AbbVie's plaque psoriasis hopeful Skyrizi scores nod from NICE

艾伯维重磅药物Skyrizi获英国物价监管机构点头,作为二线药物治疗重度银屑病

2019-07-17 14:04:00 FiercePharma

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With longtime immunology blockbuster Humira on the decline, AbbVie is looking to next-gen competitor Skyrizi to chip in. A nod from England's cost watchdog could help. The National Institute for Health and Care Excellence (NICE) recommended (PDF) Skyrizi as a second-line treatment for severe plaque psoriasis in adults who've failed on conventional treatments such as ciclosporin, methoxotrate and phototherapy. In its final appraisal, NICE said second-line Skyrizi was more effective for plaque psoriasis than Humira and Johnson & Johnson’s Il-12/23 med Stelara and similar in health benefits to J&J’s Tremfya, a head-to-head IL-23 competitor. AbbVie has touted Skyrizi as a cost-effective alternative to its closest immunology rivals. That growing field includes the aging anti-TNF class, IL-23 and IL-12/23 inhibitors, and next-gen IL-17 inhibitors like Novartis’ Cosentyx, Eli Lilly’s Taltz and Bausch Health’s Siliq. That cost edge is one reason Skyrizi rolled out a pricing plan in April to include an $88,500 first-year price on the new med—inclusive of two starter doses—and $59,000 maintenance doses. Alongside a price tag that AbbVie said beats out any other biologic for moderate to severe plaque psoriasis, Skyrizi also benefits from a less onerous dosing regimen with maintenance doses delivered every 12 weeks rather than the industry standard four weeks. Those factors taken together could lead to $3 billion in peak sales, according to SVB Leerink analyst Geoffrey Porges, though AbbVie has offered a $5 billion peak forecast of its own. Skyrizi has not only proven more cost-effective than some of its competitors but has also beaten them in clinical trials. In June, AbbVie released two-year treatment data for Skyrizi showing 72% of patients saw a 100% improvement in skin clearance over placebo. Skyrizi also worked in relapsed patients, with 84% again achieving clear skin after 16 weeks of treatment. With such a strong showing from its newest immunology entry, AbbVie has high hopes that the newer drug can absorb many of the patients—and sales—expected to be lost as Humira and its nearly $20 billion in 2018 revenue falls from that lofty peak. Soon after Skyrizi’s launch in April, AbbVie reportedly began offering 5% to 10% discounts on Humira in an attempt to secure formulary positioning for Skyrizi. Bernstein analyst Ronny Gal said the push for positioning could upset the apple cart with other immunology players and trigger a “pricing war” with payers. Gal said further discounts on Humira could be in the works if the drugmaker’s JAK-1 inhibitor candidate upadacitinib is approved by the FDA. AbbVie has already rolled out massive Humira discounts as high as 89% in Europe after the drug lost its patent protection late last year.
随着长期免疫重磅炸弹 Humira 的下降,艾伯维(AbbVie)正在寻找下一代竞争对手 Skyrizi 芯片。英国成本监管机构的点头可能会有所帮助。 国家卫生和护理卓越研究所( NICE )建议( PDF ) Skyrizi 作为第二线治疗严重斑块型银屑病的成人谁在常规治疗失败,如 cilosporin , methoxotate 和光疗。 NICE 在其最终评估中表示,二线 Skyrizi 对斑块型银屑病的疗效比 Humira 和 Johnson & Johnson's Il-12/23 med Stelara 更为有效,在健康方面也与强生(J&J)& J's Tremfaya 相似,后者是 IL-23竞争对手。 艾伯维(AbbVie)宣称 Skyrizi 是其最接近的免疫学竞争对手的一种经济有效的替代品。这一增长领域包括老化的抗 TNF 类、 IL-23和 IL-12/23抑制剂,以及下一代 IL-17抑制剂,如诺华(Novartis)的 Cosentyx 、礼来(Eli Lilly)的 Taltz 和 Bauch Health 的 Siliq 。 这一成本优势是 Skyrizi 在4月份推出定价计划的原因之一,该计划包括新医疗保险的88,500美元第一年价格(包括两次启动剂量)和59,000美元维修剂量。 除了艾伯维(AbbVie)所说的价格外, Skyrizi 还受益于一种不那么繁琐的给药养生法,每12周提供一次维持剂量,而不是行业标准的4周。据 SVB Leerink 分析师杰弗里?波格斯( Geoffrey Porges )说,这些因素加在一起可能会导致30亿美元的峰值销售,尽管艾伯维(AbbVie)已经提供了50亿美元的峰值预测。 事实证明, Skyrizi 不仅比一些竞争对手更具成本效益,而且在临床试验中也击败了他们。今年6月,艾伯维(AbbVie)发布了 Skyrizi 两年治疗数据,显示72%的患者的皮肤清除率比安慰剂高出100%。Skyrizi 还在复发患者中工作,治疗16周后,84%的患者再次获得透明皮肤。 在最新的免疫学研究项目中显示出如此强劲的表现后,艾伯维(AbbVie)非常希望这种新药物能够吸收许多患者——以及销量——因为 Humira 和它在2018年的近200亿美元收入都会从这个高峰下滑。 据报道,在 Skyrizi 于4月上市后不久,艾伯维(AbbVie)就开始为 Humira 提供5%至10%的折扣,以确保 Skyrizi 的处方定位。伯恩斯坦( Bernstein )分析师 Ronny Gal 表示,市场定位的推动可能会扰乱苹果与其他免疫公司的合作,并引发与纳税人的“价格战”。 Gal 说,如果这家制药商的 JAK-1抑制剂候选人 upadacitinib 获得 FDA 的批准, Humira 的进一步折扣可能还在继续。在去年年底失去专利保护之后,艾伯维(AbbVie)已经在欧洲推出了高达89%的 Humira 折扣。

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