dupilumab (Dupixent)

following a full submission:

dupilumab (Dupixent®) is accepted for restricted use within NHSScotland.

Indication under review: in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

SMC restriction: for the treatment of patients with blood eosinophils ≥150 cells/microlitre and FeNO ≥25 parts per billion, and ≥4 exacerbations in the preceding year, who have previously received biologic treatment with anti-IgE or anti-IL-5 therapies.

In a phase III study dupilumab, compared with placebo, reduced asthma exacerbation rates and was associated with greater improvements in lung function, in patients with asthma uncontrolled with medium to high dose ICS plus one or two controller medicines.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.