The National Institute for Health and Care Excellence (NICE) has issued a preliminary no for NHS use of Bristol-Myers Squibb's Opdivo (nivolumab)/Yervoy (ipilimumab) combination for treating a certain lung cancer.
In the UK, the combination plus two cycles of platinum-based chemotherapy is approved for untreated metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.
Opdivo is a fully humanised IgG4 monoclonal antibody which targets and blocks the PD-L1 receptor, to promote an anti-tumour immune response. Yervoy is a recombinant human anti CTLA-4 monoclonal antibody which blocks the effects of CTLA-4 to enhance T-cell mediated immune responses to tumour cells.
In an appraisal consultation document, NICE notes that clinical trial evidence suggests people who have the Opdivo/Yervoy regimen live longer than those who have platinum-doublet chemotherapy.
However, in the economic model it is uncertain how long the effect lasts, and whether people having it live longer depending on their PD-L1 status and the type of NSCLC they have, it said.
As such, the cost watchdog concluded that the cost-effectiveness estimates for the combination compared with platinum-doublet chemotherapy, atezolizumab combination and pembrolizumab monotherapy are higher than what it considers acceptable, even when end of life criteria are applied for squamous NSCLC with a PD-L1 score below 50%.
Also, NICE felt it unlikely that collecting more data in the Cancer Drugs Fund would resolve the uncertainty in the modelling, and so did not recommend the combination's use through the Cancer Drugs Fund.