WIREDGOV

In draft guidance, published today (25 March 2010), the National Institute for Health and Clinical Excellence (NICE) has asked Novartis Pharmaceuticals UK to provide more data on its product imatinib (Glivec) as an adjuvant treatment for people who have had a gastrointestinal stromal tumour removed and who are at risk of the cancer recurring.

NICE is currently appraising imatinib for this indication but the Appraisal Committee does not feel it has received enough sufficiently clear information from the manufacturer to be able to make a recommendation. The Committee has therefore requested that further data is provided relating to the clinical benefits of imatinib in particular groups of people, and the improvement in quality of life treatment may offer people taking the drug. Additional analyses on the cost-effectiveness of imatinib have also been requested.

This draft guidance has been issued for consultation and the manufacturer now has an opportunity to respond to the independent Appraisal Committee’s considerations and requests.

Andrew Dillon, Chief Executive of NICE said: “NICE already recommends imatinib for patients with chronic myeloid leukaemia and gastrointestinal stromal tumours that cannot be removed by surgery. There is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumours, but the Committee feels it has not yet been given enough information about whether the benefit of the drug is sustained and whether it gives patients improved quality of life. This is a relatively expensive drug, and we need to get clearer information about how well it works and about adverse effects of the drug before we can establish whether it is cost-effective for use in the NHS. We hope that Novartis will be able to respond to the Committee’s concerns.”

NICE’s preliminary recommendations are available for public consultation from 25 March 2010 until 19 April 2010 at http://guidance.nice.org.uk/TA/Wave20/79

Comments received during this consultation will be considered by the Committee in April. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.