This guidance updates and replaces recommendation 1.3 of NICE technology appraisal 70 (published in October 2003). Specifically, high-dose imatinib is not recommended for the treatment of chronic, accelerated or blast-crisis phase Philadelphia-chromosome-positive CML that is resistant to standard-dose imatinib.
NICE recommends nilotinib as a possible treatment for some people with chronic myeloid leukaemia (see below).
Who can have nilotinib?
You should be able to have nilotinib if:
- you have Philadelphia-chromosome-positive chronic myeloid leukaemia in the chronic or accelerated phase and
- your disease has got worse with imatinib at a dose of 400 mg a day or
- you cannot take imatinib.
NICE does not recommend dasatinib for people with chronic myeloid leukaemia in the chronic, accelerated or blast-crisis phase who cannot take imatinib or whose disease has got worse with standard-dose imatinib.
NICE does not recommend high-dose imatinib for people with Philadelphia-chromosome-positive chronic myeloid leukaemia in the chronic, accelerated or blast-crisis phase that has got worse after treatment with standard-dose imatinib.
Why has NICE said this?
NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE applies special considerations to treatments that can extend the lives of people who are nearing the end of their life.
NICE recommended nilotinib because it works as well as some other treatments available on the NHS and better than others. Although it costs more than some of the other treatments, this was justified by the benefits it provided.
Dasatinib and high-dose imatinib did not provide enough benefit to patients to justify their high cost and did not qualify for special consideration, so NICE did not recommend them.
 The dose of imatinib may be increased from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg in patients with accelerated phase or blast crisis. High dose imatinib refers to doses of 600 mg or 800 mg in the chronic phase disease or 800 mg in the accelerated or blast crisis phases.
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.