No Tykerb in the UK, calling all the UK Her2 people

fullofbeans · 03-11-2009, 07:21 PM

It is the draft decision from NICE to which an apeal can be made.. Any idea anyone?

http://www.nelm.nhs.uk/en/NeLM-Area/...Determination/

We cannot count on any NGO to help us check the pathetic answer from breakthough (the only BC organisation that is meant to be about science):

http://www.breakthrough.org.uk/who_w...nib_mar09.html

Now I am really fed up with comments about the fact that it is because it is a national health service. FYI most western countries EU and Canada have such a system but have tykerb.. so please do politic somewhere else!!! and do not dilute our debate and take a ride on it!!

Anyhow for all of us concerned if anyone wants to take the lead maybe we should have a petition ? any good advocate amongst us ? (I am more of a research person myself). By the way the final decision is to be taken on 27 March, so we need to hurry.

Jackie07 · 03-11-2009, 07:32 PM

I am bumping up this one so the other Her2 sisters from UK can see it.

caya · 03-11-2009, 08:27 PM

Full of Beans

I understand that Herceptin got approved in Canada when a Her2+ BC patient went to the press, and basically said that Herceptin was a proven drug and would save her life... this was front page news... and Herceptin was approved shortly after that. Not sure of the official date, but I believe in 2005 sometime.

Perhaps a group of you could call a press conference, maybe get your UK Breast Cancer Foundation involved, some oncs. etc.

Wish I could help more, sending you the best from Canada.

all the best
caya

hutchibk · 03-11-2009, 09:59 PM

All I can offer is that I am just so very sorry that this is happening.

karenann · 03-11-2009, 10:04 PM

I am sorry, too that this is happening.

Karen

karen z · 03-11-2009, 10:06 PM

Must all the pressure come from within the UK? What about pressure from oncologists/researchers in other countries viewing Tykerb as an important option?

03-12-2009, 12:53 AM

Sadly it is likely that the only way for this decision to be changed will be either for some clinical trial to come out which shows this drug to be so effective that it simply cannot be ignored, or someone will have to require the drug on advice from their oncologist and have their local Primary Care Trust (PCT) refuse it and then take them to court (just like Ann Marie Rogers did for Herceptin).

What might just make it a news worthy item in papers and TV is that just about every BC patient here in the UK to write to the TV companies and newspapers to highlight the issue of Tyverb (as it seems to be more commonly called here). Also if every BC patient wrote to their MP it might also just have some effect (although I dont have great hopes for UK MPs doing anything as the percentage of population involved is not big enough to make them fear losing their seats).

If there was a forum like this here in the UK to which the UK BC patients subscribed then there might be a body of opinion which might just be listened to here.

fullofbeans · 03-12-2009, 09:00 AM

Well there is something quite illogical in simply saying that more clinical trial results need to be carried out in that:

Are you saying that all the other countries such as France for example are simply making Tykerb available on no scientific background ??

Because if that it to you a satisfactory answer, well I beleive that what was said about Herceptin.. when an independent court reviewed the evidence they found that NICE was wrong.

So the real question that is emerging really is: Is NICE an independent body capable of reviewing scientific evidence??

03-12-2009, 09:23 AM

Well its not simply clinical trials they work on. They do a kind of calculation based on extended quality of life for a cost benefit case and if that comes out too expensive they wont allow it to be used. This is the problem with NICE in the UK they are cost driven as well which is why the UK have so much trouble getting these new drugs.

Ellie F · 03-12-2009, 09:43 AM

Hi ,
I am also outraged that NICE will not approve Tyverb and the pathetic response of the breast cancer charities.
What I have done so far is to contact NICE and lodge a protest against the decision, contacted two MP's and requested they raise this issue with the Minister and thirdly have contacted my trade union branch (Amicus) and put forward a resolution. Not been able to do more as recovering from surgery. A couple of problems are becoming apparent already. Firstly having raised Tyverb with two onc's their response was that they would be reluctant to prescribe as there was not enough 'mature ' data! Of course their prescribing will be governed by NICE so would be out of the question anyway.Secondly the position of the MP's, whilst sympathetic argued that NICE was an independent body appointed by gov so it would be difficult to go against their findings! Personally I believe it is all to do with money particularly now we are officially in recession.
Does anyone know GSK's position about appealing?
Due to see new onc very soon. Been contemplating what action I will take if he tells me that Tyverb could be a drug clinically indicated for me. I believe any court action may not be possible based on prohibitive costs. Any views?
Ellie

PinkGirl · 03-12-2009, 10:19 AM

I don't think other countries are basing their decisions on their own
research and clinical trials. When Herceptin was approved in Canada,
I'm sure the data etc. came from the United States. I don't think Canada
did much in the way of clinical trials on that drug.

This sounds like NICE's decision is based on $$$. The information/research/
clinical trials are all out there.

chrisy · 03-12-2009, 10:57 AM

Ellie beat me to this thought...what is GSK doing in response to this?

janieR · 03-12-2009, 01:03 PM

Hi all,

Having just come up to 3 years ned early stage breast cancer after having to worry about getting herceptin at the end of my chemo and rads and I found (via the televison) on the 23rd august 2006 that I would get it(five days before I finished rads).

Now basically I see a surgical registrar once a year (not the surgeon who did my mastectomy) I have had to fight for it but I do get yearly mammograms and ovarian scans and definitedly no oncologist and I just wanted to have something to hang on to if needed which was tykerb.

I am so furious

Janie (from the UK). Here we go again in this country ,like we had to do for herceptin!

Ellie F · 03-12-2009, 01:22 PM

Hi again,thought I might ask GSK that question tomorrow! Not too hopeful though as last time I rang them about one of their drugs two hours later I was still trying to speak to the right person.
If I get a response I will post it.
Just to have a bit more of a rant it annoyed me even more when at the end of the NICE guidelines they referred to needing more evidence from clinical trials. Clearly they don't think that research from abroad is worth considering-how arrogant
Ellie

fullofbeans · 03-13-2009, 10:08 AM

Off course it is about money it always is, but why then do the charities response to it is that they need to carry out more trials?

I agree with Elly it is very arrogant and from the charity point of view a really poor response.

Why do they not simply say that the patients are not worth the money, call a cat a cat.. If the charities agree that advance patients'time on earth are not worth the cost then they should state it honestly too as oppose to be highly patronising finishing their statement with "ask your doctor" it is painful to read.

Anyway does tyverk cost that much more than Herceptin? As well as Tyverk there is also the MAJOR ISSUE of cyber knife been disallowed.. we have seen that this operation has saved lives here with quite a few of us never recurring or many years later..

PS:Well done for writing to 2 MPs.

tricia keegan · 03-13-2009, 12:58 PM

Fullofbeans,

I was shocked at this. I'm quite close to you in Ireland and we've had Tykerb here also for the past couple of years. One of the ladies from the site here was able to avail of it when she moved here from Scotland. I think you need to certainly get some support from other cancer survivors/patients in the UK.
I don't have much in terms of practical advice but do have a suggestion. I post infrequently on a UK site which is quite busy,it's for all cancer's not just breast cancer. You may be able to drum up some support from other's there as there are quite a few breast cancer patients currently posting. The link is below-
www.cancerbuddiesnetwork.org
(I'm sure thats the correct link but if you have problems just contact me and I'll send on to you)..

Ellie F · 03-13-2009, 12:58 PM

Hi all,contacted GSK amd eventually found someone who told me that the decision to appeal was still under consideration but a decision due soon. I understand that the cost of Tykerb is comparable to herceptin but does not need to be administered IV so there is a staff cost saving.
Regarding the cyberknife issue I understand from an MP that it is acknowledged that it is beneficial but they don,t want the capital outlay for each machine (told approx £70 million each).It feels like this is a similar issue to that of PET scanners which are not routinely used here and indeed NICE have stated should not be used in the metastatic setting.
BC is hard enough to face as everyone here knows-no wonder there is a prevailing sense of doom here when t so called experts tell us we're not worth the money. Ellie

janieR · 03-13-2009, 01:10 PM

Hi all,

sorry about my rant last night. I am now going to contact as many mp's as I can to get it raised in parliament. As I said I was furious but it was no good saying that without getting motivated and doing something about it, which I am now with my husband to help .

I am also angry about the cancer charities pathetic response and also about cyberknife.

Being on this site makes you knowledgeable and I am fed up with the doctors in this country thinking they are God, they do not appreciate people like us finding out the facts before we go to see them, we often know more than they do, at least here in the uk.

Janie

Ellie F · 03-13-2009, 01:37 PM

Well said Janie. I didn't read Tricia's post properly and have just read that it's available in Ireland and ? Scotland. For goodness sake how can this be right. Glad you are contacting your MP's,the more the better.I intend to get friends in other parts of England to do this as well.Ellie

Joe · 03-13-2009, 04:20 PM

This was posted on the Herceptin/Tykerb Board:

One view of what NICE is, and how it decides in the UK
I thought it might be helpful to post an overview for those not familiar with what happens in the UK regarding the National Institute for Health and Clinical Excellence (NICE) and how it comes to its decisions.

Bear in mind that I am no expert in these matters, just an interested bystander whose 'other half' has been through what many of you here have been through with HER2 BC. I have pulled together these comments from what I have found during my searching the internet. I believe what I say here is reasonably accurate but feel free to correct me if you know better (and I'm sure some of you will).

NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health, at least this is what it says on their website. It is not always publicly viewed as independent of the government by many people who feel that they are under pressure to meet costs first and decide on treatment second.

NICE uses a Quality Adjusted Life Year (QALY) to asses how a treatment measures up and if it is over a certain threshold, currently £20,000 ($28,000 US) it will go out for appeal on whether or not to proceed, if it is over £30,000 ($42,000 US) it normally says an outright NO.

One interpretation of QALY would be how much lifespan a person would be prepared to give up to deliver one year of perfect health from the current state of ill health. By comparing QALY values before and after treatment one could calculate the benefit delivered by a given treatment to a given person.

The cost of a treatment may be relatively easy to calculate but because people may be at different ages when they receive treatment, the gain may be different according to age. A heart operation on a small child may deliver many more years of quality of life than the same operation on a 76 year old man. By taking the cost of treatment and dividing it by the years gained an overall cost benefit ratio can be determined as the 'cost per quality-adjusted life year gained' or CQG.

NICE has pledged to speed up its appraisal process so that guidance is ready between three and six months after a drug is licensed. Currently the process can take up to two years.

Nice uses independent expert committees to evaluate new drugs for use on the NHS and they use a complicated calculation balancing the cost of the drug against how effective it is at improving length and quality of life.

The calculation arrives at an additional cost per "quality-adjusted life year" over and above
the price of existing treatments and if that figure is more than £30,000 then the drug is
generally not approved for use.

But the new rules will allow this level to be breached after a public consultation found most
people agreed that greater weight should be given to drugs that provide extra months of life for terminally ill patients.

It must be remembered that all of this is done for all drugs and the NHS budget has to cover all treatments not just cancer.

Now specifically there have been two recent decisions by NICE which have been brought up on this forum.

Firstly the Tykerb (often known as Tyverb in the UK) where they have come up with what is called a Final appraisal determination (PDF document) which can be read here.
You can see more comments on this here and here. Basically this document says that NICE is going to say NO to Tykerb. This can be appealed but is going to need a lot of people supporting this but I think it will need evidence as well as numbers.

Secondly the new Advanced breast cancer: diagnosis and treatment clinical guidelines which was published in February 2009. This is the document which says that Herceptin will be withdrawn from patients with advanced breast cancer. There are two sets of documents one for health professionals and another for patients both of which can be found here.

Both of these decisions mean that it unlikely that any NHS Hospital in the UK will consider giving either Tykerb or Herceptin for advanced breast cancer in future.