Division of General Internal Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.
JAMA Intern Med. 2024 Oct 1;184(10):1186-1194. doi: 10.1001/jamainternmed.2024.3499.
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.
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.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT05497999.
高自付费用和维护性吸入器使用不当导致慢性阻塞性肺疾病（COPD）患者的预后不佳。对于如何解决这些障碍以提高依从性并影响 COPD 加重、支出或这些结果的种族差异，证据有限。
研究一项降低 COPD 维持性吸入器受益方自付费用并提供药物管理服务的国家计划，其中包括适当吸入器使用技术教育。
设计、设置和参与者：这是一项随机临床试验，纳入了 COPD 患者。所有患者均参加了医疗保险优势计划。数据于 2019 年 1 月至 2021 年 12 月采集，2024 年 1 月至 5 月进行数据分析。
邀请参加一项计划，将维持性吸入器的自付费用降低至 0 美元或 10 美元，并提供药物管理服务。邀请的随机分配用于估计邀请和计划参与的效果，总体效果和按种族效果。
使用比例天数覆盖（PDC）衡量吸入器的依从性、中度至重度加重、短效吸入器填充、总支出，以及作为探索性结果的自付支出。
在纳入的 19113 名患者中，55.2%为女性；9.5%为黑人，81.1%为白人，9.4%为其他或未知种族；中位数（IQR）年龄为 74（69-80）岁。邀请组的计划参与率（29.4%）高于对照组（5.1%）。与对照组相比，邀请组的维持性吸入器 PDC 更高（32.0%比 28.4%；调整后的邀请效果，3.8 个百分点；95%CI，3.1-4.5）；计划的调整效果（局部平均治疗效果）为 15.5 个百分点（95%CI，12.8-18.1），依从性相对增加 55%。邀请组的处方自付支出中位数（SD）较低（619.5 [863.1] 美元），而对照组（675.0 [887.3] 美元）（调整后的邀请效果，-$49.5；95%CI，-68.9 至-30.0；调整后的计划效果，-$203.0；95%CI，-282.8 至-123.2），但在加重、短效吸入器填充或总支出方面无统计学差异。在黑人个体中，维持性吸入器 PDC 的调整后邀请效果为 5.5 个百分点（95%CI，3.3-7.7），调整后的计划效果为 19.5 个百分点（95%CI，12.4-26.7）。在白人个体中，调整后的邀请效果为 3.7 个百分点（95%CI，2.9-4.4），调整后的计划效果为 15.1 个百分点（95%CI，12.1-18.1）。种族间邀请效果的差异无统计学意义（1.8 个百分点；95%CI，-0.5 至 4.1；P = .13）。
医疗保险优势计划中收到参加降低维持性吸入器自付费用并提供药物管理服务计划邀请的个体与对照组相比，吸入器依从性更高。黑人和白人个体之间计划对吸入器依从性影响的差异虽然显著，但无统计学意义。
ClinicalTrials.gov 标识符：NCT05497999。
