Novartis receives new approval from NICE for Femara

Novartis has announced that Femara, an aromatase inhibitor (AI), has been approved by NICE for the treatment of post-menopausal women with early breast cancer following surgery.

The Swiss pharmaceutical company says that the final appraisal document issued by the regulator would ensure access to life-saving treatments for thousands of women with the disease. Additionally, it marks the replacement of tamoxifen as the “gold standard” early breast cancer therapy.

NICE’s decision follows a cost-effectiveness study that demonstrated that the cost per quality-adjusted life year for Femara treatment was 21,580 pounds, compared to 31,965 pounds for anastrozole, the AstraZeneca drug marketed as Arimidex, which also gained NICE approval for the same early breast cancer indication as Femara.

Rob Carpenter, consultant breast surgeon at Barts and The London NHS Trust, remarked: “Femara has the widest range of licenses because it has the trial evidence to demonstrate its effectiveness in all these settings.

“In addition, unlike other AIs, Femara has demonstrated greater benefit in women at increased risk of breast cancer recurrence.”

Mr Carpenter cited the BIG 1-98 study that demonstrated a 29 per cent reduced risk in recurrence of breast cancer in high-risk patients whose cancer has spread to lymph nodes, in comparison to those receiving tamoxifen treatment.

Novartis recently announced its intention to fund a study comparing Femara with Arimidex to provide more head-to-head data for AIs.

The company claims Femara is now the only AI to be licensed across the “entire breast cancer treatment spectrum”, meaning it can be used pre-surgery through to cases of advanced breast cancer.

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