保局药价和招采司副司长丁一磊表示,经济学上的规模经济效应,量大,单品的生产成本就会降低。过去药品在终端进入医院使用的这个环节,还存在一定的灰色的空间,由于这次带量采购是保供,企业不需要灰色空间也能保证销量,这也是降价空间的来源。

他表示,过去药品回款平均周期是三个月到半年,有的甚至超过一年,大家都知道,企业如果到资本市场上,这些资金通过银行贷款,其一年贷款利率还是比较高的,通过及时回款的保障,其实是降低了企业的融资成本,这也将最终传导到终端的药价上来。

价格降幅高达95%

以正大天晴公司生产的恩替卡韦分散片0.5mg为例,其拟中选价为0.62元/片,降幅达到95%以上,让业界瞬间哗然。同时,恩替卡韦还有一家报价0.57元/粒,却没有中标,也成为舆论的焦点。

根据《4+7城市药品集中采购文件》规定,申报企业须按主品规的最小采购单元(即最小零售包装,如盒)进行报价,同企业同品种申报价须符合差比价规则。申报企业须同时提供中选后符合申报条件的品种清单,采购价以主品规报价为基数经差比价规则计算后确定。

同时,规定同品种符合申报条件的企业数≥2 家的,最低报价只有 1 家企业的,该企业的申报品种获得预中选资格。

可以说,文件是明确提到差比价的情况,以及最低报价中标的问题。

因此,就绝对值来说,肯定是0.57<0.62,但是它们的剂型一个是胶囊,一个是分散片,那就需要差比价计算。按照差比价规则,片剂、胶囊、分散片三者关系为1:1:1.2,将分散片换算成胶囊的价格为 0.52元/片,因此正大天晴相对低价胜出,是完全符合规定的。

据了解,正大天晴的恩替卡韦是2010年上市的,上市后经过多年的学术推广,深得医生和患者的认同,目前市场占有率超过50%。企业不但收回了高额的研发成本,也获取了一定的利润,且经过多年的持续经营,前期投入逐步摊销,技术日臻成熟,制造成本有所降低。

对于最终报出远低于目前市场销售价格的竞标价,正大天晴表示,这是经过缜密研究和反复测算,决定降低价格,最大幅度地让利患者、回馈社会。此外,力争中标也是为了保持多年来公司在肝病领域确立的领导者地位,为患者持续提供质量可靠、价格低廉的药品。

原研替代实现了

在本次11城市带量采购的拟中选结果中,只有两家跨国企业,阿斯利康的吉非替尼片和施贵宝的福辛普利钠片,价格降幅分别为76%和68%。

据央视财经报道,吉非替尼和福辛普利钠的价格,相比周边国家和地区降低了25%以上。这么看,确实在一定程度上体现了原研药降价。

然而,也有业内专家对赛柏蓝表示,本次带量采购,25个产品拟中选,跨国药企的原研药只有两个,从目前的情况看,成功把原研厂家挤了出去,基本上实现了通过一致性评价仿制药替代原研,但是,却没有实现原研药降价。

如何保证产能和质量

事实上,这次国家组织药品集中采购的11个试点城市,大概已经占到了全国1/3的药品市场,面对这么大的需求量,中标企业是否能够及时提供药品,药品的质量又将如何保证?

国家医保局相关负责人表示,在中选结果执行中,国家药监局等多部门将采取有力措施,保障中选药品的质量和供应,加强对重点品种生产流通使用全周期的质量监管,提高抽检频次,加大对违法违规企业追责力度。

此外还要求企业建立库存和停产报告制度,通过协议规范配送行为,确保供应稳定。

对于中标后的产能供应和质量保证这个问题,纵观所有中标的品种,大多都已经早有准备。

以正大天晴为例,公司有完善的质量保证和质量体系,多条生产线已经通过欧盟或美国FDA的认证,同时,恩替卡韦所有原料均由公司自行生产,现有恩替卡韦生产线的产能完全可以供应全国市场,而且质量可控。正大天晴方也曾表示,企业有能力保障药品的全国供应,不断货,且做到降价不降质,为患者提供质量一流、价格低廉的好产品。

正大天晴已经建成并投入使用的正大天晴海州制剂新区,按照中国新版GMP和美国、欧盟GMP标准设计建设,充分采用当今国内外先进的制药技术、工艺和装备,体现了“新、特、精”,达到“国内领先、世界一流”水平,为正大天晴制剂产品通过国内新版GMP认证,以及进入国际高端市场提供了充分保证。正大天晴参照国际最新科技的设计理念,最大程度地保证了产品质量的稳定性,大幅提升了生产效率。

不仅仅在生产环节,正大天晴的检验中心近年来更是陆续添置了由德国、日本和美国等国家进口的高效液相色谱仪、气相色谱仪和原子吸收光谱仪。确保正大天晴连续多年产品出厂合格率100%,抽检合格率100% 。

企业研发创新受影响吗?

如今,原料药涨价问题严重,加上一致性评价的投入成本,企业的成本也在大幅上升,如今药价大幅度下降,会不会使企业的发展受阻?

据央视财经报道,拟中选企业代表表示,国家药品集中采购是一次重大变革,倒逼企业尽快转型,走创新药物的道路和仿制药品牌化的道路。

对于本次带量采购中标的仿制药企业而言,除了保证质量和产能,很重要的一点,在中标产品价格下降的情况下,仍要继续保持创新。例如正大天晴,虽然恩替卡韦分散片的价格下降,短期内收入和利润会大幅缩减,但这不影响其创新,公司仍将继续保持不低于年销售收入10%的研发费用投入,坚持产品研发创新。

中国药科大学教授丁锦希表示,此次集中带量采购,对整个医药产业的影响是里程碑式的,也是分水岭式的。他认为,甚至可以把它提高到这样一个高度,就是国家发出了一个非常强烈的信号——中国逐渐从医药大国走向医药强国。

而在这条道路上,国内企业的创新,尤为重要。

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    2018-12-15 30397605
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    2018-12-15 hyf030
  5. [GetPortalCommentsPageByObjectIdResponse(id=1280451, encodeId=a81a128045191, content=<a href='/topic/show?id=1bd3338451e' target=_blank style='color:#2F92EE;'>#医保局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33845, encryptionId=1bd3338451e, topicName=医保局)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=医者仁心, createdTime=Sat Dec 15 02:27:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1398771, encodeId=9bfd1398e71e0, content=<a href='/topic/show?id=794413168f' target=_blank style='color:#2F92EE;'>#4+7#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1316, encryptionId=794413168f, topicName=4+7)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/D2FD7704B41C9E22364B1E54ABB223BB/100, createdBy=1df22500220, createdName=ms1260584454294838, createdTime=Sat Dec 15 02:27:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425067, encodeId=d051142506e91, content=<a href='/topic/show?id=c1219810ebf' target=_blank style='color:#2F92EE;'>#降价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98107, encryptionId=c1219810ebf, topicName=降价)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d6933946754, createdName=30397605, createdTime=Sat Dec 15 02:27:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1456213, encodeId=a71d145621318, content=<a href='/topic/show?id=3cdb2563088' target=_blank style='color:#2F92EE;'>#企业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25630, encryptionId=3cdb2563088, topicName=企业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a765759005, createdName=hyf030, createdTime=Sat Dec 15 02:27:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1497209, encodeId=bc2f149e2099e, content=<a href='/topic/show?id=82b440848a4' target=_blank style='color:#2F92EE;'>#国家医保局#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40848, encryptionId=82b440848a4, topicName=国家医保局)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=82569313637, createdName=雕雕, createdTime=Sat Dec 15 02:27:00 CST 2018, time=2018-12-15, status=1, ipAttribution=)]