Nivolumab now available for lung cancer through the Cancer Drugs Fund
In a deal between NICE and company Bristol-Myers Squibb, the immune checkpoint inhibitor nivolumab (Opdivo) has now been made available for patients with advanced nonsmall cell lung cancer (NSCLC) through the Cancer Drugs Fund (CDF).
When NICE first reviewed nivolumab for NSCLC in May 2016, it concluded that the evidence for its efficacy was not strong enough to recommend it for routine NHS use and the cost was too high. However, since the treatment does appear to be clinically effective for certain patients with NSCLC, NICE has now agreed to make the drug available to certain patients at a discount agreed with Bristol-Myers Squibb through the CDF while more evidence is gathered on its efficacy.
The decision follows new long-term survival data from the CheckMate 017 and 057 phase 3 trials presented at the European Society for Medical Oncology congress in September. After three years of follow-up, nivolumab significantly increased overall survival compared with docetaxel chemotherapy in previously-treated patients with both squamous NSCLC (16% versus 6%, hazard ratio (HR) 0.62) and non-squamous NSCLC (18% versus 9%, HR 0.73).
Nivolumab is a human monoclonal antibody that binds to programmed death-1 (PD-1) receptors on T cells, blocking PD ligand (PD-L1 and PD-L2) mediated inhibition of T cell proliferation and cytokine secretion, thus enhancing anti-tumour immune responses. It is used in the treatment of many types of cancer including advanced melanoma, classical Hodgkin lymphoma and advanced renal cell carcinoma.
NICE now recommends that nivolumab is offered to all NHS patients in England with locally advanced or metastatic squamous or nonsquamous NSCLC if they have already been treated with chemotherapy and (in the case of nonsquamous NSCLC) if their tumours express PD-L1; about 1300 patients will be eligible for treatment. NICE also specifies that treatment with nivolumab should be stopped at two years of uninterrupted treatment, or earlier in the event of disease progression. Once further long-term survival data are available, NICE will review this guidance.
Nivolumab is given by intravenous infusion in hospital every two weeks at a dose of 3mg/kg body weight. A month’s treatment costs approximately £5000 (depending on the patient’s weight) at the full list price. The most common adverse reactions are immune-related, including pneumonitis, colitis, hepatitis, nephritis and kidney dysfunction. A 10.5% rate of severe or life-threatening treatment-related adverse events has been reported in clinical trials.