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The PenTAG AR (see p. 368) concluded that effectiveness data were limited, but dasatinib and nilotinib appeared efficacious in terms of obtaining CyRs and HRs in the imatinib-resistant population. The extent to which greater frequency and/or degrees of response would impact on long-term outcomes was more difficult to conclude given the limited nature of the evidence base. In particular, only one study had compared either agent (dasatinib) with high-dose imatinib. The findings of this open-label study, that higher proportions of patients experienced positive responses to dasatinib than to high-dose imatinib, were importantly confounded by substantial crossover at an early point in follow-up.


The dasatinib and nilotinib multiple technology appraisal was continued for ‘imatinibintolerant’ people with CML.

List of abbreviations

All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices, in which case the abbreviation is defined in the figure legend or in the notes at the end of the table.


This assessment comprises an updated systematic review of clinical effectiveness and cost-effectiveness studies, a review and critique of the economic evaluations included in the manufacturer submissions and an update of the economic analysis undertaken in the previous PenTAG AR for chronic-phase CML.


We would like to thank members of our advisory group who provided expert advice and comments on the draft of this report: Professor J Apperley, Department of Haematology, Imperial College London; Professor S Bryan, School of Population and Public Health, University of British Columbia; and Professor J Goldman, Emeritus Professor of Haematology, Imperial College London.

NIHR Health Technology Assessment programme

The Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.


This report is a supplement to the PenTAG AR and, as such, the results reported herein must be considered in conjunction with the PenTAG AR. No new evidence was identified for accelerated-phase or blast-phase CML, therefore this systematic review and economic evaluation refer only to chronic-phase CML. For a discussion of findings for people with imatinib-resistant CML in accelerated phase, see PenTAG AR (see pp. 357–63). For a discussion of blast crisis-CML see PenTAG AR (see pp. 363–6).

Executive summary

In November 2009, the National Institute for Health and Clinical Excellence (NICE) issued for consultation preliminary recommendations on the use of dasatinib and nilotinib for chronic myeloid leukaemia (CML) in patients whose treatment with imatinib had failed owing to resistance and/or intolerance. This consultation process was informed by a technology assessment report on the clinical effectiveness and cost-effectiveness of dasatinib and nilotinib, prepared by the Peninsula Technology Assessment Group (PenTAG) at the University of Exeter. As a result of the consultation, NICE and the Appraisal Committee identified a need for further information on second-line interventions for people who are resistant to standard-dose imatinib. An updated draft scope was issued by NICE for further consultation, focusing on the use of dasatinib, nilotinib and high-dose imatinib as second-line therapy in patients who are resistant to standard-dose imatinib.

Health Technology Assessment programme

Director, Professor Tom Walley, CBE, Director, NIHR HTA programme, Professor of Clinical Pharmacology, University of Liverpool

Clinical effectiveness

Searching by WMHTAC and SHTAC identified a total of 8760 references after deduplication. After initial screening of titles and abstracts, 242 references were retrieved for further inspection. The total number of published papers included at each stage of the systematic review is shown in the flow chart in Figure 1. In total, 11 studies met the inclusion criteria, four (three new studies, one updated publication) of which included data published since the PenTAG AR. The present report presents data from these four studies in order to supplement and update the PenTAG AR. For data from the eight studies previously reviewed, see PenTAG AR (pp. 55–164).

Economic analysis

The aim of this section is to assess through a systematic review of the literature the cost-effectiveness of dasatinib, high-dose imatinib and nilotinib compared with each other and with other treatment options in participants with CML resistant to standard-dose imatinib.

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