Dupilumab for treating severe asthma with type 2 inflammation

Marketing authorisation indication

2.1 Dupilumab (Dupixent, Sanofi) has a marketing authorisation 'in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised FeNO [fractional exhaled nitric oxide]…who are inadequately controlled with high dose ICS [inhaled corticosteroid] plus another medicinal product for maintenance treatment'. The definition of type 2 inflammation is as in the Global Initiative for Asthma guideline.

Dosage in the marketing authorisation

2.2 The recommended starting dose of dupilumab is 400 mg, followed by 200 mg every other week, administered subcutaneously. For people with severe asthma on oral corticosteroids, or for people with severe asthma and co-morbid moderate-to-severe atopic dermatitis, a starting dose of 600 mg followed by 300 mg every other week can be administered. Dupilumab is intended for long-term treatment. Treatment should be reviewed by the specialist at least annually.

2.3 For full details of dosage schedules, see the summary of product characteristics.

Price

2.4 The list price of dupilumab is £1,264.89 for 2 prefilled syringes of either the 200 mg per 1.44 ml or 300 mg per 2 ml dose (excluding VAT; British National Formulary online accessed January 2020).

2.5 The company has a commercial arrangement. This makes dupilumab available to the NHS for all indications with a discount and it would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.