In draft guidance issued by the National Institute for Health and Clinical Excellence (NICE), the drug bevacizumab (Avastin, Roche Products) is not recommended for use in combination with a taxane for patients whose breast cancer has spread to other parts of the body.

Evidence submitted to NICE by the drug manufacturer did not show bevacizumab to significantly improve or extend the lives of breast cancer patients whose tumours have spread elsewhere in the body, This uncertain clinical benefit, combined with the amount of money the NHS is being asked to pay for the drug, means NICE is unable to recommend bevacizumab (in combination with a taxane) as a first-line treatment for metastatic breast cancer).

This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS.

The manufacturer submitted data to the Institute’s Appraisal Committee from a clinical trial comparing bevacizumab plus paclitaxel with paclitaxel monotherapy. The study found that, on average, bevacizumab could slow the growth and spread of the tumour for five and a half months longer than paclitaxel alone. However, this did not translate into improved overall survival rates with the drug only extending patients’ lives by around an extra seven weeks (1.7 months).

The manufacturer did not compare bevacizumab with docetaxel - a “gold standard” breast cancer treatment - despite research data being available. The Committee acknowledged the results of a clinical trial that assessed bevacizumab (used in combination with docetaxel) against doctetaxel alone. The data demonstrated that, while the research echoed the findings of the paclitaxel trial (that bevacizumab could slow the growth and spread of the cancer), the results were much less conclusive, raising questions over the true efficacy of bevacizumab.

Sir Andrew Dillon, NICE chief executive, said, “The clinical trial results for bevacizumab were disappointing in that they were unable to prove definitively that the drug could extend the lives of patients with metastatic breast cancer over and above currently available treatments.

“The Committee did hear evidence from a clinical expert and patient representative that the amount of time a drug can slow the growth and spread of the cancer is highly valued by patients but evidence of the length of time bevacizumab could keep the cancer under control was not robust. There was also no proof that the drug can give patients a better quality of life than paclitaxel or docetaxel.”

The Appraisal Committee also discussed the cost effectiveness of the drug (the price the NHS is being asked to pay for the level of benefit the treatment offers patients). However, when bearing in mind the uncertainties over survival rates and quality of life data, the committee concluded that the cost of bevacizumab is too high for the limited and uncertain benefit it may offer patients. The manufacturer has acknowledged that its own calculations on cost-effectiveness were ‘optimistic’.

Sir Andrew Dillon added: “It is important to remember that current breast cancer treatments like paclitaxel and docetaxel are very effective in helping to extend the lives of patients with metastatic breast cancer. For example, the study comparing bevacizumab plus paclitaxel with paclitaxel monotherapy highlighted that paclitaxel could prolong lives by just over two years, on average.”

NICE’s preliminary guidance is now available for public consultation on the NICE website until 30 July 2010. Any feedback received will be considered by the committee at their next meeting and the next version of draft guidance will be issued. Until final guidance is published, NHS bodies should make decisions locally on the funding of specific treatments.

The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.