The National Institute for Health and Clinical Excellence has once again decided that GlaxoSmithKline’s breast cancer treatment Tyverb is too expensive to be paid for by the National Health Service.

The cost regulator has issued draft guidance advising against funding for Tyverb (lapatinib), in combination with Roche's Xeloda (capecitabine), as a treatment for an aggressive form of advanced breast cancer (ErbB2/HER 2 - positive). The guidance comes after NICE published a negative appraisal consultation in October.

The committee took into consideration NICE’s supplementary advice for appraising treatments that may extend life at the end of life, and a proposal by GSK to pay for the cost of lapatinib for the first 12 weeks of a patient’s treatment. However, even with both these factors in place, NICE chief executive Andrew Dillon claimed that evidence suggestsTyverb “only extends life by a small amount of time - around 10 weeks - and costs thousands of pounds more” than Xeloda on its own.

The appraisal committee acknowledged that Roche’s Herceptin (trastuzumab) is being prescribed to some patients even after their breast cancer has progressed, an indication for which it is not licensed. It therefore looked at whether Tyverb, being an oral rather than intravenous drug, and the patient access scheme proposed by GSK, could make lapatinib a more efficient use of NHS resources than trastuzumab. However, it decided there were “considerable uncertainties” when comparing the effectiveness of the two treatments and “could also not ignore” the data presented which suggested that Herceptin was not a cost effective treatment option compared to capecitabine,

Simon Jose, general manager of GSK UK, said the company “has worked really hard to offer the best possible value to the NHS, which makes this decision particularly disappointing”. He added that “it again highlights the limitations of the NICE appraisal process when evaluating cancer treatments for patients facing a relatively short life expectancy”, noting that there are 39 NHS Trusts across the UK that have signed up for the patient access scheme, “reflecting the clinical demand for Tyverb and recognising its potential value to the NHS, and more importantly to patients”. The company will continue to offer the scheme to the NHS despite this ruling, Mr Jose concluded.

GSK went on to say that the decision “sets the UK apart from much of the rest of Europe". Lapatinib is currently funded in 18 countries including the Czech Republic, Iceland, Ireland, Slovakia and Slovenia “where it is actually more expensive than in the UK”. The company quoted Alison Jones at the University College London Hospital and the Royal Free Hospital as saying that after talking to colleagues at the recent American Society of Clinical Oncology meeting in Chicago, she saw that treatments such as lapatinib “are internationally the standard of care at this stage of the disease”. This decision “highlights the gulf developing between provision of cancer drugs in the UK and other comparable countries”, she added."

The Royal College of Physicians expressed disappointment at the ruling, describing Tyverb as an “effective therapy that is very likely to make a difference to their overall quality of life, contribution to society and survival”.