Monday, 13 July 2009

UK – NICE to Reconsider Guidance on Tyverb after GSK Appeal

The National Institute for Health and Clinical Excellence (NICE) has agreed to uphold an appeal from GlaxoSmithKline over guidance rejecting Tyverb (lapatinib) as a treatment for patients with advanced breast cancer.

Final guidance was issued in March 2009 on the drug, which did not recommend Tyverb on the grounds that it showed just “a small overall benefit” with a cost per QALY (quality assured life year) of £70,000, and therefore was not cost effective.

However, GlaxoSmithKline appealed against the recommendation and claimed that the drug was a cost-effective therapy when combined with chemotherapy and the company’s proposed patient access scheme. Under this scheme, the drug company would pay for the first 12 weeks of Tyverb treatment which would result in a QALY of £16,000.

As a result, NICE has agreed to re-assess the drug as part of the new guidance to be used when assessing end-of-life care, introduced in January 2009. This includes allowing companies and other stakeholders the right to submit evidence which they believe proves their product is cost-effective.

Further reading - An in-depth analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published March 2009)

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