1 Guidance

1.1 Omalizumab is recommended as an option for treating severe persistent confirmed allergic IgE‑mediated asthma as an add‑on to optimised standard therapy in people aged 6 years and older:

  • who need continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year), and

  • only if the manufacturer makes omalizumab available with the discount agreed in the patient access scheme.

1.2 Optimised standard therapy is defined as a full trial of and, if tolerated, documented compliance with inhaled high‑dose corticosteroids, long‑acting beta2 agonists, leukotriene receptor antagonists, theophyllines, oral corticosteroids, and smoking cessation if clinically appropriate.

1.3 People currently receiving omalizumab whose disease does not meet the criteria in 1.1 should be able to continue treatment until they and their clinician consider it appropriate to stop.

  • National Institute for Health and Care Excellence (NICE)