NICE rejects breast cancer drug Tyverb

Breast cancer drug is rejected

The British watchdog's final draft guidance follows earlier rebuffals of Tyverb, which is used in combination with Roche's Xeloda (capecitabine), as a treatment for an aggressive form of advanced breast cancer (ErbB2/HER 2 - positive). It is a last resort for those whose treatment with standard chemotherapies and Herceptin has failed.

GSK offerd to provide patients with Tyverb for free for the first three months and drew attention to evidence that it can extend the life of breast cancer patients for longer than just taking Xeloda on its own. 

However, despite these factors, NICE Chief Executive Andrew Dillon said that Tyverb "only extends life by a small amount of time - around 10 weeks - and costs thousands of pounds more" than Xeloda on its own and that the breast cancer drug does "not represent good value for money when compared with the alternative, currently available treatment".

GSK "very disappointed"

The news comes as a blow for GSK who had been hoping that the patient access programme they were offering would help the drug gain approval; 39 NHS Trusts across the UK have signed up for the scheme.  

GSK's general manager in the UK, Simon Jose, said: "GSK has worked really hard to offer the best possible value to the NHS, which makes this decision particularly disappointing. It again highlights the limitations of the NICE appraisal process when evaluating cancer treatments for patients facing a relatively short life expectancy".

Mr. Jose highlighted the demand for the patient access programme GSK is offering for use of the breast cancer drug and said that this reflects "the clinical demand for Tyverb and recognising its potential value to the NHS, and more importantly to patients."
 
GSK will, however, "continue to offer the patient access programme to the NHS despite this ruling" said Mr. Jose.

Tyverb is currently funded in 18 countries, including the Czech Republic, Iceland, Ireland, Slovakia and Slovenia and GSK commented that rejection of Tyverb by NICE has set the UK apart from the majority of European countries "where it is actually more expensive than in the UK".

Mr. Jose argued that ultimately the breast cancer drug would actually save the NHS money as well as alleviate the suffering and extend the lives of more than 2,000 women a year.       

Mr. Dillon, however, said that NICE had been examining Tyverbas a breast cancer drug for three years and that "this has been a long and comprehensive evaluation of the evidence available but only because we want to be sure the decision reached is the right one and made for the right reasons."

GSK has until June 24 2010 to lodge a further appeal against this final draft of the guidance issued by NICE.

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