NICE backs use of Bristol-Myers Squibb's Opdivo for lung cancer via Cancer Drugs Fund

The National Institute for Health and Care Excellence announced Wednesday that Bristol-Myers Squibb's Opdivo (nivolumab) will be made available through the Cancer Drugs Fund for certain patients  with advanced non-small-cell lung cancer (NSCLC) if they have already been treated with chemotherapy. The decision comes after a deal was put forward by Bristol-Myers Squibb.

When NICE first reviewed Opdivo, the agency determined that the evidence was not strong enough to recommend the PD-1 inhibitor for routine NHS use. However, NICE noted that as the therapy appeared to be more effective in some patients, it asked Bristol-Myers Squibb to make it available with a discount whilst clinical trials were ongoing. The therapy will be available for patients with advanced squamous and non-squamous NSCLC, with use in non-squamous NSCLC restricted to those whose tumours express PD-L1.

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Opdivo was approved by the European Commission in 2015 for the treatment of locally advanced or metastatic squamous NSCLC following prior chemotherapy, with the product's indication expanded the following year to include patients with non-squamous disease.

Carole Longson, director of the NICE centre for health technology evaluation, said "we know that [Opdivo] is clinically effective for some people with lung cancer, but the full extent of its benefit is not clear." Longson added "this new deal means that we can give patients access to what we know is a promising treatment whilst more evidence is gathered on its value." According to NICE, a month's treatment with Opdivo for someone with NSCLC weighing 73 kg would cost 5268 pounds ($7157).

Commenting on the news, Paul Workman, chief executive of the Institute of Cancer Research, remarked "I'm pleased to see NICE and the drug's manufacturer showing flexibility in reaching agreement on the drug's approval." Workman noted "initially the drug was priced far too high to ever have been judged cost-effective by NICE. Companies need to come to the table with their best, most realistic price offer right at the start, so we get new exciting drugs, such as immunotherapies, to patients as quickly as possible."

In April, NICE issued draft guidance recommending against NHS reimbursement of Opdivo for adults with relapsed or metastatic squamous cell head and neck cancer as the cost of the immunotherapy is too high for routine use.

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