Omalizumab for asthma
- failed to achieve adequate control despite optimised asthma therapy
- had a total serum IgE concentration ≥ 76 IU/mL
- fulfilled certain other criteria.b
b. The clinical criteria for the use of omalizumab are extensive. The full list is available on the
PBAC summary of findings
- The PBAC was satisfied that omalizumab provides, for some children and adults, a significant improvement in efficacy over placebo plus optimised asthma therapy. The recommendation for extension to children was made because clinical trial evidence demonstrated similar outcomes in children compared with those in adults.
- Limited options are currently available to treat this childhood age group, and long-term oral steroid use is unfavourable.
- The PBAC noted the clinically significant exacerbation rate was significantly lower in omalizumab plus optimised asthma therapy compared with placebo plus optimised asthma therapy in each of the analysis groups (moderate to severe, and severe paediatric allergic asthma).
- Limited paediatric safety data were considered in combination with additional data from the US and Canada.
- The PBAC considered the economic model to be reasonable (a cost-effectiveness analysis presented in the form of cost per clinically significant exacerbation avoided, and supported by accepted evidence for cost-effectiveness in adolescent and adult populations).
Changes to PBS listing
Evidence for changes to PBS listing
- a consistent reduction in asthma exacerbation rate irrespective of baseline lung function in the omalizumab-treated group
- omalizumab-treated patients required fewer days of asthma rescue medication
- omalizumab use decreased ICS in users
- fewer hospitalisations in those treated with omalizumab.
Restrictions for prescribing
Place in therapy
Omalizumab is an add-on treatment (last line therapy) for managing severe allergic asthma in patients who are treated with maximal recommended asthma maintenance medication yet remain symptomatic.
Omalizumab is effective and well tolerated in children aged 6 and over with moderate to severe allergic asthma,6,7 but safety data are currently insufficient to support the use of omalizumab in children under this age.8
The prescribing of omalizumab in children with asthma should be done in conjunction with a paediatrician, respiratory physician or immunologist.8
Dosage for allergic asthma
Treatment duration, monitoring and dose adjustments9
- Doses do not need to be adjusted for variations in serum IgE over time.
- Dose assignment after treatment interruptions or discontinuations should be based on serum IgE concentrations obtained at initial dose assignment. Serum IgE should only be redetermined for dose assignment if treatment has been discontinued for 1 year or more.
- Doses will need to be increased for bodyweight gains.
- Patients need to be assessed for treatment effectiveness (marked improvement in overall asthma control) 16 weeks after starting Xolair therapy.
- Gradual reduction of inhaled corticosteroids (under supervision) may be attempted after 16 weeks of treatment with Xolair in patients with stable well-controlled asthma. In some patients, inhaled corticosteroids can be tapered off completely.
- Pharmaceutical Benefits Scheme. Omalizumab, pre-filled syringe for subcutaneous injection, 75 mg/0.5 mL, 150 mg/mL, Xolair. Canberra: Novartis. (Accessed 4 November 2016.)
- European Medicines Agency. Xolair, INN – omalizumab. Annex 1: summary of product characteristics. London: European Medicines Agency, 2015. (Accessed 31 October 2016.)
- Normansell R, Walker S, Milan SJ, et al. Omalizumab for asthma in adults and children. The Cochrane Library 2014.
- Pharmaceutical Benefits Scheme. Omalizumab. 75 mg/0.5 mL injection, 1 × 0.5 mL syringe, 150 mg/mL injection, 1 × 1 mL syringe; 150 mg injection [1 × 150 mg vial] (&) inert substance diluent [1 × 1.2 mL ampoule], 1 pack; Xolair. Canberra: Novartis Pharmaceuticals Australia Pty Ltd, November 2014. (Accessed 4 November 2014).aceutical Benefits Scheme. Omalizumab. 75 mg/0.5 mL injection, 1 × 0.5 mL syringe, 150 mg/mL injection, 1 × 1 mL syringe; 150 mg injection [1 × 150 mg vial] (&) inert substance diluent [1 × 1.2 mL ampoule], 1 pack; Xolair. Canberra: Novartis Pharmaceuticals Australia Pty Ltd, November 2014. (Accessed 4 November 2014).
- Pharmaceutical Benefits Scheme. Omalizumab. Canberra: Australian Government Department of Health. (Accessed 14 November 2016).
- Odajima H, Ebisawa M, Nagakura T, et al. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int 2016.
- Teach SJ, Gill MA, Togias A, et al. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol 2015;136:1476-85.
- eMIMS. Omalizumab. 2016. (Accessed 4 November 2016).
- Therapeutic Goods Administration. AusPAR Omalizumab (rch). Canberra: TGA, 2015. (Accessed 7 November 2016).