QALY Ban Bill Takes Leap Forward

Michael Riotto  0:03  
There's new treatments and myeloma being developed all the time, but if the people use the QALY, you know that new treatment that might give me another 18 months to live, would be deemed too expensive, that would put a negative effect on my life and therefore, I wouldn't be able to get it. So how do you think that makes me feel? I mean, it's just not the right thing to do in my mind.

Terry Wilcox  0:25  
This week on the Patients Rising Podcast, there have been some major developments on a bill that we've been very supportive of since its inception, and it's one I think you're going to want to hear about. Welcome to the Patients Rising Podcast. I'm your host, Terry Wilcox, CEO of Patients Rising. I'm joined by my co host, who's Super Bowl Dominos emergency pizza request was rejected by his health insurance. He's Bob Goldberg, co founder of the Center for Medicine in the Public Interest. So Bob, I didn't know you could get your insurance to cover pizza. How'd you do that?

Bob Goldberg  1:01  
Well, they do cover meals. You know for people that are homebound, of course, you know, during the Super Bowl, and I'm homebound. Right, so, but apparently, I had to try a year old frozen pizza bagel for three months before getting access to a fresh pie. Even though the pizza bagels give me a lot of gas. So it turns out they use the QALY but ignores the fact that pizza bagels have freezer mold, give me side effects, and always get stuck in the toaster. But I have a ton I can reheat one for you in the microwave if you like.

Terry Wilcox  1:39  
That's okay, Bob. I'm actually good on pizza right now. But your ordeal is a great lead in because what I would love from you as a quick recap on a bill we've been supporting and pushing for pretty much forever. Of course, I'm talking about the Protecting Healthcare for all Patients Act. We mentioned it on last week's show. But this week, I'm excited to really dive in with a few different perspectives. So Bob, what would this bill do? And why are we talking about it now?

Bob Goldberg  2:11  
Well this bill is a big deal. It would effectively outlaw federal programs from using the Quality Adjusted Life Year measurement, as a way of determining whether or not a treatment is cost effective and whether it should be paid for by the federal government. Medicaid, Medicare plans associated with both managed care plans would not be able to use this discriminatory metric anymore. And we're talking about it today because at this very moment, while we're recording, this bill is being considered by the House of Representatives. And we just a few hours ago got word that it will go to the floor of the house for discussion. That's a huge step and a huge accomplishment by Patients Rising no matter what happens here.

Terry Wilcox  3:00  
Well it would be an amazing development for the QALY to be banned from use in federal programs. And I know we've discussed the QALY and why it hurts patients before. But a refresher never hurts. So here's Bill Smith, a senior analyst at the Pioneer Institute telling us why the QALY is such a bad thing for all patients. But especially those we represent.

Bill Smith  3:21  
What the QALY does is it puts a monetary value on a human life. And the thing about it is that the game is rigged because if you say that a human life is worth $100 million, then you you end up concluding that every drug should be paid for and is cost effective. If you argue that a human life is only worth $1, then virtually no drug can be cost effective. So they rigged the game basically. And they can choose the value of human life and they can go up or down in order to rate drugs, knowing that they're going to come out as either cost effective or not cost effective, depending on where they pick that threshold.

Bob Goldberg  4:03  
Michael Riotto, who you heard at the top of the show is a patient who has seen the effects of the QALY on his own life.

Michael Riotto  4:12  
So it negatively affects people like myself who basically have a chronic non curable disease, you know, I have a rare blood cancer that that just doesn't have a cure. So I'm always on medication, always on treatment. But yet, you know, they give me a value in my life and I'm just gonna pick a number and say they give me 0.3 but yet, I'm a husband, I'm a dad, I'm a taxpayer. You know, I have much more to give in my life and what happens is just about I guess probably about two years now, in myeloma which is a blood cancer I have they actually denied a treatment because they said that the cost was too expensive for the amount of reward or life that you would get out of spending that money. I find it appalling that in the year of 2024 now, that an agency, can actually put a value on one's life. I do believe that everybody, no matter what stage of life they're in, has something to contribute.

Terry Wilcox  5:11  
Now, Bill says this latest news is encouraging because he thinks patients are finally winning this battle.

Bill Smith  5:18  
I think the QALY is playing defense. And there's bipartisan concern about it. Even the Biden administration has in a recent report argued that the QALY should not be used in the Medicare program to rate drug therapies because it discriminates against people living with disabilities. So you're seeing a bipartisan consensus in the US that the QALY should not be used. And you know, this House vote is just another indicator of it.

Terry Wilcox  5:47  
Well, so everyone, just

so you know, at the time, we're recording this, the bill is on the verge of passing, but it has not yet passed. And when I say passed, if it does pass, it's going to be passing the house and then a whole new effort will start for us to get a bill through the Senate so that we can then pass it and send it to the President's desk. It has faced a little bit of pushback. But we do think that it's going to get there. Now one thing to make really clear about this bill, and Bob, you can weigh in here as well. This bill is the exact language that's already in the ACA for Medicare already. So Medicare already bans QALY. So let's be really clear about that. What this would do is extend that to Medicaid, and other federal programs, the VA, etc. So we want everyone to have a level playing field with the QALY, and it not just to be in one sector, but to be everywhere. So why do you think we're winning, Bob?

Bob Goldberg  5:49  
Well, I think we've won the political and policy debate. Public opinions clearly on our side. The reason it took so long is two reasons: One is you had people that had a vested interest in using the QALY that became arrogant and thought that they could run roughshod over the concerns and the needs of patients. Well, that day is over. So regardless of what happens in the sanitary this bill, is a warning sign to those entities and stakeholders, that means pharma as well, that want to play in the QALY waiting pool, that this is not going to be tolerated. One way or another, this bill will pass and become law sooner rather than later. And I think, particularly in an election year, this can be a very potent talking point to say that we're protecting not only the pocketbooks of patients, but their right to choose the medicines based upon what's best for them.

Terry Wilcox  7:54  
You know, one of the major arguments, Bob, going into this against this bill has been coming from the likes of AARP and AFL CIO. They argue that this bill is to benefit Big Pharma. Say it in that weird voice, because it's just ridiculous talking about in in response, we assert that the primary beneficiaries of HR 485 are patients. Yeah, I mean, even the CBO, the Congressional Budget Office, for those of you who don't know, recognizes the urgency of addressing the issue. I mean, currently there are more than $1 billion in costs incurred annually due to the denial of care, and discrimination against individuals with disabilities. Yeah, I mean, this literally transcends drug prices.

Bob Goldberg  8:39  
It's a red herring, because, you know, for the last 50 years, 40 years, the federal government has been negotiating drug prices, without the explicit use of the QALY in Medicare and VA, etc. All of a sudden, the QALY is indispensable. It's going to benefit Big Pharma. How was that possible? When, let's assume the constitutionality of the Inflation Reduction Act, Medicare pricing provisions aren't overturned? Will this change the fact that the government can basically kick a drug off of formulary if it doesn't agree to its price? No, not at all. 

Terry Wilcox  9:20  
Well, to your point, Bob, Michael, says the whole thought of QALYs gets him riled up because it's so nonsensical. And you and I have been talking about this for years. Take a listen.

Michael Riotto  9:31  
It drives me crazy. I wish I could put everything I want to say in words, but it's just the wrong thing to do, that you can put a value on my life and say, no, I'm not worth another 12 months or 18 months or three years, when in fact, I do believe that I'm a great contributor to society. And I think there's many, many patients out there with with chronic disabilities, you know, diabetics or epilepsy, that this affects them too. And it's just wrong because they can give a huge amount of life. What about somebody who's a child who has childhood cancer, and maybe they develop at a 12 or 14 in the very beginning stages of their life. And yet, if they use the QALY metric, maybe their treatment isn't approved, maybe their treatment isn't given to them. And maybe they pass. But yet, if it was, maybe they could be a productive person for the rest of their life. And then for many, many years.

Bob Goldberg  10:23  
Same thing with Bill, who looks at the ins and outs of this stuff for a living as we do, and has borne the slings and arrows of this debate is optimistic about the bill being considered on the floor. 

Bill Smith  10:36  
I'm kind of heartened by this, because the QALY has been adopted widely in Europe, most of the major countries, with the exception of Germany, use the QALY. Great Britain, France, Spain, Italy, you name it, and the United States is standing up and in the face of that and saying, no, we're not going to do it, we're going to protect patients. And we're not going to use this QALY. So I think this is a good sign for the United States political culture.

Terry Wilcox  11:03  
But Michael, being an amazing advocate like he is, knows even when a battle is won, you still have to fight the war. So what did he do as soon as he knew the bill had life?

Michael Riotto  11:13  
First thing I did was email my Congressman, I want to know where he stands. I mean, I know that he's signed on to it last year, but I don't know if he signed on to it this year. And I would expect he's very pro health. So I would expect my congressman to sign on to the bill. And if he doesn't, well, I'm definitely going to advocate that he does, you can count on that for sure.

Terry Wilcox  11:32  
So obviously, Michael knows what he's doing. He's a great advocate. He's a great example. I mean, that's one of the things and I constantly we had Michael on today and we worked with Michael on this because this just shows how important for everyone out there those that have taken the Patients Rising advocacy masterclass, those that are considering taking it, those are that are in the middle of it, those who are serving on our Senate, how important it is to develop a relationship with your congressional office, both on Capitol Hill, if you ever come you know, for when you come to DC, but also in District, you know, they have in District weeks and days all the time. But, you know, find where they can be a champion for you. And Michael is really, really good at that. So again, we're recording this before the action happens. So some or all of this could change by the time this airs, but even making it to floor discussion is a big win for patients and for advocates across the country.

Bob Goldberg  12:30  
Yeah, my last thought about the QALY is, as Michael said, we need to keep the pressure on. We need to be on guard for bait and switch if it goes to the Senate. And like you said, the the battle may have been joined. And I think we're winning that battle. But long term, we need to still be vigilant. And with more vigilance and continued pressure, we'll finally enact a bill that protects patients in a way that anyone would want to be treated.

Terry Wilcox  13:04  
Well, absolutely. And just so our listeners are aware, we aren't the only ones who think this bill would be a tremendous leap forward. We lead a letter, which we sent to House leadership offices, with more than 100 other patient organizations pushing for this bill to move forward. We're also working on our own letter with signature for patients. We have an action on our website where you can send your own letter to your congressional representative from all 50 states. Now, this is advocacy and action, so to speak. And we hope that you really consider you know, learning more about the bill, if it speaks to you. If it's something that you want to advocate for, by all means, please get in there and send your thoughts to your congressional representative. It's a big deal. We have momentum. And like I said, even if when you listen to this, it's passed the House. Start getting to know your senators.

Bob Goldberg  13:58  
Thanks to Michael and Bill for joining us. Thanks to you, Terry, and Patients Rising for helping bring this to fruition. This is an important lifeline for sustaining innovation. And again, with Michael and Bill and others that we can turn to here at patients rising, we deeply appreciate their hard work.

Terry Wilcox  14:25  
This episode of the Patients Rising Podcast is brought to you by the Patient Helpline. If you need help with an issue or problem or anything related to you getting care our team is here and we want to help. Thousands of patients and worked with our staff of patient navigators over the years. This has allowed us to narrow down the best local, state and federal healthcare resources to solve your biggest challenges. There are a number of issues we can help with, but just a few include food or housing insecurity, overcoming insurance, obstacles and much more. For you to get help. All you have to do is leave us a voicemail or send us an email using the link in the show notes.

Bob Goldberg  15:06  
So, Terry, another story that deals with the QALY that we wanted to highlight is that this coming Friday, February 16 ICER, the group that recommends using the QALY will be having a meeting to discuss their latest evidence report. The report focuses on two treatments for a rare disorder paroxysmal nocturnal hemoglobinuria. PNH, mercifully for short.

Terry Wilcox  15:37  
The evidence report questions, the long term efficacy and safety of PNH treatments, specifically some new ones.

Bob Goldberg  15:45  
Oh, what a shock. What a shock.

Terry Wilcox  15:48  
We're not gonna get into this whole report.

Bob Goldberg  15:51  
I'm not going to dignify it, because they're irrelevant now.

Terry Wilcox  15:54  
Well they especially will be if you can't use QALYs anymore. When it gets right down to it, even some of these things we're talking about the QALY band bill and other things, these are all things that are going to be helpful to patients. But it's still all things that are underlying the patient experience. Patients don't get up in the morning, when they're thinking about "oh, I've got to go to this doctor, and then I got prescribed this medicine, I have to make sure I can get this test cleared with my insurance." They're not then thinking "oh my gosh I wonder if my denial or acceptance of this is going to be determined by QALY." They're not. You know that, I know that. We're advocating for something that we know is going to help them. But at the end of the day, I always like to look at everything and say, What are patients really experiencing on the ground, right? What is the patient experience of access, affordability, and transparency?

Bob Goldberg  16:53  
Right. That is all for today, folks. We will have another episode right here next Monday. So make sure to follow the Patients Rising Podcast on your favorite podcast player, so you can be notified as soon as a new episode is live.

Terry Wilcox  17:07  
Until next week for Bob and everyone a Patients Rising, I'm Terry Wilcox, stay healthy.