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NICE expands Merck KGaA’s Erbitux reach

Backs the medicines use for patients with SCCHN

Merck

After several attempts, Merck KgAa has finally persuaded the UK medicines cost-effectiveness watchdog to back its monoclonal antibody Erbitux (cetuximab), for use in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

In a final appraisal determination (FAD), the National Institute for Health and Care Excellence (NICE) said it recommends the drug in combination with platinum based chemotherapy, offering SCCHN patients ‘sustainable’ access to a first-line therapy option.

Erbitux was first rejected by NICE for head and neck cancer in 2009 and again in 2016, concluding that the drug does not offer value for money, however it later became available on the Cancer Drugs Fund (CDF).

Dr Belinda Byrne, medical director at Merck, UK, said: “We are delighted that patients with recurrent and/or metastatic head and neck cancer in the oral cavity will continue to have access to Erbitux and that NICE has recognised the survival benefit it can offer to patients with this disease.”

SCCHN is the eighth most common cancer in the UK, with approximately 11,500 new cases diagnosed each year accounting for around 3% of all new cancer cases.

Byrne added: “Merck has worked tirelessly with NICE throughout this review and its success illustrates our commitment to working in partnership with the National Healthcare Service and NICE.”

The latest decision extends the recommendation for the previously approved cetuximab in combination with radiotherapy for patients with locally advanced SCCHN.

However, the extended use does not mean the drug is without upcoming competition. Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) recently claimed the title of the first immuno-oncology drug approved to treat adults with SCCHN in the EU, however Opdivo failed to impress NICE due to its high cost.

All eyes are now on BMS, who is currently under pressure from patient groups and cancer clinicians urging the pharma giant to lower the drug’s price.

Article by
Gemma Jones

14th August 2017

From: Regulatory

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