In final draft guidance published yesterday, the National Institute for Health and Clinical Excellence (NICE) has again turned down the use of Roche’s Avastin (bevacizumab) in combination with a taxane to treat breast cancer which has spread to other parts of the body.

NICE said it is not recommending the drug because it offers “limited and uncertain benefit for patients compared with existing treatments.” The benefits of Avastin are too small to justify its “very high” costs, the Institute added.

Roche had told NICE that Avastin’s total annual cost per patient averages more than £33,000. A patient access scheme proposed by the company, requiring the NHS to pay for the first 10 grams of the drug, would have reduced the cost to £23,000, but the scheme was rejected by the Department of Health.

Announcing the final draft guidance, NICE chief executive Sir Andrew Dillon said it is “immensely important for breast cancer patients, whose disease has spread, to prolong their lives as much as possible.” However, NICE had received no evidence from Roche to show that Avastin can significantly lengthen a patient’s life or offer a better quality of life than existing treatments, he added.

“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,” he said.

The US Food and Drug Administration (FDA) is due to decide by December 17 whether Avastin should keep its licence as a treatment for breast cancer, following a 12-1 vote against doing so by the agency’s Oncology Drugs Advisory Committee back in July.

And in September, the European Medicines Agency (EMA) began a review of the drug’s risks and benefits, following the results of a study conducted by Roche. “In comparison to results of previous studies, this study points to inconsistencies between different trials relevant for the currently approved breast cancer indication, particularly in terms of efficacy,” said the EMA.

Sir Andrew said that while NICE was aware of these developments at the FDA and EMA it had, nevertheless, decided to continue its own appraisal. “If either the FDA or the EMA announce changes to their licensing decision, which affects our advice to the NHS, we amend it accordingly,” he said.

Roche has said it is “disappointed” at the draft guidance, which is now subject to an appeal process closing at 5pm on January 4. Final guidance is expected to be published early next year.