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Last Updated: Wednesday, 9 November 2005, 13:21 GMT
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

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.




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