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Reply from DH on Dasatinib/Nilotinib

Dear all,

I received the reply from my MP who wrote to Dawn Primarolo, Minister of State for health re the issues surrounding Dasatinib & Nilotinib. The Minister states that Dasatinib was licensed for use in the treatment of CML in the EU in November 2006. As this licence covers the use of Dastinib in the UK, clinicians are able to prescribe the use of the drug on the NHS.

She also confirms that the DH have referred Dasatinib & Nilotinib for Glivec resistant CML for appraisal as part of the NICE Multiple Technology Appraisal programme. The NICE Project Manager is Ms. Jennifer ALTY (jennifer.alty@nice.org.uk)Issues around the timetable should be directed to her. The Minister then goes on to explain what NICE does, including that once NICE guidance is published, PCT's must provide funding for the uses recommended by NICE within 3 months of publication to allow clinicians to follow guidance.

This does not replace the knowledge & skills of individual health professionals who treat patients. She states that it is not appropriate for Ministers to intervene in local decision making, but PCT's should not refuse to fund treatment soley on the grounds of cost but should consider all the circumstances before making a decision. They expect PCT's to plan ahead and to consider the implications of introducing all cancer drugs that may be recommended for use by NICE.

In relation to Scotland, the Minister accepts that the Consortium assesses appraisals of medicines before NICE, but it does not consult as widely, nor does it consider the same depth of evidence as NICE. NICE decisions normally take precedence.

I'm not sure if this makes any difference, but at least the issues have been raised again with the DH.

Best Wishes,

Phil.

Well done Phil
perhaps we should print this off and shove under the noses of the respective PCT's who deny patients this life saving preparation. At the risk of annoying an awful lot of ladies, seems to be that PCT's are being run by people with no compassion and even less imagination as to patients medical needs.
Once again, well done
Have fun and keep smiling
Keith

Hi Phil,

thanks for the copy of your MP's answer from DH. Same information as usual but I think the more MP's that annoy the DH ministers then the more we make them aware of us ... the patients who are the ones that will suffer if the new generation of TKI's do not get NICE approval.

What the minister told your MP is all true but I have contacted Jenniffer Alty (my contact info says there are two ff's in her first name) who is the published contact on the NICE website and she is very heplful.

She told me that they -NICE- are waiting for the DH to give them their final decision to put the two drugs into an MTA for NICE appraisal... when I contacted the DH they said they were waiting for the Scoping and Draft consultation documents from NICE and that the decision would only be made by the DH when they received these documents from NICE.
I then contacted Jenniffer again and she confirmed this was true and apologised for not making that clear in the first place ;o))) She estimated that the relevant documents would be in place soon and that the decision would be in place by end of April/May this year.
If you read my update on the present situation... see under Newswire section... it will hopefully explain where we are now.

For patients who need urgent access to dasatinib and have been refused funding by their PCT or NHS trust then the only recourse is to go to a Patient Review Panel and fight the PCT on an individual basis.

Given that at best estimates we are looking at around 16 months before we see the NICE appraisal and, hopefully, a positive decision to fund both dasatinib and nilotinib, it is obvious that some patients who show resistance to Glivec will be in a life threatining position.

We are currently working on a way of helping such patients and one of the ways we can do this is to develop a booklet explaining the way to tackle the problem by taking the case to a Patient Review Panel.
As I reported earlier this year, we have one member of this group that did this and won against a particularly cynical PCT. He was resistant against both Glivec and nilotinib (Tasigna) but still they would not fund dasatinib.
This patient has said he will advise and help anyone in the same or a similar position.... If anyone knows of an individual that is having problems like this then please email me at sandr1ne@aol.com and I will pass on the contact details.

I hope we can produce our leaflet soon but this is a complex area and it takes quite a lot of research if we are to get it right. I also have to do this in my spare time so it is taking longer than hoped....

Whilst we wait for the NICE process to grind on the Patient Review Panel is the only way I can see of helping patients who are in urgent need and live in certain regions of England without access to dasatinib or nilotinib.

best wishes,
Sandy