Kick QALY to the Curb with Terry Wilcox

Show Notes

For more than 40 years, the quality-adjusted life year (QALY) has been devaluing the lives of older adults and patients with chronic medical conditions. Yet, thanks to organizations like Patients Rising, we may finally put these discriminatory assessments to rest once and for all. In light of the recent QALY Ban Bill introduced to Congress, we’re joined by returning guest, Co-Founder, and CEO of Patients Rising, Terry Wilcox, to break down the impact of QALYs on patients whose quality of life relies on access to critical treatments.

Episode Transcript

Adina Lasser:

Hello everyone. Welcome to This Is Growing Old, the podcast all about the common human experience of aging. My name is Adina Lasser, and I am a first-time host for the This is Growing Old podcast. I serve as the Alliance for Aging Research’s public policy manager, and I’m so excited to be here.

We’ve spoken a lot on this podcast about the quality-adjusted life year and the many challenges that come along with it. Today, we’re diving in to discuss current legislation surrounding QALY and the potential impact that it will have on patients. It’s my honor today to introduce our guest, Terry Wilcox. Terry is a passionate advocate for patients with cancer and other serious diseases. Terry is the co-founder and executive director of Patients Rising, a nonprofit patient education and advocacy organization that helps patients get access to essential diagnostics and the treatments that they need. Patients Rising is an incredible advocacy partner to the Alliance, and we’re so excited to have Terry for her second This is Growing Old episode. Terry, welcome back to the show.

Terry Wilcox:

Well, thank you very much, Adina. I’m glad to be here for your debut.

Adina Lasser:

Oh, thank you. Yeah. My first one.

Terry Wilcox:

Your first time host debut.

Adina Lasser:

Yes.

Terry Wilcox:

Happy to be here for that.

Adina Lasser:

Let’s see how it goes. All right. Well, just to get us started, can you tell us a little bit more about your background and what Patients Rising is currently focusing on?

Terry Wilcox:

Well, Patients Rising, my background, I’ve been in patient advocacy for now like 15 years. The first part of my advocacy career was all in oncology, which is why I often lead with cancer, even though we focus on all diseases at this point. But I did spend the first part of my advocacy journey with all cancer patients, and I went all over the world in both Europe and the United States, doing all sorts of conferences and things with my mentor. Her name was Selma Schimmell, and she co-founded, or she founded, I’m the one who co-founded, she founded Vital Options, which was the first organization for young adults with cancer in 1983.

Adina Lasser:

Wow.

We’ve actually been fighting QALY since we were founded…

Terry Wilcox:

So it was a very long time. And she passed away in 2014, and Patients Rising came along shortly thereafter that. So that’s my journey into starting in advocacy and then got me in Patients Rising. And currently, we have two organizations, we have Patients Rising, which is our support and education and research arm, and when I say research, I don’t mean clinical research, I mean more along the lines of patient-centered research around unmet medical needs and things like that. We do more surveys, and we work with partner organizations that are disease specific.

And then, on the C4 side, we have Patients Rising Now, which is our policy and advocacy arm, and it’s a 501(c)(4), and that’s where we do all of our lobbying and advocacy work, out of that arm. And our biggest issues for the year this year are this QALYs ban bill, which is really big for us.

Terry Wilcox:

We’ve actually been fighting QALY since we were founded, so it’s a good place to be for us here, we’ll see, knock on wood that it goes somewhere. But we’re very excited about it, about the possibility, and hopes that it will… We’re not so much concerned that… Well, anyway, we’ll get into more of that later. So we’re focused on the QALY, and then we’re focused also on PBMs. PBMs are good for us.

Terry Wilcox:

PBMs, transparency in general for patients. They should have transparency in their health plan, transparency from PBMs, transparency on anything that they’re having to pay for, period. So we’re very into that, and PBMs are one of those things that’s very opaque.

Adina Lasser:

For those that are listening, PBM stands for, “Pharmacy benefit manager.”

Terry Wilcox:

As somebody who hosts a podcast, I should have known to say that. People, they’re always griping at me that I use too many acronyms and too many-

Adina Lasser:

It’s hard not to.

Terry Wilcox:

… names, and I just say stuff, it’s like everybody’s supposed to understand what I’m talking about. But yes, pharmacy benefit managers are the people between… They’re the entity that is between your insurer, sometimes they are your insurer, which we could talk about that for days, and you getting your medicine. So there’s the pharma company, and then there’s this middle person, and then there’s you. Basically, they’re between you and the pharma company and getting your medicine. They determine how much you pay out of pocket and a lot of those scenarios. So we spend a great deal of time talking about them over on our podcast all the time.

So those are our big issues for the year, all kinds of PBM, and what I call, “General benefit design issues,” like copay accumulators and things like that. We’re also very focused on… Excuse me, I thought I was going to sneeze. We’re also very focused on a lot of the work that I know you guys are taking a lot of the lead on in the new innovations in Alzheimer’s space. So we’re involved in that, not as a mainline priority, but what we’re launching a caregiver’s podcast specifically for Alzheimer’s caregivers, a video podcast, in a couple of weeks. So we’re doing some stuff in that space as well, and you guys have been an incredible leadership in that space.

Adina Lasser:

Well, thank you. Yeah, and our listeners will have to check out your podcast as well. I think that’ll be great. Well, let’s dive into the discussion that we’re having today about value assessment and the QALY. That’s a complicated issue. And we’re wondering, as you talk directly about the challenges related to QALYs and similar measures, what resonates most with patient advocates? How do you personally make the connection to their experiences?

Terry Wilcox:

Well, I think patient advocates can make the direct experience when something can be discriminatory towards them. And the entities that use the QALY, and it’s been around for 40 years, or 50 years really, but contrary to popular belief, it’s not the gold standard. It was controversial from the minute it was used. It’s never been a perfect fit for what it’s trying to do, and I think patients understand that. You can look, even if you don’t know anything about health technology assessment, you can see when somebody is value. If a year of perfect health is one, then anything less than one is not, is everybody who has chronic and rare conditions.

Adina Lasser:

Right.

And for patients to be denied and given treatments based on imperfect modeling for a drug that’s not approved, I think we can do better, that’s all.

Terry Wilcox:

They’re all… Even though ICER and others like to say, and ICER, for those of you who don’t know, it’s the Institute for Clinical and Economic Review, they often do… I’m sure you guys have talked about that on this podcast, so this is probably not new to your listeners, but they are one of the leaders in this specific health technology space, and they do use the QALY in their measurements.

And ICER likes to say, “Well, we’re not devaluing the patient, we’re valuing the medication.” But when you look at a lot of these things, you have to look at all the nuances that are involved. ICER is inventing, they are literally inventing research that isn’t there to make their projections.

Adina Lasser:

Yeah.

Terry Wilcox:

Because in many instances, these drugs aren’t even on the market yet. They’re ways away from being FDA approved. There’s all sorts of… They model, they call it modeling, but modeling isn’t perfect.

Adina Lasser:

Right.

Terry Wilcox:

And for patients’ lives, patients to be denied and given treatments based on imperfect modeling for a drug that’s not approved, I think we can do better, that’s all. I just think we can do better.

Adina Lasser:

I agree with you. One thing that we notice is, because ICER is so set on using clinical trial data, that automatically discriminates against anybody who’s older because it’s harder to get older adults in clinical trials. Yeah, it’s a multifaceted issue. So I think we talked about this, is there anything else that you want to say about how QALYs discriminate against the populations that Patients Rising work with, including for conditions like Down Syndrome?

Terry Wilcox:

Oh, absolutely. Well, all of these conditions, as I said, as we talked about at the beginning of that question, anyone who has anything, whether they have Down Syndrome, whether they were born… I had an aunt who was born mentally and physically challenged in both aspects her whole life until she was 65. All sorts of, whether you’re born with it, whether you develop cancer, let’s say. I have another friend who, she got cancer at 28 years old, cervical cancer, and she’s fine now, but even now, she’s not valued at a perfect life because she’s had cancer, and I think each year out from that.

But that specific metric and how that values what it can look at, when you’re looking at the healthcare system as a whole and they’re making these decisions, that’s another thing ICER does. And this may get too complicated, I’m going to try to make it as simple as possible. But when they talk about these things, when they review the drugs, when they put out their reports, they talk about the healthcare system, the impact to the healthcare system. We don’t have one healthcare system in this country.

Adina Lasser:

That’s true.

Terry Wilcox:

We don’t. And so therefore, that in and of itself should be a tell that this is not going to work. This isn’t for us. We have private insurance, we have individual marketplace, we have Medicare, we have Medicaid. So are they just doing these reports? They’re talking about the healthcare system and private insurers in many instances. I don’t know if they use them exclusively to deny drugs, because I can’t say that for sure, but it’s one of the things they look at. And honestly, it’s one of the things you look at, that’s fine, but we need to have more things for them to look at. That’s my point.

You can look at ICER all day long, I’m not here to shut down ICER. ICER’s trying to come out with a more softer, gentler side, which is fine, I see it in all their reports. And maybe they will, maybe they will. ICER is ICER, but I think we need to come up with more ways that we’re looking at it as a whole. We’re looking at more real-world evidence, we’re using AI. There’s all sorts of things that we can use now to determine what’s working and what’s not working.

Adina Lasser:

Yes.

Terry Wilcox:

I always say, one of my favorite, I use it all the time, which is, if somebody can deliver a pizza to my uncle’s house with no driver, we should be able to figure this out. And somebody does deliver a pizza to my uncle’s house with no driver. So we should definitely be able to have multi-types of reports and things that we’re looking at, all of these nuances, to make it fair to all patients. To make sure that the right patients are getting the treatments they need. No, not all treatments are right for all patients. And I don’t know a single patient who would take a medication that isn’t working.

Adina Lasser:

Yeah.

Terry Wilcox:

Especially if it’s costing them a great deal of money, in out of pocket or otherwise, or it doesn’t make them feel quite right. It doesn’t make you feel very good, but you also don’t feel like you’re getting a benefit on the other side of that, why do you want to take it?

Adina Lasser:

Right.

Terry Wilcox:

So I think we should be a little… I think we should honor patients and their doctors a little bit more. I’m not saying insurance shouldn’t have any oversight, and there shouldn’t be reports of some kind to gauge these types of things, but it needs to be a lot more focused on what the patient needs, and not so much on what this healthcare system needs that doesn’t really exist. It exists in the grants and we have a healthcare system, but there’s many, as you and I have talked about, many facets to that.

Adina Lasser:

Yeah, absolutely. And I like to say, it’s called, “Value assessment.” Value to who? Who gets to decide what that value is?

Terry Wilcox:

Exactly. That’s a perfect point. We say that as well. The patient value should be what’s considered first, because like we said, patients aren’t going to just take medications just because they’re the new thing or it’s the new thing that’s out. If it’s not right for them, it’s not right for them, and patients are really savvy about that. They really are.

Adina Lasser:

Yes. I was just at actually, just like 20 minutes ago, I was at a rally by the Alzheimer’s Association where it was 900 advocates trying to get access to newly FDA approved treatment. So I think you’re right that patients are discerning and patients know what they want.

There’s all sorts of ways that we could do this and not make it cumbersome for patients, and really look at real- world evidence outcomes of how it’s affecting patients as they’re taking it.

Terry Wilcox:

Yeah. Patients know what they want, and they know… I would argue, in this particular instance, that those patients would know. I have a stepmom, she has Alzheimer’s, she is not right for any of these new treatments. I wish she was, I wish it was 10 years ago, but it’s not. She’s absolutely not right. I won’t even try because she’s so far advanced. But people know that. So there’s 900 advocates and they’re savvy enough to know, “Hey, this could be right for me. This could help me, or this could help my mom. My mom’s still driving, my mom’s still…” You know what I mean? There’s all sorts of ways to look at that, and we should be wanting patients to try that, and monitoring that through their doctors. There’s all sorts of ways that we could do this and not make it cumbersome for patients, and really look at real- world evidence outcomes of how it’s affecting patients as they’re taking it. And I think we really need to be looking at that and not really obscure modeling of things that don’t exist.

Adina Lasser:

I agree with you. I think real-world evidence is a really exciting upcoming field that I think is going to start to matter a lot in our healthcare system, if all goes well. And let’s get into a little bit, this bill that we mentioned earlier. We’ve seen some promising movement on recognition of the harms of QALYs, most recently in the House of Representatives. So this is the Energy and Commerce Committee in the house, and they’re considering H.R.485, the Protecting Health Care for All Patients Act. And that Act would ban the use of QALYs, not only in Medicare, but in Medicaid, TRICARE, the VA, and all federally supported healthcare programs. Can you tell us more about the state of play for this bill?

Terry Wilcox:

Absolutely. I think right now, I know that it’s soon to be marked up by the full committee, it passed out of obviously the health committee on the ENC recently. It’s about to be marked up by the full committee, we expect it to pass out of the full committee. When we sent our letter, that we had signed by more than 70 advocates, in support of this ban, it was sent to the full committee, and we anticipate it’ll pass out of the full committee and then it’ll go to the floor. And when it does, we’ll do something else, we have another plan. So we’ll be determining how we’re going to make the next presentation of that before it gets a vote on the forum.

We’re also talking to the Senate side. We’re talking to some folks over there who we think are going to introduce a Senate companion in a bipartisan way. And I’m not going to say anything yet because I don’t know for sure, so I don’t want to put anything out there that ends up not being true, but we are talking about those things now. So it looks good. I feel like this bill is a softball for bipartisanship. I think they should try to pass as much of this as possible, not just to give patients faith in the body of Congress, but Americans.

I think that if they tried to pass more smaller focused bills that do have a lot of bipartisan support, and not these giant bills where people have to pick and choose what side they’re going to be on, they would get a lot more done for the American people. Now, I know why they do it that other way, but I think that these bills are fantastic and there is a lot of bipartisan support. I think there’s some concerns in various

caucuses or parts of each side, actually, that maybe have some concerns, and there may need to be some things hashed out. But I think it looks good.

Adina Lasser:

Yeah. Well, and I got to listen to that markup hearing where, and the Energy and Commerce Health subcommittee, and it did seem like that people that weren’t on board before were coming on board, and we’re getting some new partners in this fight, which is really exciting.

Terry Wilcox:

Yeah. Initially it was very Republican, and I think part of that is has something to do with some wording in the IRA. There’s some issues there that I think are getting ironed out, I do think are getting ironed out, and I hope they can continue to on both sides. Because look, we’re not an organization, and I don’t think any organization would come out and say, “We’re not for you being able to assess the value of a treatment.”

Adina Lasser:

Yeah.

Terry Wilcox:

“Or how much you’re going to pay or when you’re going to start paying.” All of these things have to be considered, and depending on the government program or what it is, there’s various rules for that. And I’m not going to go into all those, but I do think banning the QALY sets a precedent that says, “Okay, we’re done with this 50-year-old metric that was never fit for this purpose anyway.” It shouldn’t have been, it’s not right for this. And it’s certainly not right for the more targeted treatments and cures and things that we have going forward. We need to find a better way.

So my point of the QALY ban isn’t to just like, “Oh, we’re not going to assess anymore and everybody’s going to get treatments.” That’s not what I’m thinking. It’s, “Let’s just be done with this. Let’s bury this metric and find a better one.” If economists want to use it as some sort of obscure mathematical exercise on their own, that doesn’t determine whether or not a patient… How a patient’s valued and whether or not they get a treatment, well, more power to them. But it isn’t the gold standard. It shouldn’t have been used all of these years as, “Oh, there’s nothing else. This is it.” No, there’s such other things. We’re actually going to be talking about some on our podcast next week.

Adina Lasser:

Oh, you are?

Terry Wilcox:

Yeah. Yeah.

Adina Lasser:

Great. Yeah. Well, I completely agree with you. And I’m wondering also, if the bill is passed into law and effectively implemented, which maybe we can get into what that means a little bit, what real-world changes do you anticipate seeing? We’ve talked about ICER, we’ve talked about the Medicare program. How immediate do you think some of those impacts will be for patients?

Terry Wilcox:

I think the most immediate impact you’ll see is how they have to adjust. I already see, I’ll be honest with you, just in the tone of various things that have already come out, ICER’s trying to pivot a little bit. I don’t know that they’re going to get rid of the QALY entirely, but they’re definitely seeing the reality that their methodology may not be the way of the future.

And that’s good to me. I want ICER to figure out other ways to do what they do. They have a lot of funders from industry. They work with pharmaceutical companies and insurance companies. They should be able to figure this out and have a… It doesn’t have to be softer, it just has to be more about patient value, and working more with disease-specific advocacy groups. That’s who they should be working with when they’re doing these treatments really close. And sometimes they do, sometimes they do work closely with disease specific advocacy organizations, and we’ve heard some good reports of that, but then the report doesn’t end up saying all that much. Even some that we’ve heard, they’ll say, “Well, we had a great time with ICER.” And I’m like, “Did you look at your budget impact report? Only like 5% of your people are going to get this medication.” According to their budget impact report, only 5% of the people should be approved.

Adina Lasser:

Wow.

There’s a lot more to fight than the QALY, but the QALY, to me, is a benchmark. It’s a line in the sand that says, “Okay, we’re going to do better now.

Terry Wilcox:

So a lot of times, patient advocates do not read all the way to the budget impact report and what that means, because then that’s where a lot of the things that we fight from a benefit design standpoint, like copay accumulators, [inaudible 00:20:53] therapy, prior authorization, that’s where all that comes in to stop the patient from getting the medication. So they put out this budget impact report, and then they do this other piece.

So there’s a lot more to fight than the QALY in many ways. There’s a lot more to fight than the QALY, but the QALY, to me, is a benchmark. It’s a line in the sand that says, “Okay, we’re going to do better now.

We’re going to do better.”

Adina Lasser:

Yeah.

Terry Wilcox:

So that’s how I see it. That’s really how I see it. The fight’s not over, everybody doesn’t get their treatments approved. What it is, is, “Hey, we can move on from this and we need to find a more patient- centered way.”

Adina Lasser:

Well, and that’s actually a perfect transition for my next question, which is that one of the challenges that we’re seeing is that the QALYs are the most prominent example of value assessment. There are other methods that have the same baked in flaws, and I’m just wondering, as the legislation moves forward, how can Congress ensure that any measures that have this common discriminatory methodological flaw, ensure that they’re not allowed to be used?

Terry Wilcox:

Well, I think there’s… It’s very interesting that you say that, because if you look at the language, and I don’t have it in front of me, from the IRA, I said to somebody when I typed it out and I was like, “Okay, this is the most obscure language that I have ever read.” And it basically just says, “You can do whatever you want. You can discriminate or not. Whatever you want to do, we’re going to figure out how to couch it so that you can do it.” That’s really what it says to me. It doesn’t protect anything, whereas the QALY ban bans the QALY. We may come back in a year from now and ban the WALY, I don’t know. You know what I mean? Or whatever the next thing is.

Adina Lasser:

Right.

Terry Wilcox:

We may have to ban the next thing. I was trying to be funny.

Adina Lasser:

I love that.

Terry Wilcox:

I don’t know, because who knows what they’re going to come up with. As I’ve said, the QALY was created, was invented, 50 years ago under duress, not everybody agreed and people fought against it. And that is not going to change. I think what will ultimately change is the nature of how we’re getting evidence in real-world time from patients, from doctors. I think there’s all sorts of things to be designed in that space that lots of people are working on. There’s lots of people working on that stuff, but it’s not here yet. It’s not all here yet. It’s not all being implemented, it’ll take a while.

But the more that we can move in that direction, we can march towards that direction, where we’re knowing if somebody who’s on a new therapy in the middle of North Dakota after three tries, she was like, “This isn’t doing anything for me.” And we knew that, and we know that she’s… We don’t have to know her name and everything about her, but we know that she’s a white… I’m going to just use myself. She’s a white 53-year-old woman who has a history of diabetes in her family, or whatever the case may be. You know some basic info, you know that didn’t work for her, that can go in a chip for whatever that line item is or column is. I just think that there’s ways to do that, it’s just going to take time. And there may, in some spaces, Bob Goldberg, who I do our show with, tells me that there are places where that is happening, but it’s not happening broadly enough.

Adina Lasser:

Right.

Terry Wilcox:

And ICER’s even talked about real-world evidence. They give it lip service, I don’t know how much they’re really using it or how much they’re doing. But I just think it’s going to be a complete work in progress. But to me, the QALY ban is exactly that. It’s banning the QALY, and that gets rid of that. Okay, we’re done with that. I wish I could say it bans all of it. I think there’s language in there, but that’s one of the language pieces everybody’s fighting. They’re like, “Who’s going to determine it’s discriminatory?” And I’m like, “Well, patient advocates may have to determine discriminatory and come back and tell you to make another bill.” I don’t know.

Adina Lasser:

No, absolutely. Well, yeah, I think that’s something that they were talking lot about in the markup, is it was originally QALY and other discriminatory metrics. And now, I think that language has been changed a little bit too, to some of the language that you were talking about with the IRA. Does-

Terry Wilcox:

I think it also brings more clarity. It does bring more clarity. Look, I don’t like ambiguous language that they can stomp all over and make a mockery of, so if the only thing is in there that we ban the QALY, then I’ll be happy with that. I will. Yeah.

Adina Lasser:

Makes sense to me. All right, and this is my last question. How can advocates get involved and get the message out there that passing H.R.485 should be a top priority for their elected officials?

Terry Wilcox:

On top of our letter, which we’re adding some more patient groups too, we’re going to try to get it to over 100 when we do the next round of the patient group letter, I think we’re over 75 now, because I’ve had some people come in late that I’ve got to add to the letter.

Adina Lasser:

Amazing.

Terry Wilcox:

We’re going to do a patient letter, like a big petition letter. So we’ll send the letter and it’ll have everybody, it’ll be pages long, I hope.

Adina Lasser:

Nice.

Terry Wilcox:

So that it’ll be just people in districts. It’ll list the person’s name, Kentucky, 01, person’s name. And we’re just going to do a patient letter with as many signatures as we can get. And at that point, the 75 or 100 groups that we’ve had go out, we’ll want to send that out and have their individuals sign on, because then that amplifies the voices of all that, right?

Adina Lasser:

Yeah.

Terry Wilcox:

So it amplifies the voice by creating a patient letter, not just a patient group letter, and it shows the magnitude of that. So that’s our next goal. That’s the goal for the floor vote, actually.

Adina Lasser:

Oh, that’s great. Yeah. And so, you can get-

Terry Wilcox:

So we’ve talked about it, we’re probably going to start working on it now, ’cause we want it to be real big.

Adina Lasser:

Yeah. Oh, that’s great.

Terry Wilcox:

But we don’t have a floor vote, so we’ll keep it open, we’ll just keep sending out. Please send it again until we get… We’ll just get as many as we can and then we’ll send them hopefully this giant PDF of all these names at the end.

Adina Lasser:

All right. Well, thank you so much Terry, and thank you to listeners for joining today’s episode of This Is Growing Old. You can learn more about Patients Rising at patientsrising.org, and you can check out the Alliances resources on QALYs on our website, agingresearch.org, and at ICER [inaudible 00:27:28] .org. You can stay up to date on the latest news and events from The Alliance by signing up for our newsletter on The Alliance website, or by following us on Facebook, Twitter, LinkedIn, and Instagram. I look forward to joining you again next time on Th s is Growing Old podcast. As always, you can find us wherever you

get your podcast. Thanks everyone.