Mepolizumab (Nucala) is licensed as an add-on treatment for severe refractory eosinophilic asthma in adults.
The NICE guidance states that 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 in the previous 12 months; and the person has agreed to and followed the optimised standard treatment plan.
The guidance also specifies that to be eligible for treatment with mepolizumab patients should have had four or more asthma exacerbations requiring systemic corticosteroids in the previous 12 months; or have had continuous oral corticosteroids of at least the equivalent of prednisolone 5mg per day over the previous six months.
Review after 12 months
NICE recommends that treatment with mepolizumab is stopped after 12 months if there has been an inadequate response.
If the asthma has responded adequately at 12 months treatment may be continued with an annual assessment of response thereafter. An adequate response is defined as: ≥50% fewer asthma exacerbations requiring systemic corticosteroids in patients with four or more exacerbations in the previous 12 months; or a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.
Mepolizumab must be provided by the company with the discount agreed in the patient access scheme. Patients whose treatment with mepolizumab had started before the guidance was issued may continue without change according to whatever funding arrangements were already in place.