CLL Support Association
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Ibrutinib victory

To all of you who supported my petition to get life saving cancer drug called Ibrutinib available to people in my situation, I have been informed by Sean O'Niel of the Times that NHS England have reversed their previous ruling and within a week I should be eligible for treatment. A formal statement is being made at lunchtime. Thank goodness as I'm very I'll in hospital at the moment and this is a huge lift.

Thank you so much for all your messages of support.

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This is absolutely fabulous news Mick and thank goodness it’s now being made public! I look forward to the full details of the formal announcement.

I’m particularly relieved because of your situation but for all of us who may be relying on this drug hopefully after a longer than 3 yr remission.

Take care and hope to see an amazing improvement soon.

Many thanks to everyone who made representations and worked really hard behind the scenes to push this issue...you know who you are! 😊

Newdawn

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I specifically asked Sean about the 3 year rule and his words were it's lifted. I'm elated as I'm so ill at the moment and it gives me great hope.

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We are all rejoicing with you Mick. The significance of this can’t be underestimated!

You’ll be back on your feet and fighting fit soon I’m sure! 😃

Newdawn

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I can't take the credit for this so many people behind the scenes did so much to make this happen in particular CLLSA Leukaemia Care, Janssen and the lead clinicians. Plus all of you who got your Mps to write in. I should have put this in the previous post but I was so elated Sat here in my hospital bed. So apologies for that. But great news providing the announcement is As good as said to me.

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F A N T A S T I C N E W S ....

VERY happy for you Mick..

And this shows how some pressure on 'The Authorities' can have a beneficial effect if we all push hard enough.

Such a shame that such an obviously stupid decision had to be reversed like this.

Dick

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Yay

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I’m really pleased for your Mick!

That’s a great victory for you and everyone in that position.. are you still going to pursue the trial or just go ahead with the Ibrutinib?

Well done to everyone who signed the petition or has written letters to MPs.

Stuart

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Hi Stuart

My first choice would be the trial. But the drugs not available yet and the consultant doesn't know when it will be. As you know I'm very ill in hospital at the moment. Depending on what happens or is offered? I'm not even sure if I'm well enough for the Ibrutinib.

The official statement is lunchtime and I'm told the drug will be available in a week under new rules. So really going to depend on my health between now and then. But I have good feelings about the trial.

You take care too.

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Hi Mick

I’m sorry to hear your still really ill.. a few more days of fighting and you’ll finally get the therapy you deserve.

Hope your better soon and best wishes.

Stuart

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Great news for you and for everyone affected both now and in the future

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This is wonderful news 💃 Your efforts will improve the outcome for so many. Keep us posted with how you’re doing.

Pam

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Hi Mick, sorry you in hospital, feel better soon. Many congrats on ibrutinib breakthrough, big achievement.

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Lovely lovely news! Thank you for all your efforts and keeping us up to date - very best wishes and everything crossed for your own health and recovery xx

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Mick - we are with you in spirit. Get well soon, so you can truly celebrate a victory in which you played a critical role.

Updated publication link as Mick's original one is now broken: england.nhs.uk/wp-content/u...

I am wondering whether we should not be pushing for a critical review of NHS England's processes for taking these decisions. This was done in a disturbingly clandestine manner and only "outed" by The Times. I wonder how many other similar decisions are being taken on the sly by NHS England.

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Thanks. I agree about clandestine way of changing guidelines. As Leukaemia Care, CLLSA and Bloodwise say it should be clear and transparent.

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Truly incredible news and I am so delighted for you. I have been following your situation and so it has brightened my day knowing you can now get the treatment you so desperately need. I echo your thanks to everyone who has worked so hard behind the scenes to get this decision reversed.

Wishing you all the very best for your ibrutinib treatment.

Helen X

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It's great news! Sorry I couldn't tell you the other day :(

I hope you get it asap.

Jackie

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Thankyou for all the hard work you have done behind the scenes x

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The link for the NHS news release does not always work:-

Try this, it is a long 19 page PDF file.

england.nhs.uk/wp-content/u...

The summary.

Our detailed considerations and conclusions are set out in a full report at Appendix A. However,

the key points can be summarised as follows:

• Firstly, the CRG had been correct in its interpretation of the evidence base for the use of

ibrutinib in 2015 (entry into the Cancer Drugs Fund) and 2017 (publication of NICE final

guidance) as being in patients considered unsuitable for treatment or re-treatment with

chemoimmunotherapy (CIT). The CRG noted that NICE endorsed this interpretation in July

2018. The CRG also considered that it had been correct to set the treatment criteria that it

did, as these were based on the available published evidence in 2015 and 2017.

• Secondly, having reviewed the latest available data, much of which has only become available

in 2018, the CRG concluded that the evidence now supports ibrutinib, on clinical effectiveness

grounds, as a treatment option in patients who have previous remission durations of 3 or

more years. Newly available data shows that ibrutinib is more effective than previously

thought in patients unsuitable for CIT and points to the likelihood of ibrutinib being more

effective in patients suitable for treatment or re-treatment with CIT than in patients deemed

unsuitable. Furthermore, the CRG reviewed the changes in clinical trials and practice as to the

choice of CIT regimens in patients with previously treated CLL as well as the 2016 and 2018

trial data and this revealed less activity for treatment or re-treatment with CIT than previously

thought. The CRG has also concluded that the recent additions to the evidence base for using

a remission duration of 3 or more years with the preceding line of therapy as a way of defining

suitability for CIT mean that it is now not one that is robust enough in 2018 for NHS England

to use in setting treatment criteria for access to ibrutinib.

• Thirdly, the CRG was unable to conclude whether expanded access to ibrutinib in patients

considered suitable for retreatment with CIT would represent a cost effective use of NHS

resources. The available evidence simply does not allow for a judgment on cost effectiveness

to be formed. Given the inevitable budget impact of expanding access, this should be noted.

• Fourthly, the CRG noted that it would welcome Janssen’s input in assisting NHS England to

mitigate the financial risk of commissioning of ibrutinib in a broader population of patients. I

am pleased to confirm that Janssen has agreed a commercial arrangement which will enable

NHS England to recommend its use in the wider population. The CRG recognises Janssen’s

flexibility and partnership approach to working with NHS England which has allowed a

solution to be developed which is a win-win for all parties involved and ensures that ibrutinib

is available to patients, while securing fair value for taxpayers.

Having considered all of the above, the CRG was unanimous in its view that, on clinical grounds,

the ibrutinib clinical commissioning treatment criteria in this indication should be amended such

that it can be made available as a treatment option for those patients who have had remission

durations of 3 years or more with their preceding line of therapy.

>>>>>>>>>>>>>>>>>>>>>>>

This sentence in the above is questionable:-

‘ Secondly, having reviewed the latest available data, much of which has only become available

in 2018. ’.

This sentence is worrying:-

‘ The CRG was unable to conclude whether expanded access to ibrutinib in patients

considered suitable for retreatment with CIT would represent a cost effective use of NHS

resources. The available evidence simply does not allow for a judgment on cost effectiveness

to be formed. ‘

Dick

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Basically the NHS document does two things

1. Try’s to justify why they had the restriction in the first place (presumably to avoid any potential legal action)

2. Explains that with essentially immediate effect they have dropped the 3 year criteria.

This is a face saving climb down and a huge victory. It’s interesting they specifically note the individual patient submissions so it is certainly worth making more of those for future similar situations in addition of course to the patient groups, doctors, etc.

We should all feel very happy as nobody is going to be forced to do FCR twice, though of course it is acknowledged that in consultation with their doctors and an informed consent regarding benefits and risks of each some people may still be treated with FCR a second time —-if they want it—— after a very long remission and if it makes clinical sense.

So glad that common sense has prevailed.

So thrilled for Mick especially.

And for those of us starting our treatment journeys eg on FLaIR at least we can know we will only have to do FCR once if that’s what we get as our first treatment.

That’s worthy of a beer or two if your doctors haven’t banned you from alcohol consumption! And it’s even raining and a bit cooler today so the world is a better place today....

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Thanks Adrian. Wish I fit enough for beer. Just had news they found an specific infection in my blood and will i be in for a few days longer. But according to the review ibrutinib won't be available to the likes of me for 2 weeks. Gives a chance to recover anyway.

Cheers

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I’ll perhaps have one on your behalf!

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Nice one

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Mick - I am thrilled for you! We never know, when we take on a cause, whether it's the initial effort, the combined efforts coming from multiple directions, or the one more name on a petition that pushes things through to a good (In this case great!) ending. You should be proud of yourself for the effort you put into this, as everyone who backed you should be!

I hope that the fact that they have found the specific infection causing your current illness means that they can now treat you with the best meds. for it. It sounds like that might be good news, also, though no one wants to spend more time in a hospital than absolutely necessary. I guess you'll have to celebrate with a drug cocktail today, but that should lead to the day when you can properly celebrate any way you want to - cake, balloons, streamers, loud noise makers, a popped cork, whatever floats your boat! Do they say that across the pond?

I hope the trial comes through for you, but I'm so glad that you now have a backup that makes sense if it doesn't. Hang in there, and keep us posted!

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Thankyou your kind thoughts are appreciated. Yes they can target the infection but it just means it will be a little longer in hospital. And I am responding well so looking good.

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This STILL seems to be about saving money:-

This sentence in today's letter is worrying:-

‘ The CRG was unable to conclude whether expanded access to ibrutinib in patients

considered suitable for retreatment with chemoimmunotherapy (CIT) would represent a cost effective use of NHS resources. The available evidence simply does not allow for a judgment on cost effectiveness to be formed. ‘

' considered suitable for retreatment with chemoimmunotherapy (CIT) '.????

In reality how many would choose Chemotherapy AGAIN after FCR. The side effects of chemotherapy can be devastating. Peripheral Neuropathy for example can be crippling for many patients.

Dick

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This was always about the money. It's only the amount of political pressure that's changed it. Unfortunately they will cut another drug and there won't be the uproar this caused. My consultant treats myeloma and he's having a similar problem with that. I don't think NHSE has knew what bit them with all the external pressure.

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Mick please let Sean of the Times know the name of that drug. I think we owe it to others that we let this be a precedent: NHSE can’t be allowed to get away with changing NICE guidance. I have a personal contact at Westminster I could also mention the name of the drug too....

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Thanks Dick

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Also note the line about the fact they did a new deal with Jaansen. Let’s not forget Jaansen have been good in this whole situation

1. They knew the health economics wouldn’t work out at the moment for first Line in the uk so didn’t even submit for that to NICE

2. They agreed with Hillman etc to fund FLAIR knowing that would reduce the numbers of people getting paid ibrutinib (if not for flair everyone will get FCR first line and so then be eligible for ibrutinib when they fail with FLAIR only a third to a quarter of enrolled patients get FCR and so would be eligible after the trial for paid ibrutinib. With 1500 patients going into FLAIR that’s a lot of free ibrutinib! It’s a wonder NHSE isn’t doing a better job of promoting FLAIR to be honest as they get a great deal out of it!

3. At the time of the NICE appraisal they did a financial deal with NHSE based on the nice guidelines (which would have included ALL patients post FCR being eligible) and factored in a predicted rate of use of paid ibrutinib giving NHSE effectively a “bulk buying discount” compared to other countries. So the price quoted is NOT what NHSE is paying.

4. NHSE reneged on deal mentioned in 3 meaning the volumes would not have been so high so Jaansen could presumably have argued the deal was void.

5. In the small print of this document it is noted that Jaansen has done a further deal with NHSE to “manage the financial risk to NHSE”. I don’t know if this is a cap on the number of patients NHSE will have to pay for or some form of discount. But it’s the mark of a responsible pharma company that this has been done.

I must say this bodes well for the future post FLAIR when if the results support it FCR may be on the scrap heap of history and it sounds like Jaansen is taking a long sensible view and so hopefully getting the eligible population wider to match the licensed indication (all CLL including first line) is going to be achievable in the future at some point.

Jaansen is definitely one of the smarter and fairer Pharma companies who look for win win situations.

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Re your paragraph 1. Perhaps at the next NICE review (2020?) Jansen could be persuaded to submit an application for first line treatment (in addition to 17p deletion) as, speaking purely from memory, I think recent data shows that Ibrutinib is much more effective first-line than second-line etc. Presumably that would have a bearing on the economics? Antony

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I don’t think the data will be strong enough for first line without FLAIR results which will be later than that. And in particular the health economics of it. You’d have to show that ibrutinib gave a much longer remission than FCR and was associated with much better quality of life. The big issue with ibrutinib is how long you have to take it for. This is why the VI combo is potentially much more attractive. Even tho it might be double the price if you only take it for two years and then you get a fantastically long remission, which in some cases may even be effectively a cure, and in those who do get regrowth it turns out they aren’t usually resistant to it, well that would be more cost effective than FCR for sure. So I suspect that VR or VI or even perhaps VIR will eventually become first line standard but ONLY when we have the results of FLAIR which could have world changing effects not just in the UK. I honestly believe we owe it to future CLLers to seriously consider whether we can volunteer for FLAIR when it’s our turn for treatment. My friends and family tell

Me I should really think of myself, however, and I get that. But even if I do think of myself if we assume one of the FLAIR arms is way worse than the other two and there’s a small difference between two of them, that’s pretty good odds of a good treatment for me as an individual. And as at 47 I’ll almost certainly have to try everything, before I die as an old man hopefully, then FLAIR with all the careful monitoring you get from being in a trial and a chance of what may be the platinum bullet (VI) well it seems a darn good option for me.

Will I be disappointed if I’m randomized to FCR you bet! But do I believe that I have a great chance of at least an initial Resonse to FCR, well yes I’d have to accept that.

Do I want to be at the mercy of an insurance company funding my ibrutinib? Not really. What if I do really well, get back to work, then want to change jobs and hence would lose the cover and the new job insurance company would not just have to agree to take me on for pre existing conditions but to take over the claim! I can’t see that working out too well and as much as I love my current job I don’t think I’d be able to do that till retirement if I return to full health. At least with the NHS they are duty bound to continue something they have started for as long as it is clinically indicated. UK is a funny system as our private insurances are cheap too ups to the NHS which are not very robust at all. And we don’t have a robust network of services privately like we do in the NHS. I use my private insurance for discreet things like dealing with a specific operation or funding a test that I’d have to wait for or not be eligible for on the NHS (so pre chemo you’d have an ECG and maybe an echo in the NHs, I’m getting a cardiac MRI privately which is a Robust screening tool...it’s almost certainly going to be normal even tho I have a lot of tachycardia but the reassurance will be so encouraging for me it worth it and if I was rich enough I’d pay for that myself.

I would never want to be treated in a private hospital for a serious infection however which might need ITU. And there’s loads of stufff the NHS does better in the UK.

.

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Thank you for your very detailed reply. You clearly have given all of this much thought and analysis. One thing I am not clear on-have you definitely decided to go on the Flair trial?

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So thrilled about this decision Mick.

Get well soon so that you can start the Ibrutinib! Brilliant.

Thanks to all of you behind (and in front)

who have worked hard

Good news for everyone who needs this drug.

Get better quick Mick.

Best wishes

Sue

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Thanks Sue.

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Absolutely DELIGHTED to hear this news, Mick. Such a relief for you, but also for the many others who were likely to face the same situation.

Wishing you all the best for the future, and strength for the next 2 weeks while you wait..

Paula

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Hi Mick so pleased to hear this great news. I hope you get well soon and start the Ibrutinib treatment you were so wrongly denied.

Take care

Ann

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Congratulations! It’s truly a miracle drug. Saved my life! Been taking it since February 2015. Cheers from Montreal Canada 🇨🇦

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I agree with all the above and now hope your stay in Hospital will be less stressed ! And much cooler !

Colette x

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Fantastic news! It has to be worth all the effort put in by yourself and many others. This has got to give you the lift to be able to start ibrutinib. Positive thinking. Well done x

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Well done Mick and everyone else involved in this fight to get Ibrutinib.

By coincidence and after months of feeling unwell and a rapidly expanding Spleen I was told today that I will be starting on Ibrutinib and will be going next week for a consultation and explanation of what to expect,and thanks to all the information posted on here by this wonderful community I can go with a feeling of ease.

Best Regards

John

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Good luck John

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Thanks Mick,hope you start feeling better soon

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Congrats to you and all the others that helped them to see the light. Hope you will be out of the hospital soon, and able to reap the rewards of your hard work!

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Wonderful news! All of the hard work of those who have been campaigning has paid off. Many, many thanks to everyone who wrote to their MPs and enabled this reversal.

I hope that you feel better soon Mick491 and are discharged from hospital. X

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Thankyou

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Mick491

Best news! Finally NHS has done the right thing.

Hope you will be better soon and able to start the medication Mick.

All our thoughts are with you.

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