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NICE no for Avastin in breast cancer

Published on 06/07/12 at 08:03am
Avastin pack shot

NICE has decided once again not to recommend Roche’s Avastin on the NHS for the first line treatment of metastatic breast cancer.

Roche, which described the final draft guidance as ‘disappointing’, wanted Avastin (bevacizumab) used as a first line treatment in combination with Roche’s own chemotherapy drug Xeloda (capecitabine).

NICE, which is expected to issue final guidance next month if there are no appeals against its decision, acknowledged that treatment with Avastin plus Xeloda could delay cancer from progressing for longer than Xeloda alone.

But it says there is no evidence to show Avastin led to an improvement in overall survival.

“There was also no information available on whether or not bevacizumab could improve a patient’s quality of life – an important point raised by the patient expert during the appraisal,” said NICE chief executive Sir Andrew Dillon.

“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,” he concluded.

Licence limited in Europe 

Avastin’s licence for breast cancer came under severe scrutiny last year when new trial data showed that it was not as effective in treating breast cancer as was once thought.

The FDA decided to rescind the drug's breast cancer licence from the US market after these studies were published, dealing a blow to the firm.

The EMA, however, decided to just restrict its use, and it can now only be given in combination with one type of chemotherapy.

To combat these problems, Roche is developing a biomarker to detect higher levels of VEGF-A, which is says may improve the results with Avastin. A biomarker could help in its fight to see the drug back on the US market, and could go some way to swaying NICE.

High cost and high QALY

Avastin has an average monthly cost per patient of around £3,700, and there was no patient access scheme offered.

NICE’s reticence boils down to concerns over the evidence presented by Roche - in particular that its figures were based on a specific subgroup of patients who had previously received a taxane, and not on the whole Xeloda cohort. 

The appraisal committee also highlighted a lack of modelling of subsequent treatments on overall survival results, and the fact that no allowance had been made for a reduction in patients’ quality of life due to side effects.

NICE says that it was therefore impossible to work out a ‘plausible’ incremental cost effectiveness ratio (ICER) per QALY gained for the two drugs together, compared to Xeloda alone for patients who had had taxane treatment.

However, NICE was sure the ICER would be higher than ‘the most optimistic ICER’ of £82,000 per QALY gained estimated for that subgroup. 

In turn that meant that the ICER for the combination compared with Xeloda alone for the whole population would have to be even higher, NICE decided.

NICE decision ‘limits’ treatment options

In a statement, Roche said: “Avastin in combination with capecitabine has proven to be an important treatment option for women who have a particularly aggressive form of breast cancer which has a poor prognosis.

“These women are often treated with a taxane when their disease is at an early stage and as a result have limited treatment options available to them if their disease progresses.” 

Breast cancer patients in England will now have to rely on doctors applying to the Cancer Drugs Fund to receive Avastin, the manufacturer concluded - although there is no such access in Wales, Scotland and Northern Ireland. 

Avastin is currently the most commonly funded drug through the Fund, and has European licences to treat breast, colorectal, kidney, lung and ovarian cancers. 

Adam Hill

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