NICE rejects head and neck cancer drug once again

England’s National Health Service could stop funding Merck KGaA’s Erbitux  in head and neck cancer after NICE said in draft guidance that it was not cost-effective.

NICE rejected Erbitux (cetuximab) in 2009, but until this year the Cancer Drugs Fund had been reimbursing it for recurrent and/or metastatic squamous cell cancer of the head and neck.

But NICE has been asked by the government to reappraise all drugs available on the massively overspent CDF, and says it cannot recommend the drug. This is despite further evidence, an indication change, and price cut being offered by the company.

Reimbursement of cancer drugs has become a thorny issue in England, where pharma wants NICE’s assessment methodologies reformed, arguing that its cost-effectiveness calculations are ill suited to high-cost, high effectiveness, targeted cancer drugs.

As part of the reappraisal the manufacturer presented further evidence, not included in its original submission, and reduced the number of patients eligible to those with mouth cancer.

Around 2,300 people are diagnosed with mouth cancer each year in England and Wales.

The company also offered a discount, the exact details of which are confidential, but the firm did say Erbitux now costs less than at the time of the original appraisal.

But NICE’s independent appraisal committee said evidence of clinical effectiveness of Erbitux in mouth cancer was uncertain, adding it was unclear why it should be more effective in that indication than others.

Because of the uncertainties, NICE said Erbitux (pictured above in production at Merck KGaA’s Darmstadt plant) was not a cost-effective use of NHS resources.

Professor Carole Longson, director of the health technology evaluation centre at NICE said: “When we originally appraised cetuximab, there were uncertainties in the evidence and we were therefore unable to recommend it for routine funding on the NHS.

“The company has addressed some of these concerns but significant uncertainties remain. This decision not to recommend cetuximab as an option for treating mouth cancer will be disappointing for some patients. However we need to make sure the NHS makes the most of its resources by only funding treatments that are both clinically effective and represent good value for money.”

NICE will consult on the draft guidance until 22 November, and will then publish a second draft before its final guidance.

Until NICE publishes final guidance, Erbitux will still be available to patients in the old CDF. Patients already receiving the drug will be able to continue their treatment.

Photograph courtesy of Merck KGaA.

 

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