NICE issued its final appraisal determination advising against NHS funding for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive). Lapatinib (in combination with Xeloda [capecitebine]) offers a new treatment option for women whose disease has returned despite treatment with standard chemotherapies and Herceptin (trastuzumab). There are very few treatment options available for these women and lapatinib offers a chance of additional time without their disease progressing. Lapatinib is the only licensed ErbB2 targeted treatment for these patients.

GlaxoSmithKline (GSK) will consider appealing the decision. Simon Jose, general manager, GSK UK commented, "We disagree with the NICE decision and believe Tyverb is a valuable and important treatment for eligible women. In recognition of the cost effectiveness challenges with drugs that treat patients with a short life expectancy, we offered the Tyverb Patient Access Programme to help ensure it was made available on the NHS. It is difficult to comment without the appearance of self interest. However, there is clearly more work to be done by all parties when flexible access programmes from industry and the recent changes by NICE for patients with a short life expectancy still fail to give them access to valuable medicines."

GSK proposed the patient access programme in the UK when NICE indicated early on in its review that it did not consider lapatinib to be cost effective in treating this patient population. In an effort to achieve a positive outcome for patients and greater value to the NHS, GSK bears the cost of lapatinib, for all eligible patients under the scheme, for up to the first 12 weeks of treatment. The NHS would commence payment only for the patients who continue to receive clinical benefit beyond 12 weeks. GSK will continue to honour the patient access programme for NHS trusts in the UK.

During the lapatinib assessment NICE proposed new advice for the assessment of treatments in small patient populations with a short life expectancy. Lapatinib is licensed for a particular type of breast cancer that affects around 2000 women a year. Therefore lapatinib qualified for review under the new advice.

GSK submitted a sub-group analysis that met the overall survival (OS) criterion of this new NICE advice. However NICE concluded that whilst the data analysis could be useful in guiding future research, as it stands it would not change their conclusions. NICE's decision reflects the difficulty in demonstrating significant survival benefits in patients at this advanced stage of disease. Furthermore, trials are often halted early for ethical reasons to allow patients to cross over to the active arm because of the effectiveness demonstrated by the medicine under study, as in the case of lapatinib.

In its final appraisal determination NICE acknowledges that lapatinib is a clinically effective option, noting that lapatinib plus capecitabine demonstrated improved time to progression (TTP) and progression free survival (PFS) - significantly delaying the progression of the cancer and controlling the disease.

GSK's NICE submission demonstrated that lapatinib, in conjunction with the patient access programme, could actually save the NHS money in patients who would have received trastuzumab (Herceptin) containing regimens. NICE acknowledged this is the majority (more than 50 per cent) of eligible patients, however NICE concluded that trastuzumab is not likely to be cost effective in this setting and therefore lapatinib plus capecitabine would not be cost effective.