NICE Appraisal Of Hormonal Treatments For The Treatment Of Early Breast Cancer, Compared With Tamoxifen, UK

Main Category: Breast Cancer
Article Date: 30 Dec 2005 - 1:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of hormonal treatments for the adjuvant treatment of early oestrogen-receptor positive breast cancer, compared with tamoxifen. NICE is expecting to issue guidance to the NHS in November 2006. For more information please go tonice.org.uk/page.aspx?o=63296. There is no restriction on the prescribing of these drugs, within their licensed indications, whilst NICE is developing guidance.

The licence indication of letrozole has just been extended (earlier this month) for adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Although the Scottish Medicines Consortium (SMC) has issued guidance on the use of letrozole following treatment with tamoxifen (in Scotland), they have not issued guidance on its use compared with tamoxifen as a first line treatment.

In the absence of NICE guidance licensed drugs and devices are assessed at a local level within the NHS, to decide whether local hospitals, GPs and health organisations will prescribe them. Once NICE issues its guidance on a technology it replaces local recommendations and promotes equal access for patients across the country.

1 - NICE is appraising 3 drugs for the hormonal treatment of early breast cancer: Anastrozole (Arimidex), Letrozole (Femara) and Exemestane (Aromasin)

2 - Anastrozole and letrozole are licensed for the adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Exemestane is not yet licensed as an alternative to tamoxifen for the adjuvant treatment of early breast cancer. It is licensed for adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 -3 years of initial adjuvant tamoxifen therapy.

About the process for licensing medicines in the UK

3 - Licensing is carried out by the Medicines and Healthcare Products Regulatory Agency (MHRA) in conjunction with the European Medicines Agency (EMEA). All medicines are assessed to determine whether they work and are safe before they are made available for widespread use in the UK.

4 - The MHRA and EMEA can only start work when a manufacturer applies for a licence for a new drug, or asks for a license on an existing drug to be extended.

5 - NICE cannot issue guidance for the NHS on new drugs until they have been licensed.

About process for appraising medicines in the UK

6 - NICE issues guidance on the clinical and cost effectiveness of selected new and existing drugs for the NHS in England.

7 - Both Scotland and Wales have introduced systems to provide local advice on new drugs. Both Scotland and Wales take NICE guidance and apply it even where they have previously issued local advice.

8 - NICE is introducing a new, shorter process to enable more rapid guidance to be issued in England and help Scotland and Wales avoid duplication in their own processes.

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