David and I will be attending the NICE appraisal committee meeting in Manchester on Wednesday. The meeting will consider the comments on the recent ACD (published Dec 2011) for nilotinib and dasatinib in 1st line therapy.
We have already given evidence to the committee both as a group and as individual patient experts, so we will be attending this meeting only as observers in the public gallery.
NICE has made it very clear that unless dasatinib is subject to a PAS (as is nilotinib), or some other formula to discount the cost to the NHS, they will not recommend its use. They have already published the TA240 which does not recommend dasatinib as a second line option. Should patients need access to dasatinib in 2nd line they will now have to apply through the Cancer Drugs Fund.
Obviously, we hope that this issue can be resolved through a PAS so that at least patients have the option of therapy with dasatinib in 1st line. However, that is a decision for the manufacturers.
NICE continue to refuse novel cancer drugs because of cost rather than efficacy. There is a cost threshold of £30,000 per therapy per year, we believe that the 'actual' threshold upper limit that the AC bases its appraisals is now lower.
There is a certain amount of guess work required but it is not difficult to arrive at this unofficial upper limit- and then make an informed guess at a figure that they are realistically willing to accept.
One thing that we have learned over the last 2 years during our strenuous efforts to get access to 2nd generation TKIs in both 1st and 2nd lines, is that although NICE has taken note of some points of objection raised by outselves and clinicans, they are certaily prepared to move 'goal posts' at any time. Unlike a few others we have spoken with recently, we see this as the present trend that is not affected by arguments centred on grounds of 'fairness' or morality and ethics, or even clinical efficacy.
The pharmaceutical manufacturing sector's response might well be to withdraw from the UK, as we have seen with decisions to close facilities by both Pfizer (a loss of 6000 jobs when they close their facility in Sandwich, Kent) and Astra-Zeneca, who announced last week that they intend to close down at least 300 research jobs in the North West.
Let's hope, for the benefit of future newly diagnosed patients, that a realistic assessment of the current situation prevails on Wednesday, and there is some movement on a 'deal'. Otherwise CML patients in England and Wales will be refused access to dasatinib altogether.
