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NICE ACD- nilotinib/dasatinib

Dear all,
here is the link that Pennie asked for (Bhiru had posted it earlier in the week) and takes you to the Appraisal Consultation Document (ACD).

www.nice.org.uk/guidance

I understand from NICE that members of the public (as opposed to official consultees and commentators) are requested to send their comments through the link on the NICE website.
see link below:

www.nice.org.uk

I suggest you comment in your own words and with your own understanding of the issues.

As I said in my previous post, the Appraisal Committee do not accept the data from the open label trials as they consider open label trials do not produce truly robust evidence.

They have stated in their conclusions that they would like to see
3 arm (dasatinib, nilotinib, HD imatinib) double blind randomised studies with clearly separated patient cohorts (intolerance to IM vs resistance to IM)in order to produce what they consider to be the best possible data.

They would then be able to produce a more favourable cost utility appraisal of both drugs.

They do not accept the evidence from the trials up to now as they consider such trial designs (open label, non blinded) seriously flawed.

They would prefer double blind RCT's that included a control group, one that would receive only 'best supportive care' rather than the TKI's. Then they would be confident that the drugs really worked.

I would argue that if the CML patient population were say, children that they would not ask for such double blind trials. This would be considered by the public to be morally/ethically unacceptable.

Let me put it this way:
If you had a cohort of 20 children all with chronic stage imatinib resistant (IMR) CML, and divided them into 4 groups.

5 received HD imatinib, 5 dasatinb, 5 nilotinib and 5 best supportive care, allowing none of them to crossover and no dose escalations according to how they respond. Would you accept such a trial would be morally correct? I think not.

The only reason that they punt out requests for such trials is that the CML patient population age is averaged at 60 years (in their model)

High cost NHS treatment for heart disease; diabetes; neo-natal care etc. are never capped or subjected to NICE HTA's.

HIV-AIDS costs are not subject to NICE HTA's. Why? because the patient population is strong, extensive and very vocal.
Learn the lessons.

Sorry to be so strident but I am very frustrated. The NHS is paid for by the UK population through a pooled risk insurance scheme. In other words you pay your insurance in case you might one day need to use the NHS. It follows therefore that some will pay their whole working lives (like my father) and never need or call upon NHS services... but he does not resent this. I paid my insurance and did need intervention... my transplant which costs more that £100,000 was not denied.

(This is the rational behind shared/pooled risk insurance e.g car insurance, however we are free to make a decision not to have a car, but cannot predict if we will remain healthy or get ill.)

If you do develop a life threatening disease like CML and there are life saving drugs available, but you are told that your life payment into the national insurance scheme now doesn't cover you because the cost it considered too high, then how do you feel? Would you consider this a fair deal?

You will have to take your on view on this. My views are personal to me.

As CML Support Group is a consultee I will be making our official objection to this ACD within the deadline for it to be considered for the Appraisal Committee's next meeting on 13th January 2010. After that meeting the FAD will be published (Final Appraisal Document)
If you wish to use your right to influence the FAD then you must act.
I think you could also write to your MP's, Doctors, PCT's and flag up that you are not happy with this economic model used by NICE. It renders human beings into objects with a consistent response the all drugs and all doses. We, as patients along with our clinicians know that this is not the case. Statisticians render everything to fit their models for their preferred outcomes.
If you support a 2 tier NHS with payment of top up fees then this sort of situation would be a consequence of that kind of system.

Sandy

Thanks for this Sandy, you have worked hard and fast to get this out into the CML and public arena.

Strident is what we had to be 9 years ago - here we go again. I will leave a VERY STRONG comment on the NICE site.

Plus if it's chain ourselves to the railings outside Parliament I'm ready !!! How about everyone else? WE CAN NOT LET THIS HAPPEN - yes I am shouting. Never did I think it would happen again, that CMLers would have to fight, shout, and stand - up to be heard to get proper treatment.

Perhaps one very important aspect that needs to be pushed forward is the age range of CMLers -there are many younger people with this cancer - where are they in the statistics?

Can CMLsupport give evidence to NICE countering this? Do we need to help you get it together, and if so how?
ATB

Pennie

Dear Sandy and Pennie

Firstly thank you Sandy for your input this morning on BBC Radio Oxford. I know its only a local radio station but its still a start. I hope I gave a balanced view. Forgot to mention that its freely available to those in clinical need in Wales and Scotland.

I have already registered my protest on the NICE website and written to my MP. I will also construct a letter to send to our PCT and doctors surgery. I will also send it to the Department of Health for good measure. Happy to chain myself to railings if that's what it takes. This is not exclusively an older persons disease. My son is only 17. He's currently doing well on Glivec but what if that changes? It sound like transplant or nothing. Also on the pooled risk that is the NHS, my husband and I take very little from the system but have paid into it collectively for 56 years.

The triple blind trial would be totally unethical if it were applied to a sample of the many younger people with CML. The reverse is also true that this is an ageist decision.

Happy to help wherever I can.

Sarah R

Some of us already know that we can't have a transplant whatever the circumstances, while some wont find out until the time comes. Thus a resistance to Imatinib would leave this group of people to suffer the consequences - if these new drugs were to be denied. Do N.I.C.E. take these things into consideration when making judgements on Dasatinib and Nilotinib? Anyone know because it would seem not. No matter what trials N.I.C.E. would like to see, there is plenty of evidence of people already benefitting from these drugs. People who are alive now and might not have been otherwise. Seems like they don't want to look at that evidence.
It smacks of their arguments to allow CML'ers to progress to advanced/blast crisis, before they were going to allow access to Glivec.

Just one other question. I had always believed that thr relative costs of the drugs - Glivec, Dasatinib and Nilotinib - were comparable. Is this not so?

As I understand it Dasatinib and Nilotinib are 25% more expensive than Glivec.
Glivec patent will run out and the drug price will drop one day,now the alarm bells must have started once the spirit trial started to give Dasatinib and Nilotnib to newly dx patients.
I thought it was very workman like aproach to start newly dx cmlers on Glivec first and proceed to the 2nd generation drugs if needed.Keeps the costs down and options open
Demo at westminster ? count me in
Michael

Hi Sarah, Pennie and Dennis,

Sarah: you were great on the radio and made your points extremely well. Well done.

As far as protesting then I strongly suggest that the NICE website is the way to go. I am going to take the line in the CML Support Groups comment to NICE that the appraisal committees modeling is immoral.
Asking for dble blind RCT's for cancer patients of any age, who have a seriously life limiting disease is not acceptable.
If we are to access life saving/prolonging drugs (and remember they will also refuse HD imatinib for accelerated and blast stage CML)then all of us need to raise our voice in protest.

I really hope the many hundreds of CML patients who access this forum and live in the UK (whether they will continue to access the 2nd gen TKI's or not) will make their comments on the NICE website.

Sarah it is great that you have already sent a letter to your MP and if you are willing it would really helpful if you could share a general template of the letter for people here to use and personalise.
Please contact me on cmlsupport@gmail.com if you are willing to help in that way.
We need to put pressure on MP's to ask questions in parliament as you already have done and also of the health ministers and Sec. of State for health -the lovely Andy Burnham ;o)

I agree that this is ACD ageist.. but it really does depend on whether you are going to stand and make your voice heard or sit in a corner like a good patient and just take what's coming.
I was told during the NICE appraisal meeting of imatinib back in 2000/1 that as the average age was 50 (not sure why in this appraisal the average age is 60) then well we'd all had a 'good innings' and would just have to accept it (certain death).

There are people who are not able to see themselves as vulnerable to cancer, but we are facing an epidemic in Europe and need to face up to how we are going to pay for this. How much are we, as UK citizens, willing to pay for a truly excellent NHS with equal access to treatment for all at the point of need?

At the moment we are concentrating on our own cancer because there is a crisis. But there are many other rare cancer patients that cannot access therapy or for whom there is no therapy because their cancers are in low numbers.
In the era of the genome, research has taken us into a new world and imatinib was the 'poster drug' for this revolution in cancer therapy. What is the point of investing in such knowledge if citizens cannot access the fruits of that knowledge?

Sandy

I am a newly diagnosed CMLer, I have been on 400mg Glivec for 2 months.

Please count me in, I took great comfort in knowing that there were 2nd generation drugs out there helping people that were unable to take Glivec for whatever reason and most importantly prolonging life.

I am appalled at the suggestions made of the 'average age of diagnoses' somehow justifying this, makes me sick to my stomach. I am 30 but my life is NO more important than others!

I am hoping that I can bring something useful to the table, as I am in Media Marketing as a profession.

Would you like me to try and contact national newspapers? I would need some support from you regarding the technicalities as CML is very new to me, but I am sure I could create some interest between us.

Please let me know.

Michelle

Double post - sorry.

There is also the situation where some, maybe quite a few, Glivec patients can't even up their current dose because of [in my case for instance low platelets] or because of intolerance. These facts need to be put to the people at NICE, because that's part of their reasoning that Glivec patients can simply raise their dose. Well what about the people that can't?

Hi Sarah,
I woud love to chat with you. My son will be 17 next month. He was diagnosed with CML in September and takes Glivec daily. I cannot believe they are considering this action.
Lynn

Hi All

This is my first posting having been diagnosed in September. I have entered the Spirit 2 trial and prescribed Dasatinib. Results this week show my bloods are all in the words of the consultant "Going in the right direction" and very pleased so far. My wife and I both went to Nottingham last weekend for our first CML conference. Very well attended and organised. During the day it was felt by the consultants that NICE would reject payments for the various drugs. The advice given out was for everybody to contact local MPs, newspaper, radios and any other media that people could come up with and to shout long and hard. As a new member I am unsure exactly how to word a document to these people and would appreciate any thoughts of how to construct the correspondence. Have been reading the web since dx and find it very interesting and informative. Please keep up the good work.

Graham

Just posted my comments on NICE website. Am about to start penning letters to MP/ Department of Health but quite apart from putting down my feelings about the potential harshness and unfairness of this guidance I'd like to put some telling comments about the calculations used in the paper but feel significantly disadvantaged as a layman in terms of not understanding the calculations!! Have we any access to the consultants who served as consulants to the NICE committee, Dr Stephen O’Brien, and Professor Jane Apperley . I see from the document para 4.3.13 that the clinical specialists criticised the Assessment Group’s model, arguing that it did not reflect disease progression and clinical practice,and that the clinical specialists said that both drugs are equally effective, and that this was not reflected in the Assessment Group model. Given the terribly bureaucratic and slow approach of NICE on these issues, I suspect attacking the accuracy of their modellling offers some advantages. Would it be possible to get some guidance from Jane or Stephen?
Sandy and others - would you have contact info?

Pennie, are you going to the Kings CH CML support group next week. I've asked for the NICE document to go on agenda.
Regards – Andy

Not sure if I will make it to Kings on Wed - am in west country for a few days R&R !

Think if you want to put in telling comments something along the lines you have used above would be good.
If you look at the stats document as well as the appraisal doc my son pulled out some pointers for me,
p18 Nilotinib effective in chronic phase.
p21 Nilotinib prob below £30k per QALY threshold.

Also I have put in my letter that the demographic spread of the disease is from early childhood onwards, not just an 'old persons' disease, plus wrote about unethical aspect of the suggested trial - Sandy talks about that in her post earlier. Her point about rare cancer is very relevant, plus the development of these specialist target drugs is the way forward in all cancer care and here they are saying that they wont pay for it!!!

Good luck with the writing.
ATB
Pennie

Hi
I have read the report on the NICE website, but I'm still a little in the dark. What exactly does this mean? Is funding being withdrawm for Dasatanib/Nilotinib? Does this mean that if Glivec/Imatinib ceases to be effective I would not have the option to try something else?
Sorry for my ignorance, any explanation in laymans terms would be appreciated!
Anna

Please see Sandy's posts on contacting her for info about writing letters etc, I am sure she will have the info in laypeoples terms ready for us soon.

But yes that's my understanding of the general tone of the document, that's what the appraisal document is proposing. No second line drug. BUT the reason its so very important that we all shout loud, write letters and fill in the consultation on line is that this is a consultation document, and we can/must put in strong objections. Time is short for this part of the process, so please get on line and register your comments on the appraisal. The final decision has not yet been made so every chance possible we need to voice our opinions and try to influence the final decision.

Dont feel ignorant we all feel lost in this horrid process, I couldn't even start to think about it for 2 days after I found out. I was frozen with fear.

ATB
Pennie

My thanks to Anna for breaking the ice for those of us not quite understanding the situation. Thanks Pennie, I get it now...Personally, I'm Imatinib resistant and responding much better to Dasatinib.
How about a Facebook group of some sort? Any ideas?
Vickie

Vickie

what a brilliant idea. Now I just have to sort out how to get on facebook. Starting that now. How do we find each other?
ATB
Pennie

Thank you all for the information. It seems unbelievable that this decision could be made, the very fact that these drugs are available and can save lives, but deemed to be expensive, beggers belief.
I will contact my local MP as well as the candidates for the impending election and will comment on the NICE website. I would love to join the facebook group and Michelle I have sent you a friend request (I hope you don’t mind).
Take care everyone
Lynn

Hi Michelle

I have sent a friend request to you on facebook, if we can get lots of us grouped together think how many extra 'friends' we can encourage to help our fight.

Take Care

Helen

removed

I think it's important to start a Facebook Group of our own in order to maintain our personal/family privacy. I have no idea how this could be best achieved. We'd need administrators and we'd need to be laying the facts in ways that all our friends could understand, whilst also presenting some of the statistics. A petition link is a really good idea.

Vickie

I now think that all we actually need to do is get a petition link that we can all paste into our Profile page on F.Book.
Vickie