Herceptin too expensive? "Yes", says Swindon PHCT
Discussion
BBC News said:
A breast cancer patient has lost her legal challenge to be allowed the breast cancer drug Herceptin on the NHS.
Ann Marie Rogers, 53, had gone to court after she was denied the drug - which is not licensed for early stage breast cancer - by Swindon NHS bosses.
They had argued they were following official advice.
Mrs Rogers' battle was seen as a test case for other women with early-stage breast cancer.
Individual circumstances
When the judge made his ruling, Mrs Rogers simply shook her head and looked downwards.
Her legal team have since said that she is "absolutely devastated" by the result of her case.
HERCEPTIN FACTS
It targets the HER-2 protein, which can fuel the growth of breast tumours
Herceptin prevents this process happening
Around a fifth of breast cancers are HER-2 positive
It is currently licensed for use in women with advanced breast cancer - where the disease has spread within the breast or to another organ
Early stage breast cancer refers to the first occurrence of the disease
The cost for one year's treatment with Herceptin is 20,000 pounds
Q&A: Herceptin
Hers was the first case of its kind to reach court.
Herceptin has been licensed in England and Wales for the treatment of advanced breast cancer.
But pressure is mounting for the NHS to use it on patients with early stage cancer, as research has shown it is effective in fighting the disease.
However, the drug has not yet been licensed for use in this group of patients.
Once it has passed that stage, it also needs to be assessed by the National Institute for Health and Clinical Excellence (NICE).
NICE, which determines if drugs are cost-effective, has said it is one of five drugs it has selected for fast-track appraisal.
Some trusts have been hesitant to fund the drug when asked, preferring to wait for it to be given a licence and approval by NHS adviser NICE, which rules on the cost-effectiveness of the treatment.
Other women had threatened legal action. But their local NHS trusts had decided to fund the drug - which costs around £20,000 per year - before their cases reached court.
Last year, nurse Barbara Clarke, 49, threatened Somerset Coast Primary Care Trust with a judicial review, but the trust agreed to provide her with the treatment before it reached that stage.
And in November, Health Secretary Patricia Hewitt intervened when North Stoke Primary Care Trust refused to fund the drug for mother-of-four Elaine Barber.
Ms Hewitt said she wanted to see the evidence upon which health bosses had made their decision and within a day the trust had reversed the decision, citing Ms Barber's "particular exceptional circumstances".
Speaking before the verdict, Matt Griffiths, prescribing adviser for the Royal College of Nursing, warned: "As individuals, we would all want access to the best treatment for ourselves and our families, but, taking a step back, NICE is the right body to be deciding about treatments, balancing greater issues such as cost and clinical effectiveness."
A friend works in Genetics and really hates all of this crap that is spinning around at the moment. The press have really gone to town on herceptin and claimed it is some sort of "smart drug" because of its genetic targetting component. It is however only relevant for a SMALL number of breast cancer sufferers (1 in 5 at best by the way). This is not because of the cost, but merely down to the fact that the woman who has breast cancer must have the particular type of the disease and be of a certain genetic make-up in the first place (not just HER-2 positive). If these requirements are not matched, the drug is next to useless and the sufferer is better of with a different type of treatment - usually radiation therapy.
The issue is that herceptin is largely quite successful for those who have the certain type of cancer and are of the required genetic make-up, so much so some doctors do claim that it is a "wonder drug" from that point of view. The media got onto this and seem to think that it is some sort of drug that will sense your genetic make-up and change its behaviour accordingly (suggested by several of the tabloids by the way). It does nothing like this. This is the first real example of genetically modified and targetting drugs - its a fantastic advance in medical science - but certainly not the "smart drug" that it is claimed to be.
Is it right to deny this woman herceptin? Dont know as I dont know the case here - though I would suggest that the combined medical brains for Swindon PCT are possibly correct. The news item does not mention if this particular woman has HER-2 in the first place! The number of cases which are being brought by cancer sufferers who will not benefit from this treatment is shocking. In fact several have already been submitted even though there is NO HOPE that they will gain anything from herceptin! So strong is their belief that the media is telling the truth they are prepared to wage war on the NHS to get what they believe they need - its actually quite disturbing!
However, this opens the flood gates to treatment of what you want on the NHS. If we allow the over-ruling of the PCT's and NICE, then we will see our already stretched NHS brought to its knees by people who demand certain types of treatment. "I pay my taxes so I expect the best".... if it were only that easy. The NHS has limited funds and if it costs £20,000 to save one cancer sufferer but that same £20,000 can save 4 diabetics - who makes the choices? Not me and not the courts.... I cannot say that one person is better than the other.... dangerous game this...
The issue is that herceptin is largely quite successful for those who have the certain type of cancer and are of the required genetic make-up, so much so some doctors do claim that it is a "wonder drug" from that point of view. The media got onto this and seem to think that it is some sort of drug that will sense your genetic make-up and change its behaviour accordingly (suggested by several of the tabloids by the way). It does nothing like this. This is the first real example of genetically modified and targetting drugs - its a fantastic advance in medical science - but certainly not the "smart drug" that it is claimed to be.
Is it right to deny this woman herceptin? Dont know as I dont know the case here - though I would suggest that the combined medical brains for Swindon PCT are possibly correct. The news item does not mention if this particular woman has HER-2 in the first place! The number of cases which are being brought by cancer sufferers who will not benefit from this treatment is shocking. In fact several have already been submitted even though there is NO HOPE that they will gain anything from herceptin! So strong is their belief that the media is telling the truth they are prepared to wage war on the NHS to get what they believe they need - its actually quite disturbing!
However, this opens the flood gates to treatment of what you want on the NHS. If we allow the over-ruling of the PCT's and NICE, then we will see our already stretched NHS brought to its knees by people who demand certain types of treatment. "I pay my taxes so I expect the best".... if it were only that easy. The NHS has limited funds and if it costs £20,000 to save one cancer sufferer but that same £20,000 can save 4 diabetics - who makes the choices? Not me and not the courts.... I cannot say that one person is better than the other.... dangerous game this...
off_again, Yes, of course you're right but I believe from reports in the more responsible media that this woman IS suitable for Herceptin treatment and has being receiving it hitherto but at her own expense. The sole reason that Swindon PHCT have refused it is that of cost effectiveness, not simple effectiveness.
The BBC also said:
Why did Ann Marie Rogers go to court?
She said she was prescribed the drug by her doctor but has been refused it by local health bosses
How can it be right that this woman, whose oncologist has prescribed the treatment, is denied it because of cost? £20k is not a great deal of money when you look at the astonishing level of excess bureacracy in the NHS. Sack just half a 'manager' and it's paid for.
motco said:
Why did Ann Marie Rogers go to court?
She said she was prescribed the drug by her doctor but has been refused it by local health bosses
How can it be right that this woman, whose oncologist has prescribed the treatment, is denied it because of cost? £20k is not a great deal of money when you look at the astonishing level of excess bureacracy in the NHS. Sack just half a 'manager' and it's paid for.
£20K for one person may not be much, but I imagine prescribing it to all those with the early form of cancer would cost allot more.
Politics is the art of the possible; I’m sure we can all think of deserving causes to spend state money on. But this money is not free or limitless. Which is why it should be prioritised.
It is a very, very difficult decision, but the NHS only has a finite amount of money, so this woman receiving Herceptin would in all likelihood mean that someone else has to wait to have heart by-pass surgery or a hip replacement or whatever.
I for one wouldn't want to be the person who decided how gets what treatment and who has to wait or even worse go without.
I for one wouldn't want to be the person who decided how gets what treatment and who has to wait or even worse go without.
motco said:
off_again, Yes, of course you're right but I believe from reports in the more responsible media that this woman IS suitable for Herceptin treatment and has being receiving it hitherto but at her own expense. The sole reason that Swindon PHCT have refused it is that of cost effectiveness, not simple effectiveness.
Absolutely - if the case is cost effectiveness then there needs to be a bigger public debate about this. Where do we draw the line and why do we do this? We the general unwashed public need to talk about this and assist our PCT's / NICE / NHS to understand what the situation is - rather than letting the politicians get their grubby little hands on it.
Additionally it would be helpful if our media would stop spinning stories and actually start informing us better as to the situation and what the issues are. If this woman is suitable for herceptin, why the hell dont they say so? Also, why are their no investigative reporters after the truth from Swindon PCT?
Oh, and as already mentioned, the reason why it costs £20,000 is that its a regular treatment drug so lots are needed. Once you start you must stay on for a period of time and it needs to be carefully monitored by professionals (side effects can be extreme - permanent heart problems, strokes, heart attacks, lung damage, fluid on the lungs, low blood pressure etc etc - its serious stuff and the full details are really not that well known!!!!). Additionally you may need to take supporting drugs with herceptin to try and counter some of the side effects (to put this into perspective - 5% get heart problems and 7% get lung problems, thats actually REALLY HIGH!). Additionally the drug is new to the market and due to its nature goes through an expensive and lengthy production process. As it is only sold in relatively small doses and isnt massively used, the costs are still high. Though the actual drug is not that expensive, the drug company involved Genetech Inc is not profiteering from this (at the moment!). Note the name - like I said, first of the widely known genetically targetting drugs..... interesting medical development...
I don't know what the papers have said about this drug, but it does seem that this whole situation is a bit farcical, and in the midde you have unfortunate people who have life threatening ailments. What makes it bad is that the poor unfortunates in the middle, are not being made aware of the particular problems.
There isn't a limitless pot of money. Undoubtedly the drug has been priced as it has because it will only work for some people.
Is it possible that the papers are trying to get at a deeper issue? I'd have thought that the deeper issue is that scientists are likely to gain an intimate understanding of the genetics of wealthy people before those of the poor.
I know bugger all about genetics, but I'd not be at all surprised if there was a "wealthy gene". Obviously this can't be true in a direct sense, what I'm trying to suggest is that certain groups of genetic attributes, describe physical traits that then make a person successful.
Speculatively, the genes of the wealthy will be analysed for engineered drugs, before those of the poor. The wealthy have the money to fund that research, should they get ill. If there are fringe benefits, i.e. that the drugs will work on other genetically similar people, thats beneficial to the drug cmpanies.
As I say I'm not sure, but it's certainly a possibility I'm thinking about.
There isn't a limitless pot of money. Undoubtedly the drug has been priced as it has because it will only work for some people.
Is it possible that the papers are trying to get at a deeper issue? I'd have thought that the deeper issue is that scientists are likely to gain an intimate understanding of the genetics of wealthy people before those of the poor.
I know bugger all about genetics, but I'd not be at all surprised if there was a "wealthy gene". Obviously this can't be true in a direct sense, what I'm trying to suggest is that certain groups of genetic attributes, describe physical traits that then make a person successful.
Speculatively, the genes of the wealthy will be analysed for engineered drugs, before those of the poor. The wealthy have the money to fund that research, should they get ill. If there are fringe benefits, i.e. that the drugs will work on other genetically similar people, thats beneficial to the drug cmpanies.
As I say I'm not sure, but it's certainly a possibility I'm thinking about.
dilbert said:
I know bugger all about genetics, but I'd not be at all surprised if there was a "wealthy gene". Obviously this can't be true in a direct sense, what I'm trying to suggest is that certain groups of genetic attributes, describe physical traits that then make a person successful.
Speculatively, the genes of the wealthy will be analysed for engineered drugs, before those of the poor. The wealthy have the money to fund that research, should they get ill. If there are fringe benefits, i.e. that the drugs will work on other genetically similar people, thats beneficial to the drug cmpanies.
As I say I'm not sure, but it's certainly a possibility I'm thinking about.
You know, you might not actually be far from the truth..... and its REALLY SCARY....
It is unlikely that there is a "wealth" gene. But clearly there is something that makes the real innovators and entrepreneurs and the big question is - it is nature or nurture? Is it our circumstances which turn us into money making machines, or are we born with something that makes us different to the bloke who is happy to stack shelves at Tesco for 40 years? Depends on how far you take things, but it is very odd when you start to think about it....
'Brave New World' and eugenics raise thier ugly heads.
I am coming to the view that development of pharmaceuticals should be publicly funded through universities, maybe as well as the multi-nationals like GSK if they wish, and simply the manufacture farmed out to the GSKs and Roches of this world. The returns would go back into funding more development, just as now, but a tight control over profits would ensure that the best treatment was available for all. The potential profits mean that companies are tempted to variously profiteer or rush drugs to the market with less than perfect clinical trials and they can and do cause huge damage occasionally. I might be naive in expecting governments to be fair in their dealings with the populace but at least they can be voted out. Try voting Glaxo-Smith-Klein out! Plus, by international agreement, duplicated developments could be avoided. It would need a vast amount of planning and agreement between the developed nations, but the gains are potentially great.
Just my two-pennyworth
I am coming to the view that development of pharmaceuticals should be publicly funded through universities, maybe as well as the multi-nationals like GSK if they wish, and simply the manufacture farmed out to the GSKs and Roches of this world. The returns would go back into funding more development, just as now, but a tight control over profits would ensure that the best treatment was available for all. The potential profits mean that companies are tempted to variously profiteer or rush drugs to the market with less than perfect clinical trials and they can and do cause huge damage occasionally. I might be naive in expecting governments to be fair in their dealings with the populace but at least they can be voted out. Try voting Glaxo-Smith-Klein out! Plus, by international agreement, duplicated developments could be avoided. It would need a vast amount of planning and agreement between the developed nations, but the gains are potentially great.
Just my two-pennyworth
dilbert said:
Speculatively, the genes of the wealthy will be analysed for engineered drugs, before those of the poor. The wealthy have the money to fund that research, should they get ill. If there are fringe benefits, i.e. that the drugs will work on other genetically similar people, thats beneficial to the drug cmpanies.
As I say I'm not sure, but it's certainly a possibility I'm thinking about.
We reached that point decades ago, not in terms of people's genes but just the kind of deseases rich, populous people get vs. the kinds of deseases poor people get (on a global scale). DRUGS ARE PRODUCT, products are designed and marketed for maximum return. End of. Maybe thats not as obvious in this country where drug advertising is banned so you go and chat to the doctors and heath professionals with a goody bag instead. Is this amorral?
aldi said:
We reached that point decades ago, not in terms of people's genes but just the kind of deseases rich, populous people get vs. the kinds of deseases poor people get (on a global scale). DRUGS ARE PRODUCT, products are designed and marketed for maximum return. End of..... Is this amorral?
No just reality.
If we want drug companies to research drugs to deal with 'poor' world diseases then we have to pay them for it. At present it is not in their interests to do so, since they will not have a large market of people who can afford their product, particularly since regardless of patents they hold, they will often soon face generic competitors. This is not amoral, simply businesses acting in the best interests of their shareholders.
scorp said:
Just a pertenant question...
Why does it cost £20k?
Surely they could cut a volume discount with the drug company if they used more of it?
Very high R&D costs are involved, the trials for pharmaceutical drugs takes ages too.
I work in pharmaceuticals and it's cheaper to put a man on the moon than a new drug on the market. If you're not in this industry you have no idea of the hoops we have to jump through to keep the FDA and MHRA and all the other national regulatory bodies happy. An you do have to keep them happy, there is no arguing with them, they say jump and you say how high...
We are having a similar debate here in NZ about Herceptin, apparently it will be funded here for breast cancer sufferers with HER-2 proteins present when clinical approval is finished. The company that developed the drug is in fact selling it pre-emptive of approval!
TBH there will be so few cases to which this drug can be effectively administered that the overall cost is insignificant.
It raises serious moral questions though about drug development by private companies and their right to withhold drugs under patent that could potentially help some women overcome breast cancer. I sincerely hope that we can find a better solution than currently exists, while I openly defend the right of the individual (be that a citizen or a cooperate entity) to hold patents perhaps some things are just too important to be “owned”? We have asked the same questions about genetic code being protected. What do you think PHers? As much as it strays from our usual beliefs, is the individual occasionally to come before free market capitalism in exceptional circumstances?
TBH there will be so few cases to which this drug can be effectively administered that the overall cost is insignificant.
It raises serious moral questions though about drug development by private companies and their right to withhold drugs under patent that could potentially help some women overcome breast cancer. I sincerely hope that we can find a better solution than currently exists, while I openly defend the right of the individual (be that a citizen or a cooperate entity) to hold patents perhaps some things are just too important to be “owned”? We have asked the same questions about genetic code being protected. What do you think PHers? As much as it strays from our usual beliefs, is the individual occasionally to come before free market capitalism in exceptional circumstances?
It all boils down to risk & resources and how we balance the two. Consider the following simple example :-
If I had £20k of NHS money and had to fund the following -
a) Hip replacement operation £10k - chance of successful outcome 100%(ish)
b) Breast Cancer Treatment with Herceptin £20k - chance of succesful outcome 20%
c) IVF treatment £4k - chance of succesful outcome 25%
Which do you choose and why?
a) is the only one that is guaranteed to work
b) is the only one that can save a life
c) are the most demanding group of patients faced by NHS managers and most likely to complain generally if they don't get what they want.
Discuss!
If I had £20k of NHS money and had to fund the following -
a) Hip replacement operation £10k - chance of successful outcome 100%(ish)
b) Breast Cancer Treatment with Herceptin £20k - chance of succesful outcome 20%
c) IVF treatment £4k - chance of succesful outcome 25%
Which do you choose and why?
a) is the only one that is guaranteed to work
b) is the only one that can save a life
c) are the most demanding group of patients faced by NHS managers and most likely to complain generally if they don't get what they want.
Discuss!
nwtony said:
I work in pharmaceuticals and it's cheaper to put a man on the moon than a new drug on the market. If you're not in this industry you have no idea of the hoops we have to jump through to keep the FDA and MHRA and all the other national regulatory bodies happy. An you do have to keep them happy, there is no arguing with them, they say jump and you say how high...
The moral of this story is make sure you get a popular disease otherwise you're screwed! I work on motor neuron disease which has at present 1 drug treatment (riluzole, that was developed for something else) and little or no chance of big business putting any money into further development of theraputic agents. If it affects less than 10,000 people anually then it won't get big money thrown at it.
Back OT. My understanding of Herceptin is that its an engineered antibody i.e. they've taken a mouse antibody raised against the Her-2 protein and iserted into into the consensus region of a human IgG1 antibody thereby creating a drug which is specific and but is not reacted to by the human immune system... very clever. The key being that you have to be one of the 20% of people whose tumours overexpress Her-2 and the drug appears to have very limited effects on early onset (presumably due to expression levels of Her-2). The bottom line is that you can't start reclassifying the licences of drugs because a patient kicks up a fuss. It would open the flood gates!
Gassing Station | The Pie & Piston Archive | Top of Page | What's New | My Stuff