Free Meds Don’t Reduce CV Events, but Tailored Messaging Does: ACCESS

NEW ORLEANS, LA—Giving low-income older adults free preventive medications for a period of 3 years doesn’t lead to a decrease in cardiovascular events, a new randomized trial out of Canada shows. However, there does seem to be some benefit from personalized education and support.

Participants in the 2x2 factorial trial, known as ACCESS, saved CAD $35 (roughly US $26) each month on average when randomized to no co-pays versus their usual out-of-pocket costs. Those randomized to the education and support program, designed by an advertising firm, regularly received messaging tailored to their characteristics and behavior.

Results for the two interventions were published in separate papers released Sunday in Circulation.

“We know that one in eight people with heart disease [in the US] has poor medication adherence. One of the reasons for that is related to the cost of medications,” said senior author Braden J. Manns, MD (University of Calgary, Canada), who presented the co-pay portion of the trial here at the American College of Cardiology/World Congress of Cardiology (ACC/WCC) 2023 meeting.

“The hypothesis was that by waiving [co-pays for CV medications] we would see small improvements in adherence,” which would reduce risk factors like blood pressure and cholesterol, he explained. The hope was that this “would lead to better clinical outcomes. And the theory states that then you prevent those expensive complications and lower overall healthcare costs.”

Unfortunately, this did not come to pass. But the researchers did see some success with the trial’s self-management education and support (SMES) program. They started out with the simple concept of “take your medicines” in mind, Manns told TCTMD. “And then the advertising company turned it into a message just like you’d see at Super Bowl Sunday, which patients liked and were willing to [engage with], and it seemed to make a difference.”

It came as a surprise, he said, that this was the intervention that had an effect. They’re currently looking at how to roll it out across the province, either through primary care or specialty clinics. “It’s very scalable,” Manns added. “And now we have lots of interest in exploring this.”

ACCESS: Cost and Support

Led by David J.T. Campbell, MD, PhD (University of Calgary), ACCESS researchers enrolled 4,761 people (mean age 74.4 years; 46.8% women). All had an annual household income below CAD $50,000 (US $37,400) and had high cardiovascular risk. Participants were randomized 2x2 to the interventions or controls:

• Usual care (30% co-payment) or no co-pay for 15 common CV medication classes
• Usual care or an SMES program tailored to their baseline characteristics, self-reported behavior, and comorbidities that involved pamphlets sent by mail, access to a personalized health website, emails with health tips and reminders to access the website, and tangible rewards, including a tote bag at 3 months, a health-tracker book at 6 months, and a pedometer at 12 months.

There was no interaction or signs of a synergistic effect between the two interventions, thus allowing researchers to look at their results separately.

By 3-year follow-up, the primary endpoint of death, MI, stroke, coronary revascularization, and hospitalization for CV-related ambulatory care-sensitive conditions did not differ based on whether patients received free medications (incidence rate ratio (IRR) 0.84; 95% CI 0.66-1.07; P = 0.162). Nor were there any individual differences for MACE, all-cause death, or CV-related hospitalizations, or in various subgroup analyses. Overall costs and quality of life were similar, too.

“Interestingly, people with the lowest incomes—people who said they had severe financial barriers—[had] not even a signal of benefit,” said Manns, noting that similar findings have been seen in studies of financial interventions in people with food insecurity and diabetes. “Maybe that offers some insight into why this didn’t work, in that people experiencing the greatest financial barriers have a lot of other barriers and that simply overcoming the financial barriers isn’t enough to improve their clinical outcomes.”

However, patients without co-pays were slightly more likely to take their prescribed statins and ACE inhibitors/ARBs than those who had to pay for their medications.

Manns urged the need for context when interpreting the data. “Policy makers will need to compare the magnitude of out-of-pocket payments in our setting compared to those associated with their insurance plans,” he said, given that their results reflect co-pays of government insurance in Alberta, Canada, where physician and hospital visits are free.

With the SMES program, there was a borderline significant reduction in the primary endpoint (IRR 0.78; 95% CI 0.61-1.00; P = 0.047), which was driven by differences in cardiovascular-related ambulatory care-sensitive conditions (IRR 0.66; 95% CI 0.48-0.90; P = 0.009). Effectiveness appeared to be greater in patients older than 75 (P = 0.02 for interaction).

Medication adherence, quality of life, and overall costs all were equivalent to what was seen with usual care.

There are many ways to get the message out, Manns said to TCTMD. Patients in particular liked getting something tangible in the mail, as compared with emails. Another option would be smartphone alerts, where patients could click through links to open up additional educational material.

As to the question of who would pay for this tailored strategy, that’s to be worked out, he said. A selling point is that it doesn’t involve hiring additional staff to provide the intervention. “In a situation where we know we’ve got gaps in our healthcare system and we just don’t have enough healthcare workers, this is actually an inexpensive way to get messages and education across instead of hiring 500 dieticians or 200 social workers,” Manns observed.

The main thing is to target a patient population and determine objectives up front, he suggested. “You get an advertising company to help design those messages that are going to be more likely to impact a patient’s behavior.”

What Keeps Patients From Taking Their Meds?

Lee Goldberg, MD (University of Pennsylvania, Philadelphia), who commented on the ACCESS co-pay presentation at an ACC/WCC 2023 press conference, described the trial as “well executed” when exploring the ramifications of its co-pay analysis.

As a clinician practicing in the US, he often hears from patients that cost is a barrier, said Goldberg. “If you would have asked me about this trial up front, I would’ve said, ‘Oh, the answer is obvious: if we remove the barrier of cost, everything will be fine.’ And, you know, it didn’t lead to the expected outcome. We didn’t see the benefit that we expected to, and explaining that is going to be critically important.”

But this is a good example of why we test potential interventions and understand the “return on investment,” he added. “What we’re seeing here is medication adherence is actually very complex, and there are many factors in addition to out-of-pocket costs—things like side effects, trust [in] the clinician, cultural belief systems, perceived benefit from our patients, burden of dosing, and even cognitive challenges of our patients—[that] impact adherence. . . . Patients with limited income may have many things competing for their time [like] housing insecurity, food insecurity, caregiver burden.”

An intervention that tackles these strains “more globally” for low-income patients might be more impactful, Goldberg suggested.