I had a conversation about Ibrutinib with my doctor today who firmly told me that Ibrutinib is unlike to become available in the UK for the foreseeable future because NICE guidelines typically only recommend something that costs <£30,000 per annum and Ibrutinib currently costs £90,000 per annum.
Anyone know any more about this and the likely trajectory for the costs of Ibrutinib?
Hi MeTooAsWell,
This may be of interest to you. It's the recent discussion with useful links on the subject.
healthunlocked.com/cllsuppo...
I sincerely hope your GP is wrong or the costs become achievable/adapt to economy of scale. Recent decision by NICE on funding refusal for breast cancer drug Kadcyla has made me nervous! (Although I understand there are significant differences in terms of longer term affects on OS length).
Newdawn
Hi MeTooAswell,
I do not have the trajectory costs, but share your interest in Ibrutinib. It is recognised in UK as possible second/third line treatment and has been offered to one contributor on here who is on an Idealisib Trial. The only precedent which I know of is AIDS medication and the ensuing bruhaha about using cheaper versions made in India. The patent on any medication is twenty years. I don't know how long Ibrutinib has been in R and D Stage. It is generally being prescribed to patients for whom there are few options, either due to refractory responses or prognostic indicators. As I have said here before, I cannot see the NHS refusing thousands of people an opportunity for at least three years' survival.
In addition, I would be sceptical about a discussion with a Doctor (GP) about a new treatment, unless they had inside information.
But we must watch and wait to see how it pans out.
Regards
zentangle
Thanks Newdawn for the BBC News piece - reassuring except of course NICE approval stands between "licensed for use" and "available for use on the NHS". As Zentangle says - let's hope that 20,000 of us have some say ... and that the Indians take an interest!
Hi MeTooAswell,
I'm reading between the lines here, but did you ask your Doctor as an ALTERNATIVE to FCR/chemo (as many have)? If so, even the Americans haven't suggested this, if you are able to tolerate/are not refractory. The debate will really heat up, when British people, who are refractory to FCR and have poor prognostic indicators, move into second line therapies and start asking for Ibrutinib, which could be any day now!
See also: hsc.nihr.ac.uk/topics/ibrut... which is NHS.
Regards,
zentangle
Hi Zentangle.
You are very perceptive! I am aware that at present Ibrutinib is only for second line ... but I did ask if it was possible to enroll in a trial in preference to FCR. Effectively you are right though I am VERY keen to avoid chemo, as I struggle to see the value of poisoning oneself and ruining one's immune system for life if there are credible alternatives!
Hi MeeToo,
It's a totally understandable standpoint. However, there are many people who have had excellent results from FCR (nine years remission + no relapse). Ibrutinib is only three years "out there" at present and no one knows what might happen to it, so we need as many treatments available as possible, particularly younger patients. I am particularly excited by ABT-199, and the trials using the doctored HIV virus, which could also be part of our arsenal.
It seems to be unfolding before our eyes at this moment in time!
zentangle
The 11q deletion is the fly in the ointment that adds to my search for an alternative to FCR ... but for now I'm condemned to chemo - am jealous of Mikey47 below. My doctor never even breathed a word about trials despite knowing full well that I had profound reservations about chemo.
FCR is considered a good therapy for 11q deleted...
Dr. Hamblin wrote in regards to the German CLL 8 trial...
At the same time as this paper was being presented at ASH the results of the German CLL8 trial were becoming known. This study confirms that adding R to FC moves patients with del 11q from the high risk to the standard risk group for both PFS and overall survival. With two studies telling us this I think we can believe it.
mutated-unmuated.blogspot.c...
There is to date no data on Imbruvica (ibrutinib) in this group...
Might be the C that equalizes.
True, don't think they ran a FR/FCR comparison trial, but as Furman points out for 11q FC was superior to F as a single agent...
Is it true that having chemo ruins your immune system for life? Only I have just finished having chemo (Bendamustine & Ofatumumab) and my consultant never mentioned that would happen. I thought I would slowly get better. You have me worried now!!!!
CLL ruins your immune system for life, 
but treatment can suppress it further. It usually comes back to some extent as the marrow clears...
cllglobal.org/CLLintro/immu...
It will be exciting to see what happens with BCR inhibitors like Imbruvica (ibrutinib) and IDELA (idelalisib) over the longterm...
Hi john133
I am 43 and 3 months post FCR chemo. 6 weeks ago ,after a bone marrow biopsy and CT scan I was told I am in complete remission (from SLL). My bloods are back to normal and I am as fit as I was pre diagnosis. I am going back to my job as an operational fireman in 4 weeks (stuck in an office at the moment) and am not concerned about my immune system whatsoever, though I am still taking co-trimoxazole and aciclovir as instructed. After reading lots of posts on this website for about 8 months, I have found 2 differing opinions regarding treatment. People who are on watch and wait seem to have a negative opinion about the harshness of chemo and its side affects during regimens. And to be honest ,I did find the whole experiance very unpleasant ( but some do not). And then there are the people who are post chemo, like me, who do feel very positive about the treatment ,because we have actually seen the results it can give. I do feel that , to a large extent, I have been given a second chance and intend to grab it with both hands.
Perhaps there are not as many positive comments about chemo because the people who have had treatment go on with the rest of there lives. The comfort and advice that we so desperately seek, especially in the early days after diagnosis, is no longer required and they may not use this site as much, if at all.
I dont know , maybe I am totally wrong , though I do believe that the FCR chemo I had ,did exactly what my heamotologist said it would do. I am still on cloud nine , full of energy after being given my news regarding remmision . I am very determined to go and live the best life I possibly can, something I do not think would have been possible without treatment.
Sorry for rambling but please do not get to caught up in the negativity of chemo, I for one feel totally differently about it.
Best regard for the future Mark
Hi Mark Your reply cheered me up a bit. I think I was on different Chemo than you. I am not sure what FCR means, was it pumped into you by needle? You also had SLL where as mine is CLL. I am not down or depressed and I get on with life although I do suffer from pains in various parts of my
body at different times. I am 71 years of age and have finished work but I hope to go backpacking in October if my health is OK. what do you think of my chances??? By the way I have two in my family in the fire service.
Good Luck
John
John, I hope this helps explain what FCR is and how it's administered;
macmillan.org.uk/Cancerinfo...
Newdawn
FCR in the U.S. is delivered by means of IV, whereas in the U.K. and Canada for example, the fludarabine and cyclophosphamide are oral medications... only the rituxan is given by IV in most cases... so it varies...
Thanks for that clarification Chris, useful to know. I understand John is from the UK so hopefully the Macmillan explanation will be relevant for him. (It's when location really does come in handy!) 
Newdawn
When I had FR, the fludarabine was a pill/tablet, but when I had RCHOP, the prednisone was tablet, the rest (vincristine, doxorubicin, rituxan and cyclophosphamide) were all by infusion.
When I switched to Etoposide, it was both pill and infusion... so, it is a very mixed bag...
Yes get what you're saying Chris. It was just an attempt to give John a rudimentary explanation of FCR because he said it didn't know what it was or how it was administered. If the Macmillan link is inaccurate/too simplistic or doesn't give sufficient variations on application, do you have an alternative link that would assist him Chris?
Regards,
Newdawn
The link is great... It discusses both oral and IV protocols for FCR.
What I'm trying to say is different treatments have different regimes... and it varies by country...
Monoclonal antibodies like rituxan and ofatumumab are delivered by IV.
However, rituxan will soon be available for subcutaneous fast infusion...
Bendamustine is delivered by IV only...
fludarabine and cyclophosphamide are both oral and IV...
Chlorambucil , Imbruvica (ibrutinib) and IDELA (idelalisib), ABT-199 etc. are all oral...
The fact is patients prefer taking a pill than having a needle driven into their vein... kinder, gentler...
Sorry, if I got off on a tangent...
Correction in Alberta FCR is all iv. Husband just had it finished 12 months ago. So far a great success. Would never know he was ever sick. He is 47 and has trisomy 12 that was doubling very quickly and was suffering from severe fatique, swollen nodes and weird infections. His disease was progressing very rapidly and was treated within 2 weeks of diagnosis. Saw CLL specialist within1 week of family physician and started chemo 1 week later. No watch and wait for him!!
High john133
FCR is fludaribine, cyclophosphamide and rituximab. The R is administered via IV and the F and R are given over 3 days in tablets. Its just a different kind of chemo given to (no offence) less mature people, as the side affects can be a little uncomfortable. SLL is in the tissue and CLL is in the blood but they are treated in the same way, both conditions are generally lumped together. Back packing in October sounds good to me, some of the lads at work are doing the three peaks in July, over 3 days, but are cycling between the mountains. I can save a place for you if you fancy it.......At 71 years young you have got decades left in you, all the best to you , and keep up with the exercise
Regards Mark
Hi Mark,
Thanks for the info I get more on this site than I do from my consultants and Doctors. I am determined to go backpacking around Indonesia etc this winter as I I have always done before I was diagnosed last year with this problem. I cannot get travel insurance because of what I have (CLL) but what the hell I am going anyway.
Good luck on the three peaks and as much as I would like to try it I do not think I am quite that fit enough yet.
John
Nice post, Mark.
Sounds like you're keeping well. I was wondering if you had ever considered going to a local Support Group? or what your thoughts on such things were.
Regards,
Steve
I was put in touch with a support group but I was a bit ill every time a meeting came up (once a month). I do think they are a good idea, I was offered councilling at hospital from specialist councillors ,but I got nothing from it, only people who have walked in our shoes know how we feel. Talking with people who are in our world, who have had the SAME cancer as us must help in my opinion.
Regards Mark
With that in mind, would you be up for attending a Manchester meeting? There is a Lymphoma Support Group at Christine's either May 14th or July 9th?
Regards
Steve
If I can get out of work I would defo be willing to go to a meeting, however as regards support for myself, I am totally ok with where I am today. I am fit and healthy, and after reading some of the posts on here feel that I must be a bit of a fraud, I genuinely feel that good after getting through the other side of FCR.
I would not have a problem with discussing my experiences and perhaps helping other people who are where I was pre chemo .
Please keep me informed of developments, regards Mark
Good to hear you feel so good. The meetings I've mentioned are 7.30 - 9.30, so let me know, or we can try to find an alternative. I'm not sure what I will get out of it, personally, but I think I would like to speak to some people face-to-face about their experiences, including your good self!
Regards,
Steve
Sincere apologies about my delay in replying, I cannot do next week but should be OK for the meeting in July. Sharing experiences I do feel would be beneficial for all, and I will always try anything once. If you go next week please let me know how you get on
Regards Mark
I have been taking Ibrutinib/Imbruvica since last September as part of the RESONATE-2 study of Ibrutinib vs Chlorambucil. I was at the point of needing treatment and asked for a second opinion and a referral to Bournemouth Hospital which is one of the centres for this international study, (which is now closed to recruitment).
Ibrutinib/Imbruvica is currently only available (in the UK) to those enrolled in trials/studies. I also wanted to avoid chemo and was fortunate to do so by keeping an eye on current and upcoming trials and being proactive. You will need to be referred by your haem/onc/Dr.
It boils down to QALYs... here are a few pdfs that discusses this from the UK perspective... most healthcare systems outside the U.S. will be sharpening their pencils...
'Quality-adjusted life years (QALYS)
A measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.
QALYS are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality of life score (on a zero to one scale). It is often measured in terms of the person's ability to perform the activities of daily life, freedom from pain and mental disturbance.'
Another problem we face in 'small markets' like Canada and Australia for example, is that the drug companies may feel it is not a viable market... that it would be a poor 'business decision' to bring a drug to market... so they never advance to the approval stage.
Bendamustine and ofatumumab are two such examples... they languished on the shelf... only recently are the drug companies seeking approval and funding now in Canada...
...
nice.org.uk/website/glossar...
scottishmedicines.org.uk/Ab...
medicine.ox.ac.uk/bandolier...
medicine.ox.ac.uk/bandolier...
medicine.ox.ac.uk/bandolier...
I remember QALYs (were they not initially DALYs?) from when I was working as part of the management team at an international health research centre in Bangladesh. All very appropriate and frankly essential in this age when we have learnt how to prolong the quantity of life (sometimes with way too little reference to quality of life).
One of my friends/colleagues at the research centre went on to head the geriatrics department of a leading research hospital in the US and visiting us one day said, "I do not know what I am doing. We can prolong life almost indefinitely now - but the quality of that life is not worth living."
Of course, given our collective background, implicit in the comment was that for a fraction of the money we could be saving millions of children in developing countries. But in line with my Living Will, I have no desire to prolong my life for the sake of doing so.
At 53 and CLL aside, fighting fit, I feel like i have a few QALYs/DALYs left!
DALYs are quite different... it is sort of a glass half full, glass half empty thing...
The disability-adjusted life year (DALY) is a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death.
en.wikipedia.org/wiki/Disab...
Ahhh ... thanks so much - that's very helpful indeed.
The disability-adjusted life year (DALY) .........the burden of disease - DALY = YLL + YLD
.... now I'm depressed. The number of years lost due to ill-health, disability .... sounds like I'm a living 'stat'.
... I'm so so tired, it's like swimming in glue ... me eyes are sore, me ears are ringing and me Oww's are back ....... ( meoww's ...??? ) sounds a bit feline ... or am I just being a bit ...catty ?
Oh well it could be worse .... I might still have this persistent sore throat, but at least I don't sound ' hoarse ' ..... we all know what happens to them ... right !
I read this brain frying article (one of a number Chris helpfully posted) and it explains why we appear to need more administrators and statisticians in the NHS than medical staff....
medicine.ox.ac.uk/bandolier...
Now this really will make you go oww YGTGO!
(But joking aside, I hope you're doing ok).
Regards,
Newdawn
Just a bad day ... payback for being out and about on Saturday
... Good grief ... you couldn't make this up ... as I am typing,my new cd has just started 'jumping' ... like a scratched vynyl record ... tracks 25 and 26
Zeus and his crowd are sitting on a cloud having a laugh at me, firing little lightning bolts in my direction .......
I think it would be wise to leave the lottery numbers for another day ....
...( Suck's thumb ... pick's up teddy ... and goes to bed )
I have heard whispers that it will be approved in UK within one or two years. Here's hoping.
Hi,your doctor is wrong to my understanding Ibrutinib is already being used in the UK.I know because my consultant said he's acquired Ibrutinib on my behalf,should my current treatment with Ofatumumab fail.I"m not alone i'm in contact with someone else who has also been offered Ibrutinib should their current treatment fail.I wish you luck in your quest.Regards Lee
Hi There,
Where are you and the hospital you attend? I have been on that Ofatumumab and I couldn't take any more chemo and would willingly try this Ibrutnib. I cannot make sense of what my consultants tell me. I get the feeling that they are overwhelmed with people like me and want you out of the door and out of sight as soon as possible.
Hi Lee,
Your post has brought a smile to my (and I'm guessing many others') face(s). Is there any possibility that you could tell us a few more details: your prognosis, location, age etc. just so that we can contextualise ourselves regarding your situation.
Regards,
zentangle
Hi Lee,
I'm ready to move to register with your wonderful doctor - where is he / are you?!
I had the most depressing consultation with some poor stand-in doctor who had been on call all weekend yesterday ... every question I asked about alternatives, options and ways to reduce the impact of chemo was essentially answered with "No" or "I don't know" ... I felt like he had just stepped out of a Kafka novel.
It shows there are ways and means if Lee can access it which is very reassuring!
Newdawn
I couldn't help but share a few thoughts
It was announced last month that while we await European licences for Ibrutinib/Imbruvica. Treating consultants can gain access using an expanded access/compassionate use program on a named basis until September, this is only available for treating patients who will not respond to available treatments and have run out of options , those in wales may have difficulty gaining access.
Once licensed, approval/recommendations have to be given by NICE for NHS access . Initially these will reflect the groups that have produced trial data, the scoping period and full appraisal can take at least another year and adding the concerns about cost justification is the reason CLLSA are supporting an on-going campaign to raise awareness of the benefit of these Transformational Therapies in CLL , To lobby UK Members of Parliament, the UK regulatory bodies and the Pharmaceutical companies. Details in thread: healthunlocked.com/cllsuppo... and the CLLSA newsletter.
It will take a lot more time for data to be created before availability can be considered by regulatory bodies for first line treatment settings for the younger fitter patients and cost justification will be the greatest hurdle to overcome. The randomised CLL10,FLAIR Phase II/III trial (Ibrutinib + Rituximab vs FCR) is not open until next month in the UK, I believe a US equivalent has just commenced. It will take several years before anything concrete can come from this. by then the landscape may have moved on further as other new treatments and new combinations progress through trials. the talk is a combination of novel non chemo therapies may produce the results needed to meet QALY requirements??? There's no doubt the future is looking very promising, but it will take time.
For UK members, there's a programme on ITV at 7.30pm tonight called, 'What Next for the NHS' and a preview suggests it's going to explore the issue of funding expensive cancer drugs. An early trailer has featured refusal of 'life prolonging' drugs for a woman said to have 'an incurable blood cancer'. Can't guarantee it's quality but a heads up for anyone interested.
Regards,
Newdawn
Here is a link to the program synopsis ... itv.com/news/2014-05-01/ton...
Mary Stanton has Hodgkin's lymphoma, the drug she can't get is ofatumumab... apparently. Very sad...
Not certain why rituxan would not be an alternative...
dailymail.co.uk/health/arti...
Thanks for posting the details Chris, I was mid dinner prep when I saw and posted it! Yes very sad and worrying indeed.
What I find particularly disturbing are comments like this following the article;-
'There is no need to take Ofatumumab to treat Hodgkin's Lymphoma when there are other ways to treat this type of cancer. For example, following a raw food vegan diet will help to put the cancer into remission. There are also other treatments such as: hemp oil, B17, sodium bicarbonate, etc.'
Isn't B17 banned in Canada and actually not a vitamin at all but ground apricot kernels (Laetrile) which contain cyanide?
Sheesh!
Newdawn
Sheesh is right... not certain how well CD20 monoclonals work with Hodgkin's actually... there are a few subtypes... it certainly isn't a standard treatment...
en.wikipedia.org/wiki/Hodgk...
If this women had CLL then transformed to Hodgkin's then perhaps CD20 would be possible... but I think then this would be a highly exceptional case...
Ibrutinib in US is 90 USD per 140mg pill full price. Std dose is 3 * 140mg/day * 365= 98,550 USD/yr or 56,206 UKP/yr at today's exchange rate
Slight fever in the evening with Ibrutinib
Trouble Getting Insurance Approval for Ibrutinib in the US?
STATIC now beginning to open at sites in the UK
