No NICE recommendation for higher-dose Glivec

NICE has today issued negative draft guidance on imatinib (Glivec) at doses of 600 or 800mg/day for patients with unresectable and/or metastatic gastrointestinal stromal tumours (GIST) whose disease has progressed after treatment with 400mg/day imatinib.

NICE recommended imatinib at 400mg/day to treat GIST in October 2004, but ruled earlier this month that it was unable to recommend the drug as an adjuvant treatment.

Andrew Dillon, Chief Executive of NICE, said: “Since the appraisal was published in October 2004, there has been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800mg/day. On this basis, we cannot recommend these higher doses of imatinib for use on the NHS.

“NICE has already recommended sunitinib (Sutent) as a treatment option for patients with unresectable or metastatic malignant gastrointestinal stromal tumours for whom treatment with 400mg/day imatinib treatment has not worked or was not suitable.”

The annual incidence of GISTs is estimated to be 14.5 per million population – approximately 791 new cases per year in England and Wales (mid-2008 population). Of these, the manufacturer of Glivec estimates that two thirds are considered to be resectable.