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Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled
David J T Campbell1,2,3,4, Chad Mitchell5, Brenda R Hemmelgarn6
1Department of Community Health Sciences (D.J.T.C., M.T., P.F., J.Z., J.F., D.V.E., B.J.M.), Cumming School of Medicine, University of Calgary, Canada.
Insights
Eliminating medication copayments for low-income older adults with heart disease did not improve clinical outcomes or reduce healthcare costs. Modest improvements in medication adherence were observed, but did not translate to better health results.
Area of Science:
- Cardiovascular Medicine
- Health Economics
- Public Health Policy
Background:
- Poor medication adherence affects 1 in 8 individuals with heart disease, partly due to copayment costs.
- Low-income older adults with high cardiovascular risk are particularly vulnerable to medication non-adherence.
- Copayment costs represent a significant barrier to accessing necessary high-value medications for cardiovascular disease prevention.
Purpose of the Study:
- To investigate if eliminating copayments for high-value medications improves clinical outcomes in low-income older adults at high cardiovascular risk.
- To assess the impact of copayment elimination on cardiovascular events, mortality, quality of life, and healthcare costs.
- To determine the effect of reduced financial barriers on medication adherence in a vulnerable patient population.
Main Methods:
- A randomized 2x2 factorial trial involving 4761 participants in Alberta, Canada.
- Intervention group: copayments waived for 15 classes of high-value preventive medications (usual copayment: 30%).
- Primary outcome: composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular hospitalizations over 3 years; analyzed using negative binomial regression.
Main Results:
- Copayment elimination did not significantly reduce the primary composite outcome (Incidence Rate Ratio: 0.84; P=0.162).
- No significant differences were observed in rates of myocardial infarction, stroke, cardiovascular death, or hospitalizations.
- A modest but statistically significant increase in adherence to statins was observed in the copayment elimination group (P=0.016); however, quality of life and overall healthcare costs did not differ significantly between groups.
Conclusions:
- Eliminating medication copayments for low-income, high-cardiovascular-risk older adults did not improve clinical outcomes or reduce overall healthcare costs.
- While copayment elimination led to a modest increase in medication adherence, this did not translate into improved major clinical endpoints.
- Financial assistance strategies beyond copayment elimination may be necessary to improve cardiovascular health outcomes in this population.
Background:
One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes.
Methods:
This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs.
Results:
A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P=0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P=0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P=0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P=0.098).
Conclusions:
In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT02579655.
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