Around 2,000 women in the UK with breast cancer could be denied access to GlaxoSmithKline’s Tyverb after the National Institute for Health and Clinical Excellence said it still considers the drug too expensive for the National Health Service.

In a bitter blow to the firm, the cost regulator has published an appraisal consultation document in which it acknowledges that adding Tyverb (lapatinib) to the chemotherapy capecitabine does indeed significantly extend the lives of patients with advanced breast cancer (ErbB2-positive) but - despite considering the drug under new end-of-life criteria and a patient access scheme proposed by GSK - concludes that it still fails on value-for-money.

GSK filed an appeal earlier this year against NICE’s original Final Appraisal Determination rejecting the drug on grounds that, while it offers “a small overall survival benefit” its price tag of around £20,969 and cost per QALY gained of around £70,000 does not represent a cost-effective option compared to current standard therapy with capecitabine.

But additional data submitted by the firm as part of the appeal, which it claims showed that Tyverb met all three end-of-life criteria – in that it is indicated for patients with a short life expectancy, offers an extension to life, and is licensed for small patient populations - as well as its original offer to pay for the first 12 weeks of treatment to help reduce the burden on the NHS were not enough to change the Institute’s position, after the cost watchdog found the cost per QALY gained remained too high above the threshold.

Commenting on the decision, Simon Jose, General Manager of GSK UK said it is “disappointing” that despite the fact that Tyverb met the end-of-life criteria and GSK’s patient access scheme the Institute is still proposing to reject the drug. However, he added the company will continue to offer the programme to individual NHS Trusts in a bid to ensure that patients have access to the drug.

Few treatment otions
Dr Alison Jones, Medical Oncologist at the University College London Hospital and the Royal Free Hospital, also expressed disappointment for all the women who would have benefited from Tyverb on the NHS. “I have witnessed myself that lapatinib can extend the lives of these women. We are now left with very few effective treatment options in cases where Herceptin has stopped working,” she said.

The company also pointed out that Tyverb has been granted funding in 18 European countries to date, including Slovenia, Slovakia, France, Spain, Germany, Italy and Ireland, which shows that patients in the UK are once again being denied access to a novel cancer drug that is widely available throughout the continent.