OBJECTIVES: To systematically review published cost-effectiveness analyses of omalizumab in asthma and to identify drivers of cost-effectiveness.

METHODS: We performed a systematic literature review by searching key biomedical databases (from inception until Jan 2018) by combining asthma, omalizumab and economic key words (limited to English language studies). Two reviewers independently screened the identified studies and extracted data; a third independent reviewer resolved any discrepancies. Drummond checklist was used to assess the quality of studies.

RESULTS: A total of 31 studies were included. The studies evaluated add-on omalizumab in patients with severe (87%) or moderate-to-severe (13%) uncontrolled allergic asthma vs standard therapy alone (mostly inhaled corticosteroids [ICS] ± long-acting beta-agonists [LABA]). The included studies covered different geographies: US (5 studies), LaCan (7), EU (14), Asia (5); 35% evaluated cost effectiveness from health-care perspective, 19% each from payer and societal perspective, 25% did not report perspective; 74% of studies used decision-analytic models (time horizon: lifelong/range: 2–30 years). Efficacy data from clinical studies (58%), observational studies (55%; national database, real-world data and patient data from single institution) and literature (19%) were used. In majority of the studies (n=23; 74%), omalizumab was found to be cost-effective vs standard therapy. Of these, 74% (17 of 23) studies reported quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) for omalizumab ranged from US$13,841/QALY to US$67,907/QALY. Overall, 29% (9 of 31) studies reported cost-effectiveness acceptability curves; the probability of omalizumab being cost effective according to local willingness-to-pay thresholds ranged from 50% to 95%. The ICER was most sensitive to cost and duration of omalizumab therapy, discount rate, exacerbations, time horizon, and utility gain. CONCLUSIONS: The majority of peer-reviewed cost-effectiveness analysis inferred omalizumab to be a cost effective add-on therapy for patients with severe allergic asthma who are symptomatic despite standard therapy (ICS/LABA).