1 Recommendations

1.1 Dupilumab as add-on maintenance therapy is not recommended, within its marketing authorisation, for treating severe asthma with type 2 inflammation that is inadequately controlled in people aged 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment.

1.2 This recommendation is not intended to affect treatment with dupilumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation 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. Oral corticosteroids may also be needed to prevent exacerbations (asthma attacks), but they cause long-term side effects. These treatments may not work well enough for severe asthma with type 2 inflammation, which can be difficult to control. Some people who have another type of severe asthma called eosinophilic asthma can have mepolizumab, reslizumab or benralizumab. These drugs, like dupilumab, are biological agents but work in a different way.

Clinical trial results show that having dupilumab plus standard asthma treatment reduces exacerbations and the use of oral corticosteroids more than placebo in people with severe asthma with type 2 inflammation. There are no trials directly comparing dupilumab with mepolizumab, reslizumab or benralizumab. Comparing these drugs indirectly suggests a reduction in asthma exacerbations with dupilumab but no difference in other asthma symptoms.

The company's population of people with type 2 inflammation is not suitable for considering the cost effectiveness of dupilumab compared with standard care. This is because it combines people eligible for biologicals (mepolizumab, reslizumab or benralizumab) with people not eligible for biologicals who can only be offered standard care. The cost-effectiveness estimates for dupilumab vary depending on whether people are eligible for mepolizumab, reslizumab or benralizumab, and what their individual treatment options are. Regardless, the cost-effectiveness estimates for dupilumab are higher than what NICE usually considers a cost-effective use of NHS resources. Dupilumab cannot be recommended for treating inadequately controlled severe asthma with type 2 inflammation.