In a U-turn from previous guidance, the National Institute for Health and Care Excellence is now planning to recommend National Health Service use of Novartis' Glivec (imatinib) for the treatment of digestive system tumours.
The cost watchdog has now published draft guidance endorsing the drug's use as an adjuvant treatment for up to three years for adults who are at high risk of relapse after surgery for KIT (CD117)-positive gastrointestinal stromal tumours (GIST), three and a half years since original guidelines rejected the drug.
Not enough evidence before
"When the original guidance was published, the committee felt there wasn’t enough evidence about key aspects of the clinical effectiveness of imatinib," explained Carole Longson, health technology evaluation centre director at NICE.
But, as data from ongoing trials has been published and there is now "clear evidence" that Glivec can delay the recurrence of GIST and in some cases increase survival, "we are pleased to be able to propose recommending the drug," she said.
Three years better than one
Clinical data showed that one-year adjuvant treatment with the drug increased recurrence-free survival versus placebo, but it was unclear if this resulted in longer overall survival. Adjuvant treatment for three years was more clinically effective, as shown by statistically significantly longer recurrence-free survival and overall survival, the Institute said.
The Committee concluded that the cost per QALY was between £3,610 and £12,100 for one-year adjuvant Glivec compared with none, and between £16,700 and £30,000 for a three-year course therapy compared with one-year.