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Leukaemia (imatinib-intolerant chronic myeloid) - dasatinib and nilotinib [ID31]

Dasatinib and nilotinib for imatinib-intolerant chronic myeloid leukaemia

Status: History
Expected date of issue: September 2011
Referral date: June 2008
Process: MTA
Topic area:
 

NICE project team

Executive Lead: Peter Littlejohns
Technical Lead: Joao Vieira
Communications manager: Alice Law
Project manager: Lori Farrar
Assessment Group / Evidence Review Group: Peninsula Technology Assessment Group, University of Exeter (PenTAG)
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Provisional schedule

Closing date for invited submissions / evidence submission: 29 April 2009
1st appraisal committee meeting: 14 October 2009
2nd appraisal committee meeting: 13 January 2010
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Consultees and commentators

Consultees Commentators (no right to submit or appeal)

Manufacturers/sponsors

  • Bristol-Myers Squibb (dasatinib)
  • Novartis (nilotinib)

Patient/carer groups

  • Leukaemia CARE
  • Leukaemia Research Fund
  • Macmillan Cancer Support
  • Chronic Myeloid Leukaemia Support Group

Professional groups

  • British Committee for Standards in Haematology
  • British Society for Haematology
  • Cancer Research UK
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians, Intercollegiate Committee on Haematology

Others

  • Department of Health
  • Welsh Assembly Government
  • Wiltshire PCT

General

  • Department of Health, Social Services and Public Safety for Northern Ireland
  • NHS Quality Improvement Scotland

Comparator manufacturers

  • Bristol-Myers Squibb (hydroxycarbamide)
  • Novartis (imatinib)

Relevant research groups

  • None

Assessment group

  • Peninsula Technology Assessment Group, University of Exeter (PenTAG)
  • National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA Programme)

Associated Guideline Groups

  • National Collaborating Centre for Cancer

Associated Public Health Groups

  • None

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Project history

Date Update
12 July 2011 Following the Appraisal Committee discussion held on the 9 June, NICE will release one Final Appraisal Determination combining the recommendations for both people with imatinib-resistant chronic myeloid leukaemia and with imatinib-intolerant chronic myeloid leukaemia.  The appraisal will now be titled as Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (part review TA70) and dasatinib and nilotinib for people with Chronic myeloid leukaemia for whom treatment with imatinib has failed because of intolerance. For further information relating to the FAD go to the new appraisal webpage.
27 January 2010

The first Committee meeting for the MTA appraising the use of dasatinib and nilotinib for chronic myeloid leukaemia in patients whose treatment with imatinib has failed due to resistance and/or intolerance took place on 14th October 2009. NICE’s preliminary recommendations were available for public consultation from 16 November until 7 December 2009. Comments received during this consultation were considered by the Committee on 13th January 2010.

As a result both NICE and Appraisal Committee have agreed that it is preferable to combine an appraisal of the three technologies, imatinib high dose (600mg and 800mg), dasatinib and nilotinib, to establish their comparative incremental  clinical –effectiveness and cost-effectiveness.  Therefore the following actions will be implemented:

  • The current dasatinib and nilotinib multiple technology appraisal will continue for ‘imatinib intolerant’ people with chronic myeloid leukaemia.
  • The dasatinib and nilotinib multiple technology appraisal for ‘imatinib resistant’ people will be rescheduled into the review of TA70, specifically related to high dose imatinib.  An updated draft scope will be issued shortly for consultation for the review of TA70 focussing on ‘resistant’ people to include the following interventions: ‘high-dose’ imatinib, dasatinib and nilotinib
5 July 2010 The Final Appraisal Decision (FAD) for this appraisal topic will not be issued as planned.  NICE Guidance Executive have reviewed the timing of the issuing of the final recommendations for this appraisal. They considered that the recommendations for the use of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia in people with imatinib intolerance could be influenced by the outcome of the appraisal for the imatinib-resistant population. They concluded that the appraisal for the imatinib-intolerant population should be deferred until the appraisal committee meets to consider the appraisal for the imatinib-resistant CML population and agreed that the release of the FAD for imatinib-intolerant patients should occur at the same time as the FAD for imatinib-resistant patients. This will involve the appraisal committee reviewing the recommendations for imatinib-intolerant patients at the time that the FAD for the imatinib-resistant patients is being considered.

Until final guidance is issued for dasatinib and nilotinib in the imatinib-intolerant chronic myeloid leukaemia population, decisions on treatment should be in line with local health policy.

The MTA for imatinib-resistant CML population includes high-dose imatinib, dasatinib and nilotinib, and a part review of TA70 and is underway with a current schedule to issue preliminary recommendations in April 2011.
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Key documents

This page was last updated: 23 March 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.