NICE no for Avastin in breast cancer
pharmafile | December 8, 2010 | News story | Sales and Marketing | NICE, Roche, avastin, bevacizumab, breast cancer, health technology assessment, hta
NICE has refused to back Roche’s Avastin for use in breast cancer patients citing the blockbuster drug’s high cost and limited benefit.
In its final draft guidance, NICE says it is unable to recommend Avastin (bevacizumab), in combination with a taxane chemotherapy agent, in women with metastatic breast cancer, because it offered “limited and uncertain benefit for patients concerned with existing treatments”.
Sir Andrew Dillon, NICE chief executive, 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 [Roche] 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.”
Dillon said that it was “extremely unclear” that the benefits, in terms of slowing tumour growth, translated into benefits of overall survival, which is “what really matters for patients”.
In considering Avastin’s incremental cost-effectiveness ratio (ICER) NICE’s appraisal committee concluded the best available estimate for an ICER for Avastin plus chemotherapy regimens paclitaxel compared with docetaxel alone to be over £115,000 and between £110,000 and £259,000 per QALY gained when compared with paclitaxel.
Roche said it was disappointed by NICE’s decision, adding that it had given NICE data from a new meta-analysis showing women with certain difficult to treat breast cancers may derive substantial benefit when Avastin is added to their chemotherapy.
The company has been at the wrong end of a number of NICE decisions over the past year and Avastin has been the biggest casualty, with all of its indications in lung, brain, kidney, breast and rectal cancers currently not recommended for use on the NHS.
Meanwhile, regulators in the US and Europe are currently mulling over whether to pull Avastin’s license to treat metastatic breast cancer patients as post-marketing trials have failed to prove its long-term efficacy.
Dillon said NICE would amend amend its appraisal accordingly, should either regulator change their licensing decision on Avastin.
NICE’s final draft guidance is still subject to an appeal process, and the Institute said it expects to publish final guidance early next year.
Ben Adams
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