David Batty and agencies 

Herceptin ‘to get UK licence’

The breast cancer drug Herceptin is set to be granted a UK licence for use in the early stages of the disease, its manufacturer Roche said today.
  
  

Herceptin
Herceptin. Photograph: PA Photograph: Roche/PA

The breast cancer drug Herceptin is set to be granted a UK licence for use in the early stages of the disease, its manufacturer Roche said today.

The European commission will issue the licence next week in line with the recommendation of the European Medicines Agency, which last month approved the wider use of the drug.

This clears the way for the National Institute for Health and Clinical Excellence (Nice), which decides which treatments should be available on the NHS, to rule on whether local health trusts should provide the drug to patients in England and Wales with early stage breast cancer.

A spokesman said it expected to issue guidance on the drug, used to treat 20-30% of breast cancer patients with the Her2 form of the disease, in July.

Last month, breast cancer patient Ann Marie Rogers won her legal battle for NHS treatment with Herceptin in the court of appeal, but the ruling still allowed primary care trusts, which run local healthcare services, to ration it for other women.

The drug halves the relative risk of a tumour returning after surgery, radiotherapy and chemotherapy, when used for a year either in conjunction with other drugs or afterwards.

Most clinical trails of the drug have only lasted a year, so questions remain over its long-term benefits.

The European Medicines Agency said last month that Roche needed to carry out further longer-term trials of the drug to evaluate the risk of side effects, such as heart problems. But the agency's committee for human medicinal products decided that the benefits of the drugs outweighed the risks.

Extending provision of the drug, which costs around £22,000 for a year's treatment, could put the NHS under further financial pressure at a time when many trusts are struggling to balance their books.

 

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