Roche faces another NICE rejection for Avastin

The National Institute for Health and Care Excellence (NICE) has issued its second draft guidance in a month turning down Roche’s Avastin for use in an advanced ovarian cancer indication.

The agency, which appraises the cost-effectiveness of medicines for use in the NHS in England and Wales, said Avastin (bevacizumab) did not represent value for money when used in combination with gemcitabine and carboplatin to treat patients whose cancer had spread outside the ovaries and had returned following initial treatment.

The draft guidance came just weeks after NICE issued a separate statement turning down Avastin for use in combination with the chemotherapy treatments paclitaxel and carboplatin to treat metastatic ovarian cancer.

Commenting on the most recent draft guidance in ovarian cancer, NICE highlighted Roche’s failure to provide clinical trial data for around one in three trial participants.

According to NICE’s chief executive Sir Andrew Dillon this was “possibly due to discontinuation of treatment, side-effects or because they had been lost to follow-up, making it difficult to know what effect this had on progression-free survival rates”.

There were also uncertainties about whether the drug could help people live longer, all of which meant NICE couldn’t be certain Avastin justified the estimated cost of £25,000 for one course of treatment.

Roche can now appeal against the recommendation, although it chooses not to NICE said it expects to publish final guidance next month.

Until then, NHS bodies should make decisions locally on the funding of the treatment, including use of the Cancer Drugs Fund.

Avastin, which has also been turned down by NICE for use in breast cancer, bowel cancer and non-small cell lung cancer (NSCLC), is the Fund’s most requested medicine, although there are concerns about future access to these drugs once the UK’s drug reimbursement system is overhauled at the beginning of 2014.

In its statement, Roche said it was “disappointed” by NICE’s decision, but it “remains committed to improving outcomes for cancer sufferers and will continue to work with NICE and the Department of Health to find mechanisms for ongoing treatment funding for patients with metastatic cancer”.

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