
It's a provisional 'no' from NICE
EDIT 16/05/12 – NICE has now approved this drug. More here.
Today the National Institute of Health and Clinical Excellence – NICE, the body that decides which drugs the NHS should pay for – has given a preliminary ‘thumbs down’ to a new prostate cancer drug, abiraterone (Zytiga), after it failed to agree a pricing scheme with its manufacturer.
As regular readers will remember, we played a key role in this drug’s development, from pioneering lab work, through pre-clinical studies, all the way up to early patient trials.
This is a deeply disappointing and frustrating decision. Since it became available last year, abiraterone has become one of the most requested drugs on the NHS Cancer Drugs Fund. Both patients and doctors alike value the extra months it gives men with their families, if their prostate cancer comes back after chemotherapy.
Chiefly, we’re upset that the healthcare authorities and the drug’s manufacturers, Janssen (part of Johnson & Johnson), can’t agree a fair price for the drug.
We also think there are some issues with NICE’s calculations, which we’ll discuss below.
Thankfully, this decision isn’t final, and can be appealed NICE is now asking for comments through its consultation process. But we’re dismayed that this will mean another long wait of many more months before there’s any hope of progress. And while we wait, there will be men in the UK who will be denied a drug that could help them.
Here’s a video of our chief medical officer, Professor Peter Johnson, explaining what he thinks about the decision:
We need to be clear: abiraterone isn’t a cure for cancer.
But for the thousands of men diagnosed every year with prostate cancer that has spread, it has the potential to ease suffering in the late stages of a terrible disease, and give men more time with their families. The average survival time for these men is just 11 months. Trials have shown that abiraterone could give them an extra four.
Vested interest?
Some will say that we’re only upset because Cancer Research UK stands to earn money from sales of abiraterone. And we do have an interest here: thanks to the way we licensed our initial discoveries to the pharmaceutical industry, we stand to receive royalties from the drug’s sale.
But those funds would be ploughed back into our urgent search for better ways to treat this terrible disease. We receive no government funding for our research – almost all our income comes from the public’s generosity. Things are tight for everyone, and we’re having to seriously prioritise our research funding. Every penny counts.
On top of this, it’s hard to tell our supporters that a drug whose development they helped to fund isn’t going to be available to patients. More recently, to try to prevent this situation arising, we’ve been much more forensic in contracts we sign with the pharma industry, to encourage them to market the resulting drugs at a price suitable for the NHS.
But we signed the original agreement to develop abiraterone in the late 80s, long before NICE was even a twinkle in the Department of Health’s eye.
Our motive is not self-interest. At Cancer Research UK we passionately believe that to help people with the disease, we have to understand what makes cancer tick, and use that knowledge to develop better treatments.
Abiraterone is a shining example of this vision. In the 1990s, we helped fund researchers at The Institute of Cancer Research to identify the molecular machinery that helps prostate cancers use testosterone to grow and spread. They developed chemicals that could interfere with this process. They tested and refined these chemicals into a drug that could make a difference. And they conducted early trials of this drug.
We watched proudly as others at The Institute of Cancer Research, with Janssen’s support, built on that platform, rigorously testing the drug in clinical trials. These trials proved that the drug could improve things for the people who really matter – patients.
So hearing that men are to be denied this drug as a routine choice is a huge let-down, and a real blow to the morale of everyone who shares our dream of conquering cancer through scientific research.
Where did things go wrong?
First, let’s look at NICE’s calculations.
Around 37,000 men are diagnosed with prostate cancer every year in the UK. Of these, about 10,000 are diagnosed with advanced disease.
But abiraterone is only currently intended for men with advanced prostate cancer who have already had chemo, which isn’t suitable for all men. We’ve spoken to a range of experts who agree that the true figure is probably fewer than 7,000 men – and we think this number is low enough for the drug to be assessed under NICE’s end-of-life guidance, which has less-stringent rules over cost.
So we think the overall cost could be more manageable than NICE’s initial calculations appear to have indicated. They disagree with us, and issued a statement to say so. But all the evidence Janssen gave them backs up our point of view; they appear to have dismissed this on the advice of a single expert.
The drug’s high cost is perhaps a more significant factor. We’re well aware that abiraterone is an expensive drug* – it costs about £3,000 for one month’s supply – and we live in straitened times. But the challenges of the current economic climate need to be shared. Janssen have offered the NHS a discount, but clearly not enough. We want them to agree a discount scheme that reflects the current financial constraints on the NHS.
If NICE tweak their sums, and Janssen are willing to compromise, we desperately hope abiraterone will be allowed to enter routine use.
Men in England with advanced prostate cancer can, of course, consider asking their doctor to apply for access to abiraterone through the Cancer Drugs Fund. But this is a finite pot of money that’s only available until 2014. It has to service the needs of patients with many other types of cancer. We mustn’t overload it, or others will suffer.
And crucially, the Fund doesn’t apply to men in Scotland, Wales or Northern Ireland (the Scottish drugs watchdog, the SMC, say they aim to appraise abiraterone by March 12th).
How long will the appeal take?
Appeals need to be submitted NICE want to hear from other experts by February 23rd, and say a final decision should be made by May. And this highlights a wider problem – NICE’s system still appears to be overly reliant on economic, rather than clinical, values. As we discussed in December, the Government is planning to reform drug pricing in the UK, through a proposal called ‘value-based pricing’. We want this new system, however it works, to be faster, more transparent, and focused on delivering positive outcomes for patients.
But that’s for the future. In the here-and-now, we’ll be consulting with our colleagues at other clinical and research organisations. If you have anything you want us to highlight, please leave your thoughts below. As well as people affected by prostate cancer, we’re also keen to hear from the people who look after them – clinicians, nurses, GPs and other carers.
We hope that the appeal is successful, responses to this consultation convince NICE and Janssen that the drug represents a real step forward for men with prostate cancer, so it can be made available on the NHS for those could benefit from it.
Henry
*Edit 03/02 – we’ve added more details about the cost of abiraterone above, in response to a request on Twitter
Edit 06/0 – after discussion with NICE, we have slightly amended the wording of a few points above.
Comments
Patrick Murphy March 21, 2012
To D Manger, I couldn’t of put it better myself.
dennis manger March 18, 2012
I was unfortunate to get advanced prostate cancer and what a lovely country we live in i have worked here all my life and well over my retirement age and like thousands more have paid into the national health from when it first started. What a generouse country we live in we can send millions of pounds to other countrys and we are classed as a rich country yet we canot give our own people a cancer drug to help them, and only the other day it was in the papers that any people comming from abroad to this country with hiv can have free treatment i am fuming thanks for nothing D manger
yvonne mulhearn March 18, 2012
Well said sir.
Gaye Ellacott February 23, 2012
If cancer research helped play a key role in the research of this drug and gave funding what right do NICE have to overprice this drug so that the NHS cannot afford to use it for the very patients it was made to help! It should be made available at an affordable cost so that the very people that need it can be treated with it. This paragraph below is from the NICE website
The National Institute for Health and Clinical Excellence (NICE) was set up in 1999 to reduce variation in the availability and quality of NHS treatments and care – the so called ‘postcode lottery’.
Our evidence-based guidance and other products help resolve uncertainty about which medicines, treatments, procedures and devices represent the best quality care and which offer the best value for money for the NHS.
My Dad is due to start taking abiraterone in the very near future and I am quite frankly appalled and very angry at what I have just read. I have raised money for cancer research and think it is a disgusting that someone should be able to stop the NHS from using a drug which could help a lot of people for the sake of overpricing a drug when they are the very people that are mean’t to be helping and fighting for rights of these people. How do they benefit from overpriceing these drugs is for profit?
Gail February 23, 2012
I’m torn on this – I think it’s disgusting that the drug companies can essentially hold the NHS to ransom, but equally I understand that when budgets are tight that end-of-life-prolonging drugs may be shelved in favour of treatments for those who have a good chance of making a recovery. I don’t have personal experience and there is no such thing as a more convenient time to die, but I can imagine how important and extra couple of months can be, to set your affairs in order, to see a child get married or to be around long enough to meet your newborn grandchild. Government budgets are set – it is not as if the NHS can go penny pinching from transport, education or defence (and neither can they go penny pinching from the NHS) in order to fund it’s bottomless pit of worthy causes.
If there is anything to be learnt from this, it is the importance of early diagnosis – life is too precious to put off going to the doctor – the longer it’s left, the greater the risk of terminal illness and being trapped on the receiving end of expensive drugs and tight budgets. My uncle is 58 and was diagnosed with prostate cancer last week – they have caught it early. I hope he does not find himself in this awful predicament in months/years to come.
dennis manger February 22, 2012
i would like to say that i a absolutely discusted with this
goverment and te national health service that they are not paying for the new drug for prostate canser i have the desease and have payed in all my life since the nhs
started and now tha i need it they ae refusing to pay for the drus i need
Mrs. D. Ford February 22, 2012
I was horified to listen on the 6pm news tonight that NICE in their wisdon are saying that they are advising that the drug Abiraterone is not going to be prescribed for Prostate Cancern Patients. I think that this an outrage.
mr l hall February 22, 2012
I hope i can get the drug
healthy man February 15, 2012
IMO some pharma companies inflate costs. Hlding a patent is not for holding lifes to ransom. I understand that its a business, but there has to be a line drawn somewhere. The NHS cant be expected to spend thousands for every patient. Hopeing for the best!
Jenny Hickey February 13, 2012
why should we bother toraise money to find new drugs.when we arenot allowed the use of them to prolong our loved ones lives.it takes the heart out of the fund raises . why bother,spend thousands to fill the pockets of the drug companys.i give up,
yvonne mulhearn February 10, 2012
As Mr michael Andrews says the list is endless. This country could be rich again if it stopped handing out billions to freeloaders and foreigners who just love all the benefits that are handed out to them. Aberaterone not only prolongs the life of the sufferer but enhances it by decreasing the pain and suffering they are in, every type of pain killer that was tried on my husband barely relieved the pain, but since he started aberaterone he is virtuallt pain free and can walk unaided. He has paid hundreds of thousands of pounds in taxs and insurance and has never claimed one penny in benefits throughout his life. As the saying goes” charity begins at home”, doesn`t seem to apply to this country tho.
Dermot Glynn February 8, 2012
Is Abiraterone available through private clinics?
Mills February 8, 2012
In terms of value (using their QALY), NICE calculated Abiraterone to cost GBP 63,200 per year. The QALY limit is typically GBP 30,000 per year, so I’m very suprised that CRUK is crying foul. Abiraterone is hugely expensive and remember is doesn’t save lives only extends them. It is very unlikely that NICE will reverse their decision at appeal.
Instead of complaining about NICE’s decision against parameters that have been laid down for many years, CRUK should do more to ensure that the fruits of their charity funded research are not wasted because the resultant drug is priced out of the market. For example they could stippulate that any treatment that exploits CRUK’s research cannot be priced above NICE’s QALY limits – easy.
I do sometimes wonder about CRUK’s motives and the conflict of interest that appears to exist between CRUK and the drug companies. How much of CRUK’s research is actually drug development R&D which could be done by the drug companies themselves (for which they can be handsomely rewarded)? How much the CRUK’s money is actually subsidising ‘big pharma’?
Syma Nizami February 8, 2012
I dont think people really understand cancer. This is one disease where no amount of money is ever sufficient. I understand recession and the whole baggage its brought upon us but thats no excuse to decline human right to access treatment. Recession was brought on by poor banking/poor govt decisions/ lack of govt control over poor banking etc.. Cancer is not brought on us by our own initiative. Why to make people suffer more when they are already facing the worst in their lives.
My dad was diagnosed with prostrate cancer. He is not in UK but I know what we all as a family went through when he was diagnosed. It felt like a death sentence to all of us. All the laughter and fun suddenly seemed to have had dissappeared from our lives. The tests and the scanning and the whole tratetment that followed made us all feel every minute a lifetime tragedy. He is all clear now. But the underlying fear that it may come back never went away. We dont talk about it yet its all there at the back of our minds.
So please dont make cancer medicaion a business deal. Dont play with peoples’ lives.
I totally support Michael Andrews above. When so much is spent – “politically” without the consent of the public why to make a life saving drug such a big issue.
karpal kaur-smith February 7, 2012
my mother and husband died from cancer as it was caught too late,but if a new drug had been developed to prolong their lives we would should have had the right to have it on the NHS.Drug manufacturers should be govened by basic buissnes practice as we are talking about peoples health,in short the price should be cost plus a reasonable profit. NO MORE
michael andrews February 7, 2012
how much did we spend on Lybia,Iraq.how much do we pay the EU to tell us what we can and cannot do,free board and lodging to terrorists.How much do we send in overseas aid to some countries that are financially better off than we are.How much do they intend to spend on the new High speed railway link that is not wanted by a very large percentage of the population.How much could be saved if HMG got rid of the large number of Quangos (remember the election promise )?How much could be saved on MPs/Lords expenses,discounts & subsidies,particularly in food and alcohol,look at the figures, along with overseas “observation/investigation trips.The list is endless and,apart from this we lose all our countries defences.Timwe HMG started spending money AT HOME where it is needed
karen lilley February 6, 2012
This drug should be widely available to all men with prostate cancer.
It saddens me so much, after all the hard work, etc that a price cannot be agreed for this.
This treatment is vital.
For some this may be their only hope.
When you look at all the waste where spending is concerned, it’s an outrage.
olga Kouri February 6, 2012
My father has been suffering from prostate cancer for 20 and a half years.Over the years his body responded well to a variety of drugs and thanks to research he has been able to fiight his desease. He is currently 85 and taking Arbiraterone in Greece through the Greek NHS system. It has cut his PSA count by half in 6 weeks! It has given him new hope and is able to enjoy life. He is currently not counting months.
I am surprised that in a country like the UK the NHS cannot find the money to help people when millions are squandered elsewhere.
Henry Scowcroft February 6, 2012
Hi everyone, thanks for all your comments – great discussion and some really interesting points raised. We just want to clarify a couple of things:
Firstly, for rather complicated reasons, we have no control over the price Janssen charge for abiraterone. Here’s a very quick summary of the drug’s history, which hopefully will explain why:
After Cancer Research UK-funded researchers at the ICR discovered the compound and did the initial preclinical work, our technology transfer company Cancer Research Technology (CRT) looked for someone to take this forward. This is because conducting the large (phase III) trials needed to prove a drug’s effectiveness is extremely expensive, and beyond the means of institutions and charities like ourselves and the ICR.
CRT assigned the rights to abiraterone to a company called BTG International ltd, who funded further development, and then in turn licensed the drug to a pharma company called Cougar Biotech, which was later absorbed by Janssen Pharmaceuticals, part of Johnson & Johnson.
As a result of these agreements, BTG International receive a small percentage from J&J in royalties from each sale of abiraterone, and in turn, they pass a percentage of this on to Cancer Research UK. While this has the potential to add up to a reasonable sum of money for us, it’s almost certainly not enough to affect either J&J’s calculations over profit, nor NICE’s preliminary decision.
Without partnering with industry in this way, we’d never be able to turn our laboratory discoveries into treatments for patients. And obviously, pharma companies need to recoup the huge sums of money they spend running expensive phase III trials.
As we said above, the original deal with BTG Ltd was signed in the late 80s – well before NICE was brought into being. Nowadays, we try as hard as we can to make sure deals signed over Cancer Research UK-funded research contain clauses that aim to ensure drugs are brought to market at a price NICE is likely to favour.
Secondly, Keith, the only abiraterone trials that have been completed to date have been for men at the end of their lives, for whom there’s no alternative treatment. This is often the case with new medicines – they’re initially tested in fairly extreme circumstances, and then gradually widened out to more people as evidence accumulates that they’re effective in more people. There are currently trials that are investigating abiraterone for men at an earlier stage of the disease, and we’re eagerly awaiting their results.
And a final point – while we disagree with this preliminary guidance from NICE, we completely recognise the difficult position NICE is put in by circumstances, and recognise the vital role they play in making sure the NHS drug budgets are kept to a manageable level.
Henry
Cancer Research UK
Ian Liston February 5, 2012
I started on the Phase II post-chemotherapy trial for Abiraterone in December 2006 at The Royal Marsden in Surrey and was still receiving benefit from the drug (as my only medication for prostate cancer) three and a half years later. I had very few side effects, none of them significant and little or no pain from the prostate cancer that had metastasised to my bones.
NICE is quoting four or five months as the time of average benefit. Be assured that I’m not the only man who counts the effectiveness received from the Abiraterone trial in terms of years rather than months – with a normal ‘quality of life’. Those beneficial years have now led me to another trial, based on genetics, which is also proving to be of significant benefit to my PC.
Others have raised the unassailable argument (see previous posts above) of how this government seems to have its priorities wrong when it comes to medical research and new drugs. I couldn’t agree more. Only 4 months ago NICE declined approval of Cabazitaxel. – Another drug researched and developed in the UK and shown to have proven benefit to certain types of prostate cancer.
Abiraterone (Zytiga) is now ‘standard treatment’ in many other countries so why should those in the UK, the country where these drugs have been researched and developed, be left out?
Such refusals by NICE must seem like hammer blows to the dispirited researchers and clinicians who have spent years of their lives working on the development of these new drugs. Who could blame them if they leave the UK to seek research posts in other countries where their work will be appreciated and put to the beneficial use of patients without quibble over cost.
Also, let’s not forget all those who have spent considerable efforts fund-raising so that these new drugs can be researched and developed in the first place. – It’s a kick in the face to them too.
We must maintain the pressure on NICE, MPs and Government ministers to ensure that this short-sighted decision is reversed so that the lives of many men, and the well-being of their families and loved ones, are saved.
B C Addison February 5, 2012
Disapointing, but lets hope and appeal will bear fruit
Prof Gerry Potter February 5, 2012
The high cost of Abiraterone is due to the high dosage used of 1 gram (4 tablets) daily. This high dose was arrived at from the Phase 1 clinical trials and shown to be the maximum effective dose. However Abiraterone is very potent and had a minimum effective dose of 250 mg equivalent to 1 tablet daily. The high dose of Abiraterone is required for the first month to achieve total androgen deprivation neccessary for tumour shrinkage. After 1 month the LHRH signals have given up trying to make more CYP17 so subside to castrate levels. Once this has happened it makes no sense to be still giving a high dose from a mechanistic point of view. So perhaps a lower maintenance dose of 1 tablet daily could be used at a monthly cost of only £750.
There is also the question of dosing Abiraterone with meals since the uptake is greatly increased with food which would allow a lower dose to be taken. However Abiraterone is currently recommended to be taken without food and this topic is the focus of current clinical trials. Trials are also looking at improved formulations that allow a lower dose to be used.
I think the costings should also take into account the money saved by not keeping someone in hospital, since Abiraterone can be taken at home.
Abiraterone has overcome many regulatory hurdles over the last 20 years of development so I am sure that it will overcome this final hurdle to be available to everyone in the UK with prostate cancer.
Alice Greenfield February 5, 2012
It is a fact of life that the government would not be able to afford every drug that could make a difference to a cancer sufferers life, even if they used their budgets more effectively. What scares me is the power the drug companies have to dictate such huge prices. While i understand that the partnership with Janssen was set up 20 years ago, and that any royalties would be pumped back into research, it is clearly complicating an already crucially difficult situation. However, there has to be no doubt about abiraterone’s importance. Those who have perhaps not had family members with cancer cannot understand the importance of an extra few months for a patient, but palliative care is still essential – we all have the right to the most dignified and pain free death that the NHS can provide, and they clearly have a budget for it.
The most frustrating part of this issue by far is that with a little leeway given by the drug company, and a little by the government (after all, it really is just a disagreement about projected figures) this drug could be available to so many.
yvonne mulhearn February 4, 2012
Thank you for your follow on supportive messages, maybe a pettition should be set up to make the drug company lower their price and shame this awful goverment into funding this much needed drug. Not only does this drug prolong the life of the sufferer but decreases the pain they are on and so gives them a better quality of life. My husband was in so much pain prior to being prescribed the drug it was heartbreaking to see him crawling on hands and feet up the stairs. He is now virtually pain free and living a realatively normal life. We are under no illusion that it is a cure, but every day he is with us and pain free is a blessing. Good luck to all of you out there with this terrible illness and I hope that you will all be able to have access to this much needed drug.
Pamela Harris February 4, 2012
I was widowed because my husband lost his life to cancer aged 59. My brother lost his life to cancer aged 46, leaving behind 4 children. I work with a wonderful man who has been diagnosed with prostate cancer aged 59. His is terminal. I look at his wife who will be widowed like me….robbed of her old age companion.
When will our government put British people first, and give them the treatment they need? All these men listed above paid in to our Nation Health ALL their lives, worked and paid taxes, and were honest and hardworking family men. Two served in our Armed Forces.
We need to seriously think about this issue…….cancer has no favourites……..who will be next to give up their life because the Government has put money before mercy?
James Ritchey July 24, 2012
Isn’t it true that the older the man with terminal prostate cancer, the shorter the time benefit he gains from treatment, such as chemo and/or hormone treatments? Accordingly, why do not trial results show survival data as a
function of ages of patients. Admittedly, doing so might make it less likely that older men (like me) are able to obtain expensive drugs than their younger counterparts. Notwithstanding, is this reason enough not to collect and publish the data? I am 81 years old. Still, I”d like to know how little time I have left. If only a month, I’d rather avoid side effects and go on to hospice treatment