Patients who receive the Global Initiative for Asthma Step 4/5 therapy (GINA 4/5) incur significantly greater direct and indirect healthcare and productivity costs than patients who do not receive GINA 4/5 asthma therapy, according to study results published in the Annals of Allergy, Asthma and Immunology.

Despite making up only 5% to 10% of the total asthma patient population, patients with severe asthma account for up to 50% of total asthma healthcare costs and 20 million lost working days. This administrative, claims-based, retrospective study analyzed 12 months of direct costs, healthcare utilization, and associated loss of productivity for adults and adolescents with asthma (N=605,614) in the United States between January 2013 and December 2014. Data were divided into 12-month baseline and 12-month postindex periods. Commercial and governmental databases were used to extract longitudinal patient, clinical, prescription, health, and productivity data.

To classify as GINA 4/5, individuals were required to have ≥1 of the following: a claim for use of medium- to high-dose inhaled corticosteroids/long-acting beta-agonists (LABA) during the baseline period, ≥1 claim for omalizumab during the baseline period, or a prescription for systemic or corticosteroids for ≥6 months of the baseline period. European Respiratory Society/American Thoracic Society criteria for severe uncontrolled asthma were used to identify patients with exacerbations and/or high use of rescue inhalers to further stratify patients within the GINA 4/5 cohort. Direct and indirect costs and loss of productivity were measured during the postindex period.

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Of a total 605,614 eligible patients, absence data were available for 10,078 patients, short-term disability data were available for 71,526 patients, and long-term disability data were available for 53,668 patients. Among the eligible patients, 15.2% (n=92,027) were identified as GINA 4/5 patients and 84.8% (n=513,587) were classified as non-GINA 4/5 patients. In the GINA 4/5 cohort, 40.4% (n=37,220) were classified as having frequent or serious exacerbations and/or high use of rescue medications, and 59.6% (n=54,807) were classified as non-high use of rescue medications.

Total healthcare costs during the course of 1 year were approximately 1.5 times greater for GINA 4/5 asthma patients than non-GINA 4/5 patients ($15,244 vs $10,860; P <.001), with roughly 50% of the overall difference stemming from asthma-related costs ($3883 vs $1670; P <.001). Furthermore, GINA 4/5 patients had greater costs for inpatient and outpatient services, office visits, and other outpatient services than non-GINA 4/5 patients, with costs for all-cause outpatient pharmacy being $2807 higher for GINA 4/5 patients and costs for asthma-related outpatient pharmacy being $1833 higher (P <.001 for both). For GINA 4/5 patients with high use of rescue medications compared with GINA 4/5 patients without high use of rescue medications, healthcare costs were higher overall ($18,233 vs $13,215; P <.001) and significantly greater across all categories (P <.001 for all).

Among patients with >1 absence, GINA 4/5 patients lost more time than non-GINA 4/5 patients (270.5 hours vs 263.3 hours; P =.045), which resulted in more work loss costs due to absence ($7227 vs $6956; P =.007). GINA 4/5 patients also lost more days of work for short-term disability compared with non-GINA 4/5 patients (44.7 vs 40.8 days; P =.014), but no between-group difference was found in productivity losses due to long-term disability. Although absence and long-term disability claims were similar between GINA 4/5 patients with and without a high use of rescue medications, those with a high use of rescue medications were more likely to have ≥1period of short-term disability and had $284 greater productivity loss per patient (P <.001).

Study limitations included the retrospective database analysis design, a lack of data on medications taken, the use of a single biologic, and the lack of including costs associated with productivity loss due to presenteeism.

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Nonetheless, study investigators concluded, “The results of this study demonstrate that having more severe asthma increases both direct costs and productivity losses. Moreover, severe patients with [high use of rescue medications] incurred the greatest overall health care costs of all groups examined, further underlining the likely link between asthma severity and costs. Future research is warranted to explore approaches to minimize and better control exacerbations, which may reduce the economic burden of asthma.”

Disclosure: This clinical trial was supported by AstraZeneca and several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. 


Settipane RA, Kreindler JL, Chung Y, Tkacz J. Evaluating direct costs and productivity losses of asthma patients receiving GINA 4/5 therapy in the US [published online September 5, 2019]. Ann Allergy Asthma Immunol. doi:10.1016/j.anai.2019.08.462