NICE has not recommended licensed drug Tarceva (generic name Erlotinib) for the treatment of locally advanced or metastatic non-small-cell lung cancer. Tarceva treats nonsmall- cell lung cancer by attacking only cancer cells. It comes in the form of daily tablets.

In its Final Appraisal Determination (issued in April 2008 – the full document can be found at commissioned following complaints and appeals in relation to its first review in March 2007, NICE explains that Tarceva would not be approved on the grounds that the new drug “could not be considered a cost-effective use of NHS resources when compared with either Docetaxel or BSC”.

The decision has caused controversy for a number of reasons, primarily because the drug will not be made available to patients in England and Wales, but will remain available to NHS patients in Scotland.

This is turn means that PCTs in England and Wales will not be obliged to fund Tarceva or make it available to NHS patients. However, NICE has stated in its guidance that patients currently receiving Tarceva “should have the option to continue therapy until they and their clinicians consider it appropriate to stop”.

NICE has since received four appeals from the British Thoracic Society, Roche Products Limited, The Royal College of Physicians & the Association of Cancer Physicians and the Roy Castle Lung Cancer Foundation & Cancerbackup. An appeal hearing was scheduled for 6 June 2008.