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Woman loses Herceptin court bid
Ann Marie Rogers
Ann Marie Rogers is devastated by the ruling
A breast cancer patient has lost her landmark legal challenge to be allowed the 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.
But the judge ruled that the trust had not been acting unlawfully.
Mrs Rogers has been given leave to appeal against the court's decision, and will be able to receive Herceptin treatment until then.
Mrs Rogers is in the early stages of breast cancer, but has an aggressive form of the disease.
Individual circumstances
When the judge made his ruling, Mrs Rogers simply shook her head and looked downwards.
She is fighting for her life
Yogi Amin, Ann Marie Rogers' solicitor
Plea to 'end the confusion'
Speaking outside the court, her solicitor Yogi Amin, of Irwin Mitchell, said: "Mrs Rogers is bitterly disappointed by the decision. It has come as a shock.
"She felt it was common sense that a policy to refuse to provide treatment, where other authorities are providing it, should be struck down."
He added: "It's an ordeal for her. This legal fight is something she is forced to do. She is fighting for her life."
Mr Amin said Mrs Rogers felt the hopes of women had been built up after the health secretary said PCTs should not refuse patients the drug solely on the basis of cost.
Making his ruling, Mr Justice Bean said he knew there were different opinions on whether or not to prescribe Herceptin to patients with early-stage breast cancer.
But he added: "The court's task is not to say which policy is better, but to decide whether Swindon's policy is arbitrary or irrational and thus unlawful.
Not illegal
Ruling Swindon had not acted unlawfully, the judge said: "Accordingly, despite my sympathy with Ms Rogers' plight, I must dismiss the claim for judicial review."
HAVE YOUR SAY
The drug hasn't been proven to the extent that it should be freely prescribed
Rae Purnell
Send us your comments
Jan Stubbings, speaking for Swindon PCT, said the judge had vindicated the trust's actions.
She added: "If something has not been approved as a treatment, and has not been through the licensing process, its safety and benefit haven't been absolutely checked.
"This wasn't an economic decision."
Mrs Rogers' case was the first 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 must first be licensed, and then assessed by the NHS drugs watchdog, 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.
In the meantime, some trusts have been hesitant to fund the drug when asked.
Other women, including nurse Barbara Clarke, 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.
Intervention
In November, Health Secretary Patricia Hewitt intervened when North Stoke Primary Care Trust refused to fund the drug for mother-of-four Elaine Barber.
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
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".
Following Mrs Rogers' High Court judgement, a Department of Health spokesman said its position remained unchanged.
He added: "PCTs need to take into consideration a whole range of factors before making a decision whether to fund Herceptin for a woman with HER2 positive early stage breast cancer.
"Ahead of a decision on licensing, or NICE appraisal, such decisions will continue to be made at a local level on a case by case basis."
But Joanne Rule, Chief Executive of the charity CancerBACUP said cancer patients would see that as 'postcode prescribing'.
She added: "The people who call our helpline want to know that decisions about their treatment depend on clinical need and not on where they live, how much money they have, or how 'exceptional' they are in comparison to someone else."
Ann Marie Rogers
Ann Marie Rogers is devastated by the ruling
A breast cancer patient has lost her landmark legal challenge to be allowed the 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.
But the judge ruled that the trust had not been acting unlawfully.
Mrs Rogers has been given leave to appeal against the court's decision, and will be able to receive Herceptin treatment until then.
Mrs Rogers is in the early stages of breast cancer, but has an aggressive form of the disease.
Individual circumstances
When the judge made his ruling, Mrs Rogers simply shook her head and looked downwards.
She is fighting for her life
Yogi Amin, Ann Marie Rogers' solicitor
Plea to 'end the confusion'
Speaking outside the court, her solicitor Yogi Amin, of Irwin Mitchell, said: "Mrs Rogers is bitterly disappointed by the decision. It has come as a shock.
"She felt it was common sense that a policy to refuse to provide treatment, where other authorities are providing it, should be struck down."
He added: "It's an ordeal for her. This legal fight is something she is forced to do. She is fighting for her life."
Mr Amin said Mrs Rogers felt the hopes of women had been built up after the health secretary said PCTs should not refuse patients the drug solely on the basis of cost.
Making his ruling, Mr Justice Bean said he knew there were different opinions on whether or not to prescribe Herceptin to patients with early-stage breast cancer.
But he added: "The court's task is not to say which policy is better, but to decide whether Swindon's policy is arbitrary or irrational and thus unlawful.
Not illegal
Ruling Swindon had not acted unlawfully, the judge said: "Accordingly, despite my sympathy with Ms Rogers' plight, I must dismiss the claim for judicial review."
HAVE YOUR SAY
The drug hasn't been proven to the extent that it should be freely prescribed
Rae Purnell
Send us your comments
Jan Stubbings, speaking for Swindon PCT, said the judge had vindicated the trust's actions.
She added: "If something has not been approved as a treatment, and has not been through the licensing process, its safety and benefit haven't been absolutely checked.
"This wasn't an economic decision."
Mrs Rogers' case was the first 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 must first be licensed, and then assessed by the NHS drugs watchdog, 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.
In the meantime, some trusts have been hesitant to fund the drug when asked.
Other women, including nurse Barbara Clarke, 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.
Intervention
In November, Health Secretary Patricia Hewitt intervened when North Stoke Primary Care Trust refused to fund the drug for mother-of-four Elaine Barber.
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
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".
Following Mrs Rogers' High Court judgement, a Department of Health spokesman said its position remained unchanged.
He added: "PCTs need to take into consideration a whole range of factors before making a decision whether to fund Herceptin for a woman with HER2 positive early stage breast cancer.
"Ahead of a decision on licensing, or NICE appraisal, such decisions will continue to be made at a local level on a case by case basis."
But Joanne Rule, Chief Executive of the charity CancerBACUP said cancer patients would see that as 'postcode prescribing'.
She added: "The people who call our helpline want to know that decisions about their treatment depend on clinical need and not on where they live, how much money they have, or how 'exceptional' they are in comparison to someone else."
Why some drugs are not worth it
By Nick Triggle
BBC News health reporter
There has been an outcry over the initial decision - since reversed - not to give a mother-of-four a drug for breast cancer.
But in the world of the NHS where money is scarce despite record levels of spending should it come as such a surprise?
Image of pills
The NHS drugs bill has risen by 46% in the last five years
When North Stoke health officials met on Monday evening to discuss the case of Elaine Barber, they had the sort of discussion that happens every day and at every level of the NHS.
The primary care trust, which is in charge of commissioning local health services, had to decide if the treatment, Herceptin, was worth the cost.
In the case of the 41-year-old mother-of-four, who is in remission, but has been warned her breast cancer could come back, the trust ruled it was not as well as citing safety grounds.
Subsequently, the trust has backtracked, following a wave of negative publicity.
But in making the original decision, North Stoke PCT spokesman Adam Whittaker said that officials thought it was not the best use of their limited resources.
He explained: "To do so could seriously affect the availability of care to other patients, including those with other cancers."
While it remains an uncomfortable fact for the public, the truth is that there is a finite amount of money available and each treatment has to be judged on price.
Cost
In NHS-speak this is known as Qaly (quality-adjusted life-year), a complicated system which gives each treatment a score for the benefit it gives in quality and length of life and is then compared to cost.
Herceptin, relatively expensive at nearly £20,000 for a year's course, would be compared to other breast cancer drugs.
But other factors come into play - and these will differ from trust to trust.
Officials also seek guidance from a range of sources, including NHS advisers NICE, local doctors and the government in the form of national service frameworks.
Spending money on one thing, means you have less to spend on another
Michael Dixon, of the NHS Alliance
Mother refused cancer drug
Historical background can be a factor too. If an area has spent heavily on, say, heart treatment in the past, it is logical it will give more consideration to new drugs targeted at that.
Chris Ham, professor of health policy at the University of Birmingham, said: "Trusts cannot do everything, so tough decisions have to made and they can differ from area to area."
In many respects the emotional debate over Herceptin - Ms Barber has said she is being left to die and Health Secretary Patricia Hewitt has demanded to see the evidence up on which Stoke's decision was based - obscures how decisions are made.
Herceptin is an unusual case. On the whole, PCTs only fund expensive drugs that are recommended by NICE, which assess drugs on cost and clinical effectiveness and also takes Qaly into account.
Trusts are free to pay for drugs that do not have the stamp of approval, but in reality it is increasingly hard to justify spending money from a limited pot on such a drug when others have been recommended.
Judgements
What is more, Herceptin has not even been licensed for early stage breast cancer - it is for advanced cases of the disease - which means NICE cannot yet look at whether it should be recommended.
An application is expected to be submitted to the UK's drug regulatory body is next year, although the Lancet medical journal says the evidence currently available is insufficient to "make reliable judgements".
Elaine Barber
Ms Barber said the decision does not make sense
But even drugs which have been licensed - hence proven to work - are not automatically recommended for treatment.
The case of an alternative drug to aspirin which came before NICE officials last year illustrates the point.
The drug was more effective than aspirin, but only marginally, and cost twice as much. The result - no recommendation.
But in the NHS chain of command, NICE recommendation does not even carry a guarantee it will be used.
PCTs which, like the rest of the NHS, face cash flow problems, are increasingly being asked to pay for a greater number of more expensive drugs.
Chain of command
While the NHS budget is rising by 7% a year, the drugs bill has been increasing at a faster rate and now stands at £8bn.
And when they are being asked to pay for more staff on improved contracts - nurses, GPs and hospital consultants are all on better contracts than they were when Labour came to power - NHS managers say it understandable that they cannot always comply with guidance.
The NHS Confederation, which represents health service managers, said trusts face a "challenging task" balancing all these priorities.
Michael Dixon, chairman of the NHS Alliance, which represents PCTs and community, said: "Spending money on one thing, means you have less to spend on another.
"The health service has a lot of competing cost pressures - waiting lists, drugs and staff numbers - and at each stage it has to make the best decision for patients.
HOW QALY WORKS
Qaly judges a year of perfect health as 1, while death represents 0
To judge quality of life, factors such as mobility, pain, depression and the ability for self-care are taken into account
So a treatment which results in four years of life with a health state of 0.75 gets 3 qalys, where as four years with health state of 0.5 is 2 qalys
The qaly is combined with cost to give cost utility ratios which are then used to judge the treatment
"That may be paying for drug treatment, or it may be paying for extra doctors. You cannot have it all."
Nonetheless, NICE is adamant its advice should be followed. A spokeswoman said: "Once NICE publishes guidance, health professionals and organisations are expected to take it fully into account."
But even then, drugs can be blocked further down the chain of command.
In a recent case in the south west of England GPs refused to prescribe a flu drug despite the local PCT saying money was available.
They felt the cash would be better spent on nurses.
The same can happen in hospitals, where consultants may decide a recommended treatment is not in the best interests of patients.
Of course, these decisions can be challenged - as Ms Barber is doing over North Stoke PCTs ruling - but that does not alter the fact that these judgements are still made.
Over the past few years, the NHS has been streamlined, improved, its' budget growing year after year...Yadda. Yadda. Yadda. Labour has been constantly setting targets that docters, nurses, hospitals, trusts, have to reach. Cutting Waiting Lists is one of them, for example.
Things is, to hit these targets, some Primary Care Trusts have been forced to overspend. (PCTs, basically areas of the country are split up, and each PCT is responsible for everything to do with medecine with in the borders, ie the hospitals, the workers, the administration etc).
That link shows the break down of the debt.
TOTAL -£83,492,000.
Big, ain't it? And that is just the West Midlands, which only accounts for a small amount of the UK population, about 5.3 million according to the 2001 Census, barely one eleventh of the population.
Now to get to the point...Does anyone who is ill have the right to medical treatment, and any medicine that might stave off death? The amount of money that the NHS can recieve is finite, it is not a bottomless pit. More hospitals are required, or rather more theates, and more equipment, and more nurses, and more docters...and all the while, the drugs bill is increasing.
A purely private medical system does not work, and the NHS could easily start sucking up as much GNP as the US system. Is there any right system?
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