Cost regulators for the National Health Service in England and Wales have turned down the use of Roche's Avastin for patients with advanced breast cancer because of uncertainties over the drug's survival and quality of life benefits.
Specifically, the National Institute for Health and Clinical Excellence has published draft guidance barring women with metastatic breast cancer access to funding for first-line treatment with Avastin (bevacizumab) in combination with the chemotherapy Xeloda (capecitabine).
Despite clinical evidence showing that the drug is able to increase progression-free survival by just under three months compared with capecitabine alone, its effect on overall survival is much less clear, nor is there any data on its impact on quality of life, the Institute said.
Coupling these uncertainties with the drug's high cost - an average monthly price tag of £3,689 and an incremental cost that is estimated to be above £82,000 per QALY - NICE's appraisal committee concluded that they could not recommend the treatment as an effective use of NHS resources.
"We want to ensure people have access to the best treatments the NHS can afford; bevacizumab has so far not been proven to be clinically or cost-effective, the Institute's chief executive Sir Andrew Dillon explained.
Nevertheless, the news will certainly come as a blow to the thousands of patients suffering from the condition, who will no doubt be hoping that additional evidence will be submitted during the current consultation period to overturn the decision.
In the meantime, decisions on funding Avastin in this setting will be made locally until final guidance is published.
In a statement, Roche stressed that Avastin in combination with capecitabine is "an important treatment option for women with breast cancer", which has "demonstrated significant improvements in progression free survival".
In one subgroup analysis of women treated with a taxane when their disease was at an early stage, PFS more than doubled from 4.2 months to 8.7 months compared to those treated capecitabine alone, and, in this setting, the drug also demonstrated a significant overall survival benefit of 7.9 months compared to capecitabine plus placebo, the firm noted.