The clinical effectiveness agency for England and Wales said in a statement June 9 that it would not recommend the chemotherapy drug lapatinib as a second-line treatment for women with an aggressive form of breast cancer, despite a proposal by the drug’s manufacturer to discount its price.
Lapatinib (Tyverb, GlaxoSmithKline), is an oral medicine that received marketing authorization throughout the European Union in 2008 for the treatment of advanced or metastatic breast cancer. It is used to treat women whose tumors overexpress the human epidermal growth factor receptor 2 protein (an estimated fifth of all breast cancers in the United Kingdom), and who have not responded to treatment with anthracyclines, taxanes, and trastuzumab.
The National Institute for Health and Clinical Effectiveness began assessing whether to recommend lapatinib even before the drug’s EU authorization was final, but had immediate concerns about lapatinib’s price, which, as part of a combination treatment with capecitabine, is estimated at £25,207 per year.
In March 2009, NICE issued early guidance against lapatinib, citing the high price; in July 2009, GlaxoSmithKline appealed the draft guidance, and proposed to provide to the National Health Service the first 12 weeks of lapatinib free for each patient.
After nearly a year of back and forth on questions of price and clinical effectiveness, the NICE reviewers determined in final draft guidance that they would not recommend lapatinib to the NHS except in the context of clinical trials.
A recent meta-analysis of three randomized controlled trials (n = 704) comparing lapatinib-containing regimens to existing treatments in women with advanced or metastatic HER-2 overexpressing breast cancer concluded that there was, indeed, a survival benefit with lapatinib. Pooled estimates suggested hazard ratios of 0.61 for progression-free survival and 0.76 for overall survival (Anticancer Drugs. 2010;21:487-93).
The NICE reviewers will reveal on June 10 what recent evidence they considered in their most recent round of decision making on lapatinib. However, the agency said in a press release June 9, “evidence suggests [lapatinib] only extends life by a small amount of time – around 10 weeks (2.4 months) – and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication – capecitabine on its own.”
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英格兰和威尔士临床疗效评价机构于6月9日发表声明，称其将不会推荐化疗药物拉帕替尼作为治疗侵袭性乳腺癌女性患者的二线药物，尽管该药的制造商已经主动提议下调该药物的价格。
拉帕替尼(Tyverb，葛兰素史克)是一种用于治疗晚期或转移性乳腺癌的口服药物，该药在2008年已获得所有欧盟国家的上市许可。该药被用于治疗人表皮生长因子受体2(HER-2)蛋白在体内肿瘤中过度表达的女性患者(据估计其大约占全英国所有乳腺癌患者的1/5)以及应用蒽环类、紫杉醇类、曲妥珠单抗类药物治疗无效的患者。
早在拉帕替尼获得欧盟最终上市许可之前，英国国家卫生与临床优化研究所(NICE)就开始评估是否应当推荐使用该药物。但该机构很快就对拉帕替尼的价格产生了担忧，据估计，应用该药与卡培他滨进行联合治疗每年需要花费25,207英镑。
在2009年3月，NICE发布了针对拉帕替尼的早期指南，其中便指出该药的价格高昂，在2009年7月，葛兰素史克就该指南草案提交申诉，并且主动提议为英国国家卫生服务体系(NHS)的每例患者免费提供治疗前12周所需的拉帕替尼。
在对药品售价及临床疗效等问题进行了将近1年的反复协商后，NICE的评审人员在最终出台的指南草案中明确指出，除了用于临床试验外，该机构不推荐将拉帕替尼纳入NHS系统。
一项近期进行的纳入3项随机对照临床试验(n = 704)的荟萃分析对包含拉帕替尼的治疗方案与现行治疗方案用于治疗晚期或HER-2过表达的转移性乳腺癌患者的疗效进行了对比，该研究得出的结论表明，应用拉帕替尼对延长患者的生存时间确实存在有利影响。联合估计表明，在患者疾病无进展生存时间与总体生存时间这两项指标上，拉帕替尼与现行方案的危险比分别为0.61和0.76(Anticancer Drugs. 2010;21:487-93)。
NICE的评审人员将于6月10日公布该机构在针对拉帕替尼所进行的新一轮决策中参考的最新证据。然而，该机构在6月9日发布的新闻稿中指出：“有证据表明(拉帕替尼)仅略微延长了患者的生存时间——大约10周(2.4个月)——但与NHS 在该适应证治疗中使用更为普遍的另一治疗方案(仅使用卡培他滨)相比，该治疗方案却要多花费数千英镑。”
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