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Tuesday 25th October 2016

Herceptin Perceptions

23rd March 2006

06032006_herceptin1.jpgHerceptin has highlighted the 'post code lottery' provision of certain drugs; Herceptin, says the Guardian, was given to 90% of Her2 breast cancer sufferers in some areas of England, and to just 10% in others.


Herceptin (Trastuzamab) is a monoclonal antibody drug that treats breast cancer, improving the way the body fights the breast cancer cells. It works by stopping one of the ways that breast cancer cells divide and grow.

Some breast cancers have higher than normal levels of a protein known as HER2 on the surface of the cancer cells, which prompts the cancer cells to grow. Herceptin works by sticking to the HER2 proteins (also known as receptors) so that the cancer cells are no longer stimulated to grow, and also helps the body’s immune system to destroy breast cancer cells.

Only patients whose cancer has high levels (over expression) of the HER2 protein will benefit from taking Herceptin. This is known as HER2 positive breast cancer and it is found in approximately 20 to 25 per cent of breast cancer patients. These cancers tend to grow faster than those that are HER2 negative.

Of the 35,000 women diagnosed with breast cancer each year, about 20,000 will be suitable for HER2 testing. From this group of 20,000 women, about 5,000 women may benefit from Herceptin. The drug could save around 1000 lives a year, at an annual cost of about £100 million. Treating a patient for one year on herceptin would cost the NHS around £20,000.

In March 2002 NICE recommended Herceptin for use in women with HER2 positive advanced breast cancer.

What has led to the interest in Herceptin for early stage Breast Cancer?

In May 2005 at the American Society of Clinical Oncology (Asco) conference in Florida the results of the Herceptin Adjuvant trial (Hera), a major international study on the use of Herceptin in early stage breast cancer, were announced. The trial data reported was that Herceptin could reduce the risk of recurrence in suitable patients by as much as 52%.

In October 2005, The New England Journal of Medicine sparked a huge reaction when it published studies which showed that adding Herceptin to standard cancer therapy reduced the recurrence rate of certain breast cancers.

The first study, by the Breast Cancer Group of international researchers and sponsored by Roche, looked at the effect of giving Herceptin to breast cancer patients who had already had surgery and a course of chemotherapy.

Almost 1,700 women received one year's treatment with Herceptin and a group of equal size were simply observed.

After 12 months, 13% (220) of the group under observation had seen a recurrence of their cancer, 34 of whom had died.

In the group taking Herceptin, just 127 women (7.5%) had seen a recurrence of their cancer, with 23 cancer-related deaths.

The second study combined results from two US trials covering 3,350 women given Herceptin either in combination with the drug paclitaxel (Taxol) or alone. Other women were given Taxol alone.

Taking both drugs together reduced the risk a woman's cancer would return by half, and the risk of death by a third.

What was the reaction to these results?

Some hailed these results as 'stunning'.  Panorama for the BBC reported that in the words of Professor Ian Smith, the lead investigator in the trials in the UK: "This is the biggest treatment development in breast cancer, in terms of the magnitude of its effect, for at least the last 25 years, perhaps as big an anything we've seen."

Dr John Toy, medical director at Cancer Research UK, said: "These are stunning results for women who have got this particular sort of breast cancer."

However, others were more cautious.  In an editorial in November 2005 the Lancet raised concerns about the data and the cardiotoxicity of the drug.  It concluded that 'the debate about the availability of Herceptin to women with early breast cancer demands cooler heads than have so far prevailed, in politics, in public, and even in medical journals.'

Healthcare organisations should not rush into using trastuzumab (Herceptin) for early breast cancer without first examining the implications on budgets of doing so, warns a Belgian health economist, Mattias Neyt of Ghent University, says the BMJ.

How has herceptin highlighted the 'post code' lottery?

Herceptin has highlighted the 'post code' lottery of care with a number of PCTs refusing to fund Herceptin; some of these cases have since been overturned, whilst others have been upheld, causing heartache to breast cancer patients.

Nurse Barbara Clark, 49, threatened Somerset Coast PCT with a judicial review, but the trust backed-down before the case and provided her with the treatment in October of 2005.

In November 2005, Health Secretary Patricia Hewitt intervened when North Stoke PCT refused to fund the drug for Elaine Barber. 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.

In February Swindon Primary Care Trust refused to pay for Herceptin for Ann Marie Rogers, and in the first case to reach the High Court the Judge ruled against Ms Rogers, but granted the opportunity to appeal. 

Another breast cancer patient, Elisabeth Cooke from Bristol, had Herceptin refused by North Bristol PCT.  She has gone to the High Court in an attempt have this overruled, but this decision has been put on hold until the results of the appeal by Ms Rogers is known.  Her treatment will continue to be paid for until this happens.  

The postcode lottery is particularly highlighted by the case of Susan Morgan who, in a case brought to political and media attention by the plea of her 10 year old daughter, was refused Herceptin treatment by Shropshire Primary Care Trust.  If she had lived two miles away in Wales she would have been able to receive the treatment as Wrexham health board's policy is to pay for the drug to treat primary breast cancer sufferers.

Mr Morgan said 'it is just a postcode lottery at the moment', reported the BBC, and the North Shropshire MP Owen Paterson reiterated that this highlighted the difference between PCTs in funding Herceptin treatment.

A mixed picture emerges of this 'lottery'; In some areas of the country patients are now able to access Herceptin, while in other areas patients are still experiencing huge difficulties gaining access to this treatment or being refused access, says the charity breast cancer care. 

A BBC survey conducted for Panorama showed that three quarters of cancer doctors are allowed to prescribe Herceptin for early stages of the disease despite it not being licensed. The poll of 390 oncologists in England and Wales found 28% were always allowed to prescribe the drug by their NHS trusts and 50% were sometimes.

What are the views on the present situation?

Jeremy Hughes, chief executive of Breakthrough Breast Cancer said that it is 'unfair and cruel' for women to know that it is money and their postcode that stands between them and this potentially life-saving treatment.

Christine Fogg, chief executive of Breast Cancer Care said that decisions would reinforce the inequalities in accessing Herceptin, and urged the Department of Health to stop the postcode lottery. 

Joanne Rule, chief executive of CancerBacup reiterated that making decisions about Herceptin on a case by case basis would be seen as 'postcode prescribing'

Not all agreed that it was a bad thing that PCTs should use their discretion in funding Herceptin prior to being licensed and agreed by NICE;

The PCTs involved say that Herceptin cannot be routinely funded before it is licensed, and approved by NICE, and that they have to make decisions on based on a whole range of factors, including 'exceptional circumstances' for the prescribing of Herceptin in an individual case.

Dr Gill Morgan, chief executive of the NHS Confederation said that PCTs find themselves under increasing pressure to prescribe herceptin off-licence.  She pointed out that licensing and regulation is there to ensure drugs are safe and effective.

The prescribing adviser for the Royal College of Nursing, Matt Griffiths, said that drug prescribing shouldn't be determined by people power alone, the bigger picture needed looking at to ensure equity in access to medicines for all patients.

Chris Ham, professor of health policy at the University of Birmingham, pointed out that trusts cannot do everything, therefore tough decisions have to made which may differ from area to area.

Referring to the ruling on Mrs Rogers a Department of Health spokesman said that PCTs needed to take into consideration a whole range of factors before deciding whether to fund Herceptin for a woman with HER2 positive early stage breast cancer. Ahead of licensing, or NICE appraisal, it is right that such decisions will continue to be made at a local level on a case by case, they concluded.

How has the Department of Health reacted?

On the 5th October 2005, Patricia Hewitt announced that all women diagnosed with early stage breast cancer would be tested for suitability for treatment with Herceptin. She also promised that as soon as Herceptin receives a licence it will be fast-tracked for use throughout the NHS.

In early November 2005 she confirmed that proposed changes to enable the National Institute for Health and Clinical Excellence (NICE) to produce faster guidance on life-saving drugs would go ahead immediately. Subject to licensing Herceptin is one of the drugs to be included in this first tranche of 5 drugs.

The intervention of Patricia Hewitt in the case of North Stoke PCT and the funding of Herceptin for Elaine Barber produced a mixed response. In a statement issued for Panorama Ms Hewitt said that she had simply reiterated her announcement from October 2005 that PCTs should not refuse to fund Herceptin solely on the grounds of its cost.

Some felt that this left NHS Trusts 'without teeth'; Nigel Edwards, director of policy at the NHS Confederation said that PCTs now find themselves placed under huge public pressure if they do not prescribe Herceptin for use in early stage breast cancer.

Despite this, some PCTs have continued to refuse to fund Herceptin, and questions are still being asked in parliament.  In February Tories argued that the "postcode prescribing" of drugs such as Herceptin is fuelling health inequalities across England, said the Guardian.

What will happen in the coming months?

In February manufacturer Roche applied to the European Medicines Agency for a licence to approve the drug as a treatment for early stage breast cancer.  With the fast track system introduced by the government this could mean that NICE are able to approve the drug by summer 2006.

Meanwhile the National Cancer Research Institute has produced a UK Clinical Guideline on the use of Herceptin for early breast cancer. This provides information to those considering prescribing Herceptin for this indication in advance of a decision on licensing and the publication NICE guidance.

An anonymous donor has contributed the £47,000 for the treatment of Susan Morgan, and the appeal decision on the case of Mrs Rogers is pending.  This will have follow on effects for Elisabeth Cooke - and for others requesting treatment with Herceptin.

According to the medical journal Annals of Oncology, extending provision of the drug could put the NHS budget under great financial pressure and lead to services for less high-profile diseases and conditions being cut, says the Guardian. The annual bill of providing the 5,000 women diagnosed per year with early stage breast cancer susceptible to Herceptin would come to £109m.

Putting the situation in the light of the present financial crisis in the NHS, Shadow Health Secretary Andrew Lansley, speaking of the future of Herceptin, noted that "It remains to be seen how PCTs will pay for the treatment. The NHS is already crippled by worsening debts, which entrench the postcode lottery."

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