There was widespread disappointment after cost regulators for the National Health Service in England and Wales stood firm on their decision to bar a specific group of patients with advanced breast cancer from access to Roche's Avastin.

The National Institute for Health and Clinical Excellence has now published draft final guidance turning down the NHS use of Avastin (bevacizumab) in combination with capecitabine for women with advanced breast cancer for whom treatment with other chemotherapy options is not appropriate. 

According to NICE's independent appraisal committee, while the evidence does suggest that the Avastin/capecitabine combo may delay disease progression for longer than capecitabine on its own, the impact on overall survival was not clear.

“Taking these uncertainties into account as well as the high cost of the drug, the committee concluded that bevacizumab was not a cost-effective use of NHS resources," explained the Institute's chief executive Andrew Dillon.

At an average per patient cost of more than £3,500 a month the drug certainly doesn't come cheap, and with regard to its actual cost-effectiveness, there seems to be some dispute over which patients the treatment is most beneficial for.

According to Roche, "a key factor of NICE’s recommendation is their lack of belief in a biologically plausible explanation for why Avastin works so well in a distinct group of patients, i.e those who had been previously been treated with a taxane...despite the progression-free survival (PFS) or overall survival (OS) benefits demonstrated in clinical analyses for this group".

Instead, it says, the Institute reviewed the data submitted "in the context of the entire population of women with metastatic breast cancer", and so failed to recognise its benefit to the taxane-treated group of patients.

Roche claims that a subgroup analysis of women previously treated with a taxane showed that Avastin more than doubled PFS from 4.2 months to 8.7 months compared to given capecitabine alone, while a significant OS benefit of 7.9 months was also observed. 

Limited options

“It is widely recognised that there is a lack options for women who were treated with a taxane when their disease was at an early stage, so it is disappointing that NICE will not consider Avastin as an effective option for these women," said David Miles, consultant medical oncologist at Mount Vernon Cancer Centre, commenting on the decision.

Roche said the move is "all the more disappointing as it means that women in England with advanced breast cancer who have limited treatment options available to them will instead have to rely on their clinicians’ successful application to the Cancer Drugs Fund in order to receive treatment with Avastin. However, there is no similar access to Avastin for patients in Wales, Scotland and Northern Ireland as yet". 

Baroness Delyth Morgan, Breast Cancer Campaign's Chief Executive, said NICE's decision "further highlights the urgent need for more treatment options to prolong and improve the quality of life for people with advanced breast cancer," and she urged clinicians and Strategic Health Authorities to use the CDF for patients who may benefit from the Avastin/capecitabine combo.