Biotech Values

[DewDiligence]

This is UK NICE’s statement on the rejection of Tasigna/Sprycel in
CML. Please note the passage that is both bolded and underlined.

http://www.nice.org.uk/newsroom/news/evidencetosupportchronicmyeloidleukaemiadrugs.jsp

NICE is unable to recommend the use of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia in patients who cannot tolerate the first-line treatment imatinib, after finding that the evidence to support their use is “very poor”.

Neither of the drugs fits the NICE end-of-life criteria, introduced to allow Appraisal Committees to consider expensive medicines licensed for terminal illnesses, as the available evidence on life extension is too weak.

But even if the end-of-life criteria had been met, the exceptionally high costs of dasatinib and nilotinib, taken together with poor quality evidence on the drugs’ effectiveness, would not allow NICE to consider the drugs a cost-effective use of NHS resources.

This latest draft guidance comes after the independent Appraisal Committee met, last month, to discuss issues around the cost-effectiveness modelling raised during the first public 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The independent committee will next met on 9 March 2010 to consider any further evidence before issuing the next draft guidance.

In other words, NICE is saying: “Lower the price and let’s talk!”