Monograph

The Ministry of Health’s Drug Advisory Committee has recommended:

• Omalizumab 150 mg powder and solvent for solution for injection as an add-on therapy to H₁-antihistamines for treating severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older, with a mean weekly Urticaria Activity Score (UAS7) of 28 and above, despite the use of, or who are intolerant to, four-times registered dose of second-generation non-sedating H₁-antihistamines.

A maximum of six 300 mg doses of omalizumab should be administered for each treatment course. Re-treatment with omalizumab can be considered upon relapse for patients who achieve an adequate response during the previous treatment course.

Adequate response to omalizumab is defined as a UAS7 score of six or below while on treatment.

Omalizumab should be prescribed by a specialist physician (immunologist, allergist, or dermatologist) with experience in managing CSU.

Subsidy status