Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (CML) (part review of NICE technology appraisal guidance 70), and dasatinib and nilotinib for people with CML for whom treatment with imatinib has failed because of intolerance

NICE technology appraisals [TA241] Published date:

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.

Dasatinib

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.

Imatinib

NICE does not recommend high-dose imatinib[1] 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.



[1] 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.

 

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