Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Oct 1;184(10):1186-1194.
doi: 10.1001/jamainternmed.2024.3499.

Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial

Sumit D Agarwal  1   2 , Elizabeth Metzler  3 , Michael Chernew  2 , Emily Thomas  3 , Valerie G Press  4 , Emily Boudreau  3 , Brian W Powers  3   5 , J Michael McWilliams  1   2
Affiliations
Randomized Controlled Trial

Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial

Sumit D Agarwal et al. JAMA Intern Med. .

Abstract

Importance: High out-of-pocket costs and improper use of maintenance inhalers contribute to poor outcomes among patients with chronic obstructive pulmonary disease (COPD). There is limited evidence for how addressing these barriers could improve adherence and affect COPD exacerbations, spending, or racial disparities in these outcomes.

Objective: To examine the effect of a national program to reduce beneficiary cost sharing for COPD maintenance inhalers and provide medication management services that included education on proper technique for inhaler use.

Design, setting, and participants: This randomized clinical trial included individuals with COPD. All individuals were enrolled in Medicare Advantage. Data were collected from January 2019 to December 2021, and data were analyzed from January 2023 to May 2024.

Intervention: Invitation to enroll in a program that reduced cost sharing for maintenance inhalers to $0 or $10 and provided medication management services. The random assignment of the invitation was used to estimate the effects of the invitation and program enrollment, overall and by race.

Main outcomes and measures: Inhaler adherence measured as proportion of days covered (PDC), moderate-to-severe exacerbations, short-acting inhaler fills, total spending, and as an exploratory outcome, out-of-pocket spending.

Results: Of 19 113 included patients, 55.2% were female; 9.5% were Black, 81.1% were White, and 9.4% were another or unknown race; and the median (IQR) age was 74 (69-80) years. Program enrollment was higher in the invited group (29.4%) than the control group (5.1%). The PDC for maintenance inhalers was higher in the invited group than the control group (32.0% vs 28.4%; adjusted invitation effect, 3.8 percentage points; 95% CI, 3.1-4.5); the adjusted effect of the program (the local average treatment effect) was 15.5 percentage points (95% CI, 12.8-18.1), a 55% relative increase in adherence. Mean (SD) out-of-pocket spending for prescriptions was lower in the invited group ($619.5 [$863.1]) than the control group ($675.0 [$887.3]; adjusted invitation effect, -$49.5; 95% CI, -68.9 to -30.0; adjusted program effect, -$203.0; 95% CI, -282.8 to -123.2), but there was no statistically significant difference in exacerbations, short-acting inhaler fills, or total spending. Among Black individuals, the adjusted invitation effect on maintenance inhaler PDC was 5.5 percentage points (95% CI, 3.3-7.7), and the adjusted program effect was 19.5 percentage points (95% CI, 12.4-26.7). Among White individuals, the adjusted invitation effect was 3.7 percentage points (95% CI, 2.9-4.4), and the adjusted program effect was 15.1 percentage points (95% CI, 12.1-18.1). The difference between the invitation effects by race was not statistically significant (1.8 percentage points; 95% CI, -0.5 to 4.1; P = .13).

Conclusions and relevance: Individuals in Medicare Advantage who received an invitation to enroll in a program that reduced cost sharing for maintenance inhalers and provided medication management services had higher inhaler adherence compared with the control group. The difference in the program's effect on inhaler adherence between Black and White individuals was substantial but not statistically significant.

Trial registration: ClinicalTrials.gov Identifier: NCT05497999.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Chernew reported grants from Humana during the conduct of the study; personal fees from MedPAC, LRV Health, National Institute for Health Care Management Foundation, MITRE, and Health Care Cost Institute; and owns equity in VBID Health and Waymark outside the submitted work. Dr Press reported personal fees from Humana during the conduct of the study as well as grants from the National Institutes of Health Agency for Healthcare Research and Quality outside the submitted work. Dr Boudreau owns stock in Humana. Dr Powers reported personal fees from Humana and owns equity in Humana during the conduct of the study as well as personal fees from Mass General Brigham outside the submitted work. Dr McWilliams reported research support from Humana during the conduct of the study; grants from Arnold Ventures and National Institute on Aging; and personal fees from Center for Medicare and Medicaid Innovation, RTI Inc, Analysis Group, The MITRE Corporation, America’s Physician Groups, and Blue Cross Blue Shield of North Carolina outside the submitted work; and serves as a member of the Board of Directors for the Institute for Accountable Care. No other disclosures were reported.

Figures

Figure.
Figure.. Assessment of Eligibility and Randomization
COPD indicates chronic obstructive pulmonary disease.
See this image and copyright information in PMC

References

    1. Global Initiative for Chronic Obstructive Lung Disease . Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease: 2023 Report. Accessed July 31, 2023. https://goldcopd.org/wp-content/uploads/2023/03/GOLD-2023-ver-1.3-17Feb2...
    1. Restrepo RD, Alvarez MT, Wittnebel LD, et al. Medication adherence issues in patients treated for COPD. Int J Chron Obstruct Pulmon Dis. 2008;3(3):371-384. doi: 10.2147/COPD.S3036 - DOI - PMC - PubMed
    1. George M. Adherence in asthma and COPD: new strategies for an old problem. Respir Care. 2018;63(6):818-831. doi: 10.4187/respcare.05905 - DOI - PubMed
    1. Castaldi PJ, Rogers WH, Safran DG, Wilson IB. Inhaler costs and medication nonadherence among seniors with chronic pulmonary disease. Chest. 2010;138(3):614-620. doi: 10.1378/chest.09-3031 - DOI - PMC - PubMed
    1. Press VG, Arora VM, Shah LM, et al. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD. J Gen Intern Med. 2011;26(6):635-642. doi: 10.1007/s11606-010-1624-2 - DOI - PMC - PubMed

Publication types

Substances

Associated data