Drug guidance
Omalizumab for treating antihistamine-resistant chronic spontaneous urticaria
Condition
Skin
2 January 2019
Published on 02 Jan 2019
Last Updated on 02 Jan 2019
Guidance Recommendations
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
Omalizumab 150 mg powder and solvent for solution for injection is recommended for inclusion on the Medication Assistance Fund (MAF) for the abovementioned indication. Omalizumab should be used in line with the clinical criteria in the MAF checklist for initial and continuing prescriptions.