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Published on 15 May 2007

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Cetuximab’s UK knockback

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The UK’s National Institute for Health and Clinical Excellence(NICE) has once again knocked back Erbitux® (cetuximab), this time forhead and neck cancer, and has defended its record on appraisingoncology drugs.

NICE, which rules on the drugs that can beprescribed on the NHS in England and Wales, has issued its final draftguidance on Erbitux, developed by ImClone and marketed by Bristol-MyersSquibb and Merck KGaA, and says it does not recommend the treatment incombination with radiotherapy for patients with locally advancedsquamous cell cancer of the head and neck.

Explaining therationale behind the decision, NICE chief executive Andrew Dillon saidthe evidence presented to the independent advisory committee did notpersuade NICE that cetuximab “works any better or offers bettertherapeutic value than existing treatments for head and neck cancer”.He added that NICE did consider whether there were any subgroups ofpatients for whom cetuximab could be clinically and cost-effective, butNICE was “not presented with any robust evidence to demonstrate this”.

Appealsagainst the decision are expected before NICE issues its final guidancenext month, but the prospects for Erbitux do not look too good. InJanuary, the committee rejected an appeal from charities over itsdecision to reject Erbitux for bowel cancer patients.

NICEis bracing itself for more criticisms about the way it conducts itsappraisals, but Mr Dillon has hit back at critics of the system. Hesaid that “contrary to reports, NICE has reviewed 39 cancer drugs for avariety of indications since its inception. Of these we haverecommended 35 for routine or selective use; only four treatments arenot recommended for use in the NHS”.

He added that the NHS”has finite resources and it is our job to ensure that these are spenton treatments that confer enough of a benefit to patients in relationto the amount of money they cost”. His comments come days after areport from Sweden’s Karolinska Institute and the Stockholm School ofEconomics which claimed that patient access to innovative cancer drugsin the UK pales in comparison with the majority of other European andthe USA.

PharmaTimes 14/5/07

 



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