NICE rejects GSK Tyverb appeal
pharmafile | October 14, 2010 | News story | Sales and Marketing | GlaxoSmithKline, NICE, Tyverb
NICE’s independent appeal board has ruled the UK drug’s watchdog did not exceed its powers when issuing guidance on GlaxoSmithKline’s Tyverb.
But the decision does still leave a door open for GSK after NICE said it would delay issuing final guidance on the drug until its off-label use alongside Roche’s Herceptin could be assessed.
NICE rejected Tyverb in June, citing high cost and limited benefit, and restricting its use in combination with Roche’s Xeloda to clinical trials of people with advanced or metastatic HER2-positive breast cancer.
Sir Andrew Dillon, NICE chief executive, said: “The appeal panel has ruled that the advisory committee that had been appraising lapatinib [Tyverb] 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.
“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.
NICE said that if DH permission is granted it would carry the new appraisal, which would include the continuing use of Tyverb post-progression, as quickly as possible.
Currently, the primary treatment for HER2-positive breast cancer is Roche’s Herceptin as either a monotherapy or in conjunction with chemotherapy.
General manager of GSK UK Simon Jose said the company decided to appeal again because it was concerned patients were being unfairly denied access to the treatment, “particularly in light of the widespread use in the NHS of trastuzumab, which is unlicensed for this patient population, and the considerable cost savings on offer as a result of the Tyverb Patient Access Programme”.
“Whilst we are clearly disappointed that our appeal has been dismissed, we take some encouragement that NICE has acknowledged there are challenges in assessing the value of these treatments and is recommending that Tyverb be considered in a further appraisal in comparison with trastuzumab,” Jose said.
“Naturally, we will continue to engage fully in the NICE process and any further appraisal, but we strongly believe that it is in the interests of patients that this needs to be done quickly and reach a clear conclusion.”
GSK said it would continue to offer its patient access programme, which gives the first 12 weeks of treatment free, to all NHS Trusts, adding that 49 have already signed up.
In the meantime, patients who are currently on Tyverb can still receive it and NHS bodies will be expected to make funding and treatment choice decisions on a local basis.
Ben Adams
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