In a new draft guidance, published on May 6th 2011, NICE has not recommended dasatinib, nilotinib or high-dose imatinib for the treatment of CML (chronic myeloid leukaemia) that is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.
'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.
The draft determination of The National Institute of Clinical Health and Excellence (NICE) which is a refusal to recommended 2nd line life saving therapy for CML patients who are resistant to 1st line therapy flies in the face of his promise.
If this cynical cost saving decision is ratified, NICE will deny CML patients living in England, Wales and Northern Ireland the choices, available to those north of the border in Scotland and other Western democratic EU Nation States, that grant them the basic human right to live out a normal life expectancy.
Confirmation of this recommendation will mean the “one chance” offer at diagnosis will be the “last chance” for the majority of those unfortunate enough to exhibit resistance to standard dose imatinib.
Please lend your support to our appeal that NICE recognise the reality of targeted cancer therapies and personalised medicine by reconsidering its decision to deny these undoubted clinically effective therapies to all UK citizens living south of the Scottish border.
We want “real choice” rather than “no choice” for all UK CML patients.