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Imatinib intolerance

Dear All,

I am trying to compile a response to the new NICE ACD for IM intolerance and would be grateful if those of you who have any or all of the following would contact me before tomorrow:

a. experienced grade 3/4 adverse effects of any kind
b. have haematological intolerance to IM (i.e blood counts drop to worrying/dangerous levels)
c. due to intolerance are now treated with 2nd generation drug

Please contact me as soon as possible with an outline of your story...... and also let me know if you are willing to talk to media etc.

As you are aware, NICE have separated off the two patient populations which means that iM resistance will be appraised at some future date as part of the TA70 reappraisal of imatinib. That might be seen as good news for resistant patients, but I must admit I remain cautious in my optimism.

However, the urgent issue now is that we have to focus on the new ACD for IM intolerance and my thinking on this is:

* the issue of inequity remains
* intolerance - haematological adverse effects- can be life threatening
* intolerance can mean that IM can only be given in a 'sub-optimal' dose supported by other drugs to support marrow function (GCSF)
* intolerance can be 'intolerable' and adversely affect quality of life

There is at least one other anomaly contained in the NICE response that I cannot go into here just yet but just to put this all this into context the cost to the NHS of funding either one of the 2nd generation drugs for IM 'intolerance' would be:

* The likely number of intolerant patients per year -approx 35 multiplied by the acquisition cost of either drug to the NHS -both just over £30-31,000 =
£1,850,000.00 per year....... ! Think about it. (sorry, noughts in wrong place- this figure should be £1,085,000.00)

I would really appreciate your support. There is rather a tight deadline for me to compile a well argued response.

Sandy

HI Sandy
I was diagnosed in March 08 and all seemed to be going well until September of that year when I became ill and after a couple of weeks was taken into hospital looking a bit like Marge Simpson (facial colour, not hair!) as my liver was not working properly - was in for two days and then released and was taken off Imatinib as it was thought it had caused the severe reaction. Have been on Dasatinib since December 08 and doing really well on it. Despite being a tortoise, my results are coming down and I have gone from BCR-ABL of 8.2 in 08 to 1.24 in November of last year. Happy to talk to anyone about this and have just got engaged so maybe that would add a nice 'personal' bit to the story.
K

Dear karena,

thanks so much for your quick response, I have emailed you privately.

Sandy

Hi Sandy
Hi Cost is £1,085,000.00 I think ?

Please contact me if you think my story would be helpful. Now on Tasigna, after intolerance (and start of resistance ) to Glivec.

Severe oedema,(swollen legs = hard to walk) periorbital swelling, dry eyes and blurred vision, skin problem = flaking peeling bleeding with slightest tear. , horrendous cramps and bone pain, particularly legs and arms. Stiffness and cramps hands and feet. Severe stomach problems- diarrhoea3/5 times a day, mouth ulcers, fatigue to the extent of feeling like a female rip van winkle! Night sweats, temperature spikes. Cold hands and feet = inner cold so couldn't get warm even with direct heat.

Hell was it that bad - just looked back into my clinical diary - yep it was.

Pennie

Hi Pennie... yes your're right of course. I have put the nought in the wrong place....figure should be £1,085,000.00.

Thanks for the details of your intolerance. I know you had a very hard time for over 5 years?
This is helpful thanks again,

Sandy

Not that I want to strengthen the NICE case, but if we have 35 new intolerant patients a year then the cost is £1M per year in year 1, but it's £2M per year in year 2... £10M per year in year 10 etc. Still peanuts in the greater scheme of things.

On the splitting of intolerant from resistant patients, call me cyncical, but I wouldn't be at all surprised if one result is that by removing the intolerant people (who probably have a higher chance of successful treatment than resistant people) the success percentages and thus cost effectiveness fall for the rest in the resistant group making it easier for them to reject it.

Dear Sandy, as you know I have gall stones as from 12 months ago and the condition has got worse. I think I have also as a result developed some difficult intolerance with my Glivec - 600 mg daily. Because the gall stones are now giving me nausea most of the time I am also finding it very difficult to keep down the Glivec tablets - which I now have to take twice a day and with food. In the past eight years I have not had any problems in keeping down glivec. Guess I have currently been receiving a much smaller dose of glivec than prescribed owing to the above situation. My PCR due to be taken next week will be awaited with some slight trepitdation. My Specialist is aware of the problem. It is not thought wise for me to have my gall bladder removed and so they are trying to dissolve the stones with tablets as of last week.

I suppose this is an intolerance brought on by a further condition but, nevertheless, is very real.

The copy letter we spoke about will be with you this week.

Love Pat P.

pat preston

Hi Phil, yes you are right about the cumulative costs... but as you also say this represents so little in cost terms and when/if you factor in the wider social cost benefit of the lives saved/ability to return to normal life etc. etc. then I think the argument is won.
I am not sure what the actual cost to the NHS of NICE appraisals like this but I am willing to bet that it far outstrips the cumulative costs of these 'expensive' therapies.

I remain cynical and agree totally with your view of why they might have chosen to split IM intolerance from resistance.

Sandy

BTW: I believe the cost to the NHS of patients missing appointments is over £500 million per year....every year.

Hi Sandy,

My story is almost bang-on Pennie's..particularly with regard to intolerance then resistance. Side effects exactly the same except, as you might remember and certainly my friends do, I lost almost complete ability to walk and also, worse than everything else, was a complete loss of mental ability with diarrhoea embarrassingly constant. Due to my PCR failing to reduce by very much, I was put on a higher dose, which I then declined to take. My PCR is doing fantastically on Dasatanib, but I do still suffer appalling pain and insomnia. The latter never having been an issue in the past.
Vickie

Hi Sandy,
I am currently trying to change to Nilotinib due to intolerance and hope that my PCT will agree. Hammersmith have recomended the change so hope it will go ahead.
Had I lived in London a prescription would have been written there and then but as I live in Herts permission has to be asked of the PCT.
One though that could be argues is why is the NHS charged VAT on drugs when there is no end user to pick up the tab. Those of us who get Glivec from the Hammersmith can sign up to get the drugs sent to our home by courier tus saving the VAT on that prescription. Why cant all expensive drugs in all hospitals be treated the same way. Imagine the saving on a national scale. Enough to pay for everyones drugs

I will help in any way I can and will meet with any MP media or anyone that might be able to helpour cause.

Steven D

Hi Sandy,
Never given my 'story' before - just been a very appreciative reader of the many contributors to this great forum. I am happy now to add my contribution to maybe help you in your data search.
At age 63 I was diagnosed with CML Sept 2006 in France - where we lived until Jun 2007. Started Imatinib, 400mg once per day, 4th Nov 06 and, apart from a steady ticking off of the side affects boxes with minor body reactions to the drug, was seeing the blood counts nicely returning to normal - not that they were dramatically high to start with, and life was fine again after the initial worries. Unfortunately I was steadily building up an allergic reaction which manifested itself mid Dec 06 as a respiratory problem. Initially treated by my local Dr., as panic attacks & depression, the condition deteriorated such that my husband insisted that I was X-rayed. This done I was quickly on my way to a Pneumologist Consultant (on a Saturday 11a.m!) who personally carried out various breathing tests before checking my blood/oxygen to reveal just 43% oxygen present. Lucky not to be hospitalized I was put on Steroids & Oxygen(which was delivered within 1hr of arriving back home)for a month.
My Dr. had been in contact with the Consultant in Rennes and on 16th Dec I was taken off the Imatinib and told it was never to be prescribed for me again.
I saw my Consultant again on 9th Feb 2007 and was prescribed Dasatinib 100mg once per day.
To be perfectly honest I have never suffered due to CML - only side affects, I was diagnosed via a routine annual blood test, in good health at the time just on hypertension tablets and an osteosporosis tablet.
I have been able to continue to live a perfectly normal life uninhibited in any way and for that I am very fortunate.
Without Dasatinib I would be approaching the last months of my life - given the expected 3 years which my Consultant said would have been my life span without the wonderful advances that have been made in the treatment of CML.
My treatment in France was excellent and I have been very lucky to have had first class care since my return to the UK.
I will be happy to answer any questions you, or others, may have.
Thank you Sandy, and all the other major 'players', who are contributing so much time and effort on our behalf.
Well done!

Irene

Hello Steven,
I hope your PCT is prepared to fund nilotinib. Talking of savings- just implementing a system of one phone call to remind patients of their appointments -like my dentist and optician does- would save over £500million every year.

Best of luck with your quest for access to the right drug and the treatment you need.

Sandy

Dear Irene, thank you for sharing your experience of imatinib intolerance. As your story clearly illustrates 'intolerance' is not quite as straight forward or simple as the word implies. It can be life threatening.

I am sure your information will help me compile a robust defence against this cynical move by NICE in the separation of the two patient populations.... if NICE feel they do not have enough data to make any recommendation at all for blast crisis patients (which means that subset will continue to have a chance to get the drugs) then how can they assess and make a recommendation for intolerance given they have stated that there is a 'paucity' of data for the intolerant group?

Best wishes,

Sandy

You have to dig a little deeper to see the true insanity of the NHS and VAT. Yes the NHS is charged VAT, but it is then able to recover it from HMRC. In order to maximise this VAT recovery they pay millions of pounds a year in fees to accountancy firms to help them with their reclaims. In essence this means the government is paying private companies huge sums purely to move cash from one government pocket to another.
Ho Hum
Phil

Dear friends,

I have asked my friend Pat Preston to post this for me because I do not have a computer but I do know about what cmlsupport are trying to do about the decision by NICE to not fund Dasatinib and Nilotanib in England. I feel that waiting for the next decision by NICE is grossly unfair to all CML patients and their Specialists. This article is mostly to try to help you Sandy but also to give hope to everyone else.

As a patient at Nottingham City Hospital for the last ten years I have lived through one aborted transplant and two new trial drugs - Imatinib and Nilotanib. I was also given the dreaded interferon for 18 months. I can only describe that as like going to hell and back. I also have a needle phobia so injecting myself was hard. The side effects of interferon were severe tiredness, loss of memory and finding it difficult to walk in a straight line.
Interferon makes a mess of your quality of life and NICe should not be recommending it now.

I was prepared for a bone marrow transplant in 2000 but the donor withdrew at the last moment. In depair I found the STI 571 (Imatinib) trial at Nottingham City Hospital and joined it. Unfortunately I soon became very prone to respiratory problems - a side effect of Imatinib - I also became prone to infections generally. I was admitted to Nottingham City Hospital haematolgy ward and spent three and a half months there during which time I nearly died. I was on continuous antibiotics and intravenous drips. I was still having to take Imatinib of course but my dose was reduced to just 200 mg daily. I also had severe odema and pain in my rib cage and joints, my eyes were like Miss Piggy and I could hardly open them.

For six years I was on 200 or 300 mg Imatinib daily because of the dreadful side effects. My PCR was not good. In 2007 I was put onto the Nilotanib trial at Nottingham City Hospital and within 8 months I became a new woman. Everybody who knew me was amazed at the new Judith - absolutely full of energy, no respiratory problems or odema or arthritic pains. I take 400 mg of Nilotanib daily and am also in remission with a wonderful PCR number!

The only thing I want to say to NICE is get real. We are such a small number of CML people in England. Leukaemia Specialists haave spent their lives studying CML and know what works and what doesn't. Let's have no more of the dark ages like NICE are forcing upon us. What about people like me who were intolerant for years and suffering on Imatinib and when switched to Nilotanib became a new person - almost normal. I fear everything is going to waste so we must keep up the fight.

Sandy, if you would like to read my hosptial file I give you permission to speak to Dr. Jenny Byrne at Nottingham City Hospital - who would support me. Also would NICE like to read my hospital file. You have my permission.

With best wishes to everyone, Judith

With my best wishes to you all, Judith Smith.