Teva Pharmaceutical Industries Ltd has announced that the National Institute for Health and Care Excellence (NICE) in England has recommended Cinqaero® (reslizumab) in its Final Appraisal Determination (FAD).
Cinqaero® is a humanised interleukin-5 (IL-5) antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
“Despite the availability of current treatment options, many patients with severe eosinophilic asthma still experience uncontrolled symptoms and serious asthma attacks,” said Ian Pavord, Professor of Respiratory Medicine at the University of Oxford. “The NICE decision will be welcomed by the clinical community as it provides access to a new treatment option for these patients.”
“Reslizumab has the potential to dramatically improve the quality of life for some people living with severe asthma, and we are delighted that it has been recommended for use on the NHS,” said Kay Boycott, Chief Executive of Asthma UK. “New monoclonal antibody treatments, which have shown success in clinical trials are likely to be effective in treating around 30-40% of those living with severe asthma, so it is imperative that they are made available. While today’s news is an encouraging step forward, it’s important to note that these treatments will only benefit a certain group of people. There remain many thousands more for whom no effective treatments are available. More research is needed so that in the future all people with severe asthma will have an effective treatment option.”
This decision is based on a dossier submitted to NICE for a Single Technology Appraisal (STA). Following issuance of the FAD, NICE will provide its formal guidance to the NHS in England. The full NICE recommendations and conditions can be viewed on their website.
“Teva is very pleased to receive this decision by NICE as we seek to expand the availability of reslizumab (Cinqaero®) globally in an effort to ensure that patients living with severe, uncontrolled asthma have access to this treatment option,” said Sven Dethlefs, SVP and Head of Global Respiratory Medicines at Teva. “The future of respiratory care shows great promise, and we are proud to be at the forefront of providing innovative medications for such a patient population whose quality of life is often severely impacted by asthma.”
The European Commission granted marketing authorisation for Cinqaero® in August 2016 as an add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled, despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. In July 2017 the German Federal Joint Committee (G-BA) confirmed that Cinqaero® provided additional benefit, with price negotiations with the National Association of Statutory Health Insurance Physicians beginning four weeks after the G-BA decision.