A 4-Year Retrospective Claims Analysis of Oral Corticosteroid Use and Health Conditions in Newly Diagnosed Medicare FFS Patients with COPD

Abstract

Purpose

We analyzed population-level administrative claims data for Medicare fee-for-service (FFS) beneficiaries to provide insights on systemic oral corticosteroid (OCS) use patterns and associated health conditions and acute events among patients newly diagnosed with chronic obstructive pulmonary disease (COPD).

Background

COPD is a progressive inflammatory disease of the lungs, characterized by acute exacerbations that may lead to increased mortality. Short courses of systemic corticosteroids (SCS) are recommended to reduce recovery time from exacerbations, although SCS use has been associated with increased risk of adverse events.

Methods

This study used 2013–2019 Medicare 100% FFS research identifiable files, which contain all Medicare Parts A, B, and D paid claims incurred by 100% of Medicare FFS beneficiaries. Descriptive statistics for patients newly diagnosed with COPD were analyzed, including OCS use, select health conditions and acute events, and COPD exacerbations. Statistical models were used to analyze the relationship between the incidence of select health conditions and events and cumulative OCS dosage.

Results

Of Medicare FFS patients newly diagnosed with COPD, 36% received OCS in the 48 months following diagnosis, and 38% of OCS episodes lasted longer than the recommended 5–7 days. Patients had a variety of health conditions or acute events in the 24-month period prior to new COPD diagnosis, such as hypertension, depression/anxiety, type 2 diabetes, or osteoporosis, that could heighten the risks of OCS use. Patients treated with >1000 mg of prednisolone equivalent OCS in the 48 months following COPD diagnosis had a higher incidence of new conditions or events, including cardiovascular disease, heart failure, hypertension, obesity, dyspepsia, infections, and depression/anxiety, than patients with no OCS use.

Conclusion

These results highlight the potential risks of OCS in COPD treatment, including prolonged use among complex Medicare patients, and reinforce the importance of preventive treatment strategies and therapy optimization early in the disease course.

Keywords:

• chronic obstructive pulmonary disease
• systemic corticosteroids
• SCS
• OCS
• COPD exacerbations
• claims analysis

Ethics Considerations

Use of the data for this study was obtained through an application approved by the Western Institutional Review Board (IRB Report ID 1887351), which is an independent review board. The patient data accessed from the Medicare 100% Research Identifiable Files complied with a Data Use Agreement (DUA) with CMS and the DUA was reviewed by CMS’s Privacy Board to ensure that the beneficiary’s privacy was protected and only the minimum data necessary was requested and justified. All data and summaries used for this report were reviewed by the CMS Chronic Condition Warehouse Analytical Review Team for compliance with CMS requirements to protect the privacy of Medicare beneficiaries’ data.

Disclosure

Michael Pollack, Anthony Staresinic, John Styczynski, and Norbert Feigler are employed by AstraZeneca. Carol Bazell, Alejandro P Comellas, Sanjay Sethi, Maggie Alston, Bruce Pyenson, Dane Hansen, and Melissa Caplen received consulting fees from AstraZeneca. Alejandro P Comellas also reports grants from NIH, personal fees from GSK, Eli Lilly, and non-financial support from VIDA, outside the submitted work. Dr Sanjay Sethi reports grants and/or personal fees from Regeneron (to institution), Sanofi (to institution), Theravance (to institution), Astra Zeneca, Boehringer Ingelheim, Chiesi, Glaxo Smith Kline, Nuvaira, Pulmotect, and Aerogen, outside the submitted work. Bruce Pyenson is on the organizing committee of Prevent Cancer Foundation’s Quantitative Imaging Workshop, which is focused on thoracic imaging and lung cancer screening. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by AstraZeneca.