The clinical effectiveness agency for England and Wales announced July 22 it has canceled development of a guideline on gefitinib as a second-line treatment for locally advanced or metastatic non-small-cell lung cancer as the manufacturer tries to develop data to support first-line treatment.
AstraZeneca has informed the National Institute for Health and Clinical Excellence that it intends to focus its efforts on gathering clinical and cost-effectiveness evidence to support the use of gefitinib, marketed as Iressa, as a first-line treatment of advanced non-small-cell lung cancer with epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation positive tumors, according to an agency announcement.
As AstraZeneca sought regulatory approval from the European Medicines Agency, the EMEA asked for more data specific to EGFR-TK positive tumors. The company then told NICE it was choosing to focus on the first-line treatment indication rather than the second-line treatment that NICE was seeking, according to the NICE announcement. NICE has begun the development of a guideline on gefitinib as first-line treatment.
EMEA recommends marketing approvals for the European Union on the basis of safety and efficacy, while NICE determines drugs’ use in the National Health Service on the basis of clinical and cost effectiveness.
NICE also published final guidelines on:
– Rituximab as a first-line treatment for chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide for those patients for whom the latter two agents are appropriate.
– Tenofovir disoproxil for treatment of HBeAg-positive or HBeAg-negative hepatitis B in patients for whom antiviral treatment is indicated. It is not indicated for patients with hepatitis C or D, or HIV.
– Identification and intervention in cases of child abuse for physicians and health care professionals.
– Prosthetic intervertebral disc replacement in the lumbar spine for patients with symptomatic degenerative disc disease, recommending that evidence is sufficient to support use of this procedure.
– Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from neurological disease, recommending that the procedure “should only be used with special arrangements for clinical governance, consent, and audit or research.”
– Sinus tarsi implant insertion for mobile flatfoot, recommending similar arrangements for governance, consent, and research.
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英格兰和威尔士的临床疗效评价机构7月22日宣布，鉴于吉非替尼生产商正努力获取支持吉非替尼作为治疗局部晚期或转移性非小细胞肺癌一线药物的研究数据，该机构将取消制订将其作为二线药物的治疗指南。
根据该机构的声明，阿斯利康公司已通知英国国家卫生与临床评价研究所(NICE)，他们将努力收集临床和成本-效果方面的证据，以支持应用吉非替尼(商品名为易瑞沙)作为治疗表皮生长因子受体酪氨酸激酶(EGFR-TK)基因突变阳性的晚期非小细胞肺癌的一线药物。
鉴于阿斯利康公司正寻求欧盟药品管理局(EMEA)的监管核准，EMEA要求其提供更多针对EGFR-TK阳性肿瘤的研究数据。根据NICE的声明，因上述原因，该公司通知NICE，他们决定选择将集中研究获取吉非替尼作为一线治疗药物的指征，而不是NICE所寻求的将其作为二线治疗药物。NICE已着手制订其作为一线药物的治疗指南。
EMEA建议欧盟根据药物的安全性和有效性进行上市核准，而NICE则根据药物的临床和成本-效果研究结果来决定其是否可应用于国家医疗保健机构。
NICE还刊发了以下指南的最终版本：
n 关于将利妥昔单抗作为一线治疗药物，并联合应用氟达拉滨和环磷酰胺，治疗对后两种药物敏感的慢性淋巴细胞白血病患者。
n 关于将泰诺福韦用于治疗具有抗病毒治疗指征的HBeAg阳性或阴性的乙型肝炎患者，而不是用于丙型、丁型肝炎患者或艾滋病患者。
n 关于医生和卫生保健专业人员如何鉴定并治疗受虐待儿童。
n 关于对患者腰椎行人工腰椎间盘置换术，以治疗有症状的退行性椎间盘疾病。指南建议在使用该治疗方法时，需有充足的证据支持。
n 关于应用肌肉内膈肌刺激治疗神经系统疾病引起的呼吸机依赖性慢性呼吸衰竭。指南建议该项治疗“只有在包括临床监督、知情同意、审核或研究在内的特殊管理措施下方可实施” 。
n 关于应用跗骨窦种植体插入术治疗移动性扁平足，指南建议采取包括临床监督、知情同意和研究在内的相似的管理措施。
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