Feb. 26, 2021

Barriers to Rare Disease Treatments

Barriers to Rare Disease Treatments

Rare Disease Day is February 28. New and exciting medical innovations and drug therapies for rare disease abound, but accessing those treatments is another challenge. Discriminatory healthcare metrics like quality-adjusted-life-years (QALYs) devalue rare disease patient lives, signaling that a patient’s life isn’t worth covering treatments and therapies. 

Dr. Bill Smith explains how QALYs are used and how it prevents patients from getting the life-saving care they need. Plus, Patients Rising Field Correspondent Kate speaks with Marni Cartelli, a rare disease patient living with complex regional pain syndrome, and Patient Correspondent Lillian Isabella celebrates Rare Disease Day by sharing her story of being diagnosed with PKU. 


William Smith, Ph.D. 

Visiting Fellow in the Life Sciences, The Pioneer Institute

Dr. William S. Smith is The Pioneer Institute’s Visiting Fellow in the Life Sciences. Smith has 25 years of experience in government and in corporate roles, including senior staff positions on Capitol Hill, the White House Office of National Drug Control Policy, and the Massachusetts Governor’s office where he served under Governors Weld and Cellucci. 

He spent ten years at Pfizer Inc as Vice President of Public Affairs and Policy where he was responsible for Pfizer’s corporate strategies for the U.S. policy environment. He later served as a consultant to major pharmaceutical, biotechnology and medical device companies. Dr. Smith earned his Ph.D. in political science with distinction at The Catholic University of America.


William Smith, Ph.D.

The Biden administration needs to look beyond ICER for evaluating drug therapies

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Senate Democrats push for public option as Biden weighs health-care reform plans

Marni Cartelli

Patients Rising Concierge 

Patient Correspondent: Lillian Isabella

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0 (6s):
On rare disease day, it is a time to celebrate though. It's time to celebrate being rare. It's a time to celebrate the community that we're a part of, and it's a time to celebrate our ability to advocate for ourselves. And I think rare and chronic and pain are falling through the cracks and are being abandoned. I just think there needs to be some kind of correction in the insurance design to make sure some of these people who unfortunately get these rare conditions or conditions where their therapies are expensive are not bankrupted.

Terry Wilcox (37s):
February 28th marks Rare Disease Day. A day to bring awareness to the policies, medical innovations, and treatments that rare disease patients depend on. The discriminatory healthcare metrics continue to devalue their lives, preventing them from accessing the care they need. Welcome to the Patients Rising Podcast. I'm your host, Terry Wilcox, Executive Director of Patients Rising, a hundred thousand members strong organization of patients with chronic illness. I'm joined by my cohost who's built an impressive Fauci snowman lookalike in his front yard, he's Dr. Bob Goldberg, Co-founder of Center for Medicine in the Public Interest.

Terry Wilcox (1m 19s):
I had this image, Bob, we have these little plastic, you know, molds that the boys and I can make little snowmen family or snow women, family, or snow people, family. And I just have this picture of this like Dr. Fauci mold. It really made me laugh.

Dr. Bob Goldberg (1m 37s):
There's so many ways I could go, but just to let you know, I was shooting for an Andrew Cuomo abstract sculpture because the snow is melting rapidly. So you can read into that what you'd like. As a matter of fact, we had snow up here in New Jersey again, but it melted away pretty quickly along with my Cuomo snowman. In any event, I'm thankful that we have power. I know what it's like having lost it during hurricane Sandy. And I know that you and I, Terry are certainly sending our thoughts and prayers, if not part of our electricity grid, to those in Texas, recovering from the recent storm. The fact is that despite of it, maybe even response to the impact of the power outtages, which again on top of COVID right, state legislatures and Congress are nominating people, dealing with budgets, wrestling with issues and policies that impact the millions of Americans living with chronic disease and that's why we're here each week.

Dr. Bob Goldberg (2m 35s):
Power outages or not to give you the latest insights and breaking news.

Terry Wilcox (2m 39s):
That's absolutely right, Bob, and I have family in Texas, and I can tell you it's been a whirlwind. You know, my Uncle has had to pull out all of his boy scout skills I have to say. He was an Eagle Scout, so he's been quite proud of that. We're also here to fight for equitable access to care, which is unfortunately a battle that's always ongoing. We talked a bit last week about how the Congressional Budget Office used metrics from the Institute for Clinical and Economic Review, otherwise known as ICER, to make decisions on drug values. There's one metric in particular that is used by ICER that completely undervalues the lives of rare disease patients. And it's known, we've talked about it here many times, Bob and I have, as the quality adjusted life year or the quality.

Terry Wilcox (3m 24s):
We've touched on this in the past, but unfortunately state legislators are still considering using this harmful metric to calculate prescription drug legislation. The quality basically says to patients, sorry, your life isn't worth it for us to pay for your treatment. It's truly a discriminatory metric that has no place in the government.

Dr. Bob Goldberg (3m 42s):
Well, plain and simple, no matter what ICER tries to say on its websites, and they had some kind of bogus legal opinion, the use of their algorithms, using average results, whether it's real world data or not, systematically is discriminatory. It discriminates against people of color, discriminates against people that are disabled. And despite what they say, you know, putting a low value of life on quality, especially for people with rare diseases. And the fact is that many insurers are using these ICER calculations to refuse coverage to these medications and treatments. Again, it's discriminatory of an impact ICER doesn't care, and we cannot have an equitable health system.

Dr. Bob Goldberg (4m 26s):
We can not eliminate health disparities that are racial or abled in nature if we use this system.

Terry Wilcox (4m 34s):
Well, that's absolutely true. And now there's a lot of work being done at state legislatures to bring attention to this issue and to prevent lawmakers from using this metric for drug pricing legislation. This week, I spoke with Bill Smith from the Pioneer Institute where they've put together a key question document for legislators that points out the important ethical methodological and condition specific considerations. Now Bill has, as anyone who's talked to him, I'm sure you have, Bob, has a wealth of knowledge on qualities, and for Rare Disease Day, we wanted to bring attention to this critical issue impacting treatment accessibility for this community. That interview will be up shortly, but first this week's healthcare news headlines.

Robert Johnson (5m 19s):
In your health news, the heat is on American businesses to do more, to help the Biden administration with its campaign to beat down the COVID-19 virus. The New York Times reports that sports leagues will set aside 100 stadiums and arenas to be used as mass vaccination sites, Uber, PayPal, and Walgreens will offer free rides to get people to those sites. Best Buy, Dollar General, and Target will give workers paid time off to get a shot. And Ford and The Gap will donate more than 100 million free masks. Biden's pandemic advisor says the response to the President's call to action has been overwhelming, and that more companies are expected to join the growing list of those offering help.

Robert Johnson (6m 2s):
The aid is needed as experts now consider whether we should expect a fourth wave of infections and deaths. That all depends on whether Americans continue to follow public health advice giving the nation time to get vaccinated. The bottom line, if we let our guard down too soon, we may give the Coronavirus the opening it needs to make a comeback. Meanwhile, the Johnson and Johnson vaccine is under review as regulators consider whether to approve its use against COVID-19. The final decision could come in the next few days. the J and J formula requires only one dose, prevents serious infections, and does not need to be kept frozen when being shipped. Previous vaccines require two doses and must be stored in special freezers.

Robert Johnson (6m 46s):
Also, new vaccine trials to address one of the COVID variants will begin soon. Drug maker Moderna says it's considering the creation of a new COVID-19 vaccine that would fight multiple strains as well as a third dose booster for its vaccine that's already in use. Enthusiasm for vaccines is growing. A new poll reporting 55% of all U.S. adults have already gotten their first dose of an available vaccine or are eager to roll up their sleeves when it's their turn. 22% say they'll wait and see, 7% say they'll get it only if required, while 15% say they definitely won't get it. Those who aren't ready, black adults and young adults were most likely to say, they'll hold off for now.

Robert Johnson (7m 31s):
Finally, the President's pick for Xavier Becerra appears headed for confirmation. The Senate Finance Committee likely to vote next week to send Xavier Becerra's nomination to the Senate floor. In hearings this week, Senators grilled Becerra the cost of healthcare, the future of Obamacare, and his plans for reopening schools. That's your health news update for this week. I'm Robert Johnson.

Terry Wilcox (7m 59s):
We've hit a saddening COVID-19 milestone this past week. More than half a million Americans have died due to the Coronavirus. It's truly shocking and saddening to look at this number. Now, Bob, you and I started this podcast right at the beginning of the pandemic. And while we are looking forward to the surge in vaccine distributions and increased immunizations, it's also important for us to take a step back and remember those that the virus has taken from us.

Dr. Bob Goldberg (8m 26s):
Yeah. And I just recall at the outset through rose colored glasses, I was projecting that we wouldn't see as much death and that the virus itself wouldn't be as transmissible, but wrong on both counts, unfortunately. And as you pointed out, Terry, that even as we look towards the future, hopefully to a reduction in hospitalizations and deaths, that the people in our families and the people in other families who have lost loved ones suddenly because of this virus should always be remembered and treasured. There's not much else we can say except it's horrible. And I think President Biden gave a very heartfelt expression of concern and compassion that resonated with lots of Americans.

Terry Wilcox (9m 11s):
You know, I remember counting at the very beginning, and you know, everyone at the very beginning, it seems like just yesterday and yet a long time ago, remember the John Hopkins website used to be THE website. You had to go every day and you would just watch that thing tick up and you would watch your state and you watch the number of deaths and the number of deaths around the world. And you know, and now we're here. And I think we do know a lot. I mean, I think we know the populations that it's affected the vulnerable, the elderly, you know, I know many friends and family who've lost, loved ones that are older, either they were in nursing homes or they just had co-morbidities that couldn't withstand getting the virus itself. Now, what do you think this means as an impact for us?

Terry Wilcox (9m 54s):
We've talked a little bit about this in the past on public health. We can do a whole series on the changes in public health that you and I think about and what we need to look at, but what do you think the impact of just COVID-19 in general and just having us live through a pandemic where we shut down our country and it's still not open all the way?

Dr. Bob Goldberg (10m 12s):
Yeah. I think we learned some valuable lessons. I mean, that's for better, for worse, that is science, science is trial and error and hopefully you learn from your mistakes quickly. Peter Hotez who I spoke to and will be on one of our upcoming podcasts made the interesting point that we were probably better prepared in some ways, in terms of tracking and surveillance internationally, but woefully under prepared at the public health level. And specifically in terms of two things, educating people about the risks and health, and then being able to come up with policies in advance that could be adjustable and flexible.

Dr. Bob Goldberg (10m 52s):
And I think, you know, we can't cover every contingency. We can't. I mean, if the virus teaches us one thing, it's trajectory, you know, gender objected to known, but movement and impact unpredictable, but we have to come up with a more adaptable and flexible public health system. That means dealing with preparedness, but it also means dealing with ways to mitigate the effect on the lives of people who would otherwise be at work and be at school.

Terry Wilcox (11m 21s):
I do think that we should be delving more into a lot of these public health issues in upcoming episodes. I think it's going to be a huge topic. And one of the things that I would love to see, you know, hindsight being 2020 or whatever it is, what would have this been like, if it hadn't have been a presidential campaign year, what would we have done differently? I'm sure quite a bit, we're too close to it now to really know what that would look like, but it is an interesting thing to ponder. One of the things that I want to talk about is, you know, there's some interesting things happening on the drug price legislation front. I mean, there's definitely an appetite for that on both sides of the aisle really, but you know Democrats now have the ball and they're going to run down the field with it. So Senator Kaine and I think Michael Bennet, Senator Bennet in Colorado, re-introduced their Medicare-X bill recently, which is a public option that they're looking at to compete on the exchanges.

Terry Wilcox (12m 13s):
There's a lot of things in it to like, I mean, you and I have talked about this. It's like our public option right now is go to the hospital. You know, I mean, if you really don't have any insurance or any access to it, or a lot of times it's often, and I can say this for members of my own family and folks that I know, a lot of times it's they just don't go get it. They don't go through the process of making sure they're covered. And that is sometimes an issue, especially for those that are relatively healthy.

Dr. Bob Goldberg (12m 38s):
I mean, coverage is important.

Terry Wilcox (12m 40s):
Care is more important though.

Dr. Bob Goldberg (12m 42s):
Care is more important. And obviously if you have to reach a $9,000 maximum out of pocket before you can get reimbursement, that it will discourage your utilization to a certain extent. But again, it speaks to the fact that, and I know we sound like broken records here, but we need to identify risk, provide the resources to prevent those risks more systematically and make sure that coverage and access is aligned with reducing that risk.

Terry Wilcox (13m 12s):
Right. A lot of times what a public option means to legislators is you get health insurance, here's your health insurance, and you and I both know that health insurance is just a plastic card in your wallet. And that healthcare is a totally different thing. It has to do with benefit design, which I hope becomes more of a buzzword on Capitol Hill because that's really, you know, the keys to the kingdom, as one might say, I mean, that's really where it all is. If you don't have that piece worked out, you're not providing care, you're just providing a plastic card in your wallet. And honestly, you can go get that at you know, any number of places.

Dr. Bob Goldberg (13m 45s):
Although I would say as this may actually happen in Congress and Mark McClellan said this on his most recent interview here, that with the rapid growth of digital health, tele-health, using text messages and so on, to stay in touch and continuity of care, keeping people out of the hospital, that infrastructure can absorb many more people and provide more care more immediately than if you got to wait to be examined in a doctor's office. So that being said, certainly, you know, filling the gaps in coverage that people have is important, but it has to go part and parcel with the development of infrastructure. And as we've pointed out in the show, making sure that if someone needs something, they're not denied access to it because of the price.

Terry Wilcox (14m 32s):
One of the things we want to talk about today before we get to our interview here in a little bit, is some of the stuff that's happening at the state level around drug pricing boards, specifically with Medicaid, FDA accelerated approval drugs, things like that. They're setting up these Boards that sort of are determining or negotiating a price sometimes based on ICER or ICER like methodologies that's happening. The first one has been done in Maryland. The first prescription drug board in the U.S. Is right there in the state of Maryland, right over the river from where I am, and it allows state and local governments to cap prescription drug prices.

Terry Wilcox (15m 14s):
Now, what do we think about this? What's this going to do to Medicaid patients and Medicaid access in Maryland?

Dr. Bob Goldberg (15m 20s):
It's going to lead to rationing. And it's the again, wrong approach. The right approach is how do we use this medicine in a way that advances the quality of care for patients. This short-term approach, which is yeah, the dollar value is expensive for new medicines, you know, a gene therapy and so on, but why haven't we learned from the Hep C lesson that there's different ways to price and pay for these products? That's really the issue. I think that there's probably a constitutional or civil rights case in there somewhere that would basically target the practice of restricting access to new drugs because someone is poor or in prison, and there's better solutions I think and we've discussed them on the show.

Dr. Bob Goldberg (16m 8s):
I can even make a snowman that represents that solution. You got to give me a little time.

Terry Wilcox (16m 15s):
I love that. I want to see that snowman. Another thing is the hearings happened this past week. One of the things that we should be on the lookout with Xavier Becerra's past is he's had a real advocacy for undocumented immigrants, providing them with healthcare. Now I have to say as somebody who doesn't like huge expansions of government programs, I also know for a fact that it's incredibly expensive to use our hospital emergency rooms for such. And I mean, that's basically what we're doing when we don't have some sort of mechanism for those that are here from other countries, regardless. I mean, even I had friends, I remember when I was in college that would go to the UK for a summer program or a semester program and they were just fascinated by the fact that they just like walked into the doctor's office and got care.

Terry Wilcox (17m 3s):
Right. I mean, I know that's socialized medicine, I know that's not necessarily what we're advocating for, but what are we doing anyway? I mean, we're not turning people away to hospitals. That's our place. Now I do know a little bit about the back end of hospitals. I know they don't jump at every Tom, Dick, or Harry that walks in off the street, but they do have an obligation. So what do you think about this? I mean, I do think that there's a place to figure this out in a meaningful, more cost effective way. Do you think that?

Dr. Bob Goldberg (17m 29s):
Yeah, I can just say that I was a surrogate for John McCain on healthcare in 2008. And I was debating the woman from the Obama team. And I think she probably fainted when I said, cause she said something to the effect of, well, we're not going to allow people who are here illegally, that's the term she used, so don't put it on me, people. This is 2008 and things change. And I said, well, I think they should. I don't think that should be subsidized fully. But I think that people who are here illegally, I mean they still need healthcare. And from a humanitarian point of view and from an economic point of view, it would be a hell of a lot more useful to allow people to create tax free health savings accounts and buy care and buy a basic coverage and then allow the existing Medicaid programs, which by the way, if you walk into an emergency room, you can get any kind of care under many circumstances, maybe cheaper and it would be less humiliating and I think people would be healthier overall.

Dr. Bob Goldberg (18m 31s):
The other thing is that there is a myth that people are here undocumented workers are pouring into the border, getting free health care. They are actually much healthier than the general population on a number of scores, diabetes and blood pressure and so on. And I'll double check those stats as we have them. So I agree with you. I think there is a way to do it and it will be a partisan issue, but it should not be a partisan issue.

Terry Wilcox (18m 55s):
I think, I mean, we're asking for a tall order here, but it's actually one, I think that we can solve. It is going to take bipartisanship and it is going to take, give and take on both sides. I mean, nobody's going to win everything they want and nobody's going to walk away with the touchdowns, even if you're technically in the majority across the board.

Dr. Bob Goldberg (19m 14s):
Yeah. Let's start with making sure that state legislatures are aware of the danger and the discriminatory impact of the quality, because once that gets into the system, then it makes all the other kinds of reforms that we're talking about a lot harder.

Terry Wilcox (19m 30s):
Well, absolutely, because a lot of that is at the state level. Primary health care is administered in many instances at the state level and it would be in the instances of undocumented workers. And with that said, speaking of quality, my segue, Bill Smith, who I consider to be an expert in many ways he's written an enormous amount about this. He's very thoughtful and we had a great discussion this week. So here is my interview with Bill Smith. He's a visiting fellow at the Pioneer Institute. Thank you for joining us today. We're really glad to finally have you on the podcast.

Bill Smith (20m 5s):
My pleasure.

Terry Wilcox (20m 6s):
We're going to talk a little bit about a favorite topic for both you and me, which is the quality and ICER and just to update our audience, Bob and I have talked about this quite a bit on the show. We've had several folks on the show that have talked about qualities and the Institute for Clinical Economic Review (ICER), which is a Boston-based entity that does value assessment reviews for new innovations or new treatments. So Bill let's just start and talk a little bit about quality adjusted life years and the quality itself, just because I always like, you know, we have new listeners every week. So I don't always like to assume everybody knows what we're exactly talking about. So just explain to us briefly or explain to our audience briefly, what is the quality?

Bill Smith (20m 50s):
So quality is a way of rating, the value of a therapeutic, according to its ability to extend life and to improve the quality of life. It uses those two poles, extend life and improve the quality of life. And the quality gives a score on each of those. So they score, on a zero to one scale. So if a new oncology drug comes out and it looks like it extends life by six months, not a full year, but six months, that drug will get a 0.5 quality. Cause it's only doing it for half a year. And then for the quality of life, they have all these elaborate standards. So if you're taking that same oncology drug and it reduces your nausea during chemotherapy by 25%, then it will get a certain score in the quality of life.

Bill Smith (21m 36s):
That score is then taken and applied to say, if it's a 0.5, the drug gets a 0.5 score on both longevity and quality of life, that score is then applied to a value that they give a year of human life. So in the case of ICER, they value a year of human life lived in good health at about $150,000, a hundred to $150,000. So if the drug scored a 0.5, they would say that drug is worth $75,000 for that year. And it's not cost-effective above that. And it is cost-effective below that price. Now there are all sorts of problems with this in part that threshold of a hundred to $150,000 could be changed.

Bill Smith (22m 21s):
It's somewhat arbitrary. If you made the threshold a million dollars, a lot more drugs would be found cost-effective. If you made the threshold a dollar, the value of human life lived for a full year in good quality is worth a dollar, then no drug would be cost-effective. So there's kind of an arbitrariness to the quality in that you can put in a threshold and that threshold will decide how many drugs are going to be cost-effective and how many are not.

Terry Wilcox (22m 45s):
One of the things that I want to dive into because we're going to talk a little bit about how these types of reports that ICER is putting out are starting to affect patients, how they might creep into what drugs are covered by their States, in their state Medicaid programs, or how those are covered, as well as what drugs are covered, possibly even at the federal level, because as you and I briefly discussed, there is some talk of perhaps a federal commission of sorts for these more specialty drugs. But let's talk a little bit about the rare disease community in general, and patients who are waiting, who have no innovation, who don't even, may not even have a treatment. And when you look at an ICER report, all it does is have a quality and a cost.

Terry Wilcox (23m 28s):
I mean, that's really the gist of their core factors of consideration by ICER. They're not considering the productivity of the patient, no health equity considerations, not what the value of just having hope for the next incremental innovation might be, the severity of their disease, etc. So can you speak a little bit about that? I know you wrote a report or a white paper of sorts a little while ago specifically about taking a bird's eye view of all the ICER reports for this community and basically they never came down in favor of the patient.

Bill Smith (24m 1s):
Yeah. There are many problems with the ICER methodology and is generally when it comes to rare diseases, things like how will life improve for a caregiver if this drug is effective, those things are not taken into consideration by ICER as far as the cost of the model or the value of the therapy. But in my mind, the biggest problem with ISER's treatment of rare disease drugs is that the threshold of the quality, the value threshold, the cost they put on a year of human life, is way too low for rare diseases. I mean, full disclosure, I'm a former executive in the pharmaceutical industry, but I know the business model of rare disease drugs is different from every other drug. If you're inventing a drug that's going to have ultimately only 4,000 customers, 4,000 patients in the whole country, and you're doing huge R and D costs, those drugs by definition are going to be more expensive than a, a blood pressure pill that 10 million people are going to take.

Bill Smith (24m 56s):
That's just the economics of it. You can argue specific drugs and whether this rare disease drug is way too expensive or not too expensive, but the reality is rare disease drugs are going to be more expensive and a lot more expensive than most typical small molecule drugs, pills that you take out of your plastic bottle. And the problem is the ICER quality, the value they attribute to a year of life lived in good health, as I said, was a hundred to $150,000 and many of these rare disease drugs are going to have six or even seven figure price tags. And so they're not going to be rated cost-effective according to these ICER parameters. And in fact, we've seen some evidence that that's true. A health affairs just studied, it's a little dated, it was 2018,they looked at all the ICER reviews of rare disease, drugs, both rare cancers and other rare diseases, and they discovered they didn't rate a single drug, rare disease drug, as cost-effective.

Bill Smith (25m 49s):
They were either rated intermediate in their cost-effectiveness, but most were rated not cost-effective. And again, that has to do with the arbitrary thresholds that they impose and what they put on the value of a year of human life. Now they've said they're trying to be flexible and change it. I haven't seen anything though that would indicate that they're taking a more benign view of rare disease drugs. In fact, I think payers themselves and ultimately ICER works to serve payers and health plans, payers are extremely concerned about gene therapies and some of these really unbelievable, innovative drugs that are coming down the line and how expensive they might be.

Bill Smith (26m 29s):
I personally am not worried. We're seeing enormous savings from generic drugs coming online and patents expiring on a lot of blockbuster drugs and so health plans and payers are saving a lot of money because of the generics and I think they can more than afford to pay for these rare disease drugs, but nonetheless they're concerned and ICER has a focus on it and their model is not well suited to rating rare disease drugs.

Terry Wilcox (26m 53s):
This is actually a whole nother show, but one of the things that I always like to touch on when you bring up payers fearing this great innovation and what it's going to cost them. Well, one of the things that we never really talk about and doesn't get talked about because we spend so much time talking about how much drugs cost, which, you know, if you look at list prices of drugs, they do cost a lot in many instances, but to your point, generics are coming down, but we never talk about the benefit design of how they might be able to adjust their business model and work with pharma and PBMs or whoever's in the mix to help pay for these things. Don't you agree with that?

Bill Smith (27m 29s):
I agree with that 100%. I think the insurance design needs a great deal of focus by policymakers because what's happening now is that a lot of people that are on a couple of generic drugs, you know, say have mild heart issues and you're on a statin for cholesterol and an anti-hypertensive for your high blood pressure. Those drugs cost nothing. I mean, absolutely nothing, it's pennies, and you might be paying a dollar or $2 a month in co-payments and that's fine. I'm not saying you should be paying hundreds of dollars because the drugs are pretty cheap, but you're paying almost nothing. If you are a patient, however, that develops a rare condition, or you have to take a specialty drug that's injected or infused, it's expensive, it's five figures or six figures a year, and you have a health plan that has high co-insurance requirements and high co-payments requirements, you could be paying 25, 30, $40,000 out of your pocket.

Bill Smith (28m 22s):
Now there are not many patients that are having this burden, but there are enough that it's a problem. It's one or 2% of patients. And I just think there needs to be some kind of correction in the insurance design to make sure some of these people who unfortunately get these rare conditions or conditions where their therapies are expensive, are not bankrupted. And whether that means raising co-pays on other patients, I'm not an insurance executive, but it seems unfair to me that you buy health insurance to prevent yourself from becoming bankrupted. And then you get on a very expensive therapy and you become bankrupt.

Terry Wilcox (28m 55s):
Exactly. I mean, we talked to many patients who have been in that situation and it isn't always just the therapy. I mean, we can go into other things that surprise medical bills, which often those hospitalization can often include a therapy that was very expensive. So there's all sorts of reasons for it. I just wanted to touch on that because it is something that definitely needs to be considered when we're talking about all of these cost issues.

Bill Smith (29m 18s):
I think it's usually important. And I do think it's the number of patients, as I said, one to 2% is small enough that it can be fixed without breaking the bank. Drug costs are not going through the roof. They're relatively flat. What health insurers are paying year to year is not growing exponentially. They can afford to fix this, and I think they really need to.

Terry Wilcox (29m 37s):
And now we're seeing now speaking as we move through the ICER track, want to talk a little bit about what we're seeing at the state level are starting to see and then we'll also talk a little bit about what we might see at the federal level. But right now there's several states, Tennessee specifically, Massachusetts, that are developing these policy commissions that are using reports such as ICER or looking at ICER like types of measurements to determine how they're going to cover new medications that are being approved through the FDA's expedited programs. Right?

Terry Wilcox (30m 17s):
So just for our audience, FDA, you can have accelerated approval, especially if there's a drug that shows efficacy, that's safe, that benefits patients who have no treatment and by law in order to get the big rebates and the discounts that Medicaid receives, they're supposed to cover all FDA approved drugs, but they're trying to make an argument in certain States that they don't have to cover these drugs because they were accelerated approval. So what are your thoughts on this and what are you seeing?

Bill Smith (30m 46s):
Well, I'm not sure I always have high confidence in some of the people running Medicaid programs. I'll just tell you a quick anecdote that when I used to go to the Medicaid Directors meetings where they'd all meet together, I'd watch them sit around the table and they would all brag about how much they were requiring their patients to use generics or making them use 90%, then the next guy would say, well, 91% in our Medicaid program, they're all bragging about this, and I was thinking to myself, you're bragging about using the oldest possible technology on your patients. This is like running a subway system and saying, no, I'm using subway cars that are older than anybody else's in any city.

Bill Smith (31m 30s):
So there's kind of this perverse understanding about therapies and how older therapies generally aren't as good as newer therapies. And it's the same thing with these FDA approvals, expedited approvals. Basically, what these commissioners are saying is we are going to try to restrict the latest and best innovations. The innovations that the FDA has said are so good, we're going to push them through quickly. It makes no sense whatsoever. I do think that there's hope around this because if they do start to use the quality, I've said this before, and we've talked about it, I believe the quality, because of its emphasis on the quality of life, is a violation of the Americans with Disabilities Act.

Bill Smith (32m 10s):
To use the quality in assessing drugs for public programs, is a violation of the Americans with Disabilities Act, and I'm not on my own and saying this, there are very prominent patient advocates who are saying it. And I think particularly the disability community needs to get engaged on this because I think if these Medicaid programs were taken to court, they would lose, they would not be able to use the quality.

Terry Wilcox (32m 32s):
Definitely. I mean, I think our audience would be interested because we do have many advocates for those of you, and you may not know, we just launched a patients advocacy training program or we're training delegates. And we're in the process right now of training I think it's 77 patient advocates across 30 states and it's a fantastic program. And we are trying to train them on detailed stuff like this because the more you as a patient know, and are able to do things to engage locally within your state, the better it is. So do explain a little bit more about your thoughts on that. Especially the American Disabilities Act, because that's an argument that a patient could make.

Bill Smith (33m 10s):
Yeah. So let's see how quality would score a drug for two different conditions. One for a person living with disabilities and one for a person not living with disabilities. So the person not living with disabilities has a certain condition. A new drug is invented, and it's going to extend that person's life for 10 years and they're going to live a good quality of life. Well, that drug is going to get a really good score because on longevity and quality of life, the two polls that quality uses to score drugs, it's getting a good score in both of those. Let's think about the person who's living with disabilities. A drug is admitted for their condition, say it's a separate condition and it's going to extend their life for 10 years, but it's not going to completely cure their disability.

Bill Smith (33m 52s):
So suppose they're non-ambulatory and they're in a wheelchair, the drug does enough to get them out of the wheelchair, but they still have to use a walker. That drug for the disabled person, even though it extends their life 10 years, is not going to get as high a rating as the drug for the non-disabled person, because it doesn't cure the disability. Yet to that person living with a disability, a drug that's going to extend their life 10 years and improve their life a little bit, is just as valuable as it is to the other person. So there's a sense in which the quality discriminates against people living with disabilities and devalues the therapies that they might be taking. So that's the argument I would make that this is a violation of the ADA.

Bill Smith (34m 35s):
You can't value the drugs for disabled folks, less than for others.

Terry Wilcox (34m 39s):
We've talked to obviously health economists, we've worked with a health economist at the Patient Access and Affordability Project, which is one of our programs, who is just adamant that the quality is just not the right answer anyway for scientific reasons, harder argument for patients to make, and then when you go into the economic realm that the ADA argument is much better for a patient advocate to be making, I believe, what do we see can change this? What can take the place of this quality road that we're going down that we all know is wrong?

Bill Smith (35m 10s):
Well, I, I think patient advocates should take hope in the British example. I've been reading the history of NICE, which is the British version of ICER and the cost-effectiveness body in Britain that rates therapies for the National Health Service and NICE is actually even more powerful than ICER because the National Service is a single payer system throughout England. So once NICE makes a decision about a drug, it's decided for everybody for the whole country. Years ago, NICE was making all these reviews of oncology drugs and the reviews were slow and delayed. They were using the quality, which isn't a good tool to use when you're raiding oncology therapies, make a long story short, the Parliament woke up one day, I think it was 2011, and they discovered after doing some research, that people in Britain had the worst cancer care in the developed world, the worst, and this generated enormous pushback from patient advocates, and new drugs that were coming out like Herceptin weren't being given out because NICE hadn't done the reviews and they were likely not to be rated cost-effective for certain people.

Bill Smith (36m 21s):
The patient advocates just descended on Parliament and said, we're not going to put up with this. We want access to these new drugs. We don't want to have second grade, third grade care in this country. And due to those patient advocates, the Parliament responded and created something called the Cancer Drugs Fund and they appropriated 200 million pounds. And they said to NICE, you're not involved in deciding cancer drugs anymore. We're just going to pay for the best therapies. And we're going to catch up with the rest of the continent. And that was largely due to the efforts of patient advocates. So I wouldn't lose hope here on this ICER thing. There are a lot of political cards to play for patients and others. And as we've seen in Britain, you can win.

Terry Wilcox (37m 0s):
Absolutely. And we've seen that with patient advocates here, you know, beating back on trying to destroy the six protected classes and a variety of other things. The advocacy world here is quite mouthy. I would say we can definitely do it as well. I do think from a federal perspective that there's champions on both sides of the aisle against the quality. I don't think it's one party or the other, but we have heard that there could possibly be some sort of, you know, newer therapy commission that might help decide drug pricing that could involve ICER. I mean, we don't know exactly or could involve an ICER like type entity or even ICER itself. Have you heard anything about that and do you have any thoughts?

Bill Smith (37m 42s):
Yeah. Yeah. I think what people are pointing to is a campaign promise of President Biden, then candidate Biden, where he had a one bullet in his healthcare platform in which he said for specialty drugs, and that would probably include orphan drugs and rare disease drugs, we're going to appoint an independent commission that's going to rate the value of these drugs. That's basically all, I read the plank itself. That's basically all it says. It's only a few sentences. And so people have been reading all sorts of things into that. They've been saying, for example, off the record, some Biden people are saying what we're looking at is using the German cost-effectiveness system which actually isn't a quality system and among European systems, it's not as good as the United States.

Bill Smith (38m 25s):
Among European systems, it's better than most. So there's this rumor that some kind of cost-effectiveness criteria is going to be applied to specialty orphan and rare disease drugs. And that would make some sense in the sense that the new innovation, the real growth what's coming out of the laboratories of the biopharmaceutical companies are specialty rare disease and orphan drugs and oncology drugs to some degree. And so that's where the costs are coming from. A lot of the older medicines, the statins for cholesterol, hypertensives, diabetes, drugs. A lot of those are going off patent actually providing a lot of savings, as I said before, but the cost growth is coming. The innovation is coming in some of these drugs for smaller patient groups.

Bill Smith (39m 7s):
So the Biden administration has put out this platform saying we're going to have some kind of independent commission to use some kind of cost effectiveness criteria to do that.

Terry Wilcox (39m 16s):
I just had a conversation the other day about a therapy that's about to go through its FDA process and it's going to treat maybe 500 people. So when you're talking about a drug that benefits 500 people, and you know, you still have to go through, you can argue the semantics of whether it's 1 billion or 2 billion or whatever, it was still expensive for 500 people. And we really have to look at that as we're trying to figure out how to move at the speed of innovation for all the patients waiting

Bill Smith (39m 46s):
The clinical trials for rare disease drugs are enormously expensive. So think about that. There's 500 patients in the whole country. So if you want to do a clinical trial for a therapy like that, and you find one patient in rural Idaho, you have to set up an entire clinic in rural Idaho to regularly take that patient's blood, to regularly take their vitals, to see how the drug might be affecting them, and their side effects, you have a whole team of people that have to land in rural Idaho for that one patient. So the R and D costs are very expensive. And then as I said, the number of customers are very few. So the rare disease model is going to make drugs more expensive. The good news is the innovations are staggering.

Bill Smith (40m 26s):
I mean you're looking at potential cures for Hemophilia, Muscular Dystrophy, I mean, unbelievably terrible diseases that have been around a long time where there are drugs in clinical trials,

Terry Wilcox (40m 38s):
Bill, I really thank you for joining us today. It's been a pleasure to finally have you on, you're such a wealth of knowledge and information about all of these things, and I definitely need to have you back because there's more that I know we could talk about.

Bill Smith (40m 50s):
Terry, an honor to be here.

Terry Wilcox (40m 55s):
This episode of the Patients Rising podcast is brought to you by Patients Rising Concierge, a new service from Patients Rising that helps patients and caregivers find the resources they need to find stability and support throughout their healthcare journey. From finding a professional advocate, to help with insurance challenges, to legal and tax counsel, to local caregiving resources and so much more, our team is standing by to help you navigate the healthcare system and connect you to the services you need to learn more. Visit patientsrisingconcierge.org or email us at askusanythingatpatientsrising.org.

Dr. Bob Goldberg (41m 47s):
Thank you for bringing us the interview, Terry. Now up next Field Correspondent, Kate Pecora, continues to bring us patient stories from across the country for Rare Disease Day. She spoke with Marnie Cartelli who shares her experiences living with Complex Regional Pain Syndrome. Take a listen.

Kate Pecora (42m 5s):
Today, I'm joined with Marnie Cartelli who's been diagnosed with Complex Regional Pain Syndrome, which is a rare chronic pain disease. Marnie, It's great to have you join me.

Marnie Cartelli (42m 14s):
Thank you so much for having me I'm happy to be here.

Kate Pecora (42m 16s):
So I want to start talking about Complex Regional Pain Syndrome and what that diagnosis means to you. As I kind of understand it, you found your diagnosis through an injury that you got back in 2015. So could you walk me through what CRPS is and how it impacts your daily life?

Marnie Cartelli (42m 34s):
Sure, of course. So Complex Regional Pain Syndrome, or CRPS, which is just easier to know it by, is a neuroinflammatory disease, which is most often brought about from an injury. It can happen spontaneously, but most often, I'd say 90% of the cases have happened after, you know, an injury and what'll happen is most times after we get injuries, you have an injury and then you heal and your nerves turn off. But in CRPS, your nerves actually are so excited that your brain never gives them the signal to turn off long after the injury is healed. And what happens is your brain learns by shortcuts. So it creates a shortcut that you're in pain constantly.

Marnie Cartelli (43m 16s):
So even after that signal goes away that you are in pain, that shortcut has been created telling your brain that you're in pain. So it's now on a feedback loop saying you're in pain, you're in pain, you're in pain. So you think you're in pain when really the nerves are not firing anymore, they're not in pain. So it'll start out in the area that you have gotten injured in. But what happens is once it reaches that chronic stage, any area that is innervated by nerves can be affected because it's now in your brain and it's all on that loop that's telling it. So treatments of the disease are targeted in one of two ways, either to interrupt that originating signal early on, or to interrupt that feedback loop that's gone on in your brain later on in the disease.

Marnie Cartelli (44m 4s):
And for me, I'm very fortunate in that I have it originating in my right upper body, on my right shoulders, where I had my originating injury and it spread down my right arm, which is where I get the worst of my symptoms. I get tremors, I get loss of muscle control. My limbs will swell or they'll go completely numb and they'll look like a skeleton. It's also spread into my left arm and it's now spread down into my left leg. But I'm fortunate in that my left leg is still responding to a lot of treatments. My upper body has gone very chronic stage if you will, and doesn't really respond to much of anything, but I consider myself incredibly fortunate in that my leg still does respond to treatments.

Kate Pecora (44m 48s):
So you've been active as a healthcare worker even before your diagnosis. So I'm wondering if the diagnosis has changed the way that you think about the healthcare system and sort of the way people react to chronic pain patients within that system, right. So chronic pain I think can be especially a difficult diagnosis to have, you know, the complete and proper support.

Marnie Cartelli (45m 9s):
I have to say, I was my harshest critic in the beginning with the chronic pain and I think that comes from the medical community. Although my circle in the medical community never doubted me. It never doubted the pain, but I think I didn't understand why I was in so much pain. It didn't make sense. So I thought I was just overreacting. Now I was, unlike most people with this condition, I was never accused of overreacting. I was never told, you know, everybody thought something was wrong, except I thought I was going crazy. I thought I must not be able to handle pain. And I'll be completely honest, my coworkers thought I was overreacting. I worked in an operating room and I was out of work while this was going on and I kept getting texts of aren't you overreacting for a shoulder issue, you know, shouldn't you be back at work by now?

Marnie Cartelli (45m 56s):
None of the physicians that were treating me ever thought that, they all believed something was going on and we had to figure out what was wrong. But the other nurses, the other scrubs, everybody else that worked in the healthcare field with me, they thought I must be making more out of this. And I don't know why that is. I don't know where in my mind I thought that pain can't be that bad, but literally the pain was so bad, I didn't understand how I could still be alive and experiencing the level of pain that I was in. I wouldn't take the pain pills I was prescribed. I had surgery and I was prescribed pain medication after, and I would literally half and quarter the pills and take the bare minimum and lay there with ice packs in bed, pack encased in ice, which anyone who has CRPS will tell you, the worst thing you can do is ice on the nerves.

Marnie Cartelli (46m 52s):
But we didn't know at the time I had CRPS so I probably did more damage by doing that, but I was terrified of pain medication because this is in 2015 at the height, well I guess we're still in the height of the pain war, the war against pain. But all you see on the news is don't take pain medication and it's terrible and one lick of a pill and you're going to become addicted. I was terrified so I didn't take it. And I would go to the doctor and I would have my pill bottle and I would open the top and be like, look, I didn't take anything. And he would lose his mind and go, I need you to take your pain medication because I need you to move. You're going to cause damage if you don't actually move. And that's exactly what happened. I caused more damage because I developed all this scar tissue.

Marnie Cartelli (47m 33s):
My shoulder locked down, I had to have a second surgery. It was an absolute mess. So I did more damage by listening to whatever preconceived notions I had in my head than actually following doctor's orders.

Kate Pecora (47m 47s):
I know that there are some special groups in your life that you've kind of been able to reach out to and to feel heard within this journey, to be able to talk to, and to be able to, you know, kind of bounce ideas off of. Could you tell me about how both large groups and small organizations have been able to support you and make you feel more empowered as you're moving through your diagnosis?

Marnie Cartelli (48m 9s):
Sure. I want to start off by saying the biggest support I've ever had were my doctors. And like you said, that is incredibly rare in rare and chronic, but it's such a necessary component because I laugh and I smile and I joke, but like so many in rare, I went through a really dark time and I almost ended up killing myself over all of this because you lose so much in the process. I lost my career. I lost so many friends. You know, I thought I lost family and it's very hard to digest all of that. And it was my doctors that got me through. It was them who realized that I hid it so well at home. My husband, and we're super close, my husband and I, you know, we're making our marriage work, you know, through all this.

Marnie Cartelli (48m 54s):
But my doctors picked up on there's something really serious going on here. And they got me into therapy and they got me help. So when I got angry and I realized I needed to do things and I needed to change, I didn't know where to start. I literally Googled how do you advocate for a rare disease, and RDLA, rare disease legislative advocates, their rare disease popped up. And I signed up for it. It was the very first thing I ever did. And I advise anyone who wants to get involved in advocacy, do it once. At least once. I do it every year, but I highly recommend it because it's a crash course in how to advocate. I was so fortunate in that my first year I got teamed up with some of the best advocates that are out there and they didn't let me hide.

Marnie Cartelli (49m 38s):
I wasn't able to stand in the back. You know, like you want to, you want to just stand back. In my first year, I don't want to do anything. And they're like, Oh, you're new. You go talk. And it was the best thing that I could have ever done. One organization in particular means a great deal to me. And I don't do work for them. They just have helped me out. And that's uplifting athletes. They're an organization that is dedicated to connecting rare and inspiring rare through sports, which actually sounds in the beginning, it was like, how is that even connected? But the truth of the matter is there's so many parallels between the sports world and the rare disease world. In particular, there was a group, an article came out about me and my struggles during COVID and one of their chapters, the Northwestern chapter, I'm wearing their shirt now, reached out to me.

Marnie Cartelli (50m 23s):
And it was a couple of kids from their Northwestern chapter reached out because they apparently were really moved by the story and they wanted to learn more about the rare disease experience and what we as patients go through. And I sat down and I had a conversation with them and I figured out I'll never ever hear from these kids again, they're 20 something years old with a life. And they're a division one school doing amazing things. I got to tell you, I talk to them all the time and they had an amazing season and we talk, they care, they raise awareness left and right for the rare disease community, we had bets the season going on. They were going to fight for the championship. And it made me realize watching them that there are a lot of parallels, the mentality that has to go into training for sports, you know, talking to them.

Marnie Cartelli (51m 12s):
And what we go through as rare disease patients. It's very similar, the sacrifices that they make, the sacrifices we make. So I really have to give a shout out to the guys at Northwestern, to Pete, to Joe, to Conrad, to PJ, you guys are doing amazing things for the rare disease community and lifting every one of us off. And thank you for that.

Kate Pecora (51m 31s):
So you talked about, you know, kind of big and small organizations that I know that, you know, over the past six years, you have, you know, taken on different roles. Like you said, even in the beginning, you were pushed to be more outgoing. So part of that has been sort of taking these leadership roles in different organizations. So could you tell me about like your different focuses, you know, specifically around policy development. I know that's, you know, close to your heart. So could you tell me about like, why that's important to you and you know, some initiatives that you've been working on?

Marnie Cartelli (52m 1s):
So for policy, there's a whole lot of stuff that's going on, but one of the big things for me is drug repurposing. The reason this is so important for me is especially within the rare disease community is the big number. Everybody knows is 95% of rare disease. Drugs have no FDA approved treatment. And CRPS is one of them. This is really personal to me because I feel that I lost my career. I lost my job because of this. One of the ways to treat CRPS is a procedure or a treatment called the stellate ganglion block, upper body. And it's an injection of a local anesthetic in your sympathetic nervous system. And what it does is it interrupts, like I was explaining, it interrupts the signal pathway down your arm. And I responded beautifully to these and I was getting them while I was returning to work.

Marnie Cartelli (52m 46s):
And we did a couple and I was able to work, but I needed them repeatedly in order to be able to work in the operating room and do it because it's off label. Even though this is a customary first line treatment for CRPS, technically it isn't FDA approved. So they were able to deny me and not give it to me and hold it up. We did fight it. And we went all the way to an administrative hearing and got it approved. But by the time I think this was six to eight months later, you know, you have to go through everything that 30 days appeal, then the denial, then another 30 days of an appeal on that denial. By the time we got it approved, when we did do the injection, it didn't work.

Marnie Cartelli (53m 30s):
So I was offered and given opioid therapy for the pain because I live in pain 24/7, and it does work for me, but I couldn't work in the operating room on opioid therapy. I can't operate on patients on opioids. So I am a big believer in drug repurposing and therapy repurposing and getting things on label so that we don't have loopholes because something is inexpensive that I would be working. I mean, on one end, I wouldn't be out here advocating, but on the other end, I wouldn't have lost my job. My family wouldn't be in the position that we're in. The disease wouldn't be running rampant through my body because since then the disease was limited to just one area and now it's spread to the complete other side and down my leg.

Marnie Cartelli (54m 17s):
Since then, additionally, I do believe in awareness and education over opioids because I believe the pendulum has swung too far in restrictions on opioids. And I believe it's a misunderstanding. I don't like to think it's out of maliciousness. I think people have good intentions. And I think there was misuse. And I believe there was over prescribing that did happen a long time ago. And I think people are working off old data. And I think they're trying corrective action that is outdated, but I think people don't understand the unintended consequences of some of their legislation that's happening and some of the guidelines. And I think rare and chronic and pain are falling through the cracks and are being abandoned.

Kate Pecora (55m 3s):
Thank you, Marnie. It was really fantastic to talk to you. I hope we can catch up soon.

Marnie Cartelli (55m 8s):
Yes. Thank you so much. This was lovely. Thank you.

Terry Wilcox (55m 12s):
Thank you, Kate. And thank you Marnie, for sharing your story with us. Now, it's one of our favorite parts of the show. As we get to hear directly from members of the Patients Rising community. Here is this week's patient correspondent.

Lillian Isabella (55m 25s):
Lillian Isabella here coming at you from New York City. So happy Rare Disease Day folks. This is an amazing day because we're able to feel connected to a community of people around a subject, and a reality for many of us that has often made us feel kind of lonely. So whoever you are out there, whatever your rare disease is, I welcome you into my heart. And my thoughts on this day, especially my rare disease is PKU. It's also known as Phenylketonuria. Basically. I can't break down the amino acid phenylalanine, which is found in food high in protein.

Lillian Isabella (56m 6s):
So I've never eaten meat in my life, can't have cheese, yogurt, beans, nuts, dairy, none of that. And I've said that monologue so many times, and you know, you get really used to explaining yourself when you've got a rare disease, you know, kind of like breaking it down for people and being strong and being open. And you know what, sometimes you just want to be and that's it on Rare Disease Day. It is a time to celebrate though. It's time to celebrate being rare. It's a time to celebrate the community that we're a part of. And it's a time to celebrate our ability to advocate for ourselves. Rare Disease Day wasn't always a thing. You know, people worked hard to make it a thing. And I think that many of us are pushing for legislative efforts right now that are not a thing that we would like to actualize.

Lillian Isabella (56m 49s):
And, you know, Patients Rising is doing a wonderful job galvanizing and getting us prepared to do that. And I am so grateful to them. My congressional district is New York City, congressional district 10. And if you don't know yours, just quickly hop onto Google and you can find out in a minute. Happy Rare Disease Day. I am proud to be rare.

Dr. Bob Goldberg (57m 16s):
Hearing from you inspires us each and every day and it shows just how important your voice is and your advocacy is. So if you have a story or experience you'd like to share, you can become a patient correspondent on an upcoming episode, just send an email to me and Terry at podcast@patientsrising.org that is podcast@patientsrising.org.

Terry Wilcox (57m 37s):
Thank you so much for joining us for today's episode. If you've been enjoying the show, and we hope that you are, we would love it if you could leave us a rating and a review on Apple podcasts. You can also share the episode with friends and family on social media.

Dr. Bob Goldberg (57m 50s):
And while you're there, don't forget to subscribe to the Patients Rising podcast for free on your favorite podcast app. Actually, Terry, what I could do for every new subscriber, I'll just make a snowman in the image

Terry Wilcox (58m 2s):
We will make a snowman of you.

Dr. Bob Goldberg (58m 4s):
Yes, exactly.

Terry Wilcox (58m 8s):
We'll be back again next week with another new episode. Until then for Dr. Bob and everyone at Patients Rising, I'm Terry Wilcox, keep your distance and stay healthy.