NHS England sees off AbbVie's Hep C legal challenge
Claims of unfair process dismissed by High Court
NHS England has claimed a victory after a legal challenge by AbbVie was rejected by the High Court, and says plans to eliminate hepatitis C by 2025 are back on track.
The court victory - and NHS England's reaction to it - reflect its growing confidence in its use of tough negotiations and procurement to drive down drug prices and strike access deals with pharma.
AbbVie is one of several companies to market the new class of hepatitis C (HCV) treatments known as Maviret (glecaprevir/pibrentasvir), which can cure patients of the serious blood infection. Maviret is in contention with rival treatments such as Gilead’s Sovaldi, Harvoni and Epclusa, to name a few.
NHS England had initially been slow in its uptake of these new curative treatments, but then last year declared it would aim to be the first country in the world to eliminate HCV, with a target date of 2025, and spending £1bn over five years to achieve this goal.
However, in order to make this £1bn stretch to treat millions of HCV patients, NHS England aimed to achieve this via its largest ever procurement process – and called on pharma companies to offer unprecedented discounts to their prices.
This is said to involve cutting prices for a course of treatment from £35,000 to just £10,000 in return for an initial three year supply contract, with an option to extend by a further two years.
AbbVie accused NHS England of not treating all bidders fairly, however, and took its case to the High Court in November.
But on Friday NHS England announced it had seen off AbbVie’s challenge, issuing a triumphant press release which detailed how the judge had dismissed the case on all counts.
It was also critical of AbbVie’s challenge, saying it had caused an unnecessary six month delay to the start of the HCV elimination programme.

NHS England's John Stewart
John Stewart, director of specialised commissioning at NHS England, said: “Court cases such as this are a waste of NHS resources and taxpayers’ money, in this case resulting in an unavoidable delay in our efforts to tackle the threat of Hepatitis C, which disproportionately affects some of the most vulnerable and marginalised people in society.
“We remain committed to driving best value to help eliminate Hepatitis C in England by 2025 or sooner, and with this court case behind us, we can now get on with the job.”
More than 32,000 patients with HCV have been treated so far with around 95% being cured of the disease in England. The plans to eliminate the disease by 2025 would put England five years head of the goals proposed by the World Health Organisation.
NHS England also took the opportunity to underline how the Hep C procurement is part of a broader exercising of its purchasing muscle – what it calls a series of ‘smart deals’ to help the NHS provide value for the taxpayer and benefits patients.
Among these is another procurement drive where AbbVie has lost out – the recent launch of biosimilar versions of its inflammation blockbuster Humira (adalimumab).
NHS England says it will save £300m by negotiating deals with five manufacturers on low cost versions of adalimumab, which has been the single biggest drug cost for the health service for some time. AbbVie was critical of NHS England for declaring in October it would make savings from the tendering process – as negotiations were still ongoing at the time.
Within weeks however, the company had agreed an ‘interim commercial offer’. It says it believes patients who are stable on their biologic medicine should not be switched to another product for ‘non medical reasons’ – but had to also ensure that its Humira was also a ‘best value’ product by cutting its price.
NHS England also pointed to two other deals struck in 2018, which illustrate a combination of fast uptake enabled by tough price negotiations - the first full access deal in Europe for CAR-T therapy (Gilead/Kite’s Yescarta and Novartis’ Kymriah) and a deal to make the MSD’s groundbreaking Keytruda available for routine use for lung cancer patients on the NHS.
2019 will see at least one more high stakes and contentious court case reach its conclusion - Bayer and Novartis are appealing against a court ruling to allow Avastin to be prescribed off-licence in wet age-related macular degeneration.
英国国家医疗服务体系 (NHS England) 在艾伯维 (AbbVie) 的一项法律质疑被高等法院驳回后宣告胜利,并表示到 2025 年消除丙肝的计划重新走上正轨。法院的胜利——以及英国 NHS 对它的反应——反映出它越来越有信心利用艰难的谈判和采购来压低药价,并与 pharma 达成准入协议。艾伯维 (AbbVie) 是数家将新型丙肝治疗药物 Maviret (glecaprevir/pibrentasvir) 推向市场的公司之一,该药可以治愈严重血液感染患者。Maviret 正与吉利德的 Sovaldi、Harvoni 和 Epclusa 等竞争对手展开竞争,仅举几例。英国国民保健服务 (NHS England) 起初对这些新的治愈性治疗方法的吸收速度很慢,但随后于去年宣布,它将致力于成为世界上第一个消灭 HCV 的国家,目标日期为 2025 年,并在 5 年内花费 10 亿英镑来实现这一目标。然而,为了使这一 10 亿英镑的拉伸治疗数百万 HCV 患者,英国国民健康服务体系 (NHS England) 旨在通过其有史以来最大的采购流程实现这一目标——并呼吁制药公司为其价格提供前所未有的折扣。据说,这涉及将一个疗程的价格从 35 000 英镑减至 10 000 英镑,以换取最初的三年供应合同,并可选择再延长两年。然而,AbbVie 指责英国 NHS 不公平对待所有竞标者,并在 11 月向高等法院提起诉讼。但在星期五,英国国民健康服务体系 (NHS England) 宣布取消了 AbbVie 的挑战,发布了一份胜利的新闻稿,详细介绍了法官在所有方面如何驳回此案。它也批评了 AbbVie 的挑战,说它导致了 HCV 清除计划开始不必要的 6 个月的延迟。英国 NHS 英格兰的 John Stewart John Stewart,NHS 英格兰专业调试主任说:“像这样的法庭案件是对 NHS 资源和纳税人资金的浪费,在这种情况下导致我们努力应对丙肝威胁的工作不可避免的延误,丙肝不成比例地影响到社会上一些最脆弱和边缘化的人群。“我们仍然致力于在 2025 年或更早的时候在英格兰推动消除丙肝的最佳价值,而在我们身后的这个法庭案件中,我们现在可以继续工作了。“到目前为止,已经有超过 3.2 万名 HCV 患者接受了治疗,其中约 95% 的患者在英格兰被治愈。到 2025 年消灭这种疾病的计划将使英格兰成为世界卫生组织提出的五年目标的领头羊。英国国民健康服务体系 (NHS England) 也借此机会强调,丙肝药物采购是如何在更大范围内发挥其采购力量的一部分——它称之为一系列“聪明的交易”,以帮助 NHS 为纳税人提供价值并使患者受益。其中包括 AbbVie 公司的另一项采购活动——最近推出的炎症重磅炸弹 Humira(阿达木单抗)的生物仿制药版本。英国国民保健服务表示,通过与 5 家制造商就低成本阿达木单抗进行谈判,将节省 3 亿英镑。阿达木单抗一段时间以来一直是医疗服务的最大药物成本。艾伯维批评英国国民健康服务体系 (NHS England) 在 10 月份宣布将从招标过程中节省资金——因为当时谈判仍在进行中。不过,在几周内,该公司已同意了一项“临时商业要约”。该公司表示,它认为那些服用生物制剂后病情稳定的患者不应该因为“非医疗原因”而改用另一种产品——但也必须通过降价来确保其 Humira 也是“最值钱”的产品。NHS England 还指出了 2018 年达成的另外两笔交易,这些交易说明了艰难的价格谈判所带来的快速吸收的结合——CAR-T 疗法在欧洲的首个完全准入交易(吉利德/Kite 的 Yescarta 和诺华的 Kymriah),以及一项使 MSD 的开创性 Keytruda 可用于 NHS 上肺癌患者的常规用药的交易。2019 年将会看到至少一个更多高风险和有争议的法庭案件得出结论——拜耳和诺华正在上诉法院裁决允许阿瓦斯汀在湿性年龄相关性黄斑变性中被取消许可。
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