GlaxoSmithKline has lost its appeal to overturn National Institute for Health and Clinical Excellence draft guidance on the use of its oncology drug Tyverb in National Health Service patients with breast cancer at this time.

The cost regulator ruled earlier this year that Tyverb (lapatinib), in combination with Roche's Xeloda (capecitabine), was too expensive for use on the NHS to treat patients with an aggressive form of advanced breast cancer (ErbB2/HER 2 - positive), and that the drug’s use should be restricted to clinical trials.

Despite taking into consideration supplementary advice for appraising so-called end-of-life treatments as well as a patient access scheme proposed by GSK under which it offered to pay for the first 12 weeks of Tyverb therapy, at the time NICE was reluctant to fund the drug because it said trials show that it only extends life by around 10 weeks at a cost of thousands of pounds more than Xeloda alone.

However, while an independent panel rejected GSK’s appeal on all grounds, the Institute said it has actually decided not to issue guidance at this time. This is because it feels that a better way of assessing the value of Tyverb to the NHS would be to assess it alongside the use of Roche’s Herceptin (trastuzumab) beyond disease progression.

While Herceptin is not licensed in this setting, “we think that it is in the interests of patients – and the NHS – to fully consider what effect using [Tyverb] in these circumstances might have on the use of NHS resources”, the Institute explained, and added that it has asked the Department of Health for permission to carry out an appraisal on the use of Herceptin for advanced and metastatic breast cancer and Tyverb together.

“Whilst we are clearly disappointed that our appeal has been dismissed, we take some encouragement that NICE has acknowledged there are challenges in assessing the value of these treatments and is recommending that Tyverb be considered in a further appraisal in comparison with trastuzumab,” Simon Jose, General Manager, GSK UK, told PharmaTimes UK News in an e-mailed statement.

“Naturally, we will continue to engage fully in the NICE process and any further appraisal, but strongly believe that it is in the interests of patients that this needs to be done quickly and reach a clear conclusion,” he stressed.

“In the meantime, GSK is committed to improving patients’ opportunity to access Tyverb and we will continue to offer our patient access programme to all NHS Trusts, with 49 having already signed up.”