The National Institute for Health and Clinical Excellence has barred Novartis’ Glivec from the National Health Service in England and Wales as an option for stomach cancer recurrence.

The cost watchdog said yesterday that it was unable to recommend Glivec (imatinib) as an adjuvant treatment for patients with who have had a gastrointestinal stromal tumour (GIST) removed and who are at risk of the cancer recurring.

While agreeing that there is evidence to show that giving patients Glivec after surgery as an adjuvant therapy can delay the recurrence of GIST, the Appraisal Committee felt evidence on key aspects of the drug’s clinical effectiveness, such as whether it extends life expectancy, duration of treatment or whether resistance develops, is lacking.

The Committee noted that all of the revised base-case scenarios for the incremental cost of adjuvant treatment with Glivec compared to none at all in the manufacturer’s submission were more £20,000 per QALY (quality-adjusted life-year) gained, except for high-risk subgroup, which was £18,800 per QALY gained. 

Even so, it argued that these estimations were still not appropriate because they fail to take into account the effects of possible resistance to the drug, and assume a 1:1 relationship between recurrence-free survival and overall survival.

Given that treatment with the drug costs around £19,500 per patient per year, “we need to be more confident about how well it works and what its side-effects are before we consider recommending it for use in the NHS”, said NICE chief executive Andrew Dillon explaining the decision.

The Committee has, however, recommend an early review date for Glivec in this setting to allow evidence on the impact of adjuvant treatment with the drug on overall survival to be assessed by the cost regulator as soon as data from ongoing trials becomes available, as expected sometime next year.

Glivec has been recommended by NICE for patients with chronic myeloid leukaemia and for those with GIST that cannot be removed by surgery.