AstraZeneca comment on NICE appraisal for asthma drug Fasenra

The National Institute of Health and Care Excellence (NICE) issued an appraisal consultation document (ACD) for Fasenra (benralizumab) for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists.

The preliminary decision is to recommend Fasenra in England, Wales and Northern Ireland as an option for treating severe eosinophilc asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta agonists only if the patient meets certain criteria.

People with severe eosinophilic asthma have elevated levels of eosinophils (a type of white blood cell) which can decrease lung function and increase the risk of asthma attacks. Benralizumab is a monoclonal antibody (biologic) that binds to the interleukin-5 receptor alpha subunit and works by inducing direct, rapid and near-complete depletion of eosinophils.

NICE propose to recommend benralizumab only if:
– The patient’s blood eosinophil count has been recorded as 400 cells per microlitre or more in the past 12 months and
– The patient has agreed to and followed the optimised standard treatment plan and has had at least 3 asthma exacerbations in the last 12 months and
– Mepolizumab is not a treatment option and
– The company provides benralizumab according to the commercial arrangement.

AstraZeneca is disappointed by this decision for a limited patient population and will continue to engage with NICE to enable access to benralizumab for a wider group of patients in England, Wales and Northern Ireland.

AstraZeneca believes that benralizumab is a valid treatment option for patients with a blood eosinophil count of 300 cells per microlitre or more and who have had 3 or more exacerbations in the last year or are taking maintenance oral corticosteroids. The NICE appraisal committee recognised that benralizumab is clinically effective as an addition to standard care in this patient population.

The committee also recognised that severe eosinophilic asthma is a debilitating condition with many distressing symptoms and acknowledged that patients would welcome a new treatment option that reduces or avoids the use of oral corticosteroids.

The committee also acknowledged that Fasenra is the only biologic available as a pre-filled syringe and offers more convenient dosing compared with existing biological treatments.

Asthma affects 5.4 million individuals in the UK, and an estimated 5% of these patients have severe asthma, with approximately half of all severe asthma patients estimated to have eosinophilic asthma.