1 Recommendations

1.1 Mepolizumab, as an add-on therapy, is recommended as an option for treating severe refractory eosinophilic asthma, only if:

  • it is used for adults who have agreed to and followed the optimised standard treatment plan and

  • the blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had at least 4 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 or

  • the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had at least 3 exacerbations needing systemic corticosteroids in the previous 12 months (so they are also eligible for either benralizumab or reslizumab).

    Mepolizumab is recommended only if the company provides it according to the commercial arrangement.

1.2 If mepolizumab, benralizumab or reslizumab are equally suitable, start treatment with the least expensive option (taking into account drug and administration costs).

1.3 At 12 months:

  • stop mepolizumab if the asthma has not responded adequately or

  • continue mepolizumab if the asthma has responded adequately and assess response each year.

    An adequate response is defined as:

  • a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or

  • a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.

1.4 These recommendations are not intended to affect treatment with mepolizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

For severe refractory eosinophilic asthma, standard therapy alone does not work well enough. So people usually also have benralizumab or mepolizumab if:

  • their blood eosinophil count is 300 cells per microlitre or more and

  • they have had at least 4 severe exacerbations needing systemic corticosteroids in the previous 12 months or continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months.

People can have benralizumab or reslizumab if their blood eosinophil count is 400 cells per microlitre or more and they have had at least 3 severe exacerbations in the previous 12 months.

There is no evidence directly comparing mepolizumab with benralizumab and reslizumab. But an indirect comparison suggests that it works as well as benralizumab and reslizumab for people with a blood eosinophil count of 400 cells per microlitre or more.

Mepolizumab is cost saving compared with benralizumab and reslizumab. So it is now also recommended for people with a blood eosinophil count of 400 cells per microlitre or more and at least 3 severe exacerbations in the previous 12 months.

  • National Institute for Health and Care Excellence (NICE)