NICE publishes appeal decision on lapatinib

The National Institute for Health and Clinical Excellence (NICE) has today (14 October) published the outcome of an appeal hearing relating to its draft guidance on the use of lapatinib (Tyverb, GlaxoSmithKline) for certain breast cancer patients.

The current draft guidance recommends lapatinib, in combination with capecitabine (Xeloda), for people with advanced or metastatic HER2-positive breast cancer but only in the context of clinical trials. NICE subsequently received one appeal from GlaxoSmithKline and this was heard by an independent appeal panel.

Sir Andrew Dillon, NICE Chief Executive, said: "The appeal panel has ruled that the advisory committee that had been appraising lapatinib on behalf of NICE followed the correct procedures when developing the recommendations, reasonably considered the available evidence and did not exceed its powers. They therefore rejected GlaxoSmithKline's appeal on all grounds.

"However, we have decided not to issue guidance at this stage. This is because we now believe that a better way of assessing the value of lapatinib is to consider it alongside the use of trastuzumab (Herceptin) beyond progression (in other words, beyond the point at which, even after using trastuzumab, the disease begins to get worse). Even though trastuzumab isn't licensed for this, it is frequently being used in this way in the NHS. We think that it is in the interests of patients - and the NHS - to fully consider what effect using lapatinib in these circumstances might have on the use of NHS resources. We have asked the Department of Health for permission to carry out an appraisal on the use of trastuzumab for advanced and metastatic breast cancer and lapatinib together. This will include the continuing use of trastuzumab post-progression. If the Department of Health gives permission, the Institute will carry out this appraisal as quickly as possible. In the meantime, patients who are currently receiving lapatinib can carry on doing so and NHS bodies will be expected to make decisions locally on the funding and choice of treatments."

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