NICE rejects Avastin for breast cancer

In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) has recommended against the use of Roche's Avastin (bevacizumab), in combination with a taxane, for the treatment of breast cancer which has spread to other parts of the body. 

In the guidance document (published December 8), NICE does not recommend the drug on the grounds that it offers limited and uncertain benefit for patients compared with existing treatments.

Sir Andrew Dillon, NICE CEO, said: "We know that it's immensely important for breast cancer patients, whose disease has spread, to prolong their lives as much as possible.

"Unfortunately, we did not receive any evidence from the manufacturer to show that bevacizumab can significantly lengthen a patient's life or, importantly, offer a better quality of life than existing treatments. Although the data seemed to show that the drug may slow the growth and spread of the cancer, the size of this effect varied between studies. Furthermore, it was extremely unclear that the benefits in terms of slowing tumour growth translated into benefits on overall survival, which is what really matters for patients."

NICE has made its decision regardless of the fact that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently reconsidering bevacizumab's licence as a treatment for metastatic breast cancer. Sir Andrew Dillon said, however, that should the FDA or EMA change their licensing decision, NICE would amend its advice to the NHS accordingly.

The draft guidance is subject to an appeal process whereby consultees can appeal for a reversal of the recommendation. Final guidance is expected to be published early in 2011. Before then, NHS bodies are able to make decisions locally on the funding of specific treatments.