July 8, 2008

GlaxoSmithKline: NICE Says No to Tyverb

The medical advisory panel to the UK National Health Service has recommended that GlaxoSmithKline's Tyverb should not be used on the NHS to treat advanced metastatic breast cancer on the grounds that it is not effective enough to justify its cost. This decision represents not only a blow to GSK but also casts doubt on how many other new cancer therapies will be available in the UK.

The UK panel ruled that, based on data showing that the median survival time for women who received Tyverb (lapatinib) along with Roche's Xeloda (capecitabine) was 74 weeks, compared to 66 weeks for a group on capecitabine alone, and the drug's cost of around $42,000 per patient per year, Tyverb would not be a cost-effective use of government health resources.

Tyverb was approved by the European Commission in June for treatment of patients with HER2-positive advanced or metastatic breast cancer in combination with Xeloda, who have not responded to other treatments. GSK hoped that as Tyverb is an oral tablet with the potential to improve patients' quality of life, this consideration would also be taken into account during NICE's assessment.

However, it seems that in situations where multiple drugs are required to treat cancer patients, together with all the necessary supportive therapy, cancer agents are just not cost-effective for the NHS. Instead, NICE has recently elected to fund the treatment of several immune and inflammatory conditions, with Abbott's Humira and Amgen's Enbrel, reflecting a focus on improving chronic conditions rather than costly extension of life for only several weeks or months.

NICE's latest decision presents a serious blow to GSK's Tyverb, as it effectively prevents it from entering the UK market. The drug is already used in the US and is reported to have generated sales of $38 million in the first quarter of 2008. Although the drug is available in the UK for private prescription, without its use on the NHS it is unlikely to generate significant sales. Furthermore, with other European Health Technology Assessment bodies increasingly looking towards NICE when making their own decisions, this outcome could negatively impact Tyverb's commercial potential in other EU markets.

Together with the recent termination of NICE's appraisal of Roche's Avastin (bevacizumab) for use in breast and lung cancer and BMS/Merck's Erbitux (cetuximab) for colorectal cancer (after the sponsors decided not to submit all the necessary data to NICE and effectively pull out of the assessment process), this news casts doubt on the chances new cancer therapies have of getting access to the UK market. Indeed, sponsors may decide to forego the UK market altogether and avoid the potential repercussions NICE's refusal can have in other European markets, which benefit from more favorable reimbursement conditions.