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英国管理部门批准将吉利德丙肝畅销药加入英国国家医疗服务体系

来源:生物谷 2014-08-18 09:17

2014年8月18日讯 /生物谷BIOON/ --在经过慎重考虑和综合评价后,英国国家健康和护理研究中心(National Institute for Health and Care Excellence, NICE)原则性批准吉利德公司治疗丙肝特效药物Sovaldi加入英国国家医疗服务体系。吉利德公司表示,NICE将在今年9月份进行最终讨论并于今年晚些时候做出最终决定。这也意味着英国患有慢性丙肝的患者将有望在医疗体系保障的范围内使用这一价格高昂的药物。此前,英国相关管理部门就曾诟病这一药物过于高昂的价格并质疑其是否物有所值。现在看来,吉利德公司又一次取得了胜利。英国有着世界上最为严格的医药审查体系,这也是为什么英国NICE的决定会影响到其他国家对药物审批的态度。

最近吉利德公司可谓是喜事不断,不久前欧盟议会医药管理部门也表态转而支持吉利德公司的Sovaldi。目前再由法国牵头14个国家的医药部门正在与吉利德公司进行商谈,以确定Sovaldi在本国销售的合理价格。目前吉利德公司在英国销售的价格约为57000美元,比在美国市场的价格低了3万美元之多。此外,不久前美国仲裁委员会驳回了罗氏对Sovaldi的版权主张,这也意味着未来相当长的一段时间里,吉利德公司将凭借Sovaldi在丙肝市场上占据统治地位。(生物谷Bioon.com)

详细英文报道:

The U.K.'s National Institute for Health and Care Excellence held up a stop sign when Gilead Sciences came calling with its next-gen hepatitis C drug Sovaldi. No question it works, the cost-effectiveness gatekeepers said. It just might cost too much.

That, in essence, is what payers in the U.S. and Europe have been saying ever since Sovaldi (sofosbuvir) hit their respective markets. But as Gilead's ($GILD) multibillion-dollar sales figures show, insurers and government payers are covering the highly effective--but highly pricey--hep C treatment.

Now, if NICE's latest coverage proposal goes through, the U.K.'s National Health Service will officially be one of them.

The agency issued provisional guidance today, backing Sovaldi as part of two different combo cocktails for "the majority of adult patients" with chronic hepatitis C, Gilead said in a statement. It's a quick turnabout for the agency, which will consider the drug at a committee meeting in September, with final guidance expected later this year.

"We are pleased that, following a very complex assessment, NICE have recognized the clinical and economic benefit of treatment with sofosbuvir and have determined it is a valuable use of NHS resources for the majority of hepatitis C patients," Stelios Karagiannoglou, Gilead's general manager in the U.K., said in a statement. "Given the high unmet need in this area, we will be working with NICE and other stakeholders to ensure hepatitis C patients are able to benefit from the treatment as quickly as possible."

In June, NICE took issue with Gilead's data in patients with particular subtypes of HCV, and criticized the company's cost analysis. Apparently, the company was able to work out many of those differences. Whether the proposed guidance includes a new patient access scheme--a.k.a. price break--wasn't clear in Gilead's announcement, but would be mentioned in any NICE statement about the decision.

The U.K. gatekeeper's decisions are always closely watched, with many countries following its lead in accepting or rejecting treatments. This one could draw an even brighter spotlight, as insurers and government payers around the world consider what to do about Sovaldi. U.S. payers have been unprecedentedly vocal about their Sovaldi quandary.

Like NICE, the private insurers recognize Sovaldi's effectiveness, but worry that the high price and high numbers of patients eligible for treatment will hack away their profits--and trigger unpopular premium hikes. Pharmacy benefits managers and Medicaid contractors have been trying to control Sovaldi spending by restricting access to the sickest patients, persuading doctors to warehouse others till competitors hit the market, even refusing coverage to recovering opioid addicts.

Meanwhile, EU governments are no more anxious to pay top dollar for Sovaldi. France's health minister recently said that 14 countries have decided to work together in negotiating prices for the Gilead drug.

Any payers interested in NICE's choice should check out the documentation that comes along with the September committee meeting and associated appraisals. One pertinent fact that wasn't included in Friday's announcement from Gilead: Even without an additional discount, the company has already offered Sovaldi to the NHS for a lower cost: $57,000, almost $30,000 less than the sticker price in the States.

相关阅读:

群虎噬龙!多家公司要求分享吉利德抗丙肝药物Sovaldi

 

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