The National Institute for Health and Clinical Excellence (NICE) has issued its 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).
Reportedly, the decision to deny NHS patients access to treatment with lapatinib follows the
request in July 2009 by NICE’s appeal panel that the appraisal committee should re-consider
lapatinib under the Institute’s end of life (EOL) supplementary guidance, final guidance is expected
later in the year.
NICE recognised that lapatinib met the EOL criteria, acknowledging
that additional data submitted by GSK demonstrated that lapatinib could offer a significant extension
to life, but they felt lapatinib was still not a cost-effective use of NHS resources. The decision
has been made despite GSK offering the Tyverb patient access programme, which allows NHS patients
in the UK free access to lapatinib for the first three months of treatment.
Simon Jose, general manager, GSK UK, said: “What is disappointing is that NICE acknowledges Tyverb
significantly extends lives but has failed to recognise the importance of this precious extra time to patients
who have very few months to live. 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.”
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Alison Jones, medical oncologist at the University College London Hospital and
the Royal Free Hospital, said: “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.”