Published: 08/12/2005 Volume 115 No. 5985 Page 12 13

Women with early-stage breast cancer see Herceptin as a potential life-saver, but health economies must cater for the needs of the whole population. And political interference makes a difficult situation even worse, as Mary-Louise Harding reports

It started with Somerset nurse Barbara Clark preparing to sell her house to fund a course of drugs that could be crucial in her fight against breast cancer.

By November, the battle for NHS funding for Herceptin for women with a certain aggressive form of early-stage breast cancer was all over the media and being discussed in parliament. The publicity culminated in a dramatic order from health secretary Patricia Hewitt that if a clinical case can be made in these cases primary care trusts should fund the drug. This is despite the fact that its use for this purpose has not been approved by the National Institute for Health and Clinical Excellence - and some say its efficacy is unproven.

However, for an NHS wrestling the twin beasts of enormous deficits and major reorganisation, the effects could be dramatic.

According to the Department of Health, about 5,000 of the 35,000 women diagnosed with breast cancer in the UK every year have the aggressive form containing the protein HER2, for which Herceptin can be prescribed.

Charity Breast Cancer Care puts the annual cost to the NHS of each patient’s treatment with Herceptin at£21,800, which has led the DoH to calculate that the drug could cost the service ‘about£100m’ a year.

How can this extra cost be absorbed? Many PCT managers recoil from the notion that there is a cost point at which they must say that these citizens’ lives are simply too expensive to save - or at least prolong. They say, however, that their duty is to apportion funds for a financial year, accounting for treatments on the basis of the needs of their entire population.

A central aim of the current reconfiguration of primary care is to strengthen commissioning and planning, but effective long-term strategic thinking is hampered by DoH diktats in the middle of the financial year to spend money that has long since been allocated (and in many cases exceeded). At least two strategic health authorities estimate that the cost to each of them of funding Herceptin for the remaining six months of the financial year is around£2m.

Many senior managers are furious about the situation, but fears over job security engendered by the PCT reconfiguration mean that even fewer than usual are willing to make a stand against political interference.

And ministerial visits to PCT chief executives at the centre of the row have produced some dramatic turnarounds: North Stoke, for example, changed its mind about funding Herceptin within 48 hours of Ms Hewitt’s decision to drop by (see timeline, below).

One senior manager describes the political ‘interference’ in difficult local decisions over Herceptin funding as ‘outrageous’ - and they are not alone in their view.

‘Herceptin is a highly promising but very expensive drug, and its case for treating early-stage cancer is as yet unproven, ’ says David Lock, head of law firm Mills and Reeve’s health department and a former government minister. ‘From the patient’s perspective it could be a lifesaver, but should NHS bodies be bounced into prescribing it for those who might benefit, in advance of clear proof?’ Mr Lock’s concerns were echoed during a special parliamentary debate in early November. MPs of all parties called on Ms Hewitt to put money behind her October statement that PCTs must fund Herceptin if the clinical case is made.

Labour MP for Staffordshire Moorlands Charlotte Atkins, a member of the Commons health select committee, said she was delighted with Ms Hewitt’s decision.

But, speaking during the parliamentary debate, she said the government should not expect cashstrapped and over-burdened PCTs ‘effectively’ to take on the role of NICE in a ‘highly charged, emotive atmosphere’. She said extra funding should be more available to fund individual cases such as the one in Somerset that precipitated the debate in the media and then parliament.

‘Trusts cannot say ‘we will invest this money now to save it over the next five or six years, ’ because each PCT has to stay within its budget year on year, ’ said Ms Atkins. ‘I have suggested to the secretary of state that in the short-term such cases should be funded not by the PCTs but by the NHS Bank.’ She argued that the cost of Herceptin will come down over the next 25 years and therefore ‘the NHS Bank should fund the drug over 25 years and reimburse PCTs accordingly’.

However, there is only so much cash in the system - and most of it has been spent before it is even available. Eastern Birmingham PCT chief executive Sophia Christie is adamant that she will not bow to political or media brow-beating, but stick to the decisions already taken.

And these have been based on meeting the commissioning requirements of the whole population.

‘The [commissioning] network [for Birmingham and Solihull, which she chairs], after proper debate at the beginning of the financial year, did not decide to prioritise Herceptin as it remained unlicensed [for this use], its case has not yet been proven, and the view was taken on balance that this intervention was not the most cost effective. We need to take into account all the evidence and make proper commissioning decisions based on firm evidence - otherwise what is it PCTs are being asked to do?’ she argues.

Ms Christie adds that her network calculates that funding the drug would cost Birmingham and the Black Country SHA over£2m for the six months to the close of the current financial year.

However, she says the anger felt among PCTs focuses on process rather than cost. ‘That money can only be found mid-year by cutting something like specialist child services, cardiac, other cancer services or long-term conditions, ’ she says. ‘Having said we must spend the money, will the secretary of state tell us which of those services she is happy for us to cut?’ A recent report by leading European health economists argues that health economies must take a more cautious approach. Ghent University’s Mattias Neyt argues in the journal Annals of Oncology that countries will have to be ‘prepared to reallocate resources, get rid of other treatments that are no longer cost effective and drive a hard bargain over the cost of the drug, ’ if they are to stand the financial strain this ‘expensive’ drug would put on them.

Inevitably the government sticks to its mantra that the NHS has had ‘record amounts of funding’.

However, responding to a question about whether the DoH would provide emergency funding to PCTs to fund Herceptin, health minister Jane Kennedy said: ‘If PCTs are having specific cost problems they should speak to their SHA’.

City and Hackney PCT chief executive Laura Sharpe said that her organisation put aside£25,000 at the beginning of the year specifically for funding Herceptin, should the need arise. However, it has already agreed to fund one patient at a cost of£24,000, and an additional case is looming on the horizon.

Ms Sharpe argues that NICE should assist the NHS in the very difficult decisions that have to be made. ‘It should be saying this intervention is more effective for population gain than that - It is a rationing debate that we do not have at the moment and cases like this just show how desperately It is needed, ’ she says.

Meanwhile, PCTs in Manchester and Leicestershire, Northampton and Rutland have announced that they will fund the treatment according to strict criteria. But according to Mr Lock, the legal system has always backed the right of health organisations to refuse treatments on the grounds that they reached a fair decision based on the needs of their whole population - to whom they have a statutory obligation.

Choice may lie at the heart of government policy. But in the case of Herceptin, the interplay between funding and the patient voice has seldom been more complex - or painful. .


June 2005 Somerset nurse Barbara Clark takes her campaign to secure NHS funding for Herceptin in early-stage breast cancer to the media. Headlines that she might have to sell her house to pay for the drug receive national press attention.

North Stoke primary care trust tells a meeting of a group of breast cancer patients that it cannot make a decision on whether to fund Herceptin for early-stage breast cancer use until it plans next financial year’s spending in March 2006.

July The Stoke women organise themselves under a ‘Fight for Herceptin Campaign’ banner and persuade six north Staffordshire MPs to take their case to health secretary Patricia Hewitt.

They request that she ensures the National Institute for Health and Clinical Excellence fasttracks guidance so it appears as soon as the drug is licensed for use in early-stage breast cancer in 2006.

The DoH refers the drug to NICE for a decision on its use in this case.

September The Staffordshire campaigners meet health minister Rosie Winterton to press their case. A study in the New England Journal of Medicine showing positive preliminary results of Herceptin trials on women with early-stage breast cancer receives international attention.

The European Medicines Agency issues a statement in response to what it describes as ‘huge press interest’, saying that it has not been approached by Herceptin manufacturers Roche for a licence for use of the drug for this use. Roche says it is working as fast as it can on the application and should be able to submit it in February 2006.

3 October National coverage is given to Somerset PCT’s decision to fund Ms Clark’s Herceptin treatment after deciding there are ‘exceptional’ circumstances.

5 October Ms Hewitt announces that all women diagnosed with early-stage breast cancer will from now on be tested to see if they have the aggressive type that may respond to Herceptin. National cancer director Professor Mike Richards meets the 38 cancer network directors to discuss implementation.

18 October South West Peninsula strategic health authority says it will put aside funding for Herceptin treatment for up to 200 women a year.

25 October A statement from Ms Hewitt says it is up to ‘individual clinicians to decide whether to prescribe Herceptin ‘and that PCTs must not refuse to fund the drug purely on the grounds of cost’.

3 November NICE and the Department of Health announce a new fast-track system for priority drugs which means NICE could release guidance within eight weeks of licensing.

8 November Ms Hewitt says she wants to examine personally the evidence that North Stoke PCT is using to justify its decision to refuse Herceptin for patients in its area.

Both cases receive national coverage and legal action is threatened.

9 November North Stoke PCT reverses its decision, citing exceptional circumstances.