Eliminating copays for common heart, diabetes drugs does not improve CV outcomes
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NEW ORLEANS — Eliminating monthly copays for 15 classes of common heart and diabetes medications did not improve clinical outcomes or reduce health care costs, despite a modest improvement in medication adherence, researchers reported.
Approximately one in eight people with CVD does not take their medications as prescribed, in part due to copay costs, Braden Manns, MD, MSC, FRCPC, the Svare Chair of Health Economics at the University of Calgary, Canada, said during a late-breaking clinical trials presentation at the American College of Cardiology Scientific Session. Most people with health insurance are subject to some form of cost sharing for medications, typically between 20% and 30%, Manns said.
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“One in six people have cost-related nonadherence,” Manns said. “They stop their medications; they change the way they take them because of the cost. In this study, we waived copayments for all CV medications and the hypothesis was that by waiving those, you could see small improvements in adherence that might lower BP, improve glycemic control and lower CV risk in those at highest risk, to prevent the most expensive complications and lower overall health care costs.”
Study design
Manns and colleagues sought to determine the impact of two interventions among low-income, older adults at high CV risk: A value-based formulary that eliminated a 35 Canadian dollar ($26) monthly copay for 15 classes of medications commonly used to lower CV risk, compared with a usual copay, and a comprehensive, novel brand engagement and self-management support program aimed at promoting health behavior changes, which was assessed separately.
The cohort included 4,761 participants aged 65 years or older covered by a provincially sponsored medication insurance in Canada, who also had high CV risk, defined as having CAD, stroke, HF or chronic kidney disease, or having two or more of current smoking, diabetes, hypertension or high cholesterol, along with a household income of less than CA$50,000 ($37,400) per year. Medications covered under the intervention included antiarrhythmics, anticoagulants, statins, non-statin cholesterol-lowering drugs, beta-blockers, ACE inhibitors and angiotensin receptor blockers, calcium channel blockers, diuretics, diabetes medications, including SGLT2 inhibitors, insulin and smoking cessation aids. Researchers assigned participants to the intervention arm (n = 2,382) or a control arm with the usual copayment (n = 2,379).
Primary outcome was a composite rate of all-cause mortality, MI, stroke, coronary revascularization and CV-related hospitalizations. Secondary outcomes included individual components of the primary endpoint as well as medication adherence (assessed with proportion of days covered, or PDC80), overall quality of life and overall health care costs. Median follow-up was 3 years.
The findings were simultaneously published in Circulation.
Clinical outcomes unchanged
The incidence rate ratio was 0.84 for the primary composite outcome (95% CI, 0.66-1.07; P = .16), 0.97 for major adverse CV events (95% CI, 0.67-1.39; P = .85), 0.94 for all-cause death (95% CI, 0.8-1.11; P = .5) and 0.78 for CV-related hospitalizations (95% CI, 0.57-1.06; P = .12).
Adherence scores for statin medications and ACE inhibitor or angiotensin receptor blocker therapy showed a modest 3% to 3.5% improvement in the copay elimination group (P = .02 and .01, respectively). There were no differences in quality of life measures between groups or any differences in overall costs; however, there was a CA$1,155 ($850) difference in copays between groups (95% CI, 964-1,345).
“This was a negative study, but interestingly, recent studies looking at financial interventions in people with food insecurity and diabetes suggest the same thing, and that is that people with the greatest financial barriers do not benefit,” Manns said. “Maybe that offers some insight into why this didn’t work. People experiencing the greatest financial barriers have a lot of other barriers. Simply overcoming some of the financial barriers is not enough to improve their clinical outcomes.”
Modest improvement in adherence
Manns highlighted several issues that may have affected the outcome. The study was powered to detect a minimally important RR reduction of 12% and assumed an annual composite primary outcome event rate of 14 per 100 participant-years; however, the observed rate was 8.4 per 100 participant-years. Adherence to medications at baseline was already relatively high, he said, and noted that the monthly copay avoided may not have been high enough to affect patient behavior or impact CV complications.
“Policymakers will need to compare the magnitude of out-of-pocket payments in our setting compared to those associated with their own insurance plans,” Manns said.
Reference:
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Manns B, et al. Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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