No Copay Is No Help for CVD Outcomes

NEW ORLEANS -- Dropping copays modestly increased heart medicine adherence among low-income patients, but didn't improve cardiovascular outcomes or cut healthcare costs, the randomized ACCESS trial showed.

People who didn't have to pay the average $35 per month toward their medication had a 16% lower relative incidence of major adverse cardiovascular events than those who continued copayments, reported researchers led by Braden Manns, MD, MSc, of the University of Calgary, Alberta.

But that difference in the primary composite endpoint of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over 3 years didn't reach statistical significance (adjusted 135 vs 161 events per 1,000 person-years, P=0.162).

This was despite significantly better rates of at least 80% adherence to statins, ACE inhibitor or angiotensin receptor blocker medication, and other drug classes by about 3 to 5.5 percentage points, Manns reported at the American College of Cardiology (ACC) meeting and online in Circulation.

Session panelist Karol Watson, MD, of the University of California Los Angeles, called it "concerning and counterintuitive," but consistent with other research showing that cutting copays just doesn't cut it for outcomes.

Financial interventions for people with food insecurity and diabetes have yielded similar neutral results, Mann pointed out. "Maybe that offers some insight into why this didn't work: the people experiencing the greatest financial barriers have a lot of other barriers. Simply overcoming financial barriers isn't enough to improve their outcomes."

Given that a number of other interventions aimed at medication adherence presented at the same ACC session also failed to have more than small impacts, Mann said, "clearly patients with chronic disease face a variety of barriers, and it's probably unrealistic to expect one specific intervention to fix it. Multiple interventions may be required."

However, a second randomized comparison in the trial, using advertising agency messaging to boost self-management of cardiovascular conditions, actually did boost clinical outcomes.

Major adverse cardiovascular events occurred at an incidence rate ratio (IRR) of 0.78 (95% CI 0.61-1.00, P=0.047) compared with usual care. That difference was driven by a relative 34% reduction in cardiovascular-related ambulatory care-sensitive hospitalizations (IRR 0.66, 95% CI 0.48-0.90, P=0.009), largely related to heart failure.

That portion of the trial, reported in a second paper in Circulation but not at the conference, used an intervention with tailored weekly messages mailed to them from a fictional character -- "Moxie" -- with information about health conditions or medications, including suggestions for chronic disease self-management and preventive care with a story to catch the reader's attention.

Medication adherence wasn't improved by the messaging intervention.

"We were not expecting that to be the intervention that was effective -- it sort of was the throw-in," Manns told MedPage Today. "We are now starting to look at whether to use this in the province, because it's really scalable."

The pragmatic trial enrolled 4,761 community-dwelling individuals 65 and older (mean age 74.4, 47% female) who had public health insurance in Alberta. Participants had to have high cardiovascular risk based on coronary artery disease, stroke, chronic kidney disease, or heart failure (or some combination of current smoking, diabetes, hypertension, and high cholesterol) and an annual household income below the equivalent of $36,700 ($50,000 in Canadian dollars).

The copay portion of the two-by-two factorial trial, accomplished administratively through existing government insurance plans, either maintained or waived the usual 30% copayment on 15 medication classes common for cardiovascular primary and secondary prevention, including statins, antiarrhythmics, antiplatelets, and blood pressure medication along with insulin and smoking cessation aids.

Analysis of time to first event (not considering recurrent events as the primary endpoint did), again showed no difference between copay groups.

Interestingly, Manns noted, a subgroup analysis showed "not even a signal of benefit" for people with the lowest incomes -- those who said they had severe financial barriers.

Limitations to the trial included the "relatively low amount" by which eliminating copays affected participants' out-of-pocket expenses, due in part to a provincial policy that capped copay costs at $25 per medication.

Also, adherence was relatively high at baseline, fairly consistent with levels reported previously from the U.S., Mann said.

"You might think, 'Well, this is in a socialized medicine system in Canada, and it may not apply in the United States,'" he added. However, he pointed out that many U.S. insurance plans have much higher patient cost caps and thus out-of-pocket burden.

"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 told attendees at the late-breaking clinical trial session.

Another concern was that the lower than expected event rate might have left the study underpowered, noted ACC press conference panelist Lee Goldberg, MD, MPH, of the University of Pennsylvania in Philadelphia.

"Would this money be better spent doing something else?" he posited.