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GSK appeals against NICE's Tyverb decision

GlaxoSmithKline has confirmed that it will appeal against NICE's decision earlier this month to deny NHS funding for Tyverb, a treatment for an aggressive form of advanced breast cancer

GlaxoSmithKline (GSK) has confirmed that it will appeal against NICE's decision earlier this month to deny NHS funding for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).  

GSK believes it has demonstrated Tyverb plus Xeloda (capecitabine) in conjunction with the patient access programme offers a clinically and cost effective new treatment option that meets a significant clinical need. NICE concluded that Tyverb is an effective treatment for eligible women, but rejected it on the grounds that it was not a cost effective use of NHS resources. NICE also acknowledged, however, that most women whose disease has progressed, despite treatment with Herceptin (trastuzumab), continue to receive this recommended treatment, a situation that is unlikely to be cost-effective.

Nice's recommendation that patients with advanced ErbB2-positive breast cancer do not get access to the drug, was made despite GSK offering a patient access programme whereby it would fund patients through a 12-week programme to show the drug's effectiveness. The NHS would only have to pay for those patients who were still benefiting from Tyverb after 12 weeks. Several local NHS Trusts have already signed up to the scheme.

According to Simon Jose, General Manager, GSK UK, the company's NICE submission demonstrates that Tyverb, in conjunction with the patient access programme, could actually save the NHS money. GSK's analysis suggests that the cost effectiveness of Tyverb in the context of the patient access programme (sensitive to the proportion of Herceptin used in clinical practice) demonstrated a cost per QALY gain for Tyverb of just over £16,000 versus the usual care given to these patients, which includes standard chemotherapy and Herceptin regimens.

"We have appealed against the decision, but will 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," Simon Jose said.

30th March 2009

From: Healthcare

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