NICE says no to GSK breast cancer drug
pharmafile | June 10, 2010 | News story | Sales and Marketing | NICE, Tyverb
NICE has issued final draft guidance restricting use of GlaxoSmithKline’s breast cancer drug Tyverb to clinical trials, citing high cost and limited benefit.
The decision is a blow for the firm and amounts to a rejection in all but name for the drug as a monotherapy for metastatic or HER2-positive breast cancer.
GSK had hoped a ‘patient access programme’ involving the company providing Tyverb for free in the first 12 weeks would help it gain approval.
NICE said they had taken the proposal into consideration when assessing Tyverb for use in combination with Roche’s Xeloda (capecitabine), but that Tyverb still did not represent good value for money when compared with Xeloda used on its own.
Sir Andrew Dillon, NICE chief executive, said: “We are disappointed not to be able to recommend lapatinib but evidence suggests it only extends life by a small amount of time – around 10 weeks (2.4 months) – and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication – capecitabine on its own.”
In March last year NICE rejected Tyverb on similar grounds but in August reconsidered the drug under its new more lenient approach for end-of-life drugs, after GSK appealed the previous rejection.
GSK UK’s general manager 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.”
Jose added: “We will continue to offer the patient access programme to the NHS despite this ruling.”
GSK commented that the decision from NICE sets the UK apart from much of the rest of Europe as Tyverb is currently funded in 18 countries including Czech Republic, Iceland, Ireland, Slovakia and Slovenia at a higher cost than in the UK.
The company has until 24 June 2010 to lodge a further appeal against this final draft of the guidance.
Ben Adams
Related Content
Digital mental health technologies – a valuable tool in supporting people with depression and anxiety
The potential benefits of digital mental health technology for managing depression, anxiety and stress, together …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
NICE recommends Pfizer’s new once-weekly treatment for haemophilia B on NHS
Walton Oaks, 21st May 2025 – Pfizer Ltd announced today that the National Institute for Health and Care …
