NICE denies NHS access to Tyverb

Tyverb has been rejected by NICE for breast cancer, despite the manufacturer’s efforts to comply with the new guidance on treatments for small patient populations with a short life expectancy.

NICE has issued an Appraisal Consultation Document (ACD) rejecting oral Tyverb (lapatinib) in combination with capecitabine for the treatment of an aggressive form of advanced breast cancer (ErbB2-positive).

The decision to reject lapatinib follows an appeal in July this year that the Appraisal Committee should re-consider 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 to gain access to important new medicines. Manufacturer GSK submitted additional data demonstrating that lapatinib met all three of the EOL criteria.

However, although NICE recognised that lapatinib met the EOL criteria, the Appraisal Committee felt that it was still not a cost-effective use of NHS resources.

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.”

Lapatinib is funded in 18 other European countries, for the treatment of women whose advanced breast cancer has returned despite treatment with standard chemotherapy regimes including intravenous Herceptin (trastuzumab).

Dr Alison Jones, Medical Oncologist at the University College London Hospital and the

Royal Free Hospital, commented: “I am disappointed for all the women who would have benefited from lapatinib 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.”