The National Institute for Health and Clinical Excellence has agreed to uphold GlaxoSmithKline’s appeal over its decision not to recommend Tyverb as a treatment for patients with advanced breast cancer on the National Health Service.

In March, the cost watchdog for England and Wales published a final appraisal determination claiming that, while Tyverb (lapatinib) shows “a small overall survival benefit” for patients with ErbB2 positive breast cancer, its cost per QALY (quality assured life year) gained is around £70,000, and so “is not a cost-effective option compared to current standard therapy with capecitabine”.

However, the world’s second largest drugmaker quickly filed an appeal against this decision, claiming that it had shown that the drug plus chemotherapy, in conjunction with its proposed patient access programme, “offers a clinically and cost effective new treatment option that meets a significant clinical need”.

In addition, GSK argued that taking into account its proposed patient access scheme - whereby it pays for the first 12 weeks of Tyverb treatment to reduce the financial burden on the NHS – the cost per QALY is actually £16,000, a far cry from the NICE-calculated figure of £70,000.

Now the Institute has agreed to uphold GSK’s appeal in light of new advice, issued at the beginning of the year, on the appraisal of treatments for small patient populations with short life expectancies, after an appeal panel ruled that the company and other stakeholders should be allowed to submit evidence under this new ‘end-of-life’ criteria.

Unmet need
GSK is obviously thrilled by the news. Simon Jose, General Manager of the firm’s UK operations, said he welcomes the decision, and added that while the company appreciates NICE has “some very tough decisions to make, especially in this end of life setting…given the considerable survival benefits that Tyverb offers these women, we believe it deserves full and thorough consideration”.

According to GSK, around 2,000 women in the UK could benefit from treatment with the drug, and Dr Alison Jones, Medical Oncologist at the University College London Hospital and the Royal Free Hospital, says it is “great” that NICE will reconsider Tyverb as there is “a significant unmet medical need for women with this aggressive form of advanced breast cancer”. As Jones points out, women with the disease “have very few treatment options left available to them” and she claims that Tyverb, when combined with capecitabine, “offers a chance of additional time without their disease progressing”.