UK's NICE does "U-turn" over Merck Serono's Erbitux

The National Institute for Health and Clinical Excellence (NICE), the UK advisory body responsible for evaluating the effectiveness of drugs and clinical treatments in England and Wales, has gone back on a previous decision, issuing a Final Appraisal Determination recommending the use in the National Health Service of Erbitux (cetuximab) in combination with radiotherapy for the treatment of locally-advanced head and neck cancer in patients that are contraindicated to all forms of platinum-based chemoradiotherapy.

The drug is marketed in Europe by German drugmaker Merck KGaA's Merck Serono and generated first-quarter sales of 145.0 million euros ($226.8 million) for the firm. The NICE rejected the use of Erbitux on the NHS early last year (Marketletter February 12, 2007), while the Scottish Medicines Consortium - an equivalent body for Scotland - approved it in summer 2006 and the European Medicines Agency (EMEA) cleared it March 2006.

This announcement signifies a step forward for patients with head and neck cancer in England and Wales as they will soon have access to this potentially life saving treatment, the drugmaker says. Once the full guidance has been published, expected on May 29, it will be fully implemented across the NHS within three months.