NICE shuts down AZ's Tagrisso—and backs a Pfizer rival instead

阿斯利康重磅肺癌药物Tagrisso未能获得英国监管机构支持,因其价格太高

2019-07-09 15:07:00 FiercePharma

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England’s cost watchdogs won’t get behind AstraZeneca blockbuster Tagrisso in previously untreated patients with EGFR-mutated lung cancer. But in a change of events, they’re instead backing a Pfizer challenger. Friday, the National Institute for Health and Care Excellence (NICE) deemed Tagrisso too expensive for routine NHS use, dealing a blow to AZ’s sales ambitions. NICE already endorses Boehringer Ingelheim’s Gilotrif, Roche’s Tarceva and AstraZeneca’s own Iressa, it said (PDF), and while Tagrisso has topped both Tarceva and Iressa in trials, there’s no evidence that it can beat out Gilotrif. While the body sometimes covers a drug under its Cancer Drugs Fund while companies collect more data, NICE shut down that option for the British drugmaker. “It does not have the potential to be cost effective at the price offered,” it said. Tagrisso runs at £5,770 for a pack of 30 tablets, and the confidential discount AZ served up wasn’t enough to sway the gatekeeper. Meanwhile, though, Pfizer can’t say the same. After an initial rejection, NICE came around to support its Vizimpro on Friday, and it made clear that Pfizer’s price break on the drug was responsible for the about-face. Vizimpro, new on the scene after picking up its European green light for first-line patients in early April, has only topped Iressa in the clinic, and “an indirect comparison suggests there is no difference between” it and Gilotrif “in terms of how long people live or how long it is before their disease gets worse,” NICE said (PDF) in final draft guidance. Still, though, “the most plausible cost-effectiveness estimate is within what NICE normally considers an acceptable use of NHS resources,” it wrote. Pfizer, for its part, was pleased with the decision. “We welcome NICE’s decision,” Olivia Ashman, oncology medical director at Pfizer UK, said in a statement, adding that “lung cancer remains a challenging condition to treat and we are pleased that clinicians managing patients with EGFR-mutated NSCLC will now have access to this important medicine.” AstraZeneca, though, likely isn’t too happy with the latest developments—and it wouldn’t be the first time it ran into frustrations with NICE. Back in 2016, it faced a NICE delay on Tagrisso in previously treated patients, and then-U.K. head Lisa Anson said the company was “very disappointed.” “It takes longer for NICE to agree on the same data set that other markets have had and granted access to,” she griped in an interview with The Telegraph.
在以前未治疗的 EGFR 突变肺癌患者中,英国成本监管机构不会支持阿斯利康( AstraZeneca )的重磅炸弹 Tagrisso 。但在一系列事件中,他们反而支持辉瑞(Pfizer)的挑战者。 上周五,美国国家卫生与保健卓越研究所( NICE )认为 Tagrisso 的常规 NHS 使用成本太高,这打击了 AZ 的销售雄心。NICE 已经认可勃林格殷格翰(Boehringer Ingelheim)的 Gilotrif 、罗氏(Roche)的 Tarceva 和阿斯利康(AstraZeneca)自己的 Iressa ( PDF ),虽然 Tagrisso 在试验中都超过了 Tarceva 和 Iressa ,但没有证据表明它能击败 Gilotrif 。 虽然在公司收集更多数据的同时,该机构有时会在其癌症药物基金( CancerDrugFund )下覆盖一种药物,但 NICE 关闭了这家英国制药商的选择。该公司表示:“它不可能以所提供的价格实现成本效益。”Tagrisso 每包30片平板电脑的售价为5770英镑,而 AZ 提供的保密折扣不足以影响看门人。 与此同时,辉瑞(Pfizer)也不能这么说。在最初的拒绝之后, NICE 上周五开始支持其 Vizimpro ,并明确表示辉瑞(Pfizer)制药的价格突破是造成这种局面的原因。 今年4月初, Vizimpro 在一线病人身上拿到了欧洲的绿灯后,刚刚在诊所中超越了 Iressa ,“间接比较表明”它和 Gilotrif “在人们的寿命和疾病恶化之前的时间上没有区别”。NICE 在最终指南草案中表示。 尽管如此,该报告写道,“最合理的成本效益估算仍在 NICE 通常认为可以接受的 NHS 资源使用范围之内。” 辉瑞(Pfizer)对这一决定感到满意。“我们欢迎 NICE 的决定,”辉瑞(Pfizer)英国公司( Pfizer UK )肿瘤医学总监奥利维亚•阿什曼( Olivia Ashman )在一份声明中表示。他补充称,“肺癌仍是治疗的一种具有挑战性的疾病,我们很高兴管理 EGFR 突变非小细胞肺癌(NSCLC)患者的临床医生现在可以使用这一重要药物。” 然而,阿斯利康(AstraZeneca)对最新的发展可能并不太满意,而且这也不会是它第一次遭遇 NICE 的挫折。早在2016年,该公司就曾在之前接受治疗的患者身上遭遇 NICE 的延迟,当时的英国负责人 Lisa Anson 表示,该公司“非常失望”。 她在接受《电讯报》( The Telegraph )采访时抱怨道:“ NICE 需要更长时间才能就其他市场已经获得并允许进入的相同数据集达成一致。”

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