UK's NICE latest decision on GSK's Tyverb and Pfizer's Sutent is negative

16 March 2009

Despite recent indications that the UK's National Institute for Health and Clinical Excellence (NICE) might be more flexible on  cost-effectiveness issues relating to life-savings drugs (Marketletter  January 12), it has come out with a negative final opinion on UK drug  giant GlaxoSmithKline's advanced breast cancer drug Tyverb/Tykerb  (lapatinib) and global pharmaceutical market leader Pfizer's Sutent  (sunitinib), for the treatment of gastrointestinal stromal tumor.

The NICE, which advises on medicines that should be made available on  the National Health Service on the UK, excluding Scotland, has concluded  that Tyverb is not cost-effective for the state service, despite GSK's  offer on cost-sharing. The company has previously said that it would  fund the treatment for patients for the first 12 weeks to demonstrate  its effectiveness, after which the NHS would pick up the tab for those  still benefiting from the drug, the only licensed therapy for  ErB2-positive breast cancer, says GSK.

According to the Institute, lapatinib produced only a small overall  survival benefit of a few weeks and that it came at a cost per  quality-adjusted life year (QALY) of GBP94,000 ($131,656). It argued that,  even with the company funding the first 12 weeks of treatment, the cost  would still be GBP70,000 per QALY.

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