Abstract
Background: Utilization trends of omalizumab, a first-in-its-class asthma biologic approved in 2003 for individuals not controlled by inhaled corticosteroids (ICSs), may reveal lessons in patient selection. Objective: To describe utilization patterns for omalizumab since its introduction in 2003, with a focus on patient-level characteristics of patients for whom omalizumab was initiated. Methods: Using a large US database of administrative claims, we identified privately insured and Medicare Advantage beneficiaries with asthma between 2003 and 2015. Characteristics of incident (no omalizumab use in the previous 12 months) and prevalent users of omalizumab for asthma were described and omalizumab use trends graphed. A comparison cohort (1:5 matching proportion) of nonomalizumab users was compared with incident omalizumab users on demographic characteristics, medication adherence (medication possession ratio [MPR]) for ICSs and/or ICS/long-acting β-agonist (ICS-LABA), exacerbation frequency, and asthma control in the 6 months before omalizumab initiation. Results: We identified 7,658 prevalent and 3,399 incident omalizumab users. Omalizumab incidence peaked in the second quarter of 2004 at 0.65 per 1,000 individuals with asthma, whereas prevalence peaked in the fourth quarter of 2006 at 3.22; as of fourth quarter 2015, rates were 0.14 and 1.96, respectively. In the 12 months before omalizumab initiation, 72.5% had low adherence (MPR ≤ 0.75) and 48.6% had very low adherence (MPR ≤ 0.5) to ICSs and/or ICS-LABA. In the period 2003 to 2015, the mean number of exacerbations in the 12 months before incident use ranged from 1.50 to 2.11 and the proportion that had poor asthma control (≥3 rescue inhalers dispensed) ranged from 54% to 67%. Incident omalizumab users were less likely to have good asthma control than the matched cohort of nonusers (adjusted odds ratio, 0.53 [0.48-0.59]). Conclusions: Omalizumab use for asthma has been gradually decreasing following a peak shortly after its market availability. Many omalizumab users have low or very low adherence rates for ICSs and/or ICS-LABA in the 12 months before omalizumab initiation.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1568-1577.e4 |
| Journal | Journal of Allergy and Clinical Immunology: In Practice |
| Volume | 6 |
| Issue number | 5 |
| DOIs | |
| State | Published - Sep 1 2018 |
Bibliographical note
Funding Information:Conflicts of interest: N. D. Shah has received research support from the Centers for Medicare & Medicaid Services, Patient-centered Outcomes Research Institute, Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute, Agency for Healthcare Research and Quality (AHRQ), National Science Foundation, and National Center for Advancing Translational Sciences. P. Karaca-Mandic has received consultancy fees from Tactile Medical and Precision Health Economics and has received research support from Merck. J. S. Ross has received research support from FDA, Medtronic, Inc, Johnson & Johnson, CMS, Blue Cross-Blue Shield Association, The Laura and John Arnold Foundation, FDA, and AHRQ. M. A. Rank is employed by Mayo Clinic. M. M. Jeffery declares no relevant conflicts of interest.
Publisher Copyright:
© 2017 American Academy of Allergy, Asthma & Immunology
Keywords
- Asthma
- Asthma control
- Asthma exacerbation
- Medication adherence
- Omalizumab
