This morning, the UK’s drug guidance body, NICE, announced its preliminary decision on whether the NHS should use four new cancer drugs – bevacizumab, sorafenib, sunitinib and temsirolimus – to treat people with kidney cancer that has spread (‘metastatic renal cell carcinoma’).
Despite clinical evidence that these drugs can actually help, NICE has decided that they’re too expensive. In essence, NICE doesn’t think that these four drugs are value-for-money for the NHS.
We’re very disappointed with this decision, and we feel it raises fundamental questions about how NICE evaluates cancer drugs, particularly for cancers that only affect a relatively small number of people.
NICE have stressed that this is a preliminary decision, and are undergoing a public consultation. Cancer Research UK will be making representations to NICE on the matter.
That’s why we’d like to hear what you have to say – if you have a strong opinion on this, please leave your comments below.
Clinical trials for rare diseases
The gold-standard method of testing whether a treatment works and is safe is the clinical trial – a careful look at how a new treatment compares against the treatments currently in use.
The more people enrolled on a clinical trial, and the longer it lasts, the more sure researchers can be about its results.
But only about a couple of thousand people every year are diagnosed with metastatic renal cell cancer*. And only one in ten people diagnosed with this stage of the disease is alive five years later.
So, for relatively rare diseases like this, it can take a long time to run trials large enough to gather watertight evidence about how well new treatments work.
No other treatment options
Currently, the only available treatment for metastatic renal cell cancer is immunotherapy. This halts the disease’s progress for just four months on average. But if people are unsuitable for immunotherapy, or it doesn’t work, that’s it. There’s no other treatment option.
So doctors urgently need new treatments for this disease. And the four drugs NICE has rejected have shown considerable promise in clinical trials.
New generation therapies
These four drugs are part of a new generation of cancer drugs, developed after years of painstaking research. They target key processes within the body that get hijacked when cancer develops.
Trials looking at whether these drugs can help people with metastatic renal cell cancer to live longer have had extremely encouraging results. NICE’s assessment contains details of several such trials.
In fact, several of the trials were stopped early, to allow those people not receiving the new treatment to have it. Other trials showed that some of these drugs could stop the cancer from growing for several months more than immunotherapy alone. That doesn’t seem much, but when you’re trying to beat cancer, those extra months can mean a lot.
NICE agreed that patients tended to live longer when they were given these drugs. But they felt that the evidence wasn’t sufficiently robust. And when they put the data from the trials into their computer models, they found that the drugs cost a lot (£20,000 – £35,000 per patient per year) compared to the benefit they brought patients – too much for them to recommend that the NHS prescribes these drugs.
These computer models were developed to look at giving drugs to large numbers of people. We question whether they’re valid for looking at relatively uncommon diseases like kidney cancer that has spread.
We’re also worried that NICE is setting the bar too high with regard to the strength of evidence they require to approve these drugs. Doctors don’t have a lot to offer people with advanced kidney cancer. If these drugs can help them – and the clinical trials show that they do – shouldn’t they be made available?
Share your views
We’re keen to work with NICE to improve their drug assessment mechanism for ‘orphan’ diseases – diseases that affect relatively few people. But we want to hear from you. If you’d like to share your views on this decision, please email [email protected] or post your comments below.
If you have questions about cancer or its treatment, including kidney cancer, please visit our patient information website, CancerHelp – or contact our cancer information nurses. There’s also more information on NICE’s decision on advanced kidney cancer on CancerHelp UK
*A note on the stats:
According to the figures used from the NICE report, for 2006, 17 per cent of renal cell cancer cases were stage 4 disease, i.e. metastatic. If we were to apply this figure to the 2005 cancer incidence figures that we have published for the UK then this would mean that there are fewer than 1,100 cases of metastatic renal cell carcinomas in the UK each year.
However, data from the South East of England in 2005 showed that a quarter of kidney cancers were diagnosed with distant metastases, with a third of cases having unknown stage. If the South East of England was representative of the UK then we could assume that there are least 1,500 cases of metastatic renal cell carcinomas. But if the unstaged tumours followed the same distribution as those that are staged then this could rise to as many as 2,250 cases per year.
However, assumptions have been made with all these figures, which produce very different results. This underlines the necessity to have excellent quality staging data to assess just how many people are affected by distant metastases, for all cancer sites – not just renal cell carcinomas.
Alec Melvin August 17, 2008
NICE seems to be run by accountants. They probably have a human life benefit/cost ratio versus drug cost program which makes their decisions automatically. No doubt if they had been involved in benefit/cost evaluation for streptomycin in the 1940’s/1950’s they would have decided this antibiotic was too expensive for the treatment of TB. Someone needs to ask them what monetary value they put on the lifespan measured in months of a kidney cancer patient
Peter Scott August 17, 2008
If something works it should be made available whatever the cost and make the cutbacks on the wars. Why is it that we could afford a war in Iraq but cannot afford to keep people alive. This is all wrong.
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Anne Gorton August 16, 2008
As part of the organising committee for CRUK Relay for Life we are raising funds to enable CRUK to do their outstanding work WHAT FOR are we to turn round and say to those discovering better treatments sorry guys good job but its to expensive to be of use .Money and costs shouldnt be the issue drugs like Sutent work and should be available to those that need it whatever the cost
d t r August 16, 2008
There is going to be a demonstation on the Wed 27th August outside NICE headquarters.
HIGH HOLBORN LONDON at 12 noon ….
Please let everyone know.The moor that demonstrates the better chance we stand.
Hilary Neillans August 15, 2008
I had my kidney removed four weeks ago because of a tumour growing in the ureter, and hopefully the cancer will not have spread any further. Having lived with the stress of the initial investigation, diagnosis and operation from which I am still recovering, I can only imagine the devasation if I was to be told that the cancer had spread, but that I could not have any further treatment.
If only a couple of thousand people a year are diagnosed with advanced kidney cancer then surely the money can be found to give this relatively small number of people the best possible chance of survival.
Money is found to support many self inflicted illnesses, such as smoking and drug related diseases, so it seems unbelievable that the same resources aren’t available for the small number of people who develop kidney cancer.
Its sad to think that our Health Service was once the envy of the world, but now we are way down the list when compared to most European countries.
Sue August 15, 2008
How can NICE put a price on someones life? It would be useful to meet the people involved in this decision.
Annie August 15, 2008
Why not try and get the NICE decision changed by supporting the petition on the 10 Downing Street website.
Martyn Right August 15, 2008
How can the goverment be so shallow and uncaring?
They allow the NHS to fund sex change operations and yet will not help the unfortunate with cancer of the kidney.
They also help themselves to public funds everyday and yet refuse to pay for these drugs.
If a member of the ruling bodies was affected then I’m sure a exception would be made in their case.
Also anyone wanting assylum in the UK should have a full health check before they are allowed to claim on the NHS.
It is about time we looked after the people who have paid into the system for their whole lives.
Shaz Maxwell August 15, 2008
This is disgusting the people that make these decisions want to try living with kidney failure or another of these terrible illnesses.After caring for someone with Renal failure we would have tried anything to make his and our family life better and putting a price on suffering especially someone elses suffering is not ok.I also donate to renal failure charities and cancer research and no-one has asked me were i want the money to be spent. I thought i was doing good for the benefit of others not as healthy as myself but it seems not.
MrsL Murry August 15, 2008
It is not just NICE but the government must take their fare share of the blame as well for not giving cancer patients the treatment that is required. The UK for too long now has got to the situation where there is not enough money in the pot to treat every one that it should be. There has been in the past certain illnesses Aids for one where expense never came into whether patients were treated or not, it would not have been “fashionable” not to treat them.
Now we have too many people coming from abroad, never having paid anything but all getting treated, it’s another of our systems that seriously needs looking at, those of us that have paid all our lives into the NHS will not get the treatments we require. The sums for the NHS don’t add up but the government & NICE wont admit to it. How would they feel for a member of their own families not to get the treatment that would help them live longer.
Jill Peck August 15, 2008
I have been moved to tears of sadness by reading about sufferers of kidney cancer being denied drugs that may prolong their precious lives, and at the same time moved to tears of rage by reading of the money and resources wasted by the NHS and the Government. What about initiating a £10 on-the-spot charge to every person who turns up at A&E with some self-inflicted problem such as alcohol poisoning (if they can afford to drink themselves into a stupour, they can obviously afford the “donation”), and giving this money to the people who need it to pay for their life-saving drugs? Judging by the huge numbers of people who are treated free of charge in A&E units all over the country for this type of problem (we’ve seen it on countless documentaries), it ought to raise enough to cover the cost of life-saving drugs for those who deserve them. Simple idea, but it could be effective. Is there anyone who works in an A&E department who could give an estimate of how much this might raise every Friday and Saturday night?
Sharon Lowe August 15, 2008
A few months ago I lost my mum to bowel cancer. She bravely fought her illness and although she lost her battle, she was at least given all the chances possible for survival. She found the physical processes involved in trying to stay alive at best torturous, but at least she had hope! She was willing to try everything within her reach to beat cancer. If people aren’t willing to give up on themselves then no-one else should have the right to give up on them either – including our elected government!
Cancer affects everyone in the family, not just the person undergoing the treatment. Everyday we mourn her loss, but at least we know that there was nothing else that could have been done. Like most people with cancer there were no reasons why she developed the disease, she was just unlucky. People suffering with kidney cancer are NO different and they ALL should be given the most appropriate treatment for them as individuals. If that includes being given expensive drugs that may only prolong their lives by a few weeks then sobeit! Sometimes hope is all that remains when all else fails. If it also means that surviving relatives know that that their loved one was treated with compassion and fairness right to the end, then the money was, in my opinion, well spent!
We all know, especially in today’s rocky financial climate, that budgets have to be squeezed and spending prioritised, but there are some pots of money that seem to have no bottom! As others have mentioned above, the Government doesn’t seem to have trouble wasting money and how much have we spent now in Afganistan? Our soldiers are in a foreign land fighting for liberation. Can’t our own government see that British cancer suffers are just asking for their support to fight their own personal battles for individual liberation from almost certain death? I am sure that no-one urging for these drugs to be made available really wants any branch of the NHS to be squeezed to pay for them, just more money allocated from mis-directed pots elsewhere.
If we don’t have our health and compassion for our fellow human beings, regardless of why they are calling upon the NHS, what have we got?
Good luck and best wishes to all of you who are currently fighting cancer. My thoughts and prayers are with you.
Annette Kimber August 15, 2008
It is very sad that whilst there are new advances in medicines patients are not able to benefit unless they can afford to fund this themselves. I would want my family to be given every opportunity to live!
I work for the NHS and realise that NHS funding is not a bottomless pit, but surely life saving or life prelonging drugs should be high on the priorities.
TRACEY MASON August 15, 2008
What a terrible decision and what a dreadful blow to the poor sufferers of this dreadful disease. I can see both sides to the argument, but its true that too much money is being wasted on non life threatning conditions and supporting individuals who have never contributed to the NHS and also those who do nothing to help themselves.
Please though do not listen to these people who say” do not give to cancer charities,” the things they have achieved over the years have led to many people going on to live normal healthy lives due to the advances in knowledge on how to treat this illness, WE ARE ALL AT RISK no matter how you look after yourself.
A curable condition that can be managed by health and diet!! ……DEAR GOD!!! what an insult to the millions of sufferers of this wicked disease.
Health Researcher August 15, 2008
The problem here is the success of a cadre of academic economists in presenting their work as though it is an equivalent science to that of the labororatory and clinical sciences that lead to new treatments. However, Economics is a theoretical social science, not a natural science like biology or chemistry.
Unlike knowledge about the pathological processes, economic appraisals are socially cosntructed – that is the underlying concepts are politically contingent. They don’t look like that, of course, because they are expressed using mathemetical terms. The QALY (Quality Adjusted Life Year) which is the measure put forward by health economists for assessing the value of new treatments, was designed quite deliberately to meet the requirements of the Thatcher government in the 1980s as it sought to control costs.
NICE economic reviews are carefully desinged to consider only direct costs to government (via the NHS) but not the personal costs to patients, families, friends etc, or other agencies (e.g. local authorities, charities, the DWP). The underlying assumptions of these economic models are not easily understood by policy makers, clinicians or lay people because they are presented as mathematical models. Since very few of us have the high level maths skills it is hard for people to criticise reviews or advocate alternatives.
Economic evaluations are now presented as though they are scientific facts when, in fact, they are no more than theoretical speculations expressed in mathematical terms. These make them incomprehensible to clinicians and patients alike, and this lack of comprehension protects neoclassical economic theory from questioning (which is what we are talking about, it sounds complicated but actually it is very dull).
It is astonishing that the major research charities and patient advocacy organizations – or even journalists – haven’t cottoned on to this. If peoples’ lives are to be calculated using politically contingent theoretical models, then perhaps we should pay more attention to what these are.
Cancer Research UK should start to aggressively question the theoretical economic models that underly NICE reviews. They need to attack these model’s assumptions about what matters and support critical economic research in the same way that they fund critical developments in the biosciences. Like other research charities, they should start asking serious questions about whether the economic evaluations that they fund within drug trials play a part in perpetuating this problem. After all, it is those evaluations contribute to the NICE reviews that decide how treatment is rationed…..
Anne August 15, 2008
Do NICE care about people? I’ve just read some of the other blogs and my heart goes out to these brave people. How can a group of people make these decisions when we have the drugs to help others? Why promote the development of drugs if we are not going to use them.
How many of the NICE body, have been touched by a loved one having cancer? I do not understand how it is a post code lottery in this day and age, I Ithough we all paid the same taxes to the same body?
If a drug is availsble then we should use it even if it is not “cost effective”
Helen Pengelly August 15, 2008
It’s good to see these drugs are being rejected but it’s a sheme it’s for the wrong reasons. The only people that benefit are the drug companies. More needs to be done to expose the truth, cancer is a natural reaction of the body trying to heal itself. It is a curable condition that can be managed by diet and health living but sadly that isn’t profitable.
Teresa – I don’t give to cancer charities either because I suspect they are party to this knowledge and part of the cover-up. Cancer is big business and it is innocent people who suffer as a result.
Jennie August 15, 2008
My young sister passed away in November from kidney cancer, because she didn’t lie in the correct postal code area she was declined the drug that would have prolonged her life.
Like Teresa I wonder why we give to Cancer charities anymore as although they produce these drugs that will help Cancer patients – we have a body who decide on whether or not people shall live! Who gave them permission to act as God?
There is a lot of money wasted in this country and it is about time that someone stood up and demanded that the use of drugs is not dependent on how much they cost. If it can save or even prolong someones life then it should be available.
Teresa August 15, 2008
I don’t give to cancer charity’s anymore as I don’t see the point of researching to finds cure’s only to be told that you can’t have them because they are too expensive.
Jacky & Colin Jones August 15, 2008
Our nephew who has cancer at 44yrs of age had a kidney and a rib removed last January 2008. Surgeons found a secondary cancer had spread to the lung, which is in the form of polyps. He is undergoing treatment by taking the drug SUNITUB. After his first course of treatment he had a scan, which showed a slight decrease in the size of the cancer after just one month.
This drug is one of three drugs N.I.C.E. has announced a draft decision NOT to allow funding for which is the only effective treatment for this type of cancer the reason given that it is not cost effective.
We can accept this reasoning if the cancer was caused by self abuse such as smoking, alcohol or drugs but we cannot accept for our nephew who has never smoked, taken drugs and only drunk alcohol in moderation.
Can you imagine what stress, anger and upset this has caused him, his partner and his mother and father and to all the other people and their families in the country whose sons or daughters has this life threatening decease.
Please, please do not let this draft become a reality.
A very concerned and sincere
Aunt and Uncle.
wendy August 15, 2008
Our dad has just turned 66 (July 08), he had been retired for just 10 months when he was diagnosed with advanced kidney cancer. What a shock that was to him (he had no clue) and what devastation to the family. He has just had his follow-up appointment after a course of radio-therapy. He is going to start Interferon but his consultant told him the best drug for him would be Nexavar. He wants to live to enjoy the life he had before this destructable disease took hold, he wants to enjoy his 7 grandchildren, he wants to do the things he & my mum planned for retirement. WHY WHY WHY!!!!!!!! does NICE think it can play god. (We know there is not a bottomless pit of money, but when the NHS & government are wasting billions of pounds each year on furnishing second homes or the top cats getting above inflation pay rises – We could go on!!!!!!!!!!!). What value are NICE putting on human life, how can you sleep Prof Peter Littlejohns all 4 drugs have proven effectiveness. What if it happens to you or one of yours (I hope to god it doesn’t) but what would you do then?????
ann s August 14, 2008
I live in Spain and am currently being treated for advanced Ovarian cancer, Here in Spain there are NO restrictions on any drugs for any cancer. As usual with the UK it all boils down to money, I thought the medical profession are there to save lives !! Perhaps the money should be directed to the people who really need it and not to people with self inflicted illness caused by obesity, smoking etc.,
Beverley Pocock August 14, 2008
As a 48 year old woman with kidney cancer, I am now sentenced to a very shortened life and probably won’t get to my 50th. I work for the NHS and appreciate that there is not a bottomless pit of money, but I do question how NHS funding is allocated for other things that we, as parents, should take responsibility for such as childhood obesity for example. I did not choose to develop kidney cancer and no-one can tell me categoricallywhy I have, other than it is not genetic. Can the drugs companies do more to reduce the cost of these drugs?
I hope NICE will reconsider this decision and allow people like me to make the most of the time we have left and use it as usefully as possible,
d t r August 13, 2008
the news this week about NICE’s decision to not pass these drugs for genral use for kidney cancer is imoral.these drugs give hope to people inflicted with this horrible disease.Without hope they have nothing.These drugs have been proven to exstend life expectancy .The desision should be over turned.
MAKE A DIFFERANCE EMAIL [email protected] HAVE YOUR SAY.
andrew (son of KC patient) August 13, 2008
Just to say that my impression is that there’s so much support out there, but it’s split between different patient groups/blog sites etc – who is actually going to be responsible for pooling all the comments/facts/individual pieces of research together/ I would like to challenge all the owners of the sites where these comments are made to make sure they all arrange ONE National coordinated response which can be used to show the extent of public outcry at this decision. I would also challenge evryone who wants to overturn this decision to bombard media and to keep this story in the press until it is over turned.