In its Final Appraisal Determination (FAD) on lapatinib (Tyverb®) for previously treated women with advanced or metastatic breast cancer, whose tumours overexpress HER2, NICE has recommended that the drug (in combination with capecitabine), within its licensed indication, should not be used, except in the context of clinical trials, as it is not a cost effective use of NHS resources. Women currently receiving lapatinib should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

The Appraisal Committee had accepted the estimates of clinical-effectiveness reported in the main lapatinib RCT. However, it did not consider that lapatinib had demonstrated that it was cost effective in comparison with capecitabine or vinorelbine, either with or without the patient access scheme. The appeal period for this appraisal will close on 27/03/2009.