GlaxoSmithKline revealed yesterday that it is putting up a fight against the National Institute for Health and Clinical Excellence’s decision to oust its breast cancer drug Tyverb from the National Health Service.

The world’s second largest drugmaker has filed an appeal against the Institute’s current stance that Tyverb (lapatinib) is not an effective use of NHS resources, because the firm maintains it has shown that the drug plus chemotherapy, in conjunction with the patient access programme, “offers a clinically and cost effective new treatment option that meets a significant clinical need”.

Earlier this month the UK’s cost watchdog published a final appraisal determination claiming that, while Tyverb shows “a small overall survival benefit”, its cost per QALY gained is around £70,000, and so “is not a cost-effective option compared to current standard therapy with capecitabine”.

The decision came despite a lowering of the cost-effectiveness threshold for life-extending medicines during Tyverb’s appraisal, as well as a proposed patient access scheme by GSK under which it offered to pay for the first 12 weeks of treatment with the drug.

While GSK conceded in its original submission that Tyverb is not the most cost-effective therapy when compared with chemotherapy alone, it pointed out that less than 50% of patients with the ErbB2 positive form of breast cancer actually receive just chemotherapy in clinical practice, and so Tyverb-based regimens could actually offer a cheaper alternative than those containing Roche’s cancer drug Herceptin (trastuzumab), which the group says many women receive even after their disease has advanced.

Moreover, the company is also contesting NICE’s cost-effectiveness analysis as taking into account the proposed patient access scheme GSK’s own calculations put Tyverb’s cost per QALY of “just over £16,000 versus the usual care given to these patients, which includes standard chemotherapy and trastuzumab regimens”, which is well below the Institute’s own figure of £70,000.

Tough decisions
Commenting on the appeal, Simon Jose, General Manager of GSK UK, said: “NICE has some tough funding decisions to make…[but] Tyverb, in conjunction with the patient access programme, could actually save the NHS money”.

And besides the fact that Tyverb is currently the only drug specifically licensed to treat the ErbB2 positive form breast cancer, the company also points out that it has been granted funding in 16 European countries to date, including Slovenia, Slovakia, France, Spain, Germany, Italy and Ireland, which means patients in the UK are once again being denied access to a novel cancer drug available to others throughout the continent.

But pending the appeal, GSK has promised to continue to offer the patient access programme to individual NHS trusts “to help ensure Tyverb is available to the women who could benefit from it”.