ACCESS Tests Effect of Eliminating Co-pay on CV Outcomes

Over the past decade, cardiovascular outcomes trials have become a mainstay of the American College of Cardiology Scientific Sessions. But this year will offer a twist—a trial where the intervention is not a therapy, but the elimination of the co-payment for well-known high-value therapies, such as statins, for low-income senior citizens. On March 5, Braden Manns, MD, MSc, a nephrologist and health economics researcher at the University of Calgary, will present the late-breaking study, “A Randomized Trial Assessing The Impact of Eliminating Copayment For High Value Preventive Medications for Low-income Seniors With Cardiovascular-related Chronic Diseases,” or ACCESS. Manns explained that the randomized trial grew out a previous government project that showed copayments were a barrier to adherence for many low-income seniors in Canada. ACCESS randomized more than 4700 patients over 65 years of age, with the government waiving co-payments for one arm to receive 15 standard classes of therapy to treat coronary disease, stroke, heart failure, chronic kidney disease, diabetes, hypertension, and hypercholesterolemia. The primary outcome is a composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary vascularization,and hospitalization for chronic condition. Secondary outcomes include hospital costs, quality of life, and adherence to statins. Manns previewed the trial with The American Journal of Managed Care® (AJMC®).

Transcript

Your trial design is somewhat similar to other outcomes trials, except the intervention is not a drug—it’s the elimination of a co-payment. Can you tell us how you developed the trial design?

The interesting thing about this study was it was a pragmatic trial of a health policy, and there's not many of them out there. It's very rare that a health policy gets subjected to a randomized trial. But there were some other unique things to this study. We advertised in local pharmacies and patients called the toll-free number, and they got enrolled actually through the phone. They provided consent to the through the phone with a survey group with Alberta Health Services that we worked with, and then people were mailed out a package to enroll into the study. We collected all outcomes using administrative data—health administrative data. So, we measured adherence to their medications, we measured health care costs, and we measured all of those clinical outcomes….And we collected those with routine, health administrative data, including all the outcomes…whether they lived or died, whether they had a heart attack or a stroke, whether they ended up in hospital for bypass surgery, for instance, or whether they ended up in a hospital for their heart failure.

The only thing that we collected from them is annually we sent them quality of life questionnaires. We also sent them a few questionnaires about their perceptions about medications. And so I hope what other what people take out of this study as well, is that this it's possible to do studies of randomized trials of the highest quality—trials of health policies—and do them without spending thousands of dollars per participant, which should be the usual mantra in a medication study or a study by new intervention. We did this study for much less than that.

Although this study was done in Canada, do your results have applicability to payers in the United States?

There's a perception out there that in Canada, we have Medicare, and that's very different than then what you have in the United States. I would say that for people who are over the age of 65, actually, health care coverage is not that dissimilar in Canada and United States. Once you turn 65, of course in the United States, you you've got coverage for medications, you've got coverage for medications subject to cost sharing, you've got coverage for doctor visits, and you know in the hospital. [At] less than age 65, coverage can look a little bit different in Canada in the United States. But actually, again, if we look at drug coverage, drugs are not automatically for provided for; Canadians don't automatically have drug insurance. Typically, they do if they're unemployed, or they have challenges with their health abilities; they're provided for people over the age of 65. And so actually then people can apply for private drug insurance, just like in the United States. So, the things that would be different in the United States and what insurers will want to look at is, what would be the cost that their clients, people who are insured by that company, what would be the typical costs that a person would bear? And if the typical costs that a person would bear are similar to what seniors would be bearing through the health insurance plan, that we have medication insurance plan, and I think our results would be relatively applicable.