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Last Updated: Thursday, 8 June 2006, 23:13 GMT 00:13 UK
Q&A: Herceptin
Herceptin
The drug is already used for advanced cancer
The breast cancer drug Herceptin has been recommended for women with early stage breast cancer in draft guidance from the NHS drugs watchdog.

But what does that mean for women with the disease?

What has happened?

The National Institute for health and Clinical Excellence (which covers England and Wales) has said in draft guidance that Herceptin should be prescribed to women with early stage breast cancer who could benefit from it.

Final guidance will be published in July.

Meanwhile, the Scottish Medicines Consortium has issued its own final guidance, recommending Herceptin should be made available now.

Does this mean women can get the drug now?

In Scotland, it will now be up to individual cancer specialists to decide if the drug is right for their patient.

But in England and Wales, women will have to wait until the final guidance has been published by NICE next month.

Primary Care Trusts (PCTs) will then have three months to put the mechanisms and money in place so that women in their area can be given Herceptin.

If they miss that target, they could be taken to court.

What does Herceptin do?

It 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.

Last October, Health Secretary Patricia Hewitt pledged that all women with breast cancer could undergo a test to see if their cancer was HER2 positive.

The cost for one year's treatment with Herceptin is around 20,000.

How much benefit does Herceptin give?

A major study, including 5,000 women around the world with early stage breast cancer, showed a year's course of the drug could reduce the risk of the disease returning.

After three years, 80.6% of women who had received Herceptin as well as surgery and chemotherapy or radiotherapy were disease-free, compared to 74% of women who had not been given the drug.

Who should be given the drug?

Around 41,000 women are diagnosed in the UK each year with breast cancer, most with early-stage disease.

But only around a fifth of breast cancers are HER2 positive.

And around 10% of women with HER2 positive cancers will have some form of heart problem which means they should not take Herceptin, because there have been indications in research that it can worsen such conditions.

These include:

  • Very poor ventricular function - which can be a sign of heart failure
  • Heart failure
  • Heart rhythm disorders (uncontrolled arrhythmias)
  • Severe chest pain (angina pectoris) which requires medication
  • A heart attack which has killed tissue in the heart wall (transmural infarction)
  • Uncontrolled high blood pressure

What has happened in the courts?

In April 2006, the Court of Appeal decided that Ann Marie Rogers from Swindon should be given Herceptin.

But judges said the ruling would not "open the floodgates" as only women who met the clinical criteria for Herceptin would qualify for the drug.

She had been prescribed the drug by her doctor but had been refused it by local health bosses, leading her to borrow 5,000 to fund her treatment.

An earlier High Court decision had upheld Swindon Primary Care Trust's refusal to fund Herceptin.

Mrs Rogers' case was the first to reach the High Court, as previous legal actions by women have resulted in NHS trusts backing down and funding the drug.




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