The National Institute for Health and Clinical Excellence has this morning issued a final appraisal determination rejecting the provision of GlaxoSmithKline’s advanced breast cancer drug Tyverb on the National Health Service.

The Institute has ruled that the drug is not a cost-effective use of NHS resources despite the drugmaker’s proposed patient access programme, under which it offered to pick up the tab for the first 12 weeks of treatment with Tyverb (lapatinib).

“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,” explained Simon Jose, General Manager of GSK UK. And he added that while it is difficult to comment without the appearance of self interest, “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.”

During the Institute’s appraisal of Tyverb NICE updated its guidance for the assessment of life-extending drugs for small patient populations - raising the cost-effectiveness threshold to help patients get better access to these medicines – and so GSK submitted a sub-group analysis that met the survival criterion of this new advice. However, the data failed to shift the Institute’s position, “reflecting the difficulty in demonstrating significant survival benefits in patients at this advanced stage of disease”, the firm stressed.

According to GSK, its submission to NICE showed that Tyverb, in combination with the proposed patient access programme, could be a cheaper option than treating patients with Herceptin (trastuzumab) based regimens, but the Institute argued that this is not a relevant comparison as Herceptin is not likely to be cost-effective in this setting.

Dr Gillian Leng, NICE Deputy Chief Executive, that an independent advisory committee concluded that Tyverb does produce a "small overall survival benefit (in the order of a few weeks), and some benefit in delaying disease progression compared with current standard treatment" but that even with proposed patient access scheme the cost per QALY gained is around £70,000 and so is not cost-effective option compared to current standard therapy with capecitabine.

The company is obviously disappointed with NICE’s decision, with which it “strongly disagrees”, and says it is considering an appeal.

Not looking good for Sutent
It is also looking increasingly unlikely that patients with rare forms of stomach cancer will get access to Pfizer’s Sutent (sunitinib) on the NHS.

The Institute has issued draft guidance – which is now open for consultation - rejecting the use of Sutent for treating advanced gastrointestinal stromal tumour.

According to a NICE spokesperson, an independent advisory committee has accepted that the drug is clinically effective "but is minded not to recommend sunitinib, as a treatment option for people with unresectable and/or metastatic malignant GIST because of uncertainty in the economic analysis provided by the manufacturer".

The Institute has now asked Pfizer to provide NICE with "further clarification and analyses of this data" before the next independent advisory committee meeting on April 8.

Last year Sutent was also turned away by NICE for use in advanced kidney cancer, but the decision was reversed in February following the extension to the acceptable cost threshold of end-of-life drugs.