Listen to Health Affairs Ryann Tanap and Vabren Watts in the first of many "Health Equity Corner" episodes on This Week discuss the latest from the health equity department and unpack what Leqembi, the newly approved Alzheimer's disease drug, could mean in the health equity space.
Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join editors from Health Affairs, the leading journal of health policy research, and special guests as they discuss this week’s most pressing health policy news. All in 15 minutes or less.
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Vabren Watts
Thanks for joining “Health Affairs This Week”. I’m Vabren Watts.
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Ryann Tanap
And I'm Ryann Tanap.
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Vabren Watts
So you'll be hearing from the health equity team more this year. We will try our best to give you stories that really have a health equity spin onto it. And I would just like to say happy New Year. This is the first time that you have heard my voice this New Year. And Ryan, I will say over the past month, even though last month it was another year, it all seems like the same because we've been really busy within the health equity department here at Health Affairs.
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Ryann Tanap
Yes we have. I don't think there was a down season for us.
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Vabren Watts
No, no, no. It was not. Like I would definitely say it seems like November, December was like when some of the busiest months I know, like Ryan, you were getting ready, you know, to plan out everything for the 2023 year and what we're going to do. And then we really just closed out the year with our Health Equity Fellowship for Trainees.
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Vabren Watts
We did have a session which included attorney Daniel Dawes, who really spoke to our Fellows about, you know, being a health equity researcher and then just the history of structural racism within the U.S.
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Ryann Tanap
Right, and we also had a session with Courtney McCluney who talked to us about rest as a means for resistance and in our work and in diversity, equity and inclusion and health equity in particular.
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Vabren Watts
Yes. And you know, that is needed, like, that whole rest and recovery and like you said, rest as a means of resistance. So make sure for 2023, if you have not made out your New Year's resolution, really incorporate taking time to rest in there, it would definitely benefit you. So, you know, Ryan, so you know, this week we have to talk about something that happened this week.
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Ryann Tanap
Yeah. So Friday, last Friday, the FDA approved a new drug, new Alzheimer's drug called lecanemab, which will be sold as Leqembi, is actually approved through an accelerated approval process. And according to the trials conducted by the developers, the drug actually slows cognitive decline in patients in the early stages of Alzheimer's and I mean, you and I have noticed this treatment has been getting a lot of news
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Ryann Tanap
buzz. Why is that?
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Vabren Watts
So you know, interestingly, so when I first heard this, I was actually on the treadmill at the gym Monday morning. That's when it actually came out. But it was actually, you know, accelerated on Friday, as you said. So in a previous life, when I was a science journalist full time, I used to report on a lot of clinical trials for Alzheimer's drugs.
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Vabren Watts
Let's just say that over the past few decades, research and development for Alzheimer's drugs have had a 99.6% failure rate. I mean, some organizations and some news media outlets just really just round that up to 100. So so, you know, I remember, you know, when I used to, you know, start, you know, tracking these drugs in their development, it would take like a few months to a year.
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Vabren Watts
And then all of a sudden the trials were halted. The outcomes were not there, you know, as it relates to these drugs over that was probably over the past eight years, those outcomes did not really advance the field of Alzheimer's treatment.
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Ryann Tanap
So now that this new drug has made it through an accelerated approval process, it's really, would you say, encouraging?
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Vabren Watts
Yes and no? I mean, I mean, it made it through the accelerated approval process, but yet it's still not fully approved by the FDA. And so, you know, some people, you know, may not know what the accelerated approval process is.
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Ryann Tanap
So the accelerated approval pathway, it actually allows for drugs that address serious conditions that also fill an unmet medical need to be approved based on a surrogate endpoint. And in this case, the surrogate endpoint is the, I believe it's called a beta-amyloid plaque.
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Vabren Watts
You know what? That is correct. Yeah. They really been looking at how beta-amyloid plaques really impact Alzheimer's. It is a hallmark to Alzheimer's disease. And like, they have been creating drug after drugs, really looking at beta-amyloid plaques and a few other hallmark biomarkers for Alzheimer's disease. But this is one that has really been in the forefront.
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Vabren Watts
So with a new drug, lecanemab, the drug is given as a monoclonal antibody infusion every two weeks. And just so everyone knows that the new drug, lecanemab, is not a cure.
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Ryann Tanap
Right. It's not a cure, but it may give those with Alzheimer's more time with loved ones. I also read that the drug won't be widely available anytime soon.
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Vabren Watts
Yes. So the drug actually comes out in like two weeks. It's supposed to come out the week of the 23rd. But however, Ivan Cheung, who is the U.S. Chairman and CEO of Eisai, said that the expected cost for the drug is 25,000 a year per patient. That is quite pricey. And then to add to that, as of April 2022, the Centers for Medicare/Medicaid Services or CMS as we know it, they do not allow coverage of FDA approved treatments for target amyloid in the brain.
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Vabren Watts
The only exception is if an individual is enrolled in an approved clinical trial.
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Ryann Tanap
Isn’t Alzheimer's one of the leading causes of death for older adults?
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Vabren Watts
Exactly. You know, you know, the CDC says that Alzheimer's is the fifth leading cause of death for adults, 65 and older in the U.S. And it is the seventh leading cause of death for all adults. An estimated 6.5 million Americans over 65 live with Alzheimer's disease. In other words, one in 9 million Americans over 65 has the disease in the U.S. And of those 6.5 million, around 1 million have early stage Alzheimer's.
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Ryann Tanap
So what about historically marginalized populations? How does this impact them?
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Vabren Watts
So Black Americans and those who are part of the Hispanic Latino community have the highest rates of Alzheimer's disease and other dementias and when, or if, individuals from these populations get diagnosed, it's usually at the later stages of the disease. So when it comes to this new drug that is coming out, that is really looking at early onset and does not reverse brain damage or memory loss, it sort of makes you wonder if inequities will arise as it relates to which populations will receive it or who will be more, you know, prominent to, you know, to receive this drug treatment.
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Vabren Watts
This is on top of a recent Alzheimer's Association report stating one third of Black Americans and one fifth of Hispanics as well as Asian Americans, perceived discrimination as a potential barrier for assessing Alzheimer's care.
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Ryann Tanap
So I want to emphasize that point. This is the case for health care across the board. There really is a cultural lack of trust in the health care system, especially among historically marginalized populations like you just listed. That distrust stems from structural racism, which is rooted in many of the systems throughout our country. Really.
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Vabren Watts
Right. You know, this was outlined in February 22 issue “Racism and Health”. You know that was one of Health Affairs’ like popular issues. And, you know, whether if the racism stems from experience with discrimination while navigating complex health settings, low personal health literacy rate, transportation barriers or socioeconomic status, there are many factors that may prevent access to care, particularly among marginalized populations.
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Vabren Watts
You know, one of the things that, you know, Ryan, that you're working on is really, as I sort of mentioned, like, the low health literacy rates. And I know that you're, you know, providing programs in, like, education to really try to increase health literacy. And I know you also talked about what personal health literacy plans and organizational health literacy plans.
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Ryann Tanap
Right. There's a lot to dig in there, but there's definitely a lot of factors I think we need to keep in mind when we're advancing health equity and particularly as it relates to this new drug. I wanted to emphasize that concern you have, like who is going to have access to it?
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Vabren Watts
Exactly.
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Ryann Tanap
So before we wrap up this episode, we hope that you all have a restful Martin Luther King Jr. Day, which is next Monday the 16th. And we're also honoring National Day of Racial Healing on the 17th. It happens every year on the Tuesday following MLK Day. And it's a time to come together and inspire reflective action and create a more just and equitable world, which I think really speaks to the work that we do, Vabe.
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Vabren Watts
Oh, yes, exactly. So, you know, we would just like to say thanks for listening to another episode of “Health Affairs This Week”. If you like the podcast, tell a friend, leave a review or subscribe wherever you listen to your podcasts. I'm Vabren Watts.
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Ryann Tanap
And I'm Ryann Tanap.
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Vabren Watts
Goodbye.
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Ryann Tanap
Bye.