following a full submission assessed under the orphan medicine process:
dupilumab (Dupixent®) is accepted for restricted use within NHSScotland.
Indication under review: the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
SMC restriction: patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable.
Four phase III studies demonstrated superiority of dupilumab in improving signs and symptoms of atopic dermatitis when compared with placebo, as monotherapy or in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dupilumab. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
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