Dasatinib, high dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia: a systematic review and economic evaluation

Abstract

Treatments for patients with CML have included hydroxycarbamide, interferon alfa, stem cell transplantation and acute leukaemia-style chemotherapy. More recently, tyrosine-kinase inhibitor drugs have been developed. Imatinib was the first tyrosine-kinase inhibitor to be used for treating CML. It is considered to be effective and is recommended by NICE for the treatment of CML in the first line.1 Subsequently, dasatinib and nilotinib, also tyrosine-kinase inhibitors, have been developed and are being used for the treatment of CML.

Guidance on second-line treatment for those patients developing resistance to imatinib is less clear. In clinical practice, imatinib at high doses is frequently used. Dasatinib and nilotinib may also be treatment options. However, there have been no evaluations of the clinical and cost effectiveness of these treatments compared to each other or to most of the older treatment options for patients with imatinib-resistant CML. Economic evaluations of dasatinib and nilotinib compared to interferon alfa with cytarabine have been conducted (appendix 8 of CML assessment report2).

The function of this review is therefore to assess the clinical and cost effectiveness of high dose imatinib, dasatinib and nilotinib compared to each other or traditional technologies such as hydroxycarbamide, interferon alfa, stem cell transplantation and acute chemotherapy for the treatment of patients with imatinib-resistant CML.

This report is a part update of a previous report undertaken to inform the NICE MTA of dasatinib and nilotinib for people with imatinib resistant and imatinib intolerant CML,2 where the current report focuses on those with imatinib resistant disease only.

The HTA Programme commisioned this technology assessment report on behalf of the National Institute for Health and Clinical Excellence.