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药品也跨界:罗氏癌症药物Avastin能治疗眼疾

2015-2-28 作者:佚名   来源:生物谷 我要评论0
Tags: 癌症  贝伐单抗  黄斑变性  


英国一些有影响力的临床医生最近向国家卫生署(NHS)提出申请:将罗氏公司的癌症药物Avastin阿瓦斯丁(即贝伐单抗)用于衰退性眼障碍疾病,比如湿性年龄相关黄斑变性(AMD)。因为他们在临床工作中发现了该药物对黄斑变性的显着疗效,同时该药的成本效益价值较高。

来自120家临床试验委托机构的医生联名对国家卫生署施压,希望能取缔现在对Avastin的处方限制。因为该药除了能治疗癌症,还可以治疗湿性年龄相关黄斑变性。如果此愿望能够实现,就能每年为国家卫生署节省15,800万美元,这节省下来的资金就可以用于其他医疗设施的完善。

国家卫生署临床研究委员会副主席Amanda Doyle博士说道:“作为一名临床医生,我看到了随着社会的老龄化,越来越多的人患上了眼部慢性疾病;作为一名委员,我有责任把每个英镑花到刀刃上”。罗氏的Avastin虽然是以癌症药物的名义上市的,并未经批准用于眼疾的治疗,但是在实际应用中,医生会给黄斑变性的患者介绍使用此药。Avastin与罗氏旗下治疗眼底新生血管疾病的Lucentis(兰尼单抗)的机理类似——抑制视网膜上异常血管的增生。Lucentis是罗氏和诺华联合销售的,在美国以及欧洲都已上市,说明书上明确标示着可以治疗黄斑变性,但价格较Avastin贵一些,每个剂量大约700法郎,而后者只需60法郎。拜耳以及再生元制药公司联合推出的Eylea(阿柏西普)也是另一种经批准治疗上述眼疾的药物,每个剂量大约816法郎。因此,Avastin多么物美价廉啊!

罗氏和诺华对Avastin治疗眼疾并不赞成,他们说Avastin和Lucentis各有所长,Lucentis对于治疗眼疾更安全。

国家卫生署以及相关监管部门正在进行各种调查,尽量满足这些医生的申请,但他们并没有最终的决定权,除非Avastin的制造商递交相关申请资料,但到目前为止,罗氏似乎并无这方面的行动迹象。这倒也合乎情理,要想将Avastin用于黄斑变性的治疗,只能再次进行相关的临床试验,这是必须的,而这必然耗时耗力。

医学总会(GMC)行政长官Niall Dickson说:“我们的法规明确规定,对国家卫生署的所有资源必须高效利用。Avastin对于治疗黄斑变性的这一方案实在需要慎重考虑。如果仅仅是简单的法规问题,修改法规就能使这种疗效好、价格低同时又安全的药物获批的话,我们何乐而不为呢!” 目前看来,临床上将Avastin作为处方药治疗黄斑变性的希望还很渺茫。

英文原文:

UK Doctors Push NHS To Use Roche Holding Ltd. (ADR) Avastin For Wet AMD

A group of leading doctors in the UK are calling on NHS for off-label use of Roche’s cancer drug Avastin for the treatment of wet age-related macular degeneration

A group of leading doctors in the UK recently called on the National Health Service (NHS) to go for off-label use of Roche Holding Ltd. (ADR)’s (OTCMKTS:RHHBY) cancer drug Avastin (bevacizumab) for the treatment of patients suffering from a debilitating eye disorder, on the back of the significant clinical as well as cost benefits that the drug offers.

Influential doctors from 120 clinical commissioning groups pushed NHS to eradicate the “current barriers” that have been inhibiting them from prescribing Roche’s Avastin off-label, for treating patients with wet age-related macular degeneration (AMD). These doctors remained adamant that their demand, if fulfilled, could lead to almost £102 million, or $158 million, in yearly savings for NHS, which could then be reinvested in focusing on providing other effective patient services.

Dr. Amanda Doyle, co-chair of NHS Clinical Commissioners, commented: "As clinicians, we are seeing an increase in the incidence of this chronic eye condition due to an aging population, and as commissioners we have a responsibility to ensure that every pound spent is done so to the best effect."

Roche’s Avastin, although not licensed for the eye disease and actually a cancer medicine, is still being used off-label for treating wet AMD, as it works in the same way as Roche’s Lucentis by inhibiting growth of abnormal blood vessels in the retina. Lucentis (ranibizumab), sold inside the US by Roche while marketed in Europe by Novartis AG (ADR) (NYSE:NVS), has been approved for treating wet AMD, but due to its higher price than Avastin, it has fast been losing its market share. Avastin costs only £60 per dose, while Roche’s Lucentis is priced at almost £700, making it an expensive option for wet AMD patients.

Bayer/ Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Eylea, another drug approved for the said eye disease, costs around £816 for each dose; Avastin, therefore, is a cheaper treatment option compared to both Lucentis and Eylea.

Novartis and Roche have been opposing the off-label use of Avastin against wet AMD since long, saying that both Lucentis and Avastin have been approved for different indications and Lucentis has been proved to be a much safer treatment option than Avastin.

NHS and other regulatory authorities are looking into complying with the demand of the doctors to remove the barriers that prevent them from prescribing Avastin as an off-label treatment option for wet AMD, but they do not have much power to push for a final approval of Avastin as a treatment option for wet AMD; the final approval can only come if the original manufacturer of the drug submits an application for the purpose. Roche, on the other hand, has no plans to apply for a license for Avastin for wet AMD, a move which would require the company to spend a significant amount of time and assets in carrying out the required trials.

Niall Dickson, chief executive of the General Medical Council (GMC), said: “As our guidance makes clear, we support the efficient use of NHS resources and we are sympathetic to the argument that a better solution needs to be found for the use of Avastin in the treatment of wet age-related macular degeneration (AMD).If it were simply a matter of changing GMC guidance to allow doctors to prescribe a cheaper but equally safe alternative medicine, we would do it."

The National Institute for Health and Care Excellence (NICE), the cost watchdog which has the responsibility to analyze the cost effectiveness of various drugs used by NHS, can only recommend those drugs which have already won regulatory approval; Avastin’s chances to be approved for the treatment of wet AMD, so far, seem very dim.

 



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