Tuesday, 9 February 2010

NICE Appraisal Of Dasatinib And Nilotinib For Chronic Myeloid Leukaemia

The National Institute for Health and Clinical Excellence (NICE) has updated its draft guidance on the use of dasatinib (Sprycel,made by Bristol Myers-Squibb) and nilotinib (Tasigna,made by Novartis) for chronic myeloidleukaemia.

Following the previous public consultation and subsequent independent Appraisal Committee meeting on 13 January 2010, both NICE and the appraisal committee agreed to split the appraisal of dasatinib and nilotinib for chronic myeloid leukaemia into two separate appraisals.

To effectively appraise a new treatment, the Committee compares it to an existing one. In this case, high dose imatinib (glivec, 600 mg or 800 mg per day) has been identified as a comparator for dasatinib and nilotinib for people who are 'resistant' to imatinib (standard treatment with imatinib (400 mg per day) has stopped working), although it clearly cannot be a comparator for people who cannot tolerate imatinib. 

To read more click HERE to view the full report on the Medical News Today Website.

1 comment:

The CML Support Group said...

Please sign our petition at:

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