You are here

NICE- Appraisal meeting for dasatinib/nilotinib and high dose imatinib for IM resistant CML in chronic phase

Dear All,

As some of you are aware, NICE are in the throws of an multiple technology appraisal of dasatinib, nilotinib and high dose imatinib for use in imatinib resistant CML in chronic phase patients.

Yesterday I finished writing CML Support Group's comment (endorsed by Leukaemia Lymphoma Research, Macmillan and Leukaemia Care) and have finally sent it off to NICE within the deadline! 

NICE have asked CML Support Group to send 2 patient representatives to the appraisal meeting in Manchester on Tuesday April 12th. I would like to ask members of this forum who are in chronic phase and are resistant to imatinib and who are either taking dasatinib or nilotinib to come with me to the meeting. It would mean staying over in Manchester on Monday night. 

Please let me know asap by contacting me at cmlsupportgroup@gmail.com if you are willing to attend this meating. All accommodation and travel costs will be covered by CML Support Group.  

It would mean that you will be asked questions about your therapy and response etc. by the appraisal committee in order that they can take into account the effectiveness of the 2nd gen. TKI's in the resistant (rather than the intolerant) population.

Thanks,

Sandy

Dear All,

I need to find someone quite quickly so for all those of you who are IM resistant and have a good response to either of the 2nd gen. drugs PLEASE contact me if you are willing to attend the meeting. This is very important for the future of IM resistant patients getting access to 2nd generations TKI's. Your positive experience will help ensure this happens.

All expenses are paid for and you will NOT have to speak, only answer questions should one of the committee wants to clarify something.

Sandy

Are you

Resistant to imatinib? Responding to dasatinib or nilotinib? Want to help make sure both 2nd Gen drugs are available to all CML patients?

If you are free on April 12th please get in touch

Sandy 

Sorry Sandy

if i fell into that criteria i would be there with you, but i am on imatinb and only have been for a few wks sorry x

Hi Sandy

Not sure i fall into the right category - I ended up with my liver going haywire and having to come off Glivec before going onto Dasatanib?

K

Hi Karena .... this time the appraisal is for the resistant population- I am hopeful that it will be good news but you can never be totally sure  which is why we need to keep fighting for the right to the best therapies ;o)

thanks so much for the offer- I am hopeful that we will find another resistant patient (I had a resistant mutation before dasatinib or nilotinib were even in clinical trial ... but I was lucky to have a matched donor so went on to have a transplant)

best wishes,

Sandy

Thank you for your support ;o) ......you need to concentrate all your efforts on getting to 0%- leave the fighting to others for now ;o)

Hope you are doing OK and not suffering too much with side effects

Best wishes

Sandy 

Dear All,

just to say that we have a IM resistant patient who has volunteered to attend the NICE meeting with me on April 12th. Thanks Bob ;o)

Best wishes,

Sandy

Hi

Just wondering how the meeting went with panel. When will there be a decision.

Regards

Steven

Hi Steven and all,

I cannot say much at the moment- we are subject to strict confidentiality agreements and cannot be seen to divulge the internal processes of NICE appraisal committees.  However, I can say that we (prof. Apperley,Prof. Clark, Bob and myself) tried very hard to convince the committee of the great need for access to both drugs. Both professors were able to point to compelling clinical evidence which supported this. Bob told of his own experience and dramatically improved response to dasatinib over imatinib, and I made a few comments in support of the wide age range at diagnosis and made a plea to understand the wider social cost savings of TKI's for CML.

One committee member said that it was good that they were given the opportunity to meet face to face with patients and this helped their decision making process easier. So... all in all I have no clear idea of how it really went. We were only allowed to stay for the initial part of the meeting - the decision is taken later on in the closed part. I would say that I was a little concerned at the overall 'atmosphere' but then it is difficult to judge these things.

I have been told the it is very hard to second guess NICE and its various committee decisions so I remain hopeful that in this instance they will base their decision on the very clearly positive clinical evidence as opposed to overwhelming pressure to cut healthcare costs. However, it would be fair to say that they might succumb to pressures to 'save' money.

The meeting was quite daunting (40 strong committee with complicated cost effectiveness models from expert economists and statisticians etc.) but I think for the most part we managed to get our message across.

However... the ACD it might be negative and we should prepare for this.... which I am in the process of doing by planning our next moves should the decision be negative.

Consultees will hear during the first week of May (diverting attention in a week dominated by wedding and referendum?)  But the decision is embargoed until NICE publish it on their website the following week so I will have to remain silent until then I am afraid. 

All I can say is that I am hopeful of a good outcome... but I am not entirely confident. 

Best... Sandy