Draft guidance issued by the National Institute for Health and Clinical Excellence has turned down a higher dose version of Novartis’ Glivec for the treatment of patients who have had a stomach tumour removed.

The cost watchdog said it was unable to recommend high dose Glivec (imatinib; 600/800mg/day) for the treatment of patients with metastatic or unresectable gastrointestinal stromal tumours (GISTs) who do not respond to the standard dose of the drug (400mg/day) because of a lack of new clinical and cost effectiveness data to support its use on the National Health Service.

Novartis said it acknowledges the difficulties in developing a cost effectiveness analysis given the limitations of the available data, but is “deeply concerned…that NICE chose to disregard the available clinical evidence, clinicians views and patients’ needs by issuing this guidance” said Panos Alexakos, Oncology General Manager for Novartis UK & Ireland.

Despite conceding that there is some evidence to suggest that Glivec, which NICE has already approved for patients with chronic myeloid leukaemia and for those with GIST that cannot be removed by surgery, could delay the disease recurring in certain people who have had their tumours removed, “it is not clear that it increases survival or that it improves patients’ quality of life”, explained the Institute’s chief executive Andrew Dillon.

“At about £19,500 per patient per year, this is a relatively expensive drug, and we need to be sure about how well it works and what its side-effects are before we can recommend it as cost-effective for use in the NHS,” he added, defending the decision.

However, there is still hope for Glivec in this setting. Aside from the fact that the recommendations are still in the draft phase, NICE’s Appraisal Committee has recommended that the appraisal be considered for review at an early stage so that evidence on the impact of adjuvant treatment with the drug on overall survival – sometime anticipated next year - can be considered as soon as it comes available.