You are here

NICE MTA dasatinib, nilotinib and high dose imatinib for imatinib resistant CML

 

NICE: Appraisal consultation document Dasatinib, high-dose imatinib and nilotinib for the 

treatment of imatinib-resistant chronic myeloid leukaemia (part review of NICE technology appraisal guidance 70) 

Appraisal Committee’s preliminary recommendations is:

Dasatinib, high-dose imatinib and nilotinib are not recommended for the treatment of chronic myeloid leukaemia that is resistant to standard-dose imatinib.   

People who are currently receiving dasatinib, high-dose imatinib or nilotinib for the treatment of chronic myeloid leukaemia that is resistant to standard-dose imatinib should have the option to continue treatment until they and their clinicians consider it appropriate to stop.  

Please read the CML Support Group Press statement on the Home page.

A bad day for most CML patients in England, Wales and Northern Ireland.

I can detect a certain cynical manipulation of the announcement date by NICE to avoid today’s news being announced a week today on Friday the 13th. For make no mistake about it , today’s news amounts to a grave crisis for patients in the UK living outside Scotland who might go on to develop resistance to or become intolerant of 400mg imatinib. Never mind all those that are yet to be diagnosed.

The NICE Appraisal Committee have decided NOT to recommend dasatinib, nilotinib or high dose imatinib (typically 600 or 800mg) for patients who develop resistance to standard dose (400mg) imatinib, currently the first line treatment for CML patients.

In doing so they have chosen to discount not only the evidence of leading UK clinicians that these three treatment options produce distinct benefits for CML patients but also ignores the results of their own commissioned assessment that concluded that there were discernible improvements in outcomes following their use.

I am sure you are as equally shocked as I am.

We need to remember that 40% of CML patients show resistance or intolerance to standard dose imatinib, so this is something that will affect many of us.

Those most immediately affected will be patients showing a sub optimal response to 400mg imatinib as they will not be able to increase the dose, or those already displaying signs of resistance to imatinib but have not yet changed therapy.

Since we do not have sufficient knowledge about how resistance develops or can identify those who are likely to become resistant, this is news will worry the majority currently receiving the standard dose of imatinib.The options will be limited to Hydroxyurea, interferon or, for the small minority for whom it is suitable, a stem cell transplant. Unless you live in Scotland or can move to a western European member state.

The Appraisal Committee are fully aware of lack of effectiveness of Hydroxyurea and Interferon compared to the three TKI's as they are also aware that transplant is not an option for the majority.

Why have they decided to turn the clock backwards?

They say that there is not enough evidence available from single arm studies and consider that such studies have been constructed and conducted in a manner that is unable to produce robust data in order to establish how much benefit resistant patients gain from one or other of the drugs in this appraisal. All the studies mentioned show clear benefit and better responses but the committee find they don’t meet required standards.

But they will never be a clinical trial that is acceptable to them because the patient populations for this rare disease is too small to be able to generate sufficient recruits to such trials ,and those that might be recruited are far to smart to stay on a trial arm that means they have to take substandard treatment.

There will never be enough evidence in order to convince them.

What can you do and what is CML Support doing to try to get the Committee to reverse its

recommendation?

Well the good news is that if you are living in Scotland or are willing and able to migrate to Scotland, you will be OK as all three options are available there. The other good news is if you are fortunate enough to already be receiving treatment for resistance/intolerance with dasatinib or nilotnib, then you can be sure that you will be allowed to continue as long as you are responding and your doctor agrees.

Timelines:

Responses to the negative recommendation will be accepted up to May 27th. Individual responses from patients and members of the public should be made through the NICE website by email link.

A Final  Determination (FAD) of the pelimenary appraisal will considered when the committee meets again on June 9th in Manchester.

CML Support Group has issued a press release urging the appraisal committee to reconsider its recommendation.

see copy of this on the home page

* will present a detailed formal objection to NICE before May 27th deadline

* will work with McMillan Cancer Support, the Leukaemia & Lymphoma Society and Leukaemia CARE to ensure a co-ordinated response to NICE

*will work with leading CML clinicians who are members of the various professional associations to ensure they are aware and are supportive of our views.

*will seek support from CML patient advocacy groups within the EU and beyond in a letter writing campaign which will target the health ministers and the Secretary of State for Health

  • *Set up an online petition to be delivered to NICE by May 27th

*Travel to Manchester on the June 9th to make sure we have a visible, if  silent, presence at the FAD meeting.

*write to the relevant Department of Health Ministers and in particular Andrew Lansley expressing outrage at this retrograde step in an era when patient choice is supposed to prevail

  • *try to generate media interest in our campaign over the next three weeks

*Target relevant MP's and ask them to put questions to the house

 

What can you do?

*Comment by email link through the NICE website.

  • *Write individual letters to the Department of Health Ministers, Secretary of State for health, your local MP,   your regions MEP and national and local papers/media to express your concerns.

letters to your constituency MP's are very important   Please feel free to use the templates for suggestions on content and style but please personalise your letters as much as you can.

  • *Try to visit your local MP at their weekly surgery and lobby them face to face- demand they submit parliamentary questons to the health ministers

*We must act now, in all the ways outlined above, to put enough pressure on NICE to persuade them to reverse their peliminary recommendation to refuse therapy with dasatinib, nilotinib for resistant CML on the NHS.

We must try to succeed for the sake of all patients especially future newly diagnosed CML patients and for those who might go on to prove resistant or have sub-optimal responses to standard dose imatinib.

 

Sandy

I found out yesterday that I am now resistant to Imatinib and was disgusted to hear of NICE's decision as I, and many others I'm sure, now face a fight to get it.

How can they mess with peoples lives in this way! I am the mother of 3 children the youngest being 4 so are they saying my life is not worth the money it would cost to put me on Dasatinib or Nilotinib, how can they put a price on life!

I shall certainly be lobbying my MP, e-mailing NICE and anything else that would help.

I'd like to attend the meeting in June too, is that possible?

 

Jackie

Hi Sandy

 So much for the Primeminister talking about getting rid of NICE

Please can you point me and others in the direction of these templates again.

 

Many thanks

Steven

This is shocking news for all of us and after such a hard fight too. A grim day. I hope the media pick up on this again.

The sooner NICE is disbanded the better - how they can make this sort of decision is beyond me but hopefully enough pressure can be put on to make them look again at this and give hope to the people who need this therapy.

Back to petitions and MPs i think

K

Please see link to Telegraph who have an article on the NICE draft recommendation.

http://www.telegraph.co.uk/health/healthnews/8495374/Leukaemia-sufferers-denied-drugs-available-in-Scotland.html

We will have letter templates uploaded asap. Needless to say we have been working hard on the press release which I sent to a number of journalists early this morning.

Please take time to read the press release on the home page- 

Over the next few days we will have a new petition uploaded on this site too. Please bear with me, there is a lot to do :o)

I will put up links to MP's and MEPs etc as soon as I get time.

Sandy

http://www.nice.org.uk/newsroom/pressreleases/DasatinibImatinibAndNilotinibForCML.jsp

I am truly gutted about this decison i have only been diagnosed since the 21st Feb 2011 and have been on imatinib for 8wks. This news is so concerning and worrying for all. I always had the hope that if the imatinib didn't work then there were other options avaliable to me and others. Now i feel really deflated and sad. I took my diagnosis well and have been dealing with it as many others have but i always had the hope that disatinib and nilotinib were my other options.

Sandy is there anything i can do to help here. I am happy to be in Manchester if needed please direct me to anything that can be of help.

Thinking of us all here and hoping the future is bright

 

Naomii x

Having been at the apraisal, letting the committee know how effective the treatment of thse drugs can be, what Dasatinib has done for me, & listening to what both Sandy &  the expert clinicians had to say, it really should have been a done deal, with a bright future for all CML patients who need these treatments.

 Having said that I am not surprised at the decision, as the cost appears to be the overiding factor, with NICE being blind to the facts presented, & the fact that they are never going to get the trial evidence that they are looking fordoes not seem to come into their thinking.

As Sandy says we all need to contact our own MP, as well as making a comment on the NICE web site, & try to raise the profile of this terrible decision.

Bob 

Dear Sandy,


Thanks for your detailed article. I want to write to my MP right away. However could you point me in help me as to how I have to write such letters. Is there a standard format and if so, please send me the link.


I am a CML patient on 800 mg and I know how helpful Glivec is. So what is the current recommendation by NICE on people who are ALREADY on a High Dose Imatinib?


I am willing to support any initiative towards this and request you to keep me posted on activities.


Best regards,
R M

Sandy, the N.I.C.E. refusal is for imatinib "resistant" patients. What figures are available for the success of Dasatinib and Nilotinib when used by this group of people?

I have asked to see my MP, so I really do need some figures to put to her.

One thing that strikes me  that the NICE Panel does not seem to to include any cancer specialist. this is a list from the nice document Appraisal Committee members

The Appraisal Committees are standing advisory committees of NICE. Members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. There are four Appraisal Committees, each with a chair and vice chair. Each Appraisal Committee meets once a month, except in December when there are no meetings. Each Committee considers its own list of technologies, and ongoing topics are not moved between Committees.

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website.

Dr Kathryn Abel
Reader and Consultant Psychiatrist/Director of Centre for Women’s Mental Health, University of Manchester

Dr David Black
Director of Public Health, Derbyshire County Primary Care Trust, Chesterfield

Dr Daniele Bryden
Consultant in Intensive Care Medicine and Anaesthesia, Sheffield Teaching Hospitals NHS Trust

Dr Andrew Burnett
Director for Health Improvement and Medical Director, NHS Barnet, London

Dr Mary Cooke
Lecturer, School of Nursing, Midwifery and Social Work, University of Manchester

Dr Chris Cooper
General Practitioner, St John’s Way Medical Centre, London

Professor Peter Crome
Consultant Geriatrician and Professor of Geriatric Medicine, Keele University

Dr Christine Davey
Research Adviser, North and East Yorkshire Alliance Research and Development Unit, York

Dr Wasim Hanif
Consultant Physician and Honorary Senior Lecturer, University Hospital Birmingham

Dr Alan Haycox
Reader in Health Economics, University of Liverpool Management School

Dr Peter Jackson
Clinical Pharmacologist, University of Sheffield

Henry Marsh
Consultant Neurosurgeon, St George's Hospital, London

Professor Gary McVeigh
Professor of Cardiovascular Medicine, Queens University Belfast and Consultant Physician, Belfast City Hospital

Dr Eugene Milne
Deputy Regional Director of Public Health, North East Strategic Health Authority, Newcastle upon Tyne

Dr Neil Myers
General Practitioner, Glasgow

Ruth Oliver-Williams
Head of Nursing/Quality Improvement Lead Surgical Services, Royal Derby Hospital

Dr Danielle Preedy
Lay member

Dr Martin Price
Head of Outcomes Research, Janssen-Cilag, Buckinghamshire

Ellen Rule
Programme Director, NHS Bristol

Dr Surinder Sethi
Consultant in Public Health Medicine, North West Specialised Services Commissioning Team, Warrington

Professor Andrew Stevens
Chair of Appraisal Committee C, Professor of Public Health, University of Birmingham

Dr John Stevens
Lecturer in Bayesian Statistics in Health Economics, School of Health and Related Research, Sheffield

Dr Matt Stevenson
Technical Director, School of Health and Related Research, University of Sheffield

Professor Paul Trueman
Professor of Health Economics, Brunel University, London

Dr Judith Wardle
Lay member

Hi All,

Grrrr. Just had to get that out there. As with all of you we'll be doing what we can to protest as loudly as possible.

With so much to think about before the FAD is published I don't wish to create any red herrings, but I'm concerned at the possibility that standard dose imatinib may also be at risk here.  I really hope I'm wrong but in the notes section on the NICE website I saw that they mentioned the ongoing assessment of the 2nd gen TKIs as first line treatment, as well as for imatinib intolerance. Tucked away I also saw that it said they would be reassessing standard dose imatinib as a first line treatment. 

Sandy - any chance you know better and cen tell me I am worrying over nothing, or that it was just a typo?  With this extraordinary decision over dasatinib and nilotinib for resistent patients my fear is that they are going to keep pushing and remove funding for imatinib altogether. 

Wishing you all much strength and "good voice" for the coming weeks' protest

Bhiru 

I met my MP in 2009 during the last NICE appraisal and have written the following email to him today.  It is specific to our circumstances and everyone should take up the matter with their MP in their own words but it may be some help to get others started on their own letters and emails.

"Further to our meeting in November 2009 and the subsequent correspondence, I am very sorry to have to return to this subject.  I had thought that with the commitments in the Conservative election campaign and the formation of the coalition government, we were through this problem but NICE is still with us and making what I think is a cruel and unfair decision. 
 
Last Friday, the NICE appraisal committee published a preliminary decision not to recommend dasatinib, nilotinib or high dose imatinib for NHS treatment of CML patients who are resistant to standard dose imatinib.  This is a devastating blow for CML patients who are showing early signs of resistance to imatinib.  They are at most immediate risk, facing a bleak future and very short life expectancy on previous treatments that are known to be virtually useless, but all patients currently with a good response to standard dose imatinib will be extremely worried that they may develop restistance.  
 
The critical point is that NICE does not deny that these new drugs are more effective than imatinib.  The appraisal committee accepts the evidence from leading expert clinicians that the new drugs show clear benefits and the assessment report says "the results of single arm studies suggest that the interventions dasatinib, nilotinib and high dose imatinib can lead to improvements in haematological and cytogenetic responses in people with imatinib resistant CML."
 
It seems that the problem is that whilst the study data is robustly positive, the committee is dissatisfied with the design and execution of the single arm studies which, they conclude,  render the data substandard.  The committee insists on a gold standard clinical trial model,  even though such a model is totally impracticle in the real environment of a rare and potentially fatal disease.   It is totally unreasonable to expect CML sufferers taking part in trials to remain on drugs that are known to be less effective or virtually useless to satisfy their requirements for trials.  Those patients' lives are seriously at risk.
 

Whilst we are both very pleased that the standard dose of the front line treatment, Gleevec, continues to treat my wife Denise effectively, we have always found it comforting to know that there were other drugs becoming available to fall back on if she were to become intolerant or resistant.  We are also very mindful of others who may need these drugs.
 
We are therefore doing all we can think of to try to influence the final decision that NICE will make.  We would like you again to put some questions to the (new) Health Minister and take the matter up directly with NICE on our behalf.  This is urgent as a final decision will be taken soon after the 27 May deadline for responses.
 
Please let me know if you require more information to help us.  Thanking you in anticipation of your further assistance."

It is important that we all take this up, both with NICE and with our MPs, in order to do as much as we can to get this appalling decision reversed.

Simon
 

Hi simon

i was just wondering if you could tell me how i find my local m.p. I have not had to contact him before. I know that his name is David Jones but i'm unsure how i get hold of him. Also, i will be e-mailing the local press as well and your e-mail has helped to get me started on my draft so thank you.

 

Naomii

MPs' email addresses are available at www.parliament.uk.

I think the one you want is jonesdi@parliament.uk assuming you live in Clwyd West.

Simon

One extra point that I feel should be included which would really help with the cost of the drug and maybe take the wind out of the NICE sails is that VAT is charged on all drugs which at the current rate is 20%

However my hospital has an arrangement with a company that if the drug is delivered to my home by Courier then the hospital will not be charged VAT which on my Nilotinib alone is some considerable saving.

Multiply this by the several thousand CML patients around the country we are starting to talk several hundred thousand pounds if not millions. Now multiply this for all expensive drugs for all conditions and we have now covered the cost of all drugs for all types of sufferers.

Surely this is a point that needs making in no uncertain terms.

Simon, an excellent letter.   I have written my own to my MP, but, hope you don't mind, I have plagiarised some bits of yours.

Good luck,

John

Thank you for this Simon, I have now wrote to my M.P. and await his response. I will also be writing to various others and will update if i get a response.

Thanks

Naomii

Having read the NICE report, it seems that in three years so far, the trials of both dasatinib (4.1.6) and nilotinib ((4.1.10) in chronic phase CML have resulted in none of the recipients’ disease progressing to the next stage.  How long this can continue is unknown and the Committtee have made assumptions which may or may not be valid.   I guess that, if imatinib has been assessed on the same basis, some 2000 to 3000 people now living would be dead. 

I also note that, under the NICE life-extending end-of-life criteria, a drug can be funded if the effect is only an extension to a short prognosis, but if the drug works too well, i.e. the patient survives long-term with a reasonable quality of life, the cost becomes unacceptable.   It would seem that this is a Catch 22, no-win situation.   If the drug doesn’t work very well, you can have it and you die, but if it works too well, you can’t have it, so you die.   Can’t have drugs extending life by too long, can we!

John

Just to let every one know that i have e-mailed my local M.P. today and also have friends and family doing the same. The M.P. has just got back to me asking for my address so i am assuming he will be in contact soon. I will be e-mailing further individuals in due course. Sandy i have many friends and family asking a bout a petition that can be sent to NICE do i make my own here or is there a template that can be used. My mother works in a NHS hospital and can get a lot of names on the petition and my friends range from police officers to school teachers and so on, so i reckon that i could potentially get a few thousand names would this be of assistance.

 

Thanks Naomii

We are working on the final text for the petition- which you will be able to access from here..... and it should go live by tomorrow late afternoon at the latest. 

best... Sandy

Steven

I noticed this too, and I also agree with John's point about Catch 22 and what would have happened if imatinib had been turned down.

These appraisals demonstrate that the NICE system is not fit for purpose when it comes to innovative cancer therapies, especially for small patient populations, and needs urgent review.  It's also a sad illustration - another one - that the UK is a second rate country when it comes to access to innovative medicines and has an inconsistent attitude to modern healthcare. We want the industry to set up shop here but won't buy their products. Go figure that.  This is not the first NICE refusal and it certainly won't be the last.

I am writing to my MP and the Health Secretary.  We need to get this firmly in the media, too.

Richard

Below is an article into days Daily Mail. Its disgusting that all this money is being take fraudulantly. If it was there then we would not need to worry. Prehaps we could include this in our letters as well.

NHS loses £3bn a year to fraudsters... but bosses don't try to stop the drain on cash By Jenny Hope Daily Mail

The NHS is losing more than £3billion a year in fraud, with cash being stolen to fund stud farms, ghost employees and private school fees.

Fraudsters are siphoning off taxpayers’ money that could otherwise be spent on patients’ healthcare needs including expensive cancer drugs, according to an alarming report.

The amount being lost is equivalent to everything the Health Service spends on cancer, drugs, hip replacements, cataracts and dentistry.

Waste: Money being siphoned off could be spent on expensive cancer drugs and other patients' healthcare needs

But the figures also indicate that many NHS managers are making little effort to stem  the losses, with some trusts having no anti-fraud measures in place.

A ‘culture of secrecy and complacency’ means the  public is being kept in the  dark while billions are draining out of the NHS at a time when it has to make savings, it  is claimed.

Hi Everyone,

Is anyone currently having a sub-optimal response to imatinib who would be willing to talk to the media about themselves and NICE’s recommendation?

 For those who don’t know me, I garnered quite a lot of media attention for this campaign last time around (Daily Mail, BBC, ITV, London Evening Standard, various local newspapers around the country). With the contacts I made I’m hoping to do the same again this time around. However now that I’m on nilotinib and results and side effects are lower my story isn’t quite so urgent, so I was hoping to include someone else who’s in a similar position to me last time around. Someone who’s currently on imatinib, but is having a sub-optimal response. This way, if they want to include my story as an ongoing narrative, we can say how nilotinib has improved my life and how NICE’s recommendation may wreck that of another (and many others).

I’d also like to highlight what else I did last time as I feel it was quite effective, and it may help others who want to help but are a bit lost about what to do:

 

-          Write a letter to your local MP. 

I realise this can be quite difficult, but once you have a letter it can be reproduced and sent on to other ministers (or passed on to friends and family to send on to their MPs). Last time around I wrote a letter that Sandy used as a template letter. I’m going to slightly modify it this week, and I’m happy to send it to Sandy and see if she wants to upload it again. You can find your local MP at http://findyourmp.parliament.uk/

 

-          Meet face to face with your local MP.

Most MPs have surgery at least once a week/fortnight.  As much of an impact that a letter will have, this is magnified enormously by meeting face-to-face. Last time around I met my then local MP, Vince Cable, which helped keep my story in his mind. He even spoke to the media for me.

 

-          Send your template letter to everyone you know (on facebook, email, or any other medium) to send to their local MP. And make sure they send it on to everyone they know to send on to their MP.

I sent a template letter to all my friends and family on facebook and in my email addresses. I asked everyone I knew to send the letter to their local MP and, very importantly, to ask all they know to do it. Based on who got back in touch with me over a thousand people sent this letter to their MPs. If we ALL did this, MPs would be bombarded by this campaign, and couldn’t ignore it.

 

-          Modify your letter and send it to David Cameron, Andrew Lansley (Secretary of State for Health), Nick Clegg and Ed Miliband (and maybe even Vince Cable, who’s very vocal about the Tories at the moment).

 

-          Write a letter to the letters pages of the national newspapers (email addresses are easy to find – I’ll publish them if needed later) and include a photo if you are directly affected.

 

-         Write your comments on NICE's ACD at http://guidance.nice.org.uk/TA/WaveR/99/Consultation/DraftGuidance by 27th May. Get your family to do the same.

 

Good luck everyone.

Has anyone considered contacting with Novartis or Bristol - Myers Squibb. At the end of the day its business and these guys might loose it, knowing reality they will use their forces to influence NICE decision too.

Hi

I have this afternoon spoken with Novartis PR as tomorrow I am being interviewd by my group of local newspapers in N.W. London.

I am one of Novatis's faces in their booklet "your complete guide to CML and Glivec"

I did ask for some Material to take with me to the interview and she did give me some pointers but as to press releases with figures they were reluctant as I was a patient and not a member of the press so that may look like I am in there pocket sort of thing

Prehaps someone on Dasatanib would like to get in touch with BMS.

Hi Steven... you could take along our press statement to your interview. It might be of some interest to them. Good luck and well done.

Just to confirm, there are a number of patient volunteers with the right profiles that are willing to speak to the press and some journalists have been in touch with them.Unfortunately regarding the National press like Daily Mail etc. they chose to disregard this news in favour of more lightweight stories featuring various royals and celebraties.

However, as the weeks go on we hope things might improve. Local news media are always interested potentially. Hopefully you will get your message accross. 

Please update should anything come of it.

Sandy

Hi Jed,

I would be interested in talking to the media, I have a reporter from the local newspaper coming tomorrow.

My dose was put up to 600mg a month ago but my latest bmb results were not good, 85% up from 57% 3 mnths ago so my haematologist says I really need to change to Dasatinib as I am resistant to Imatinib but, because of NICE's decision, he'll have to fight to get it for me.

You can contact me on Quelline@aol.com.

Thanks

Jackie

I have got loads of my friends and family on board now, we are in the process of setting up a group page, where we can give instructions of what people can do to help, i will upload the template letters when they are ready and we will go from there. I will send details of the group tomorrow so we can all join and add things where needed, as the majority of you know much more than i do so i'm sure we can generate loads of interest here.

Hope this is helping.

Thanks Naomii

Ok the group name on facebook is "fight for critical cancer drugs" (this can be changed if needed) One of my cousins has designed the group so please feel free to add anything. We have 184 members so far and that was in the first 5 minutes. As soon as the template letters are on here i can post on to the group so we can get people to send to all M.P's etc. please feel free to add anything to the group and get as many people as we can to join it.

Thanks Naomii

There are two versions of the NICE document on the net, dated 1 February and 4 May

Here: http://www.nice.org.uk/guidance/index.jsp?action=article&o=47297

and here:  http://guidance.nice.org.uk/TA/WaveR/99/Consultation/DraftGuidance

and they seem to say quite different things.

For example, from 1 Feb para 4.1.6

4.1.6 For dasatinib, in chronic-phase CML median progression-free survival was not reached in any trial, with the longest follow-up being 3 years. In accelerated-phase CML median progression-free survival was 25.2 and 26.1 months in a mixed imatinib-resistant/imatinib-intolerant population, and in blast-phase CML progression-free survival was 2.8–5.8 months, based on the data from a mixed imatinib-resistant/imatinib-intolerant population. The median overall survival in chronic-phase CML was not reached in any trial at 36 months, and in accelerated-phase CML a median overall survival of 30.75 months was reached in one trial (mixed imatinib-resistant/imatinib-intolerant population).

From 4 May, para 4.1.6

4.1.6 Progression-free survival was reported in one of the single-arm studies, the dose-ranging RCT and the comparative RCT; no updated progression-free survival data were included in the update of the comparative RCT. In general, the data on progression-free survival were immature, and median survival had not been reached. At least 75% of people with CML in the chronic phase were without disease progression for 2 years or more. Estimates of overall survival were reported in two studies and were also immature. According to the data, more than 80% of people with chronic-phase CML were alive for at least 3 years.

Am I missing something, or did some new data miraculously arrive betwen those dates?

John

Am I being daft, I can still only see the original petition from last year, is that the one we are using?

thanks Naomi, will send you several template letters as it will depend on who the target is which sort of argument you employ.

We now have a list of MP's who are for and and list against the NHS reforms- this is good information as it will help target them individually with the right arguments.

will be in touch re: Facebook etc. although it might be good if we can tie in The CML Support Group with the facebook group. Just to drive the traffic really and for consistant messaging- petition links etc. 

bw,

Sandy

Hi everyone

I've been a lurker on here since my husband was diagnosed in December 2010. He's on 400g Glivec and has been doing really well until things slowed down a bit recently. Anyway, I'll leave the intro for another time - I'm devastated by the recommendation, as just three weeks ago the specialist nurse was talking about the possibility of moving onto dasatinib. So, after reading your posts I've spent the morning emailing my mp, health ministers etc. I'l do everything I can to help.

Best wishes to you all.

Is anyone interested in doing a radio interview on this subject on Friday? It can be done over the phone. I dont feel i have enough knowledge on this subject as of yet. Can you please let me know. Thanks

Also the facebook group is doing well but i have been told today that the petition that is on there is the wrong one. Soon as we get the new one and also the letter templates can we put them on the group page please s i have many people ready to send letters and sign the petition etc.

Thanks

Naomii

Sandy please feel free to tie the facebook group and the cml support group together, this support group is the knowledge behind CML so please go ahead. I'm not very good with facebook so have my cousin helping me, the group has now got over 1100 people signed and majority are willing to send letters etc where needed, also all are willing to sign the petition. Just let me know what you all want on there and i will put it on, or feel free to do it yourself. We have generated a lot of local radio/media interest from the group and there are also a few national papers looking at it.

Thanks again

Naomii

Hi, I've been searching for ages - have the template letters been uploaded yet?! If so, please can you tell me where I can find them?!  

Many thanks x

I have had a response from my local MP Nadine Dorries in it she says of NICE “decisions in the past have seemed utterly perverse”. She continues “the Government will introduce a new system of value-based pricing which will make effective treatments affordable to patients on the NHS”. Later she says “the Government will focus NICE’s role on what matters most – advising clinicians on effective treatments and quality standards – rather than making decisions on whether patients should access drugs that their doctors want to prescribe”. Her final comments are “NICE will not be able to issue formal restrictions on the use of treatments on the NHS”.

It sounds good but what will the new system be, how will they decide what is ‘value-based’ and when will it all happen?

She talks the talk, but can she walk the walk. What if anything is she going to do to help the cause. I suspect she hasn't actually said. You need to chase her again for some real answers.

Bob

Dear Naomi,

you can find the correct petition via the link I posted yesterday and again today. Let me know if you have further problems by contacting me on cmlsupportgroup@gmail.com

Re radio interview: I cannot do it as I am traveling to a CML conference in Amsterdam on Friday/Saturday and Sunday.

Hopefully someone else might volunteer. P

bw Sandy

Have already written to her again but it seems talk is what they do, these pesky politicians; getting them to actually do anything else is very hard. She is an ex nurse apparently so she should have some sympathy.

David Jones replies:

Mine is exactly the same response as above, word for word. In fairness I don't really understand what this means, do i have to pay for the drugs if i need them? When will these changes come in? Will it mean the drugs are availiable or not? I don't get it.

I am writing to the health minister and various others also.

Last night I was interviewed by my local paper and photographed holding a box of Imatinib and Nilotonib,

About 20 minutes ago I phoned LBC radio staition which is currently talking about money for cancer drugs and I put the point accros as well as I could. James Whale has liver Cancer some years ago so was interested in what I had to say.

I did say at the end that it felt like the Nice panel where like the terrorists of the NHS. He laughed but knew where I was coming from as he had the same battle some years ago and set up the James Whale cancer fund.

There was a 3 year study on Dasatinib which reported some time in 2008. I think it was done at Imperial in the UK.

I know because I was told that the expectation, based on data from that trial over 3 years, for patients with good response was that it would be maintained in approximately 80% of cases.

John

Thanks for your letter. Could you kindly confirm with your MP what 'value-based pricing' means.


Looking forward to your feedback.


Best regards,
RM

It basically means the price the Government pays for drugs will be based on therapeutic benefit. Under that approach, drugs that make a big difference ought to get a higher price - perversely, if the initial clinical data is right that's where dasatinib and nilotinib should end up..

This isn't currently the approach and in any case prices are not determined by NICE.  They are there to assess whether drugs and treatment represent value for money as priced.  However while it isn't NICE's job to set prices they look to me to be clearly trying to influence them by rejecting "expensive treatments" on a pretty regular basis now.  My understanding is that basically both roles are to be taken away from NICE under plans for reform. Can't come soon enough.