NICE swayed by long term Glivec data

NICE has reversed a long-standing block on using Glivec in GIST tumours, saying new evidence has persuaded it to change its mind.

Final draft guidance published today proposes to recommend Novartis' Glivec (imatinib) for up to three years for people who have had a gastro-intestinal stromal tumour (GIST) removed and who are at high risk of their cancer returning.

GISTs are found in the digestive system, most commonly in the stomach and small bowel. Some are benign and cause few symptoms. If they become cancerous and are confined to one area, they can often be removed surgically.

NICE reviewed the drug for gastro-intestinal stromal tumour (GIST) in 2010, but rejected its use on the NHS because of 'several uncertainties' about the evidence base. The cost-effectiveness watchdog says it can now recommend the drug because further clinical trial data has been amassed which proves its clinical and cost effectiveness.

The Institute says Glivec can now be used after surgery, as adjuvant therapy, for up to three years for adults who are at high risk of relapse.

Commenting on the draft guidance, Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: "When the original guidance was published, the committee felt there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."

One clinical trial showed that one-year adjuvant Glivec increased recurrence-free survival compared with placebo but it was unclear if this resulted in longer overall survival. Another clinical trial showed that adjuvant treatment with Glivec for three years was more clinically effective than giving it for one year, as shown by statistically significantly longer recurrence-free survival and overall survival during clinical trial follow-up.

At a dose of 400 mg per day, Glivec costs £20,700 for one year of treatment, and £62,100 for three years.

The Committee concluded that the cost per QALY (Quality Adjusted Life Year) was between £3,610 and £12,100 for 1-year adjuvant imatinib compared with no adjuvant treatment, and between £16,700 and £30,000 for three year adjuvant imatinib compared with one year adjuvant imatinib.