1 Recommendations

1.1 Benralizumab, as an add-on therapy, is recommended as an option for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists, only if:

  • the person has 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 4 or more 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 (that is, the person is eligible for mepolizumab) or

  • the blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more exacerbations needing systemic corticosteroids in the past 12 months (that is, the person is eligible for reslizumab).

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

1.2 If benralizumab, mepolizumab 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 benralizumab if the asthma has not responded adequately or

  • continue benralizumab 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 benralizumab 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

Severe asthma is usually treated with inhaled corticosteroids plus another drug, such as a long-acting beta-agonist. These may not work well enough for eosinophilic asthma, which is a type of severe asthma that can be difficult to control. Continuous oral corticosteroids may be needed to prevent exacerbations (asthma attacks) but they can cause long-term side effects. Some people are able to have mepolizumab or reslizumab, which are recommended for slightly different populations. They are biological treatments, as is benralizumab. Biological treatments help to control the asthma, and may allow the oral corticosteroids to be reduced.

Clinical trial results show that taking benralizumab plus standard treatment reduces exacerbations and the use of oral corticosteroids, compared with placebo. There are no trials directly comparing benralizumab, mepolizumab and reslizumab, and the relative clinical effectiveness of these treatments is not known. In an indirect comparison of benralizumab with mepolizumab, there is no significant difference in asthma exacerbations.

The company's mixed population is not suitable for considering the cost effectiveness of benralizumab compared with standard care. This is because it is a population of people with a blood eosinophil count of 300 cells per microlitre or more, who have had 3 or more exacerbations in the previous year, and includes some people who are taking maintenance oral corticosteroids. This combines people who are eligible for mepolizumab or reslizumab with other people with less severe disease who are not eligible for biological treatments and can only be offered standard care. The absolute treatment benefit and cost effectiveness of benralizumab varies depending on whether patients are eligible for mepolizumab and reslizumab and what their individual treatment options are.

For people who cannot have mepolizumab or reslizumab and standard care is the only option (that is, with an eosinophil count of less than 400 cells per microlitre, who have had 3 or fewer exacerbations in the last 12 months and are not taking oral corticosteroids), the clinical effectiveness of benralizumab is uncertain. This is because these people comprised a small percentage of the trial population and the cost-effectiveness estimates are higher than can be considered cost effective.

Benralizumab is clinically and cost effective compared with mepolizumab for people with an eosinophil count of 300 cells per microlitre, who have had 4 or more exacerbations or are taking maintenance oral corticosteroids, or both. It is also cost effective compared with reslizumab for people with a blood eosinophil count of 400 cells per microlitre or more, who have had 3 or more exacerbations in the past 12 months. Therefore, it can be recommended for people who could have mepolizumab or reslizumab.

  • National Institute for Health and Care Excellence (NICE)