Department of Health
United Kingdom

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.

A representative of the CML Support Group said 'Patients are angry, frightened and very frustrated by the provisional recommendation by the NICE appraisal committee- a recommendation that seems to us to have much more to do with cost cutting than with a rational appraisal of two highly effective and innovative therapies.

If the recommendation is upheld, and NHS funding of these therapies is refused in cases of imatinib intolerance, it will undoubtedly cost lives. It is a shocking prospect that UK citizens, who prove to be intolerant to standard dose imatinib (Glivec) will be denied access to such effective and life-saving alternatives. Clinicians will find themselves unable to offer these therapies to their patients in the knowledge that expert clinicians in Germany, France, the Netherlands and other EU countries, will continue to treat CML patients with these life-saving therapies. NICE have clearly acknowledged that both nilotinib (Tasigna) and dasatinib (Sprycel) are clinically effective and very well tolerated oral therapies.

It is difficult to understand why NICE have singled out imatinib (Glivec) intolerant patients in chronic or accelerated phase CML (but not blast phase) for a provisional recommendation that they alone should be denied access to these life-saving therapies. As a consequence, this group of patients, who currently represent around 30-40 British citizens of all ages, will suffer an appalling injustice that puts them at great risk of dying from acute (blast) phase CML.

We call upon the Secretary of State for Health to ensure all CML patients intolerant of Glivec (imatinib) have equality of access to these life-saving drugs.

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The NICE: Be NICE to Cancer Patients petition to Department of Health was written by Sandy Craine and is in the category Health at GoPetition.