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NICE Initial Recommendation: One Step Closer To Backing Aromatase Inhibitor Treatment For Women With Early Breast Cancer


5/23/2006 11:25:33 AM

FRIMLEY, England, May 23 /PRNewswire-FirstCall/ -- Encouraging news for postmenopausal women with early breast cancer was published today by the National Institute for Health and Clinical Excellence (NICE). The preliminary recommendations (Appraisal Consultation Document (ACD)) from NICE, the body which provides guidance to the NHS, looked at the class of drugs known as aromatase inhibitors (AIs), which includes Femara (letrozole), Arimidex (anastrozole), and Aromasin (exemestane). AIs have been recommended for the adjuvant (post-surgery) treatment of early oestrogenreceptor-positive invasive breast cancer in post-menopausal women, in accordance with their licensed indications.

Professor Rob Coleman, Consultant Oncologist at the Weston Park Hospital in Sheffield said, "The inclusion of aromatase inhibitors in the adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women has been shown to be more effective than the previous standard of 5 years of tamoxifen. The ACD published today is therefore very promising and I hope to see a positive opinion from NICE in November that will allow women routine and uniform access to the endocrine treatment programme recommended by their specialists."

Novartis Oncology welcomes this positive initial guidance, which recommends Femara for the treatment of women directly following surgery, as well as for those women who have completed five years of standard adjuvant tamoxifen use (extended adjuvant use). Femara is the only aromatase inhibitor to have a licence in the extended adjuvant setting. "The ACD from NICE closely follows the recent recommendation from the Scottish Medicines Consortium (SMC) (8 May 2006)[1] for the adjuvant use of Femara and supports Novartis' long-standing belief in the important role AIs play in the treatment of breast cancer. It is critical that women with breast cancer throughout the UK have equal access to the most appropriate treatment options," said John Ketchum, Head of the UK Novartis Oncology Business Unit.

The recommendation includes an independent cost-effectiveness analysis conducted by NICE, which showed that for primary adjuvant treatment for five years, the costs per quality-adjusted life-year (QALY)(x) gained were GBP21,580 with Femara (letrozole) and GBP31,965 with anastrozole when compared with tamoxifen therapy for the same time period. Based on this analysis, both treatments were considered to be cost effective by NICE in comparison with tamoxifen.

The ACD provides initial recommendation from NICE, following input from professional and patient care groups. Following comments from stakeholders and further review from the committee, the final guidance on the use of aromatase inhibitors in early breast cancer is due to be published November 2006; it is at this point that the NICE guidance comes into effect.

(x) QALY is a common health economics term that is used to compare the impact of treatments. One QALY is equal to one year of perfect health.

Notes to Editors:

NICE Appraisal Committee's Preliminary Recommendations[2]

The aromatase inhibitors anastrozole, exemestane and letrozole, within their licensed indications, are recommended as options for the adjuvant treatment of early oestrogen-receptor-positive invasive breast cancer in post-menopausal women.

The choice of treatment strategy (that is, primary adjuvant treatment with an aromatase inhibitor, switching from tamoxifen to an aromatase inhibitor or use of an aromatase inhibitor after completion of 5 years of tamoxifen treatment) should be made after discussion between the responsible clinician and the patient about the risks and benefits of the options available. Consideration of the strategy to be adopted should include whether the patient has received tamoxifen as part of their treatment so far, the side-effect profiles of the individual drugs and, in particular, the assessed risk of recurrence..

About Femara

Femara is now the first and only aromatase inhibitor (AI) licensed for treatment across the entire breast cancer treatment spectrum - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.[3] A once-a-day oral aromatase inhibitor, it is currently indicated in the UK for:

- Adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer

- The treatment of early invasive breast cancer in postmenopausal women who have completed prior standard adjuvant tamoxifen therapy

- Newly diagnosed postmenopausal women with advanced breast cancer

- Postmenopausal women with advanced breast cancer in whom tamoxifen, or other anti-oestrogen therapy has failed

- Neoadjuvant (pre-operative) therapy in postmenopausal women with localised hormone receptor-positive breast cancer, to allow subsequent breast conserving surgery in women not originally considered candidates for breast-conserving therapy

About Novartis

Novartis AG is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com

About Breast Cancer Care

Breast Cancer Care has been one of the leading providers of breast cancer information and support across the UK for the past thirty years. If any woman with breast cancer has concerns or wants a free factsheet on Femara, they can contact Breast Cancer Care's free and confidential helpline - 0808-800-6000 or alternatively visit www.breastcancercare.org

References [1]. http://www.scottishmedicines.org.uk/ (last accessed 16 May) [2]. http://www.nice.org.uk/ (last accessed 23 May 2006) [3]. Femara Summary of Product Characteristics. November 2005

Novartis Oncology

CONTACT: For further queries or information about Breast Cancer Careplease contact the press office on +44(0)20-7551-8033 /+44(0)20-7551-8032.. Press Office, Novartis Oncology, Tel:+44(0)1276-698691; Sabrina Gallon, Ruder Finn, Tel: +44(0)20-7462-8965,Email: sgallon@ruderfinn.co.uk; Sarah Snee, Ruder Finn, Tel:+44(0)20-7462-8906, Email: ssnee@ruderfinn.co.uk


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