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Thousands of arthritis sufferers will be denied treatment with proven benefits by a decision not to pay for a new drug.
Guidance issued by the National Institute for Health and Clinical Excellence (NICE), the watchdog that controls access to drugs on the NHS, will recommend today that the drug does not represent value for money, although it has been shown to improve dramatically the severest symptoms of arthritis in almost half of patients.
The draft ruling comes on the day that Alan Johnson, the Health Secretary, will announce that he is tearing up a price-fixing agreement with pharmaceutical companies in an attempt to reduce unneccessary waste of drug funds.
The Times has learnt that the Health Secretary has decided to take on pharmaceutical giants as the NHS’s £8 billion annual drugs bill comes under pressure from expensive new medicines.
Abatacept, which has the brand name Orencia, is the latest of a new generation of drugs to be blocked by NICE on the ground that it is not cost-effective.
About 400,000 people in the UK have rheumatoid arthritis, of whom a tenth (40,000) have a severe form. Many benefit from a class of drugs called anti-TNFs but about a third do not. This group, of around 12,000 patients, could potentially benefit from new drugs such as abatacept. Its manufacturer, Bristol Myers Squibb, estimated in its application to NICE that around 3,500 patients a year would benefit.
Published data shows that in trials abatacept produced a 50 per cent reduction in symptoms in about 40 per cent of the patients who used it in conjunction with an older drug, methotrexate.
The cost would be about £9,300 a year for an average patient, but all would be sufferers who had already been treated unsuccessfully with anti-TNF drugs, which are equally expensive. Those who gained no benefit would have been taken off the drug swiftly.
The NICE decision was described by patient groups as devastating. Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society (NRAS), said: “This is extremely bad news for people living with severe rheumatoid arthritis.
“Denying patients the option of abatacept leaves some of them with the unacceptable choices of being put back on to treatments they have already failed on, palliative care or taking large doses of steroids, which have unacceptable side-effects over the long term.”
The NICE ruling will be open to consultation, and final guidance is not expected until the end of the year. A spokesman said: “Having examined cost-effectiveness analyses on the drug against a range of comparators, the committee concluded that abatacept could not be considered a costeffective use of NHS resources.”
The problems of balancing drug costs against benefits have led a growing number of patients who are denied treatments to resort to legal action.
The Government hopes to free more money for treatments by renegotiating the five-year profit control agreement that it signed with drug companies just two years ago. The move comes after a report by the Office of Fair Trading recommended that the NHS move to a new system that matched the price it pays for drugs to how effective they are, after finding widespread evidence of overcharging.
Some of the most inflated prices are for treatments for blood pressure, cholesterol and stomach acid, which are prescribed to millions of patients a year. Although some cost ten times as much as alternatives they offer little or no extra benefit, the report found. It concluded: “We have identified hundreds of millions of pounds of expenditure per year that could be used more cost-effectively under value-based pricing, allowing patients greater access to drugs and other healthcare benefits they are currently being denied.”
Representatives of pharmaceutical firms were warned by Mr Johnson that he was intending to tear up the agreement. A statement from the Department of Health will seek to strike a conciliatory tone, emphasising the contribution made by drugs giants to the economy and in developing new medicines.
Nevertheless, the drugs industry is likely to fiercely resist attempts to renegotiate the price regulation scheme. In the wake of the competition watchdog’s report this year Richard Barker, the director-general of the Association of the British Pharmaceutical Industry, said: “The UK gets its life- improving and life-saving medicines at a fair and reasonable price.”
A Department of Health official told The Times that Mr Johnson could not ignore the findings of an independent watchdog after a thorough 18-month investigation that compared the prices paid in Britain with those paid abroad. He added that the Health Secretary had not yet decided whether to accept the recommendations in full.
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Stop giving free prescriptions to illegal immigrants. My husband had to pay for essential medecines for Arthritis, Heart Disease and Leukaemia out of his Benefits. He had lived here all his life and paid into the system since he left school at 15.
Stop paying for sex-change ops. If they want one let them pay for it privately.
Breast reduction is sometimes clinically necessary, but breast enlargement should be paid for privately.
Economic migrants should pay for any medical treatment and recoup the costs when they return to their own country. I had to pay for seeing a doctor and for medication in France, and recouped the cost when I came home.
These few cost cutting measures should free up a load of money for supplying necessary drugs to people who have paid into the system all their lives.
Beryl, WINDSOR, England
I think that this is disgusting that someone suffering from such pain should be denied vital drugs that could radicaly change their life for the better. I have first hand experience as my mum was a sufferer and unfortunatly denied these vital drugs. It is to late for her as she died 4 months ago but it is not to late for other sufferers still fighting their everyday pain today.
Zainab Shariff, London, England
Brian lee likes to throw that "48 mil uninsured in US" number around but doesn't bother to tell you the survey group that came up with this number INCLUDED those who were uninsured for just 1 day @ year. It also included illegals that had no right to be here in the first place and who should not be eligible for health care of any kind in the U.S.
He mentions drugs are more costly in the U.S., he is right. But it is the very cost of those drugs to U.S. that allows the R & D that could not be spent on developing new drugs for serious illnesses if the money was not available to the drug companies. So nations who are buying a particular drug at a goverment set cost are doing so on the backs of Americans who foot the bill for the R & D costs.
No patient should be denied drugs that improve the quality of their lives, for any reason. But they are and that is why we have people coming from Canada to get drugs in the U.S. I don't want the government in my health care. Period.
retire05, Everywhere, USA
Are we not worth it those who have paid in all our working life when people come here just for free medical help .surely we should have the major consideration
Ron Sealey, Croydon, GB
Sadly, this drug and others like it will not be available tp suffers in the UK.
Our Prime Minister this week gave £100,000,000 to the UN for operations in Africa. This is in addition to the £6,500,000,000 already earmarked for International Development for the year 2007/8. (see Treasury website)
While Mr brown is prepared to assign figures like these at the drop of a hat then it will be at the expence of the young and old of our countrymen.
Nigel Graham-Miller, Valencia, Spain
I would have a guess that the people who make these decisions,are not in pain or have to worry about paying for private treatment. Who are these people, I am sure we would all like to know who is making these decisions, they are faceless how do we find out who they are so they can be accountable for there decisions and answer too us.
J.HART, Hockley, UK Essex
People with sever rheumatoid arthritis live in excruciating pain which cannot be alleviated with palliative care. Steroid usage increases the risk of heart failure and strokes dramatically, even if taken for a short time. Heart failure drugs already cost the NHS a fortune. Stroke after-care costs the NHS and local councils a fortune. This refusal by NICE will condemn not only those with arthritis, but also their families and carers to a shortened life filled with both physical and emotional agony.
Anna Ellis, Rugby,
My newphew has been crippled by this disease for 10 years. He is 36 years old, unable to work and existing on disability benefit. In an attempt to control the disease he takes a lethal cocktail of drugs which are damaging him more than they are helping him which, in turn, leads to a higher dependency on the Nationa Healt Service. He is rapidly approaching a situation of needing daily care. How can depriving him of new drugs possibly be cost effectve - these new drugs just might provide the relief he so desparately needs to finally begin a self-sufficient life. Perhaps the National Institute for Health and Clinical Exellence hope he will be driven to end his life and therefore save them money - take heart, this state of affairs is not so far away as this young man feels he cannot endure this minute by minute suffering for much longer.
Julia Edge, Wrexam,
National Institure for Curtailing Expenditure, are doing their job well.
Rob Bain, Derby,
As National Insurance payers those sufferers are surely entitled to the best medical care the NHS can give. Will this stupid government stop wasting our money and start treating those who are suffering with some respect. It is about time that medical treatment is given to patients when needed and cost should not be a consideration. Why is it that in Wales they get free NHS prescriptions and we have to pay in England? This government is an absolute disgrace and needs to tighten up its act now.
Kristina Law, Leicester, UK
Why bother to do further research into any drugs if people are being denied the ones that do work. Enough charities are constantly begging for money for research - why? We are not going to be allowed the benefit of any research at this rate.
Norma, Halifax, UK
perhaps if someone at NICE lost the use of there hands due to athritis they would think differently but what,s the betting that it will be available in scotland very soon
d.jones, stafford, england
Might I suggest that people who read this and are as annoyed as I am about yet another denial of relief to sufferers on the grounds of 'cost ' remember this when the next general election is held?
Ian Gregory, Accrington,
Once again we see treatment denied. My daughter in law has kidney cancer. She is at present paying for Sutent, having been denied by the NHS. When the money runs out in a year, then she has around six months of life. Thanks NHS and NICE, If this mother of two very young children was a smoker, needed certain plastic surgery, was a drug addict she could get help. So the innocent suffer whilst those who choose to smoke or have a drug habit get help.
C, Darken, Nantwich, UK
Irresponsible. Incompetent. You have elected officials who do not know how to appropriately allocate resources (ala OFT report), and cannot make a simple prior authorization guideline to narrow the scope where abatacept will be cost-effective. Why not limit to people who have failed all other therapy? As to brian lee's comment about the US healthcare system (obviously a Michael Moore drone), the US healthcare system is one of the best in the world. It has its flaws, but that is due to lawyers (crazy settlements), greed (lawmakers, plaintiffs) driving up malpractice, and treatment of the uninsured. Without the US open economy model which bears the brunt of the world's drug costs, do you really think that (1) drug makers would be motivated to R&D new entities; or (2) drug costs in countries with "universal healthcare" would be so cheap? If the US went to a Canadian/European model, drug costs around the world in these socialized systems would skyrocket in order to offset the costs of R&D.
Jeff, Denver, Colorado
I suffer from Reflex Sympathetic Dystrophy, which really is a Cinderella condition. Very little research is being done into it and it doesn't feature in NICE's directives regarding pain relief at all. I live with constant and severe pain and, while there is a drug that would almost certainly alleviate my symptoms, it is only available to MS sufferers. While I have every sympathy with them, they are not the only ones living with pain on a daily basis. NICE seems to be devoid of all logic in a lot of its decisions and downright cruel in many more. If they or members of their families suffered from rheumatoid arthritis they would be outraged if they couldn't get the best treatment possible, likewise Alzheimer's, macular degeneration and so on. They need to experience living with these conditions, maybe actually spending some time with sufferers, before they make decisions that will blight people's lives perhaps irrevocably.
Yvonne Wilson, Norfolk, UK
Having waded through the OFT's report I am relieved to see the DoH finally getting the Government off it's backside to do something about drug pricing. PPRS has been a reasonable means of controlling manufacturers profits but has done little to control prices or demand for medicines. Let's hope a new scheme can be introduced to ensure that the NHS can continue to deliver more healthcare to more patients and save more lives!
Isabel Parker, London, UK
People can argue about where the line must be drawn on what treatments can and cannot be afforded in a public health system but unfortunately there has to be a line somewhere. I am sure that nobody wants people to be denied the best available options and I am certain that NICE have one of the worst jobs in the world trying to make the best of the constraints that operate, but the fact is that there is not enough money to treat everyone and everything. The government does have a clear duty to focus its health spending on getting the best "value" for society and can rightly be criticised for some of the wastage in the system but at the end of the day there is only so much money to go around and someone somewhere will lose out. All the talk of revolutions / elections etc will not change this.
mike, herne bay,
If developing new drugs is left to capitalist economics, it's inevitable that situations like this will arise. In this case, at least, the market has failed to meet a real need, and resources are being wasted on shareholders while people suffer. Choosing to deny treatment to certain kinds of patient on moralistic grounds, as some have suggested, is divisive and impracticable (e.g. what about the relatives of people who use legal or illegal drugs? who decides to what extent someone is responsible for their own health?) and anyway wouldn't solve the problem; NHS resources would still be limited, some drugs still too expensive.
John Stiles, Nottingham, England
I am about to go into a meeting at work - something that I would not be able to do if it were not for anti-TNF and other conventional drugs. I would be confined to bed and unemployed at the age of 49. I am one of the few thousand who suffer a very severe and aggressive form of arthritis. Without these drugs I would very quickly require expensive joint replacement surgery and other treatment to keep me living a life that wouldn't be worth living because of extreme pain in all my joints and tendons. I take pride in the fact that I am able to work full-time, support my family and contribute to the community in which I live. The authorities should take action in cases where a limited health budget is wasted in patching up drunks and druggies who arrive at every A&E in the country every weekend.
NICE also wanted to stop people being treated with more than 2 anti-TNFdrugs - I am on my third and this new drug, with a different mode of action, offered hope when the current drug stops working.
Norman Webster, East Grinstead,
This is an economic no-brainer. Rheumatoid arthritis is an agonising disease that reduces fit and productive young people to disability and dependence. I've had it for years and have only now been offered anti-TNF drugs, having repeatedly failed on older medications. Meanwhile, my joints have become more and more damaged and my pain unbearable. My GP doesn't even like prescribing decent pain relief because it costs money. Yet I've struggled to keep in work, pay full tax and NI and don't claim benefit. I've been so ill this year I was off work for months, and doubt I shall be able to continue without better treatment. I only wish a few politicians had this terrible disease - then they might realise it is a life sentence of agony. If NICE has it's way, one without parole. All treatment guidelines should take into account the cost of making patients unemployable and requiring full-time care if not treated appropriately.
Eve, London,
To Brian Lee
In the UK the NHS is not free. We all pay for it by tax from our salaries every month from the day we start working to the day we retire, whether or not we have need for it-National Insurance.
Reg , Reading, England
It is of course unreasonable to expect NHS coverage to provide for every treatment for every condition.
However, we should expect to know in advance what we are covered for, and to have an absolute right without regard to budgetary constraints to those treatments for which we are covered, if we fall ill with that condition.
The problem with the present situation is not that NICE will not approve abatacept. The problem is that even if NICE does approve it, it does not mean that we can get it. It will depend on where we live and what the state of the SHA budget is at the time we present. In short, what we are covered for and whether we get treated, and when, is a matter of the whims of 'managers'. It should be a matter of right.
This is little better than insurance fraud. It is a defined contribution, undefined coverage health care plan. The private sector would never get away with it.
Frederick DesLauriers, London, England
Arthritis sufferers are the genuine 'suffer in silence' brigade. It is an agonising complaint and I can only assume that those unNICE people who decided the drug is too expensive have no conception of this, or indeed know of anyone who suffers from arthritis. Once again, those of us who are being denied the drugs must wonder at the generosity of the Health Service in providing drug addicts with their drugs etc. etc.
Heather Thomson, Huntingdon,
What is the point of developing new drugs if they are not going to allowed to be used. because of cost. This seems to be another waste of money. Perhaps if NICE personnel were sufferrers the matter would be different.
Gillian Bayliss, Rhyl,
Could be worse . In the USA we have 48 million without any health insurance & drugs much more expensive here than in the UK. Think yourself lucky you have the NHS even with its failings its better than our system of medical greed . We have a great system for those that can afford it.
brian lee, medina, USA Ohio
Is this drug available on the NHS in Scotland. Is it only Emgland that is again denied?
Jack Taylor, Andover, hAMPSHIRE
I am presuming that this ban obviously only applies to patients in England, as health is devolved. And I also guess that the English tax payer will be funding this little goody for the Scots via the Barnett Formula.
I'm with Michael - we need a revolution!
Lynn, Ormskirk, England
Not a revolution - just an election. Unfortunately, though, all the mindless idiots that voted for Herr Diktator Blair will now vote for his successor. Will just one of you name ten positive acheivements of New Labour? Achievements, please, not unquantifiable spin.
Oh, and I don't count anything that involved meeting a target they had set for themselves.
Roger Tilbury, Worthing, England
Sadly, this drug and others like it will not be available tp suffers in the UK.
Our Prime Minister this week gave £100,000,000 to the UN for operations in Africa. This is in addition to the £6,500,000,000 already earmarked for International Development for the year 2007/8. (see Treasury website)
While Mr brown is prepared to assign figures like these at the drop of a hat then it will be at the expence of the young and old of our countrymen.
Nigel Graham-Miller, Valencia, Spain
As a suffererer of severe rh (as are many thousands of people in this country) I am appalled that the decision is to be taken not to trial this new drug. I have tried, through my doctor, most of the drugs available, including methotrexate and am aware of long term side effects of this particular drug and have always paid for my medicine through private insurance, which is extremely expensive.
It is disgusting when so much money from the tax payers in this country is being used to fight unnecessary wars, used to jet our Government officials, Prime Minister etc. etc., to "jollies" that sufferers not only from RA but other diseases, are not to benefit from perhaps a medicine which could give so much hope to thousands.
Marilyn Whittle, Buckinghamshire, United Kingdom
How ironic. The NHS are concerned about the cost of a drug that stops your joints getting so stiff. A few years ago they were concerned about the cost of a drug that had the opposite effect on your bone!
Rod Munch, Northampton, UK
Why don't we stop treating people for ailments caused by thier own choices, such as those caused by cigarrettes or alcohol, and direct this money to those who have real illnesses such as arthritis
jim , Motherwell,
It's time that we too are able to make our own generic copies of these medicines. If third-world countries can do it, so can we.
Health always trumps wealth. If all the big drug companies go bust, we can use our massive savings on doing the research and manufacture in the state sector, thus strengthening our research institutions and keeping our money in the country.
Vincent Murphy, London, UK
And yet, unneeded managers are not.
Farrukh, Woking, UK
N.I.C.E turns N.A.S.T.Y -[national association to scrimp on treating you]
misterp2, lower brailes,
What a bloody country! We can spend billions on Wars and ID Card schemes,but we deny the sick.
We need a revolution.
Michael J Rigby, Blackburn, England