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Waiving Co-Pays for CV Meds Doesn’t Cut Clinical Risk: ACCESS

A simple strategy for making important prescription meds more accessible to low-income, high-cardiovascular-risk older adults — waiving prescription insurance co-payments — won’t improve their clinical risk or even cut their overall healthcare costs, suggests a randomized trial conducted in Alberta, Canada.

Patients in the ACCESS trial who paid nothing to fill prescriptions for statins or medications for hypertension, diabetes, or other chronic diseases, for a modest monthly savings, were only slightly more adherent to their meds than a control group. The latter patients paid their usual copayments per Canada’s universal public pharmaceutical insurance plan for people 65 or older, set at 30% of the prescription’s cost to a maximum of $25 (currently $18 US).

The two groups did not differ significantly on the trial’s primary endpoint of death or cardiovascular (CV) events, nor were there differences in quality-of-life measures.

It’s possible that the modest savings from the intervention wasn’t incentive enough to boost their medication use in a way that made a clinical difference, proposed Braden Manns, MD, University of Calgary, Alberta, during his presentation of the trial March 5 at the American College of Cardiology (ACC) Scientific Session/World Congress of Cardiology (WCC) 2023, held live and virtually from New Orleans.

Manns is also senior author on the paper published online the same day in Circulation, which cautions against generalizing the results beyond Canada to other countries.

“Given the modest copayments associated with government medication insurance in Alberta, Canada,” the report states, “the findings may not be generalizable to countries like the United States where copayments and other forms of cost-sharing can be significantly higher.”

The study entered seniors with an annual household income less than $50,000 Canadian ($36,300 US) who had coronary artery disease, heart failure, or chronic kidney disease or at least two major risk factors among current smoking, diabetes, hypertension, and dyslipidemia.

For those assigned to the intervention, copayments were waived for a slate of high-impact medications known to improve CV risk. As a result, they saved an average of $35 Canadian per month (about $25 US) compared with out-of-pocket costs in the control group.

But clinical outcomes were similar in the intervention and control groups and there was no difference in overall healthcare costs, which included costs for medications, hospitalizations, clinic or emergency-department visits, outpatient care, imaging, and laboratory testing.

Although the findings may seem counterintuitive, “I think that what we’re seeing here is that medication adherence is actually very complex,” Lee R. Goldberg, MD, MPH, not part of the trial, said at a media presentation of ACCESS held during the sessions.

Medication adherence can be influenced by many things besides out-of-pocket costs, said Goldberg, Hospital of the University of Pennsylvania, Philadelphia. “Things like side effects, trust for the clinician, cultural belief systems, perceived benefit by our patients, burden of dosing, even cognitive challenges in our patients are all things that impact adherence.”

He noted also that “patients with limited incomes may have many things competing for their time in addition to medication adherence — housing insecurity, food insecurity, caregiver burden. If they’re caring for a loved one, they may not be caring for themselves.”

With that in mind, Goldberg said, “maybe an intervention that looked more globally around addressing some of the challenges of our low-income patients may actually be the intervention that will make the difference.”

In ACCESS, researchers assigned 4761 persons in Alberta age 65 or older with the chronic high-CV-risk conditions or risk factors and in low-income households (47% were women) to have prescription copayments eliminated for the course of the study or to continue with their usual copayments. The primary outcome of death, myocardial infarction, stroke, coronary revascularization, and CV hospitalization could be evaluated in 2373 and 2372 patients, respectively.

Copayment waivers were arranged with the provincial government on prescriptions in 15 drug categories known to improve clinical outcomes in such patients, including statins and other lipid-modifying meds, beta-blockers, renin-angiotensin-system inhibitors, antianginals, diuretics, other antihypertensives, antiarrhythmic agents, antiplatelets, oral anticoagulants, and antiglycemic medications.

The incidence rate ratio (IRR) for the composite primary endpoint for the copayment-elimination group compared with the control group was 0.84 (95% CI, 0.66 – 1.07, P = .16). Nor were IRRs for the primary-endpoint components significantly reduced or elevated.

The intervention and control groups showed no differences in overall health-related quality of life according to EQ5D-5L index scores at baseline and after 3 years.

That copayment elimination failed to influence clinical outcomes is “concerning and counterintuitive” but consistent with other studies that have explored incentives for medication adherence, observed Karol E. Watson, MD, PhD, in the panel discussion following the trial presentation.

It’s noteworthy, however, and maybe a limitation of ACCESS, that adherence rates for at least for some types of drugs were not high in either the copayment-elimination group or the control group, and that may have influenced the results, said Watson, who directs the Women’s Cardiovascular Health Center, University of California Los Angeles.

For example, she noted, adherence rates for statins were 72% in the copayment elimination group and 69% for the control group, and for ACE inhibitors or angiotensin receptor blockers they were only 66% and 63%, respectively.

Indeed, she said, “adherence rates were so dismal overall that maybe it was hard to see a difference.”

The study was funded by Canadian Institutes of Health Research, Alberta Innovates, and the University of Calgary. Manns reported no relevant financial relationships. Goldberg discloses receiving consulting fees or honoraria from Abbott Laboratories, Respircardia/Zoll, and VisCardia; and research grants from Respircardia/Zoll. Watson discloses receiving consulting fees or honoraria from Novartis, Amgen, Boehringer Ingelheim, and Esperion.

American College of Cardiology Scientific Session/World Congress of Cardiology 2023. Session 406 – Late-Breaking Clinical Trials III: 406-16 – A Randomized Trial Assessing the Impact Of Eliminating Copayment For High Value Preventive Medications For Low-income Seniors With Cardiovascular-related Chronic Diseases. Presented March 5, 2023.

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