UK's NICE gives final 'no' to NHS use of Novartis cancer drug Glivec; Novartis now holds 77% of Alcon

In another negative decision on the use of cancer drugs on the National Health Service in England and Wales, the National Institute for Health and Clinical Excellence (NICE) says it has been unable to recommend Swiss drug major Novartis' (NOVN.VX, NVS) Glivec/Gleevec (imatinib) as an adjuvant treatment for people who have had a gastrointestinal stromal tumour (GIST) removed and who are at risk of the cancer recurring. This follows an earlier negative recommendation in the spring (The Pharma Letter March 24).

There is evidence to show that giving imatinib after surgery, as adjuvant therapy, can delay the recurrence of GIST, the NICE noted. However, there is currently a lack of evidence about key aspects of the clinical effectiveness of the drug, in particular whether adjuvant imatinib extends life expectancy, how long treatment should be continued and whether resistance to imatinib develops. If resistance develops as a result of treatment after surgery, that could reduce the benefits of imatinib if a patient needs it at a later stage after their cancer has recurred, the agency argued. More mature evidence is expected to be available in 2011 and the Appraisal Committee has therefore recommended that the appraisal be considered for review once this information is available.

Andrew Dillon, Chief Executive of NICE said: "Although there is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumors, it is not clear that it increases survival or that it improves patients' quality of life. At around £19,500 ($30,240) per patient per year, this is an expensive drug, and we need to be more confident about how well it works and what its side-effects are before we consider recommending it for use in the NHS.â