G-BA confirms Teva's Cinqaero gives minor additional benefit in severe asthma
The German Federal Joint Committee (G-BA) has determined that Teva Pharmaceuticals Europe's Cinqaero (reslizumab) provides minor additional benefit in certain asthma cases.
The decision means that the European subsidiary of Israeli-based Teva Pharmaceutical Industries will enter reimbursement discussions with the National Association of Statutory Health Insurance Physicians in Germany.
According to the company, the decision is based on data from two phase III pivotal studies (study 3082 and study 3083) evaluating the effect of the drug on patients with severe eosinophilic asthma who were treated regularly with corticosteroids in addition to the treatment for acute exacerbations.
The G-BA judged the studies to be appropriate in order to derive evidence for a minor additional benefit that is valid for the next three years.
In August last year, Cinqaero was approved by the European Commission as an add-on therapy in adult patients with severe eosinophilic asthma, which is inadequately controlled despite high-dose inhaled corticosteroids along with another medicinal product for maintenance treatment.
Teva Pharmaceuticals Europe Respiratory head Luca Frangoni said: "We welcome the positive assessment by the G-BA in Germany, which recognises the value that Cinqaero brings to people living with severe eosinophilic asthma.
"We are excited that, following this favourable G-BA decision, patients will be able to continue to access Cinqaero and we look forward to further positive decision across Europe."
There are currently only limited treatment options available for patients with severe eosinophilic asthma, and the condition can be difficult to control, leading to life-threatening asthma attacks, impaired lung function and quality of life, and possible hospitalisations.
New targeted treatments such as Cinqaero works by targeting interleukin-5 (IL-5), a molecule shown to play a key role in the symptoms of this type of severe asthma.
It is reported that in adults with severe eosinophilic asthma who had already received high-dose therapy with corticosteroids and further medicinal products, the use of Cinqaero led to a decrease in asthma exacerbations.