NICE reverses guidance on Novartis' Glivec for GIST

As a result of new clinical data, the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance proposing to recommend Swiss pharma major Novartis’ (NOVN: VX) Glivec (imatinib) people who have had a gastro-intestinal stromal tumor (GIST) removed and who are at high risk of the cancer recurring.

This appraisal reviews previous guidance (NICE technology appraisal guidance 196) issued to the National Health Service in 2010. At that time, NICE did not recommend imatinib, but further clinical trial evidence has become available since then, which addresses several uncertainties. This is why the current final draft guidance now recommends imatinib after surgery, as adjuvant therapy, for up to three years for adults who are at high risk of relapse.

Now have clear evidence imatinib can delay GIST recurrence

Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “When the original guidance was published, the committee felt there wasn’t enough evidence about key aspects of the clinical effectiveness of imatinib. However, the results from ongoing trials have now been published. There is clear evidence that giving imatinib after surgery can delay the recurrence of GIST and in some cases increase survival.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.