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Breakthrough decision on Herceptin

– but where’s the cash?+

After months of national debate, NICE has fast-tracked its decision on the breast cancer drug Herceptin, which was licensed in May. This is good news for patients, but could be a nightmare for an NHS already in financial crisis. Pf reports.

LEADING CANCER CHARITIES have welcomed NICE’s recent decision to allow the use of Herceptin in early-stage breast cancer, but have urged the Government to do more to help PCTs fund the treatment.
    Campaigners heralded the decision as a major breakthrough in the treatment of the disease, but the NHS Confederation has warned that funding it will have major financial repercussions for the NHS. In response, charity Cancerbackup has led calls for the Government to set up an ‘Innovations Fund’ to help local PCTs finance treatment.

No more postcode lottery
    Joanne Rule, Chief Executive of Cancerbackup, said that the decision brought an end to the postcode lottery of Herceptin, and that women with early breast cancer who are HER2-positive will feel immense relief. “Breast cancer patients across England and Wales are currently experiencing a dreadful postcode lottery: denied Herceptin because of where they live or how ‘exceptional’ their lives are deemed to be. This can stop now. The Government’s Health Service Circular 1999/176 makes it crystal clear that PCTs do not need to wait for guidance to fund licensed treatments.”
    However, Rule warned of funding battles ahead and encouraged the Government to take action. “We hope this means that no woman will be forced to fight for treatment to help save her life,” she said. “We urge PCTs to implement this guidance by funding the treatment to patients when clinicians recommend it. The Department of Health should help PCTs by announcing an Innovations Fund to assist local areas absorb the costs of new treatments.”
    Cancerbackup’s thinking has also been mirrored by Breakthrough Breast Cancer, a leading UK charity that fights breast cancer through research and education. Jeremy Hughes, Chief Executive of Breakthrough Breast Cancer, agreed that the decision could signal the end to postcode prescribing, but said this would only be the case if women were sure that they could be tested to see whether Herceptin was suitable for them.

NICE has issued draft guidance that Herceptin should be prescribed to appropriate women with early-stage HER2 breast cancer • Final guidance will be published this month • SMC has issued final guidance recommending that Herceptin be made available immediately • PCTs in England and Wales have three months following the final decision to put mechanisms and money in place so that women in their area can be given Herceptin • Herceptin targets the HER2 protein, which can fuel the growth of breast tumours • It is already licensed for use in women with advanced breast cancer, where the disease has spread within the breast or to another organ. • Around 41,000 women are diagnosed in the UK each year with breast cancer, most with early-stage disease • Only a fifth of breast cancers are HER2-positive, and around 10% of women with HER2-positive cancers will not be allowed Herceptin because they have heart conditions • Herceptin costs around £20,000 for one year’s treatment. • Analysts predict the drug could cost the NHS £100 million per year.

“Herceptin has highlighted challenges for the NHS in ensuring patients receive new, targeted and effective treatments.”
– Jeremy Hughes, Chief Executive of Breakthrough Breast Cancer

    “Nationwide, HER2 testing is being put in place and all women diagnosed with breast cancer need to know this test will be available quickly,” Hughes said. “Herceptin has highlighted challenges for the NHS in ensuring patients receive new, targeted and effective treatments. Breakthrough’s research scientists are part of a world-wide programme to bring more treatments like this from the lab bench to the hospital bed. We welcome the speed with which NICE has assessed Herceptin under its new fast track system. Attention must also be given to ensure PCTs plan to fund such new treatments.”

The campaign for breast cancer treatments has been a high-profile debate.

Are cutbacks inevitable?
    While the approval is clearly good news for health outcomes, the economics of the decision have not met with the same enthusiasm. Herceptin has been shown to benefit women with HER2-positive breast cancer, which comprises around a fifth of all breast cancer cases in the UK. Although 10% of this figure will not be allowed the drug because of concern that it could exacerbate heart problems, over 5,000 women would still be entitled to receive Herceptin. Analysts have predicted this could cost the NHS over £100 million each year, and could trigger cutbacks elsewhere within the NHS budget.
    Dr Gill Morgan, chief executive of the NHS Confederation, which represents over 90% of NHS organisations, welcomed the NICE announcement and reiterated the Confederation’s belief that the licensing and regulatory processes are there to ensure that new drugs are both safe and effective. However, she said there was no doubt that the Herceptin ruling would present a significant financial challenge to some NHS organisations. “Primary care trusts plan their expenditure some 18 months in advance and so when a new and expensive drug is licensed, and no new funding provided, it inevitably causes difficulties.”

“There will always be a finite amount of money and difficult decisions will always need to be taken. We strongly believe that those decisions are best made by clinicians and trusts locally.”

– Dr. Gill Morgan, Chief Executive, NHS Confederation

    PCTs receive a fixed allocation of money to deliver all the services for their local community, and have to make difficult decisions on competing priorities. This year, Morgan said, many PCTs have been faced with decisions about spending money on expensive drugs, cutting waiting lists and investing in infertility treatments. “Every decision about spending taxpayer’s money is a moral one because a pound spent on one drug means a pound less for another. There will always be a finite amount of money and difficult decisions will always need to be taken. We strongly believe that those decisions are best made by clinicians and trusts locally.”
    Dr Jonathan Fielden, Deputy Chairman of the BMA’s Consultants Committee, told the BBC: “The NHS will now have to find the money to fund this treatment. We have already heard how huge amounts are being wasted on management consultants. The government needs to rethink its strategy and spend money that has been earmarked for the NHS on benefits to patients, not pie-in-the-sky political ideas.”

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