The Pharmaceutical Journal
Vol 269 No 7220 p555
19 October 2002

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NICE approves imatinib for patients with chronic myeloid leukaemia

National Health Service organisations have three months to ensure that funding is available for imatinib (Glivec), after guidance was issued by the National Institute for Clinical Excellence this week.

Tim Root, chief pharmacist at the Royal Marsden Hospital, London, told The Journal that in terms of obtaining funding for imatinib the hospital had not come up against any huge problems. “As far as I know, this reflects the experience elsewhere in the country but it is still early days and the problems may come when patient numbers start to build up,” he said.

NICE recommends that imatinib should be a treatment option for adults with Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) who are in the chronic phase of the disease if they are intolerant of interferon-alpha or if interferon-alpha treatment has failed to control the disease.

It also recommended that imatinib should be an option for adults with Philadelphia-chromosome-positive CML in the accelerated phase or blast crisis, provided that they have not previously had treatment with imatinib.

The guidance is a change from the recommendations made in a provisional appraisal published in May, in which NICE suggested that imatinib should only be made available to patients in the accelerated phase of CML. After a consultation period, NICE published its final appraisal, which included the recommendations finally taken up in this week’s guidance.

“This was a significant change,” Andrew Dillon, chief executive of NICE said at a briefing on 15 October. He explained that during the consultation process more data became available and the appraisal committee reflected on what experts and patients groups had said about the provisional recommendations. “At the second meeting [of the appraisal committee] it was decided that the provisional guidance was too cautious.

“This shows that the consultation is genuine,” he said.

The approximate annual cost of imatinib is between £19,000 and £28,500 for a patient in the chronic phase of CML, and between £28,500 and £38,000 for a patient in the accelerated phase or in blast crisis depending on the dose. NICE estimates that its guidance will increase NHS costs by between £11.8m and £15.8m during the first year.

NICE’s guidance on the use of imatinib, available in full at www.nice.org.uk, is the institute’s 50th health technology appraisal.