IMPACT OF CHANGES IN THE 2019 GINA TREATMENT CLASSIFICATION: ASSESSMENT IN A REAL-WORLD SETTING

Abstract

SESSION TITLE: Allergy and Airway Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: The 2019 Global Initiative for Asthma (GINA) recommendations included major changes. For example, patients requiring high-dose inhaled corticosteroids (ICS) combined with a long-acting beta agonist (LABA) are now uniquely assigned to Step 5, whereas in previous recommendations this category included patients requiring medium- and high-dose ICS combination treatments. There are limited data available describing how these changes affect classification of patients across GINA Steps. Our objective was to characterize the impact of these 2019 changes in a real-world setting. METHODS: This retrospective analysis was based on open source patient claims data acquired from Symphony Health for the period of 10/2013-10/2018. Patients ≥18 years of age who had ≥ 2 claims indicating asthma on separate dates, 2 years of active enrollment prior to the index date, and who could be classified according to GINA 2018 and GINA 2019 criteria were included in the analysis. RESULTS: From a total sample of ∼4.2 million patients, ∼2 million met the criteria for this analysis. Five percent of the total sample did not meet predefined inclusion criteria. When patients were classified according to GINA 2018 criteria, 28%, 13%, 12%, 31%, and 5% were assigned to GINA Steps 1, 2, 3, 4, and 5, respectively. When GINA 2019 criteria were applied (still classifying patients on short-acting beta agonist only as GINA 1), 28%, 13%, 12%, 17%, and 19% were classified as GINA Steps 1, 2, 3, 4, and 5, respectively. Data were also evaluated by healthcare provider specialty; GINA Step 5 patients accounted for 6% and 23% of primary care providers’ asthma patient populations in 2018 and 2019, respectively. This change was consistent with the shift in the overall population, irrespective of provider. Similarly, among allergists and pulmonologists, the proportion of GINA Step 5 patients increased from 10% to 29%, and 14% to 33%, respectively. CONCLUSIONS: Overall, two-thirds of patients retained the same GINA Step classification across the 2018 and 2019 classifications, while one-third moved to a different step when applying GINA 2019. Most of the change occurred in GINA Steps 4 and 5; nearly half of patients classified as Step 4 according to 2018 criteria (high-dose ICS/LABA) moved to Step 5 when 2019 criteria were applied. CLINICAL IMPLICATIONS: The 2019 changes in the GINA recommendations allocated a higher proportion of patients to GINA Step 5. Early adoption of these revised recommendations may provide better understanding of the impact of ICS treatment allocation to the level of disease severity and related management across health care providers. Sponsored by GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. DISCLOSURES: Consultant relationship with Novartis Please note: $5001 - $20000 Added 05/29/2020 by William Busse, source=Web Response, value=Consulting fee Consultant relationship with Sanofi Please note: $20001 - $100000 Added 05/29/2020 by William Busse, source=Web Response, value=Consulting fee Consultant relationship with GlaxoSmithKline Please note: $5001 - $20000 Added 05/29/2020 by William Busse, source=Web Response, value=Consulting fee Consultant relationship with Regeneron Please note: $1001 - $5000 Added 05/29/2020 by William Busse, source=Web Response, value=Consulting fee Consultant relationship with AstraZeneca Please note: $1-$1000 Added 05/29/2020 by William Busse, source=Web Response, value=Consulting fee No relevant relationships by Carlos Camargo, source=Web Response No relevant relationships by Harshad Chiddarwar, source=Web Response No relevant relationships by Nicola Hanania, source=Web Response No relevant relationships by Fernando Holguin, source=Web Response Employee relationship with Gossamer Bio Please note: >$100000 Added 05/29/2020 by Gina Nelson, source=Web Response, value=Salary Employee relationship with Gossamer Bio Inc. Please note: >$100000 Added 05/29/2020 by Hector Ortega, source=Web Response, value=Salary No relevant relationships by Emily Pennington, source=Web Response