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Dr Orly Vardeny Previews Session on Barriers to Novel Treatment Access at ACC 2022


Orly Vardeny, PharmD, MS, core investigator, Center for Care Delivery and Outcomes Research, and associate professor of Medicine, University of Minnesota Medical School, discusses key barriers to access of novel therapies and what sessions she’s looking forward to during the American College of Cardiology's (ACC) 71st Annual Scientific Session.

There are several barriers limiting access to new therapies for cardiovascular diseases, particularly the lack of awareness of other comorbid conditions that may preclude certain populations, said Orly Vardeny, PharmD, MS, core investigator, Center for Care Delivery and Outcomes Research, and associate professor of Medicine, University of Minnesota Medical School.

Vardeny will participate in 2 sessions at ACC 2022: "Creative Ways to Overcome Pharmacotherapy Disparities" and "Tricks and Tips for Overcoming Barriers to and Access to New Therapies."


What are some of the key barriers to accessing new therapies that you’ll be talking about in your session at ACC 2022?

So, there are several barriers to new therapies, especially novel therapies that are new on the market, where clinicians may not be as comfortable using these new medications. Part of it is that once clinical trials are completed and the medications make it into the guidelines, the next step that clinicians are going to look at is, does the patient in front of me qualify for this medication depending on if they match the patients that were enrolled in clinical trials.

So, real-world data and evidence generation is important to supplement clinical trial data to help inform some of those questions of generalizability of study results to the more general population, including patients that may not have been included.

So, part of it is just hesitation for new medicines. Another is potentially perceived barriers, or perceived safety concerns, and lack of awareness that some of these medications can be used safely, even among patients that have certain comorbidities. An example of that is patients with heart failure who also have chronic kidney disease [CKD].

I think there's often a hesitation for using mineralocorticoid receptor antagonists, for example, in patients with CKD. And we know that although these should not be used in patients with, for example, an eGFR [estimated glomerular filtration rate] less than 30, they can be used in patients with renal dysfunction with an eGFR less than 60.

I think that people tend to be hesitant, because of that reason, for patients with CKD. Another example is patients that have higher than normal potassium levels, or hyperkalemia, where we know that a potassium level of say 5.0 shouldn't preclude the use of these medicines. We may need to adjust the dose, but it's still possible to use some of these novel agents, such as sacubitril/valsartan, for patients even at the higher range of potassium levels.

Are there any sessions at ACC 2022 you are particularly looking forward to?

I always look forward to the late-breaking clinical trials, because it's great to see in real time and really exciting to see in real time those presented and the new data that come out, but also to be there for the discussions that ensue from the studies—how clinicians and other researchers are reacting to these data as they are first presented and the interpretation and the implication for clinical practice. As people start to talk about that, almost immediately it's really exciting to be there in person to share in that conversation.

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