I eventually found the correct page on the NICE website. Good news for nilotinib- not so for dasatinib and high dose imatinib. Of course this has implications for blast phase patients as nilotinib is not thought to be effective in that phase- whereas dasatinib has shown efficacy for some BC patients.
It goes without saying that newly diagnosed patients will suffer inappropriate care and inequity should appeals agains this decision fail.
This descision shows that it is purely a matter of cost, & has nothing to do with the effectiveness of the TKI's to treat patients.
If Novartis had not reduced their price then Nilotinib would have been turned down as well, it just shows that all of their talk of needing proper clinical trials to the efficacy of the drugs before they could them for use was a complete load of rubbish, But they will never admit to that.
There are appeal routes and I know Sandy is looking at those. I don't know for sure if they will but I would not be surprised at all if BMS (who make dasatinib) appeal.
I think you are right to feel strongly, as NICE has taken the easy route to approve nilotinob because they have achieved the discount they set out to get, and refuse dasatinib because they haven't. The decision does not begin to address the fundamental problems with the appraisal and the criticisms of the original ACD and its methodology, raised in particular by the clinicians (who were concerned that their evidence was misinterpreted and has been incorrectly represented). It doesn't even acknowledge the latter point, which reflects very poorly on NICE. This is all about cost and not effectiveness - the line shifted after the ACD though the NICE press office continued to bang on about effectiveness - and takes no proper account of the actual needs of CML patients. It's about driving down prices.
It is illustrative of the quality of this appraisal generally that NICE has published the pre-publication draft (which is marked "confidential" and has some missing information in it)!
I think MPs need to be aware that this is not the end of it and the outcome is only half good (and that the crictisms of the appraisal have not been addressed). I plan to write to Vince Cable again pointing this out.
Appeals process is complex and as Richard says we are trying to decide how best we can do this. We can only appeal on the issue of 'process' ...we are not allowed to use any arguments that we have used previously.
As far as I know individual members of the public are not allowed to apeal directly through the NICE system- so the only way we can do this is through CMLSG. I am not sure how we will do IT, but we only have 15 working days to do find a way to argue that they have not followed the correct process, the deadline is 2nd September.
It might be that we can argue that they have not had the correct model for appraising novel therapies in orphan diseases (like cml).... but it needs careful consideration.
I suggest that if you feel strongly that you keep up the political pressure- but try the tack that Richard suggests.
Unfortunately for us, the fact that nilotinib is now offered through a PAS, which is more or less a price cut, has undermined all the arguments about efficacy etc. This FAD confirms that NICE is all about cost (we knew that all along didn't we) rather than evidence of effectivness.
Sandy
I have just made time to read the NICE decision in full together with all the submissions made by everyone who responded to the consultation.
I am truly horrified. This an unfair and flawed process from beginning to end. Some of the comments by Jane Apperly in her response put some simple and very clear points about the process, the incorrect information used by NICE, the fact that the statistical studies can be altered dramatically in outcome by small changes in the input assumtions, that an oral presentation went so fast that even she was unable to respond rationally, the wrong belief on the part of the Committee (oft repeated) that hydroxycarbamide and allogeneic transplant are suitable alternative treatments for all patients, which they patently are not and the Committee was so told by the Consultants. So it goes on. This is what happens when there there are no CML specialists on the Committee and NICE continues with its inability (or conscious blindness?) to devise new procedures to deal with innovative drugs. This was not a consultation. It was a farce.
The only thing that altered the Committee's view was a Novartis' Patient Access Scheme for Nilotinib (ie it will be cheaper than it might otherwise have been).
This NICE "system" is irrational and perverse. We are a third world country in cancer treatment whatever David Cameron and Andrew Lansley may say to the contrary.
Can I express here my very sincere thanks to everyone who responded to the Consultation, particularly Sandy for the work on this, to Jane Apperly and the other Consultants who responded to the Consultation and to Novartis for putting in place a Patient Access Scheme for Nilotinib. All of you have contributed to saving the lives of many CML patients, who would otherwise have been left by NICE with no effective treatment. That will include my wife if she ceases to respond to Glivec. Thank you all from the bottom of my heart.
