- Cost related medication non-adherence is a common problem among patients with cardiovascular disease and is associated with poor clinical outcomes. Whether eliminating co-payments for a large number of medications meant to treat a broad set of chronic diseases would translate into improved clinical outcomes is unknown.
- ACCESS was a randomized controlled trial in Canada in which the copayment of 15 medication classes commonly used to reduce cardiovascular events was waived in the intervention group and the cost was unchanged in the control group.
- Copayment elimination did not reduced the primary composite outcome of death, myocardial infarction, stroke, coronary revascularization, or cardiovascular-related hospitalization over 3 years of follow up. Adherence to statins was significantly higher in the intervention group.
Poor medication adherence is common among patients with or at risk for heart disease. While this problem is multifactorial, one of the recognized potentially modifiable barriers to medication adherence is cost. Whether elimination of copayment for a broad set of medications for primary and secondary cardiovascular prevention would improve cardiovascular outcomes is not known.
On March 5, 2023, Dr. Branden Maans of the University of Calgary presented the results of ACCESS: A Randomized Trial Assessing the Impact of Eliminating Copayment for High Value Preventive Medications For Low-income Seniors With Cardiovascular-related Chronic Diseases during the Late Breaking Clinical Trial session of ACC.23/WCC, with simultaneous publication of the manuscript in Circulation.1
This was a randomized 2×2 factorial trial which studied 2 different interventions in Alberta, Canada: one was the elimination of copayment for a group of preventative medications for cardiovascular disease, and the other was a self-management education and support program. The study authors determined no evidence of interaction or synergy between the interventions; hence they are being reported separately. This session was focused on the first intervention, comparing the effect of waiving the 30% co-payment versus paying the usual cost (which is capped at maximum of $25 CAD per medication dispense) for 15 classes of medications used to improve cardiovascular outcomes (including cholesterol lowering drugs, beta blockers, ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, diuretics, antihypertensives, antiarrhythmics, nitrates, anticoagulants, anti-platelet, and anti-hyperglycemic medications). The study population was community based adults aged >=65, had prescription coverage via the Canadian province-sponsored insurance, at high cardiovascular risk, and with a household income <50,000 CAD/year. Participants were not blinded; to reduce bias the administrative data codes used to measure the outcomes were defined in advance. The primary outcome was a composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalization over 3 year follow up. The rates of the primary outcome and its individual component were compared between the intervention and control arms with negative binomial regression. The secondary outcomes included quality of life, medication adherence (defined as “number of days dispensed” / “number of days between prescription renewals”), and overall healthcare costs.
Overall, 4761 patients were randomized and followed for a median of 3 years. The number of primary outcome events in the intervention arm was not significantly different than the control arm (521 vs 533 respectively, IRR 0.84 CU 0.66-1.07, p=0.162). There was also no difference in each of the individual components of the primary outcome, in quality of life over time, or overall healthcare costs. However, the proportion of patients adherent to statin was statistically higher in the intervention arm (0.72 vs 0.69, mean difference 0.03, CI 0.006-0.06, p=0.016). The intervention patients on average saved $35 CAD per month.
In conclusion, elimination of copayment for a broad set of cardiovascular medications among low income adults Alberta, Canada on government-sponsored insurance did not result in improved clinical cardiovascular outcomes over a median 3 years of follow up, but did slightly improve medication adherence. “Overall, in my interpretation, this is a negative trial,” said Dr. Maans. The study authors should be commended for testing hard clinical outcomes as the endpoint for a trial evaluating a policy intervention.
- Campbell DJT, Mitchell C, Hemmelgarn B, et al. Eliminating Medication Copayments for Low-income Older Adults at High Cardiovascular Risk: a Randomized Controlled Trial. Circ [Published Ahead Print] 2023;