NICE decides not to recommend lapatinib for women with advanced breast cancer

NICE rejects lapatinib for advanced breast cancer

The National Institute for Health and Clinical Excellence (NICE) has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

Lapatinib is designed to treat HER2-positive breast cancer, in which the tumour over-expresses the HER2 protein, which helps cancer cells to grow.

The drug works by blocking signals from the HER2 receptor on the surface of cells, thereby stopping cancer cells from growing and spreading.

Final draft guidance from NICE states that the drug is only recommended in combination with capecitabine (Xeloda) in the context of clinical trials for women with advanced or metastatic HER2-positive breast cancer.

But, those who are already receiving lapatinib should be allowed to continue taking the drug if they and their doctors wish.

NICE said that its decision was reached after an extensive consultation and evaluation of evidence, which suggested the drug has limited benefit and, at an overall cost of about £25,207 per year when combined with capecitabine, is not cost-effective.

The institute applied its new supplementary guidance for appraising treatments that may extend the lives of terminally ill patients, and took into consideration a cost-sharing proposal by the manufacturer.

Despite this proposal - under which the manufacturer would have met the cost of lapatinib for the first 12 weeks of each patient's treatment - NICE's appraisal committee concluded that the drug was still not a cost-effective use of NHS resources when compared with existing treatments.

Chief executive Sir Andrew Dillon revealed that the committee had been investigating lapatinib since 2007 and had conducted a "long and comprehensive" evaluation of the available evidence.

"We are disappointed not to be able to recommend lapatinib, but evidence suggests it only extends life by a small amount of time - around ten weeks (2.4 months) - and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication - capecitabine on its own," he explained.

The committee also considered the potential of oral lapatinib to replace intravenous trastuzumab (Herceptin), which works in a similar way to lapatinib and is sometimes used in women with advanced breast cancer, even though it is not licensed for this purpose.

However, a lack of quality data meant that it was unable to fully assess the benefits of lapatinib in comparison to Herceptin.

Sir Andrew said: "The committee felt that it had not been presented with evidence of the drug's efficacy for specific groups of patients likely to continue treatment with trastuzumab (Herceptin) after their disease has progressed and that recommending lapatinib could serve to displace other cost-effective NHS treatments."

Manufacturers and other stakeholders have an opportunity to appeal against this final decision from NICE until June 24th 2010, after which final guidance will be published.

Hilary Tovey, policy manager at Cancer Research UK, said: "We are disappointed that NICE and the manufacturers have failed to come to a decision to make lapatinib available on the NHS.

"Cancer Research UK is already supporting clinical trials to find out whether lapatinib is more effective than other treatments for some women with breast cancer. We hope the results of these trials will provide better evidence to support the introduction of lapatinib on the NHS in the future."