Cost regulators for technologies funded by the NHS in England and Wales say they currently are minded not to recommend routine use of Teva's asthma biologic Cinqaero.
Cinqaero (reslizumab) was approved in Europe in August as add-on therapy for adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another maintenance therapy, on the back of data showing statistically significant reductions in the frequency of clinical asthma exacerbations compared to placebo.
But the National Institute for Health and Care Excellence is asking for further clarification and an updated cost-effectiveness model for its appraisal of the therapy, a humanised interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology.
The Institute is seeking more information on the effect of Cinqaero on exacerbations for subgroups of asthma patients with three or more or with four or more exacerbations in the previous year, and stressed that adjustment for a placebo effect should not be included.
Also, the cost-effectiveness model should incorporate appropriate administration costs, including the need to go to hospital for cannula insertion and supervised infusion, and drug wastage using only the licensed 100-mg vial.
The committee has also recommended that Teva consider how its therapy may affect oral corticosteroid usage and its consequent adverse effects and their costs.
Uncontrolled asthma impacts a large number of patients, presenting a major challenge for clinicians and a significant burden on healthcare systems. According to Teva, it is estimated that the market for severe asthma biotech drugs could exceed $7.5 billion a year in the US and Europe alone.