英国国家卫生保健优化研究所(NICE)似乎要推翻之前推荐罗氏旗下癌症药物特罗凯（厄洛替尼）有限制使用的指导草案。NICE负责英格兰与威尔士NHS用药的成本效益评价，该机构于今年2月份曾表示正对推荐罗氏特罗凯及阿期利康旗下吉非替尼用于非小细胞肺癌(NSCLC)治疗进行审查。
新的指南可能推翻NICE之前的推荐，当时NICE推荐厄洛替尼（一种与癌症有关的表皮生长因子受体蛋白抑制剂）作为一款NSCLC患者二线药物被纳入NHS用药范畴。
该机构认为，使用EGFR（表皮生长因子受体）抑制剂一线治疗失败之后，再次治疗在临床实践中并不常见，因为肿瘤对这些药物的敏感性降低，另外，数据显示厄洛替尼在没有任何EGFR基因突变的NSCLC患者中，在延长无进展生存期上不如多西他赛有效。
这项决定是在咨询患者、医生及罗氏之后做出的。根据罗氏的信息，失去特罗凯的二线治疗药物推荐，每年可能影响2000名一线治疗失败后而又不耐受多西他赛的患者。
NICE reverses decision to restrict Tarceva access
Roche says “voices of clinicians and patients have been heard”
The National Institute for Health and Care Excellence (NICE) looks likely to go back on previous draft guidance that would have limited the use of Roche's cancer drug Tarceva.
In February this year NICE, which assess the cost-effectiveness of treatments for NHS use in England and Wales, said it was reviewing its recommendations for both Roche's Tarceva (erlotinib) and AstraZeneca's Iressa (gefitinib) in the treatment of non-small cell lung cancer (NSCLC).
The new guidance would have overturned NICE's previous recommendation, which allows Tarceva – an inhibitor of the EGFR protein associated with cancer - to be used on the NHS as a second-line treatment for patients with NSCLC.
This was down to the agency's position that retreatment of NSCLC after failure of first-line therapy with an EGFR inhibitor is not common in clinical practice because of reduced sensitivity of the tumour to these treatments, as well as data that suggested that Tarceva was not as effective as docetaxel in extending progression-free survival (PFS) when used in NSCLC patients without any mutation in the EGFR gene.
NICE now appears to have backtracked on this potential new recommendation and has published guidance that does back the continued use of Tarceva for people with relapsed NSCLC.
This decision was made following consultation with patients, doctors and Roche, causing the pharma company to proclaim in its response: “The voices of clinicians and patients have been heard.”
According to the company, losing Tarceva's recommendation as a second-line treatment would have affected up to 2,000 patients a year who fail first-line therapy and cannot tolerate docetaxel.
Dr Mick Peake, consultant physician at the University Hospitals of Leicester NHS Trust and clinical lead for the National Cancer Intelligence Network (NCIN), said he was “glad” that NICE took patient opinion into consideration and reverse its negative stance.
“I am therefore extremely relieved that erlotinib will continue to be available through the NHS as a treatment option for patients with relapsed NSCLC,” said Dr Peake.
This latest guidance is now up for consultation with comments welcomed until April 29. A final decision on the use of Tarceva and Iressa is expected by September.
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