NICE rejects AstraZeneca's breast cancer drug Faslodex

NICE has announced its decision to not recommend AstraZeneca’s breast cancer drug Faslodex (fulvestrant) in women who have oestrogen-receptor-positive, locally advanced breast cancer or breast cancer that has spread to other parts of the body, who have not already had treatment with hormonal therapy (aromatase inhibitors or tamoxifen).

Faslodex inhibits the growth of cancer tumours by blocking the action of oestrogen. While the appraisal committee noted that the treatment was able to halt disease progression by three months compared to aromatase inhibitors, it rejected it on the basis that current efficacy data is not robust enough to suggest its use would result in better overall survival versus existing therapies.  

"While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that its effectiveness is uncertain in terms of extending life compared to aromatase inhibitors, which are currently the preferred NHS treatment," remarked Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE. "There is a need for more effective treatments for locally advanced or metastatic breast cancer to delay the need for chemotherapy and to extend survival. But NICE has to ensure that the NHS provides treatments that bring benefits which are value for money. As fulvestrant has not been shown to be cost-effective, we can’t justify diverting NHS funds from other areas of healthcare in order to fund its use."

'As fulvestrant has not been shown to be cost-effective, we can't justify diverting NHS funds from other areas of healthcare in order to fund its use," she added.

The drug just last week scored an expanded indication from the FDA in the US, and is now available as monotherapy treatment for breast cancer.

In response to the rejection, an AstraZeneca spokesman commented: "AstraZeneca believes fulvestrant is a significant therapy option for this group of patients who present with advanced disease, who for a variety of reasons have not been diagnosed or received treatment with hormonal therapy for breast cancer previously. AstraZeneca is disappointed with this initial draft guidance and will continue the dialogue with NICE to enable this treatment option to be made available for this important group of patients."