NICE has updated its draft guidance on the use of Bristol Myers-Squibb’s dasatinib (Sprycel) and Novartis’ nilotinib (Tasigna) for chronic myeloid leukaemia.

Following a public consultation, both NICE and the appraisal committee have agreed to split the appraisal of dasatinib and nilotinib in this indication into two separate appraisals.

The current appraisal relates to patients who are ‘intolerant’ to the standard treatment, imatinib (or Glivec), for whom NICE does not recommend dasatinib and nilotinib.

An appraisal into the use of the drugs in patients who are ‘resistant’ to imatinib will be incorporated into an upcoming review of NICE guidance on high-dose imatinib for chronic myeloid leukaemia compared to standard imatinib treatment.

In response to other criticisms 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. A second Appraisal Consultation Determination (ACD), or first draft, has been issued for further consultation.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, said: “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.

“The cost of the drugs is also extremely high and before committing limited NHS resources to fund them, we need 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.”

The draft recommendations are now open for public consultation. The manufacturers have also been given the opportunity to provide further evidence for the independent committee to consider at its next meeting in March 2010.

This entry was posted on Monday, February 8th, 2010 at 6:18 pm and is filed under Home Page News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.