1.1 Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory eosinophilic asthma in adults, only if:
the blood eosinophil count is 300 cells/microlitre or more in the previous 12 months and
the person has agreed to and followed the optimised standard treatment plan and
has had 4 or more asthma exacerbations needing systemic corticosteroids in the previous 12 months or
has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months and
the company provides the drug with the discount agreed in the patient access scheme.
1.2 At 12 months of treatment:
stop mepolizumab if the asthma has not responded adequately or
continue treatment if the asthma has responded adequately and assess response each year.
An adequate response is defined as:
at least 50% fewer asthma exacerbations needing systemic corticosteroids in those people with 4 or more exacerbations in the previous 12 months or
a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.
1.3 This guidance is not intended to affect the position of patients whose treatment with mepolizumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.