Petition Tag - dasatinib

In a new draft guidance, published on May 6th 2011, NICE has not recommended dasatinib, nilotinib or high-dose imatinib for the treatment of CML (chronic myeloid leukaemia) that is resistant to standard-dose (400mg) imatinib.

The Committee noted the wide range of results across the interventions. The Committee acknowledged the clinical specialist view that for CML that is truly resistant to standard-dose imatinib, high-dose imatinib was unlikely to be as beneficial as dasatinib and nilotinib, and that high-dose imatinib would be less well tolerated than dasatinib and nilotinib.

The Committee therefore agreed that in practice, dasatinib and nilotinib would be preferred over high-dose imatinib for people with imatinib-resistant CML.

The Committee also agreed that there was no good evidence to distinguish between dasatinib and nilotinib, a conclusion also supported by the clinical specialists.

The Committee concluded that it is clear that dasatinib, high-dose imatinib and nilotinib provide clinical benefit for people with imatinib-resistant CML. However, the Committee agreed that the paucity of the evidence base means that the magnitude of the benefit is uncertain.

Interpretation ...

'We know these drugs are good- we know they are better than anything that has been used previously- but we can't measure exactly how good they have been or might be in future- '

We know that, ethically, there can never be the kind of trial that would prove beyond all doubt that these drugs really do work- therefore its better to deny access until such time that data from a randomised double blind 4 arm clinical trial has been collated and which proves beyond all doubt that 2nd generation TKI therapy translates into long term progression free survival for the majority of CML patients resistant to first line standard dose imatinib.

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The Chronic Myeloid Leukaemia (CML) Support Group have grave concerns about the provisional recommendation contained in the Appraisal Consultation Document of dasatinib and nilotinib for ‘imatinib intolerant’ Chronic Myeloid Leukaemia.

We question the wisdom behind the appraisal committee's decision to separate the two sub-groups of patients because we understand that it is difficult to separate 'intolerance' from 'resistance' with clinical precision. We also point out that in actual clinical practice, both categories of patients who have failed to respond to Glivec, already enjoy increased progression free survival and quality of life benefits from therapy with Tasigna and/or Sprycel within the UK and throughout Europe. Separating the two sub-sets of patients in order to assess the Glivec intolerant group in isolation is, in our view, not only cynical but absurd and unethical.

Should the appraisal committee's recommendations be upheld, patients with chronic or accelerated phase CML who prove to be intolerant to Glivec, will be offered other treatment options from a list of far less effective therapies used prior to the introduction of Glivec. Several of these options can in themselves be life threatening, most have well documented seriously debilitating side effects and one is purely palliative. With the exception of stem cell transplantation, which has relatively high morbidity and mortality rates, and for which is inappropriate for the majority, in almost all cases of CML the alternative options suggested by the committee, do nothing to halt the progression of the disease and for this reason alone are rarely used in current clinical practice.

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