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BMS' Opdivo Garners Positive Draft Recommendation From UK's NICE in Second-Line NSCLC

NEW YORK – The UK's National Institute for Health and Care Excellence on Thursday proposed to cover the anti-PD-1 drug nivolumab (Bristol Myers Squibb's Opdivo) as a second-line option for patients with certain kinds of non-small cell lung cancer.

In a draft guidance, NICE supported the availability of nivolumab for National Health Service patients with locally advanced or metastatic squamous or non-squamous NSCLC, as long as they have received chemotherapy in the first-line setting (but not a PD-1 or PD-L1 inhibitor) and their tumors express PD-L1. Patients can receive the drug for two years or until their cancer progresses.

NICE said in a statement that the average cost for a course of nivolumab treatment is £2,633 ($3,400) based on its list price. However, BMS is providing the drug for the NHS population at a discount, which NICE did not disclose.

Until this recommendation is finalized in October, nivolumab will continue to be available to NSCLC patients through the Cancer Drugs Fund, which is another pathway by which NHS patients can get access to treatments that don't meet NICE's cost-effectiveness threshold based on current evidence. As a condition of CDF funding, BMS collected additional data in squamous NSCLC patients within the CheckMate-017 study and in non-squamous patients in the CheckMate-057 study, and analyzed addition datasets available within the CDF.

The agency made its decision to recommend the drug based on data showing a survival advantage for PD-L1-positive NSCLC patients on nivolumab compared to docetaxel in the second-line setting. NICE estimated that approximately 2,000 NSCLC patients in England will meet the proposed eligibility requirements for nivolumab therapy.