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NICE rejects aggressive breast cancer drug

NICE has rejected GSK's Tyverb in combination with capecitabine for the treatment of an aggressive form of advanced breast cancer

The UK's National Institute for Health and Clinical Excellence (NICE) has issued its Appraisal Consultation Document (ACD) rejecting GlaxoSmithKline's (GSK) oral Tyverb (lapatinib) in combination with capecitabine for the treatment of an aggressive form of advanced breast cancer (ErbB2-positive).

The decision follows the July 2009 request of NICE's appeal panel that the appraisal committee should reconsider lapatinib under the Institute's end of life (EOL) supplementary guidance.

The EOL guidance was specifically developed to help small numbers of patients, who have only a few months to live, gain access to important new medicines. GSK submitted additional data demonstrating that lapatinib met all three of the EOL criteria. 

Though NICE recognised this, it felt lapatinib was still not a cost-effective use of NHS resources. This decision was made despite GSK offering the Tyverb Patient Access Programme, which allows National Health Service (NHS) patients in the UK free access to lapatinib for the first three months of treatment.   

Simon Jose, general manager, GSK UK, commented: "NICE developed additional criteria specifically to help secure greater patient access to new treatments that offer precious extra time at the end of life. It is disappointing that, despite acknowledging Tyverb meets these criteria and GSK offering to bear the cost of lapatinib for up to 12 weeks, NICE is still proposing to reject lapatinib. We will continue to offer our patient access programme to individual NHS Trusts to ensure patients have access to Tyverb."

Twenty-six Trusts have enrolled in the patient access programme to date. 

21st October 2009

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