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Connecting ALS is a weekly podcast produced by The ALS Association in partnership with CitizenRacecar. We aim to discuss research and technology developments, highlight advocacy efforts, and share the personal stories woven through the community.
Sara van Geertruyden:
The easiest way to advance something better and to advance the kind of innovation that everybody's looking for in terms of how we value healthcare is to pass that bill. Everybody's fighting in the states over this issue and how states may be using QALYs, and passing that bill would make it a lot easier.
Jeremy Holden:
Hello, everyone, and welcome to Connecting ALS. I am your host, Jeremy Holden. In 2019, the National Council on Disability released a report and issued a recommendation to Congress that lawmakers banned the use of quality-adjusted life years, commonly referred to as QALYs, and similar mechanisms in federal healthcare systems to determine cost-effectiveness of medications and treatments. Quoting here from that report, "NCD found sufficient evidence of the discriminatory effects of QALYs to warrant concern, including concerns raised by bioethicists, patient rights groups, and disability rights advocates about the limited access to life-saving medications for chronic illnesses in countries where QALYs are frequently used. In addition, QALY-based programs have been found to violate the Americans with Disabilities Act." End quote.
Regular listeners to Connecting ALS may recall some of the conversations we had around the use of QALYs last year when ICER was analyzing the cost-effectiveness of drugs in the ALS treatment space. Now, while Medicare has been prohibited from using QALYs since the enactment of the Affordable Care Act in 2010, other federally run healthcare systems are permitted to use the measures despite the urging of the National Council to extend the ban on their use. Quoting, again, from the National Council's 2019 report, "The US government does not have a single comprehensive policy on QALYs. Some federal agencies are banned from utilizing measurement tools like QALYs, while some state and federal partnership program, such as the Medicaid programs, may. NCD is troubled, that health insurance providers, government agencies, and health economists are showing increasing interest in using QALYs to contain healthcare costs despite QALYs discriminatory effect." End quote.
But now a bill is moving its way through Congress that could expand the prohibition on QALYs to include all federal health systems. That bill, introduced in January and recently advanced in a House subcommittee, would strengthen and extend existing protections against the use of QALYs and similar metrics to all federal programs. Joining me now to talk about that bill is Sara van Geertruyden, executive director at the Partnership to Improve Patient Care. Sara, thanks so much for coming back and being with us here on Connecting ALS.
Sara van Geertruyden:
Thank you for having me. It's nice to be back.
Jeremy Holden:
Talking about a subject that is near and dear to your heart and career, and just to kind of level set with folks who maybe didn't pay super close attention to the ICER conversation we were having on this show a year ago, what are quality-adjusted life years? What are equal value life years gained? What are we talking about when we're talking about QALYs and evLYGs?
Sara van Geertruyden:
Yes. We'll start with QALYs. evLYGs seems to be having a renaissance of interest. The QALYs are a metric that's used in cost-effectiveness analysis of treatments, and they're known to devalue disabled lives because people with disabilities, seniors, patients with chronic conditions, typically experience a potential for health that's less than their healthier counterparts. Treatment that extends or improves their life may result in fewer QALYs than a treatment developed for a non-disabled or younger population, where the treatment returns them to, what we would call, perfect health.
As QALYs are assigned by both quality and quantity of life, the incremental QALY assessment with prioritized providing treatment to a non-disabled population with a longer theoretical life expectancy and otherwise perfect health over a population that has a disability or a chronic condition. So, for the ALS population, I'm sure that would be very concerning.
And then there's this equal value life years gained, which, as I mentioned before, seems to have gotten a lot of interest lately because it has been mentioned a good bit in Capital Hill discussions just recently. It wasn't really a metric before the last few weeks that was getting much attention, which is interesting. It is a metric that was created and is used by the Institute for Clinical and Economic Review, ICER, that you mentioned earlier, and it's typically a supplement to their current calculation of QALYs.
People with disabilities would consider both of those to be biased measures of effectiveness. So you have the QALY which incorporates some measures of value, reflecting quantity and quality of life, but discriminates against people with disabilities, and then you have this equal value life years gained, or evLYG is what people call it, which disregards any value of a medicine other than its ability to extend life. For instance, if a treatment makes you feel better, but it doesn't necessarily extend your life, it is not going to farewell under the evLYG calculation. Anyway, that's the summary. I know that was probably long.
Jeremy Holden:
No, no, it's great. It's an important topic and I don't want to glide over the depth that's necessary to understand it. Roughly we're saying, I'm fortunate in that I am an able-bodied person, so something that is going to extend my life, a treatment, that's going to be seen under a QALY regime as having more value than something that is going to have an impact on somebody with a disability?
Sara van Geertruyden:
Yes.
Jeremy Holden:
Is that roughly what we're talking about?
Sara van Geertruyden:
Roughly, yeah.
Jeremy Holden:
Yeah. QALYs, let's stick with QALYs because I think that's the big that that's the big one that we're dealing with, how are they currently used throughout the healthcare system?
Sara van Geertruyden:
When applied to coverage and reimbursement decisions, you can imagine a QALYs or an evLYG or similar measures of cost-effectiveness can result in discrimination, which you would call a violation of the ADA and other disability rights laws. There's also a statutory ban on the use of QALYs and Medicare that I think is also important to raise.
Way back in 1992, Jess said to one state that had a Medicaid waiver application, "We're going to reject your waiver because you're using QALYs to determine what your Medicaid services will be and what's covered." But nevertheless, we do know that these metrics are being used by payers and P&T committees make decisions about coverage, things like prior authorization, step therapy. And so it should be a bridge too far to deny care to those with significant lifetime health needs just because they may never achieve some preconceived notion of optimal health. But unfortunately, we do see these metrics being used in various ways that are not necessarily transparent. But that is why groups like ICER exist. They have an data analytics team that puts together this information for payers, for P&T committees, for their use to make these kinds of decisions.
Jeremy Holden:
1992, we were going back to. This has been something that CMS has been dealing with for over 30 years in some capacity.
Sara van Geertruyden:
Yeah. It's an interesting backstory. In 1992, when Jess made that decision to reject that Medicaid waiver, I think there was a sentiment that this issue was at least somewhat handled, at least in the Medicaid context. It created a precedent. It was right after the Americans with Disabilities Act had passed in 1990. Yet here we are, and we actually have found out that same state is still using QALYs, they just hadn't been using them in a very transparent way. But now that it is transparent, there's a tremendous amount of advocacy going on at the state level to try to get QALYs banned within the state and within the Medicaid program and to shift away from using that measure. But it is interesting how the measure, continuously, it just keeps coming back even after people think it's gone.
Jeremy Holden:
Well, and you know mentioned earlier that that, under current law, Medicare is prohibited from using QALYs. That dates back to the Affordable Care Act, right?
Sara van Geertruyden:
2010. Yes.
Jeremy Holden:
Yeah. So the 13 years on, and that brings me to Protecting Health Care for All Patients Act, which I know [inaudible 00:08:51] supports, the ALS Association supports. What is Protecting Health Care for All Patients Act? How would it address this issue of how QALYs are used by federal health insurance plans?
Sara van Geertruyden:
That legislation would advance the recommendation of the National Council and Disability, which called for Medicare's existing ban on the use of quality-adjusted life years and similar measures, which is how it's said in statute, that discriminate to be extended then to the federal programs that are in the jurisdiction of the Energy and Commerce Committee. So this is a bill coming out of the Energy and Commerce Committee in the House of Representatives, and that includes Medicaid. So the Medicare ban on use of QALYs would essentially be extended to programs like Medicaid.
The National Council and Disability, for anyone who doesn't know, is an independent federal agency that advises Congress and the administration on disability policy. And so they had a report back in 2019 that had a series of recommendations, including advocating for consistency across programs to bar QALYs.
There's been some back and forth about what the bill actually does, but it's actually quite simple if you look at the legislation and if you actually read the legislation in the context of what it's amending. It doesn't really do anything to the current Medicare law, but what it does do is extend those protections against the use of QALYs to these other programs that are listed. So it's Medicaid, including Medicaid Managed Care organizations, Medicare Advantage, Part D, CHIP, those kinds of programs that are within the Energy and Commerce jurisdictions. It just creates a consistent policy, right? Because right now the statute only applies to Medicare and it's potential application to other programs has really been just through that 1992 decision related to a state Medicaid waiver. So I think this is just a way of creating some clarity about, these are metrics that discriminate. They're barred.
Jeremy Holden:
Yeah. And you mentioned consistency. It's something that 2019 report from the National Council referenced, is that we don't have a consistent policy across the federal government, and one of those recommendations was to get closer to that. You mentioned the House subcommittee. There was some movement on the bill maybe a week or so ago. What's the current status of the bill, and what are some of the next steps? What are you hearing in terms of the legislative process over the coming weeks and months?
Sara van Geertruyden:
The process is going to be interesting. There was a hearing on the bill on, I think, February 1st of this year. The National Down Syndrome Society testified in favor of the bill, later passed out of the subcommittee on just a voice vote with both sides, the Democrats and the Republicans, agreeing to continue to work on the language. When it reached full committee recently, it, unfortunately, did not garner Democratic votes. I think there had been some advocacy from the academic community against it, and there was some mischaracterization and misunderstanding about the bill that it somehow had something to do with Medicare as opposed to being about the extension of the existing Medicare law to other programs. And so some Democrats, I think, were concerned about that.
But good news is that ranking member Anna Eshoo, who's ranking of the subcommittee at Energy and Commerce, she's a Democrat, she did not vote. She abstained from the vote and voted present because, and then colloquially, with the chair at the hearing, had the chair agree with her that they would work together on the bill before it went to the floor. So we still have our fingers crossed. Democrats are very much on record supporting the ban on the use of QALYs, so our hope is that by the time it gets to the floor, it is bipartisan. But we're just going to wait and see in terms of how those offices work together to get it to a bipartisan place.
Jeremy Holden:
The issue, advancing a good faith argument, that QALYs are intending to solve or help policymakers solve is this issue of figuring out costs and pricing in the healthcare system. My question is, are there alternatives to QALYs, to equal value life year gains, that get to the issue of fair and accurate pricing and cost controls, but not in a discriminatory way?
Sara van Geertruyden:
Yes, and that's been a hot topic. It's the, if not QALYs, than what, topic. We hear that a lot. I keep looking back at the statute for the Inflation Reduction Act, which is the statute that created the new drug price negotiation program. I think it's an interesting reference point. It has CMS focus on factors of therapeutic benefit, so therapeutic advance, comparative clinical effectiveness research, unmet need. It allows the agency to look at certain cost data that gets submitted too, but I think it's important to note that it never gets into using a measure of cost-effectiveness, which is what has become so controversial. This idea that you can come up with a way to say whether something is worth it or cost-effective.
So in terms of alternatives, I think we continue to be strongly supportive of using information about therapeutic benefits to understand how a treatment impacts outcomes that matter to patients and people with disabilities. And I think you'll see the advocacy community weighing in significantly on what that means in terms of what high quality, good data looks like that the agency could be using in this process. Anyway, I think that's a very interesting point to make.
And then, we've also been following, closely, the work of the Innovation and Value Initiative, which they've been advancing this concept of multi-criteria decision analysis and have done a few, they've actually run that in, I think, three conditions now, where it gives stakeholders the ability to weight the measured outcomes that are most relevant to their goals. Anyway, I think there's a lot out there in terms of innovation that's happening in this field, but certainly in terms of how payers and policy makers make decisions, I guess we would urge reliance on the comparative clinical effectiveness research that's really more focused on the therapeutic benefit and the quote-unquote, "Cost-effectiveness of something that potentially can work against people who don't fit the averages."
Jeremy Holden:
Yeah. Those are the questions I had for you, Sara, be before I let you go, any closing thoughts or anything that I didn't think to ask that you think is important for listeners to know as the fight against QALYs moves forward?
Sara van Geertruyden:
Support Protecting Health Care for All Patients Act, please. I think the easiest way to advance something better and to advance the kind of innovation that everybody's looking for in terms of how we value healthcare is to pass that bill. Everybody's fighting in the states over this issue and how states may be using QALYs, and passing that bill would make it a lot easier.
Jeremy Holden:
Well, Sara, thanks so much for your time this week.
Sara van Geertruyden:
Thank you so much.
Jeremy Holden:
I want to thank my guests this week, Sara van Geertruyden. If you like this episode, share it with a friend. And while you're at it, please rate and review Connecting ALS wherever you listen to podcasts. It's a great way for us to connect with more listeners. Our production partner for this series is CitizenRacecar Post-Production by Alex Brower, production Management by Gabriela Montequin, supervised by David Hoffman. That is going to do it for this week. Thanks for tuning in. We'll connect with you again soon.