NICE Updates Draft Guidance on Dasatinib and Nilotinib for Chronic Myeloid Leukemia
From M2 Europharma (February 9, 2010)
9 February 2010 - The National Institute for Health and Clinical Excellence (NICE) said today it has updated its draft guidance on the use of dasatinib (Sprycel, made by Bristol Myers-Squibb (NYSE: BMY)) and nilotinib (Tasigna, made by Novartis (VTX: NOVN)) for chronic myeloid leukaemia.
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.
NICE is about to start a review of its current guidance on high dose imatinib for chronic myeloid leukaemia (TA70), so this review will now incorporate an appraisal of dasatinib and nilotinib compared with high dose imatinib for people who are "resistant" to standard imatinib treatment. The current appraisal will continue for "imatinib intolerant" people only.
Also in response to comments received during public consultation the Assessment Group carried out additional analyses addressing the issues raised concerning the cost-effectiveness modelling, and these further analyses were discussed by the Committee. This additional evidence and its consideration by the Committee now needs to be viewed by consultees, therefore a second Appraisal Consultation Determination (ACD), or first draft, has been issued for further consultation, NICE said.
In its latest draft, issued for public consultation today, NICE does not recommend dasatinib and nilotinib for chronic myeloid leukaemia in patients who are intolerant to imatinib.
Professor Peter Littlejohns, Clinical and Public Health director at NICE, said that the Committee heard from clinical specialists that in their opinion dasatinib and nilotinib are clinically effective. However, the evidence available to support this was very poor, with no studies comparing either drug to other treatments, added Littlejohns and further said that the cost of the drugs is also extremely high and before committing limited NHS resources to fund them, NICE needs to be sure they are effective. It would be heartening to hear that the pharmaceutical company manufacturers are prepared to share some of the very high cost of the drugs with the NHS, added Littlejohns.
NICE also said that these draft recommendations are now open to public consultation, and the manufacturers have been given the opportunity to provide further evidence for the independent committee to consider at its next meeting, on 9 March 2010. Following this meeting the next draft guidance will be issued.
Until NICE issues final guidance, NHS bodies should make
decisions locally on the funding of specific treatments. Once NICE
issues its guidance on a technology it replaces local
recommendations across the country.
Posted: February 2010