The clinical effectiveness agency for England and Wales said that it is recommending the drug rituximab in combination with the chemotherapy drugs fludarabine and cyclophosphamide for people with relapsed or refractory chronic lymphocytic leukemia.

The National Institute for Health and Clinical Excellence’s decision on rituximab was widely expected following draft guidance in March – however, the final guidance, issued July 28, mandates that the drug combination also be made available to patients who have been treated with rituximab (MabThera, Roche) as part of a clinical trial but at a lower dose than the licensed initial dose (375 mg/m² , and subsequent doses of 500 mg/m²), and to patients who received rituximab in the context of a clinical trial but in combination with other drugs besides fludarabine and cyclophosphamide.?

These patient groups had been excluded in NICE’s draft guidance; the change came after appeals from U.K. Chronic Lymphocytic Leukemia Forum, the Royal College of Pathologists, and the British Society for Hematology.

Patients not eligible for combination therapy with rituximab under the new guidance are those whose condition did not previously respond to fludarabine or who relapsed within 6 months of treatment, and those who had previously been treated with a full dose of rituximab. Current NICE guidance recommends rituximab as a first-line treatment option for chronic lymphocytic leukemia.

For people who previously received rituximab outside of clinical trials, or for whom fludarabine and cyclophosphamide are not considered appropriate, the drug, in combination with chemotherapy, is recommended only in the context of research.

Also July 28, NICE issued guidance recommending oral capecitabine (Xeloda, Roche), in combination with a platinum-based regimen, for the first-line treatment of inoperable advanced gastric cancer, and gefitinib (Iressa, AstraZeneca) for the first-line treatment of people with locally advanced or metastatic non–small cell lung cancer who test positive for the epidermal growth factor receptor tyrosine kinase mutation. Gefitinib works by inhibiting EGFR-TK; in patients without the mutation, the drug is not effective.

Both decisions adhere closely to draft guidance issued in late May.

While capecitabine tablets had been considered by NICE to be a cost-effective alternative to intravenous fluorouracil, the standard treatment, the price of gefitinib, another oral medication, was considered high by NICE, whose final appraisal determination hinged on a cost-sharing agreement with the manufacturer. Under the access scheme proposed by the manufacturer and accepted by NICE, gefitinib tablets will be provided for free to the National Health Service for patients treated for up to 2 months and, for all others, at a single fixed cost regardless of the length of treatment.

The National Health Service has 3 months to begin implementing NICE’s new guidance.

Earlier this month, on July 21, NICE announced that it had catalogued its technology appraisals, including drug appraisals, since 1999 and that it had recommended 67% of treatments to the NHS in line with their licensed indications. A total of 16% of treatments had been recommended for narrower use than licensed, such as certain patient groups. Six percent of treatments, NICE said, were approved only in the context of clinical research, and 11% were rejected outright, usually because of cost or lack of efficacy data.

 

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3月份，指南草案出台后，人们普遍期待英国国家卫生与临床优化研究所(NICE)对利妥昔单抗做出这一决定；然而，7月28日发行的最终指南规定，应向接受利妥昔单抗(商品名美罗华，罗氏制药公司生产)治疗的患者提供该联合用药作为临床诊疗的一部分，但应低于许可初始剂量(为375 mg/m²，随后剂量为500 mg/m²)，同时，还应向临床试验中接受利妥昔单抗治疗的患者提供除了氟达拉滨和环磷酰胺以外的其他联合药物。

 

在NICE的指南草案中，这些接受利妥昔单抗治疗的患者被排除在外；因此而招致英国慢性淋巴细胞白血病论坛、皇家病理学院和英国血液学协会的呼吁，才使得指南的内容发生变化。

 

新的指南规定，不适合采用利妥昔单抗联合治疗的患者包括：既往经氟达拉滨治疗无效或治疗6个月内复发的患者，以及曾使用全剂量的利妥昔单抗治疗的患者。当前NICE指南推荐将利妥昔单抗作为慢性淋巴细胞白血病的一线治疗药物。

 

对于曾经在临床试验外接受过利妥昔单抗治疗的患者，或者被认为不适宜使用氟达拉滨和环磷酰胺的患者，该药与化疗的联合治疗方法仅仅推荐在临床研究的背景下采用。

 

7月28日NICE发行的指南还推荐口服卡培他滨(capecitabine，商品名希罗达，罗氏制药公司生产)联合以铂为主的疗法用于无法手术的晚期胃癌的一线治疗，同时该指南还推荐吉非替尼(商品名易瑞沙，阿斯利康制药公司生产)用于表皮生长因子受体酪氨酸激酶(EGFR-TK)突变测试呈阳性、局部晚期或代谢性非小细胞肺癌患者的一线治疗。吉非替尼主要通过抑制EGFR-TK而发挥作用；对于没有EGFR-TK突变的患者，该药治疗效果并不显著。

 

这些意见与5月底发行的指南草案非常接近。

 

卡培他滨片剂被NICE考虑为静脉注射氟尿嘧啶这一标准治疗策略的廉价替代方案的同时，另一口服药物吉非替尼也被NICE高度关注，而该药的最终评估裁定主要取决于NICE与制药公司的成本分摊协议。根据由制药公司提出的、被NICE接受的许可方案，吉非替尼片剂将被国家卫生服务体系用于免费治疗患者达2个月之久；而对于其他患者，NICE将以一种单一固定成本的方式对他们进行治疗，而不需考虑治疗期的长短。

 

国家卫生服务体系将用3个月的时间来着手实施NICE新的指南。

 

7月21日，NICE宣布其已经将其技术评估编入目录，包括自1999年以来的药品评估，NICE还宣称其已经向国家卫生服务体系推荐了67%的符合许可适应证的治疗用药。总共有16%的治疗策略被推荐在其许可范围内限制使用，如特定患者人群。NICE称，6%的治疗方案仅被批准用于临床研究，并且11%的治疗方案完全被否定，这常常是由于成本问题或者缺乏疗效数据。

 

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