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德国FJC扩大药品审查——拜耳、安进将面临药品降价

  1. 安进
  2. 拜耳
  3. 药品审查

来源:生物谷 2013-04-22 12:03

2013年4月18日讯 /生物谷BIOON/ --德国联邦联合委员会(Federal Joint Committee,FJC)将对已上市药品开展一项更全面的成本效益审查(costs and benefits review)。

2013年4月18日讯 /生物谷BIOON/ --德国联邦联合委员会(Federal Joint Committee,FJC)将对已上市药品开展一项更全面的成本效益审查(costs and benefits review)。在今日召开的会议中,FJC决定将拜耳(Bayer)血液稀释剂拜瑞妥(Xarelto)、安进(Amgen)骨质疏松症药物Prolia、Gruenenthal制药和强生(JNJ)的止痛药(如Nucynta)纳入药品审查范围。该审查同时也将涵括同一类别下的其他治疗药物,这意味着也将对勃林格殷格翰(Boehringer Ingelheim)的血液稀释剂Pradaxa进行评估。

此次审查中,药品的成本-效益分析只是第一步,最终结果可能会导致药价的下降。

每个药品的成本-效益评估结果,将成为制药公司与德国法定保险人(Germany’s statutory insurers)之间价格谈判的基础。

拜耳在此前的一份电子邮件声明中称,已经料到Xarelto会被要求进行成本-效益分析,同时也已做好了准备,但拒绝透露更多的细节。勃林格殷格翰发言人Reinhard Malin称,公司对Pradaxa的效益审查非常有信心。安进、Gruenenthal、强生发言人未立即发表评论。(生物谷bioon.com)

英文原文:

Bayer, Amgen Face Price Cuts as German Panel Expands Drug Review

By Naomi Kresge - 2013-04-18T13:57:36Z

Bayer AG (BAYN) and Amgen Inc. (AMGN) are among drugmakers who may face price cuts as a German agency begins a broader review of the costs and benefits of medicines already on the market.

Bayer’s blood thinner Xarelto, Amgen’s Prolia for osteoporosis and painkillers like Nucynta from Gruenenthal Pharma GmbH and Johnson & Johnson (JNJ) are among the targeted products, the Federal Joint Committee decided in a meeting today. The review encompasses other treatments in the same category as each of those medicines, meaning that Boehringer Ingelheim GmbH’s blood thinner Pradaxa will also be assessed.

The analysis is the first step down a path that may end in price cuts. The results of each cost-benefit assessment will form a basis for price negotiations between drugmakers and Germany’s statutory insurers, part of a law passed in November 2010 as Chancellor Angela Merkel’s government sought to save more than 2.2 billion euros ($2.87 billion) in spending on medicines.

Though price talks on newly introduced drugs started in 2011, this is the first time the agency has laid out broad plans to target medicines that were on the market before then, Kai Fortelka, an agency spokesman, said in a telephone interview before the meeting.

Bayer had expected Xarelto to be called up for a cost- benefit analysis, and had prepared, the Leverkusen, Germany- based drugmaker said in an e-mailed statement. Bayer declined to comment in more detail until the analysis is finished.

Boehringer spokesman Reinhard Malin said that the Ingelheim, Germany-based company had expected the review, and that it was confident that Pradaxa’s benefits would be shown.

Spokespeople for Amgen, Gruenenthal and J&J weren’t immediately available for comment.

The Federal Joint Committee is scheduled to hold a press conference about the price review today at 4 p.m. in Berlin.

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