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Scotland clears Femara for early breast cancer

Published on 09/05/06 at 01:32pm

Femara has been recommended for use in Scotland to prevent breast cancer returning after surgery, prompting its manufacturers and stakeholders to urge NICE to follow suit.

The Scottish Medicines Consortium (SMC), Scotland's equivalent to NICE, recommended the drug's use in postmenopausal women with hormone receptor-positive invasive early breast cancer following surgery (known as adjuvant use).

Manufacturers Novartis have welcomed the news, but have underlined the fact that patients outside Scotland will have to wait around six months before similar guidance is issued in England and Wales. Northern Ireland does not formally follow NICE or SMC guidance and has no equivalent body of its own.

Femara is an aromatase inhibitor, a new class of drugs which block the production of oestrogen, a hormone, which encourages the growth of breast cancer in many women.

These patients are known as 'hormone receptor-positive' and the SMC says clinical data shows Femara is more effective in preventing the return of the cancer in these women than current standard treatment tamoxifen.

AstraZeneca's Arimidex is another aromatase inhibitor and is Femara's main rival. Arimidex has been recommended for the same indication since March 2004 in Scotland, but like Femara is still awaiting appraisal by NICE.

This is not the only example of where England and Wales are lagging behind Scotland. Femara is also licensed for use in early breast cancer following five years of tamoxifen therapy, and is recommended in Scotland but not England and Wales.

Most recurrences of breast cancer happen after the five-year period, and Femara has been proven to be more effective in preventing its return than standard therapy. The SMC recommended Femara for this indication in March 2005, but patients south of the border must wait until November this year for NICE's guidance.

The longer wait for NICE's guidance - and fears that it might not recommend the drugs - has led stakeholders to make their feelings known ahead of NICE's decision.

Emma Pennery, Nurse Consultant at Breast Cancer Care commented: "Aromatase inhibitors, such as Femara, are beneficial in all types of hormone receptor-positive, postmenopausal breast cancer, which represents around 80% of all breast cancers.

"With new data increasingly showing these treatments to be more effective than tamoxifen, we hope to see a NICE appraisal that supports the use of aromatase inhibitors in the treatment of early breast cancer and equal access to the best treatment options for all breast cancer patients throughout the country."

Rob Carpenter, consultant breast and endocrine surgeon and associate director of cancer services at St Bartholomew's Hospital, London said: "It is a pity that women must wait for approval of aromatase inhibitors [outside Scotland] however, in England, Wales and Northern Ireland they can receive these drugs in the interim if they have their oncologists' approval."

Mr Carpenter's remark links into the ongoing controversy surrounding another breast cancer drug, Herceptin. Many oncologists are now prescribing the drug to women with early breast cancer, even though it has not yet been licensed in the indication and NICE has not recommended its use.


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