STAT+: Pharmalittle: Eisai executive to retire; Express Scripts adds three Humira biosimilars to formulary
Top of the morning to you, and a fine one it is. Birds are chirping and cool breezes are wafting by the Pharmalot campus, where the official mascots are racing about the grounds. As for us, we are ensconced doing the usual sorts of things — updating our to-do list, brewing cups of stimulation (our choice today is chocolate raspberry) and foraging for items of interest.
Speaking of which, we have gathered the latest bushel for your perusal if you scroll down a wee bit. Of course, all of this means that it is time to get cracking. So here we go. We hope you have a smashing day and conquer the world. And as always, please do stay in touch …
Eisai announced that Ivan Cheung, who ran its global Alzheimer’s drug program, will retire at the end of the month and be replaced by the son of Eisai chief executive officer Haruo Naito, STAT writes. The move comes after Cheung led the push for U.S. approval of the breakthrough medicine Leqembi. Keisuke Naito, 34, a senior vice president and chief strategy and planning officer, will become acting global Alzheimer’s officer. Cheung’s resignation comes less than a week after Eisai and Biogen were granted full approval for Leqembi in the U.S. The drug is the first medicine shown to slow progression of the disease, which afflicts some 6 million Americans.
Express Scripts will add three biosimilar versions of AbbVie’s blockbuster arthritis treatment Humira to its list of preferred drugs, Reuters notes. The biosimilars include branded and unbranded versions from Sandoz, the generic unit of Novartis, as well as one from Boehringer Ingelheim. Express Scripts, the pharmacy benefits manager owned by Cigna, said the biosimilars would be included as preferred brands on its formulary. The drugs, launched this month, add to competition for Humira in the U.S. that started in January with the launch of a biosimilar by Amgen that is already on Express Scripts formulary.
1 year 9 months ago
Pharma, Pharmalot, Biosimilars, Pharmaceuticals, STAT+
STAT+: Up and down the ladder: The latest comings and goings
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.
And here is our regular feature in which we highlight a different person each week. This time around, we note that Reata Pharmaceuticals hired Rajiv Patni as executive vice president, chief R&D officer. Previously, he worked at Global Blood Therapeutics, where he was chief medical officer.
But all work and no play can make for a dull chief medical officer.
1 year 9 months ago
Pharma, Pharmalot, Pharmaceuticals, STAT+
STAT+: Pharmalittle: PBMs are targeted in yet another congressional bill; access to new Alzheimer’s drug may not happen quickly
Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of salted caramel mocha for the occasion. We can practically taste the Jersey shore.
Meanwhile, our ever-growing to-do list requires attention. Sound familiar? So, here are some items of interest. Have a great day and hope you conquer the world, everyone …
Coherus BioSciences agreed to resolve a dispute over its plans to launch a lower-priced version of AbbVie’s Humira rheumatoid arthritis drug, Reuters writes. Earlier this month, Coherus said it will launch a biosimilar version of the drug at an 85% discount to the $6,922 list price and partnered with Mark Cuban Cost Plus Drug Company to sell it at $569.27. AbbVie alleged it breached an older deal granting Coherus a non-exclusive license to commercialize a biosimilar version in the U.S. as of July 1. AbbVie will not terminate the initial licensing deal based on its notice. It would have to serve another notice and give Coherus time to resolve the breach if it chooses to end the deal.
Expanded access to the Alzheimer’s drug from Eisai and Biogen is unlikely to happen quickly even if the Food and Drug Administration decides follow-up studies confirm the drug helps slow the disease, Bloomberg News explains. Medicare said that “broader” coverage would begin “on the same day the FDA grants traditional approval.” But patients, doctors, and analysts are all doubtful, citing the limited information publicized by the agency on how the registry will work. For the registry to succeed, it must be easy for prescribers to use, they argue. Researchers and others also will need real-time data to show whether the drug is beneficial and safe, they added.
1 year 10 months ago
Pharma, Pharmalot, Biosimilars, Pharmaceuticals, STAT+
Debt Deal Leaves Health Programs (Mostly) Intact
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
A final deal cut between President Joe Biden and House Republicans extends the U.S. debt ceiling deadline to 2025 and reins in some spending. The bill signed into law by the president will preserve many programs at their current funding levels, and Democrats were able to prevent any changes to the Medicare and Medicaid programs.
Still, millions of Americans are likely to lose their Medicaid coverage this year as states are once again allowed to redetermine who is eligible and who is not; Medicaid rolls were frozen for three years due to the pandemic. Data from states that have begun to disenroll people suggests that the vast majority of those losing insurance are not those who are no longer eligible, but instead people who failed to complete required paperwork — if they received it in the first place.
This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Lauren Weber of The Washington Post, and Jessie Hellmann of CQ Roll Call.
Panelists
Jessie Hellmann
CQ Roll Call
Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Lauren Weber
The Washington Post
Among the takeaways from this week’s episode:
- Lawmakers and White House officials spared health programs from substantial spending cuts in a last-minute agreement to raise the nation’s debt ceiling. And Biden named Mandy Cohen, a former North Carolina health director who worked in the Obama administration, to be the next director of the Centers for Disease Control and Prevention. Though she lacks academic credentials in infectious diseases, Cohen enters the job with a reputation as someone who can listen and be listened to by both Democrats and Republicans.
- The removal of many Americans from the Medicaid program, post-public health emergency, is going as expected: With hundreds of thousands already stripped from the rolls, most have been deemed ineligible not because they don’t meet the criteria, but because they failed to file the proper paperwork in time. Nearly 95 million people were on Medicaid before the unwinding began.
- Eastern and now southern parts of the United States are experiencing hazardous air quality conditions as wildfire smoke drifts from Canada, raising the urgency surrounding conversations about the health effects of climate change.
- The drugmaker Merck & Co. sued the federal government this week, challenging its ability to press drugmakers into negotiations over what Medicare will pay for some of the most expensive drugs. Experts predict Merck’s coercion argument could fall flat because drugmakers voluntarily choose to participate in Medicare, though it is unlikely this will be the last lawsuit over the issue.
- In abortion news, some doctors are pushing back against the Indiana medical board’s decision to reprimand and fine an OB-GYN who spoke out about providing an abortion to a 10-year-old rape victim from Ohio. The doctors argue the decision could set a bad precedent and suppress doctors’ efforts to communicate with the public about health issues.
Also this week, Rovner interviews KFF Health News senior correspondent Sarah Jane Tribble, who reported the latest KFF Health News-NPR “Bill of the Month” feature, about a patient with Swiss health insurance who experienced the sticker shock of the U.S. health care system after an emergency appendectomy. If you have an outrageous or exorbitant medical bill you want to share with us, you can do that here.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The New York Times’ “This Nonprofit Health System Cuts Off Patients With Medical Debt,” by Sarah Kliff and Jessica Silver-Greenberg.
Jessie Hellmann: MLive’s “During the Darkest Days of COVID, Some Michigan Hospitals Made 100s of Millions,” by Matthew Miller and Danielle Salisbury.
Joanne Kenen: Politico Magazine’s “Can Hospitals Turn Into Climate Change Fighting Machines?” by Joanne Kenen.
Lauren Weber: The Washington Post’s “Smoke Brings a Warning: There’s No Escaping Climate’s Threat to Health,” by Dan Diamond, Joshua Partlow, Brady Dennis, and Emmanuel Felton.
Also mentioned in this week’s episode:
KFF Health News’ “As Medicaid Purge Begins, ‘Staggering Numbers’ of Americans Lose Coverage,” by Hannah Recht.
Click to open the transcript
Transcript: Debt Deal Leaves Health Programs (Mostly) Intact
KFF Health News’ ‘What the Health?’Episode Title: Debt Deal Leaves Health Programs (Mostly) IntactEpisode Number: 301Published: June 8, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?”. I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week from the smoky, hazy, “code purple” Washington, D.C., area on Thursday, June 8, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.
Joanne Kenen: Hi, everybody.
Rovner: Lauren Weber, of The Washington Post.
Lauren Weber: Hi.
Rovner: And Jessie Hellmann, of CQ Roll Call.
Hellmann: Hello.
Rovner: Later in this episode we’ll have my interview with KFF Health News’s Sarah Jane Tribble about the latest KFF Health News-NPR “Bill of the Month.” This month is about the sticker shock of the American health care system experienced by residents of other countries. Before we get to this week’s news, I hope you all enjoyed our special panel of big health policy thinkers for our 300th episode. If you didn’t listen, you might want to go back and do that at some point. Also, that means we have two weeks of news to catch up on, so let us get to it. We’re going to start this week, I hope, for the last time with the fight over the debt ceiling. Despite lots of doubts, President Biden managed to strike a budget deal with House Republicans, which fairly promptly passed the House and Senate and was signed into law a whole two days before the Treasury Department had warned that the U.S. might default. The final package extends the debt ceiling until January 1, 2025, so after the next election, which was a big win for the Democrats, who don’t want to do this exercise again anytime soon. In exchange, Republicans got some budget savings, but nothing like the dramatic bill that House Republicans passed earlier this spring. So, Jessie, what would it do to health programs?
Hellmann: The deal cuts spending by 1.5 trillion over 10 years. It has caps on nondefense discretionary funding. That would have a big impact on agencies and programs like the NIH [National Institutes of Health], which has been accustomed to getting pretty large increases over the years. So nondefense discretionary spending will be limited to about 704 billion next fiscal year, which is a cut of about 5%. And then there’s going to be a 1% increase in fiscal 2025, which, when you consider inflation, probably isn’t much of an increase at all. So the next steps are seeing what the appropriators do. They’re going to have to find a balance between what programs get increases, which ones get flat funding — it’s probably going to be a lot of flat funding, and we’re probably at the end of an era for now with these large increases for NIH and other programs, which have traditionally been very bipartisan, but it’s just a different climate right now.
Rovner: And just to be clear, I mean, this agreement doesn’t actually touch the big sources of federal health spending, which are Medicare and Medicaid, not even any work requirements that the Republicans really wanted for Medicaid. In some ways, the Democrats who wanted to protect health spending got off pretty easy, or easier than I imagine they expected they would, right?
Hellmann: Advocates would say it could have been much worse. All things considered, when you look at the current climate and what some of the more conservative members of the House were initially asking for, this is a win for Democrats and for people who wanted to protect health care spending, especially the entitlements, because they — Republicans did want Medicaid work requirements and those just did not end up in the bill; they were a nonstarter. So, kind of health-care-related, depending on how you look at it, there was an increase in work requirements for SNAP [Supplemental Nutrition Assistance Program], which is, like, a food assistance program. So that will be extended to age 55, though they did include more exemptions for people who are veterans —
Rovner: Yeah, overall, that may be a wash, right? There may be the same or fewer people who are subject to work requirements.
Hellmann: Yeah. And all those changes would end in 2030, so —
Weber: Yeah, I just wanted to say, I mean, if we think about this — we’re coming out of a pandemic and we’re not exactly investing in the health system — I think it’s necessary to have that kind of step-back context. And we’ve seen this before. You know, it’s the boom-bust cycle of pandemic preparedness funding, except accelerated to some extent. I mean, from what I understand, the debt deal also clawed back some of the public health spending that they were expecting in the billions of dollars. And I think the long-term ramifications of that remain to be seen. But we could all be writing about that in 10 years again when we’re looking at ways that funding fell short in preparedness.
Rovner: Yeah, Joanne and I will remember that. Yeah, going back to 2001. Yeah. Is that what you were about to say?
Kenen: I mean, this happens all the time.
Weber: All the time, right.
Kenen: And we learn lessons. I mean, the pandemic was the most vivid lesson, but we have learned lessons in the past. After anthrax, they spent more money, and then they cut it back again. I mean, I remember in 2008, 2009, there was a big fiscal battle — I don’t remember which battle it was — you know, Susan Collins being, you know, one of the key moderates to cut the deal. You know, what she wanted was to get rid of the pandemic flu funding. And then a year later, we had H1N1, which turned out not to be as bad as it could have been for a whole variety of reasons. But it’s a cliche: Public health, when it works, you don’t see it and therefore people think you don’t need it. Put that — put the politics of what’s happened to public health over the last three years on top of that, and, you know, public health is always going to have to struggle for funds. Public health and larger preparedness is always going to happen to have to struggle for funds. And it would have, whether it was the normal appropriations process this year, which is still to come, or the debt ceiling. It is a lesson we do not learn the hard way.
Weber: That’s exactly right. I’ll never forget that Tom Harkin said to me that after Obama cut, he sacrificed a bunch of prevention funding for the CDC [Centers for Disease Control and Prevention] in the ACA [Affordable Care Act] deal, and he never spoke to him again, he told me, because he was so upset because he felt like those billions of dollars could have made a difference. And who knows if 10 years from now we’ll all be talking about this pivotal moment once more.
Rovner: Yeah, Tom Harkin, the now-former senator from Iowa, who put a lot of prevention into the ACA; that was the one thing he really worked hard to do. And he got it in. And as you point out, and it was almost immediately taken back out.
Weber: Yeah.
Kenen: Not all of it.
Weber: Not all of it, but a lot of it.
Kenen: It wasn’t zero.
Rovner: It became a piggy bank for other things. I do want to talk about the NIH for a minute, though, because Jessie, as you mentioned, there isn’t going to be a lot of extra money, and NIH is used to — over the last 30 years — being a bipartisan darling for spending. Well, now it seems like Congress, particularly some of the Republicans, are not so happy with the NIH, particularly the way it handled covid. There’s a new NIH director who has been nominated, Dr. Monica Bertagnolli, who is currently the head of the National Cancer Institute. This could be a rocky summer for the NIH on Capitol Hill, couldn’t it?
Hellmann: Yeah, I think there’s been a strong desire for Republicans to do a lot of oversight. They’ve been looking at the CDC. I think they’re probably going to be looking at the NIH next. Francis Collins is no longer at NIH. Anthony Fauci is no longer there. But I think Republicans have indicated they want to bring them back in to talk about some of the things that happened during the pandemic, especially when it comes to some of the projects that were funded.
Kenen: There was a lull in raising NIH spending. It was flat for a number of years. I can’t remember the exact dates, but I remember it was — Arlen Specter was still alive, and it … [unintelligible] … because he is the one who traditionally has gotten a lot of bump ups in spending. And then there was a few years, quite a few years, where it was flat. And then Specter got the spigots opened again and they stayed open for a good 10 or 15 years. So we’re seeing, and partly a fiscal pause, and partly the — again, it’s the politicization of science and public health that we did not have to this extent before this pandemic.
Rovner: Yeah, I think it’s been a while since NIH has been under serious scrutiny on Capitol Hill. Well, speaking of the CDC, which has been under serious scrutiny since the beginning of the pandemic, apparently is getting a new director in Dr. Mandy Cohen, assuming that she is appointed as expected. She won’t have to be confirmed by the Senate because the CDC director won’t be subject to Senate approval until 2025. Now, Mandy Cohen has done a lot of things. She worked in the Obama administration on the implementation of the Affordable Care Act. She ran North Carolina’s Department of Health [and Human Services], but she’s not really a noted public health expert or even an infectious disease doctor. Why her for this very embattled agency at this very difficult time?
Kenen: I think there are a number of reasons. A lot of her career was on Obamacare kind of things and on CMS kind of quality-over-quantity kind of things, payment reform, all that. She is a physician, but she did a good job in North Carolina as the top state official during the pandemic. I reported a couple of magazine pieces. I spent a lot of time in North Carolina before the pandemic when she was the state health secretary, and she was an innovator. And not only was she an innovator on things like, you know, integrating social determinants into the Medicaid system; she got bipartisan support. She developed not perfect, but pretty good relations with the state Republicans, and they are not moderates. So I think I remember writing a line that said something, you know, in one of those articles, saying something like, “She would talk to the Republicans about the return on investment and then say, ‘And it’s also the right thing to do.’ And then she would go to the Democrats and say, ‘This is the right thing to do. And there’s also an ROI.’”. So, so I think in a sort of low-key way, she has developed a reputation for someone who can listen and be listened to. I still think it’s a really hard job and it’s going to batter anyone who takes it.
Rovner: I suspect right now at CDC that those are probably more important qualities than somebody who’s actually a public health expert but does not know how to, you know, basically rescue this agency from the current being beaten about the head and shoulders by just about everyone.
Kenen: Yeah, but she also was the face of pandemic response in her state. And she did vaccination and she did disparities and she did messaging and she did a lot of the things that — she does not have an infectious disease degree, but she basically did practice it for the last couple of years.
Rovner: She’s far from a total novice.
Kenen: Yeah.
Rovner: All right. Well, it’s been a while since we talked about the Medicaid “unwinding” that began in some states in early April. And the early results that we’re seeing are pretty much as expected. Many people are being purged from the Medicaid rolls, not because they’re earning too much or have found other insurance, but because of paperwork issues; either they have not returned their paperwork or, in some cases, have not gotten the needed paperwork. Lauren, what are we seeing about how this is starting to work out, particularly in the early states?
Weber: So as you said, I mean, much like we expected to see: So 600,000 Americans have been disenrolled so far, since April 1. And some great reporting that my former colleague Hannah Recht did this past week: She reached out to a bunch of states and got ahold of data from 19 of them, I believe. And in Florida, it was like 250,000 people were disenrolled and somewhere north of 80% of them, it was for paperwork reasons. And when we think about paperwork reasons, I just want us all to take a step back. I don’t know about anyone listening to this, but it’s not like I fill out my bills on the most prompt of terms all of the time. And in some of these cases, people had two weeks to return paperwork where they may not have lived at the same address. Some of these forms are really onerous to fill out. They require payroll tax forms, you know, that you may not have easily accessible — all things that have been predicted, but the hard numbers just show is the vast majority of people getting disenrolled right now are being [dis]enrolled for paperwork, not because of eligibility reasons. And too, it’s worth noting, the reason this great Medicaid unwinding is happening is because this was all frozen for three years, so people are not in the habit of having to fill out a renewal form. So it’s important to keep that in mind, that as we’re seeing the hard data show, that a lot of this is, is straight-up paperwork issues. The people that are missing that paperwork may not be receiving it or just may not know they’re supposed to be doing it.
Rovner: As a reminder, I think by the time the three-year freeze was over, there were 90 million people on Medicaid.
Kenen: Ninety-five.
Rovner: Yeah. So it’s a lot; it’s like a quarter of the population of the country. So, I mean, this is really impacting a lot of people. You know, I know particularly red states want to do this because they feel like they’re wasting money keeping ineligible people on the rolls. But if eligible people become uninsured, you can see how they’re going to eventually get sicker, seek care; those providers are going to check and see if they’re eligible for Medicaid, and if they are, they’re going to put them back on Medicaid. So they’re going to end up costing even more. Joanne, you wanted to say something?
Kenen: Yeah. Almost everybody is eligible for something. The exceptions are the people who fall into the Medicaid gap, which is now down to 10 states.
Rovner: You mean, almost everybody currently on Medicaid is eligible.
Kenen: Anyone getting this disenrollment notification or supposed to receive the disenrollment notification that never reaches them — almost everybody is eligible for, they’re still eligible for Medicaid, which is true for the bulk of them. If they’re not, they’re going to be eligible for the ACA. These are low-income people. They’re going to get a lot heavily subsidized. Whether they understand that or not, someone needs to explain it to them. They’re working now, and the job market is strong. You know, it’s not 2020 anymore. They may be able to get coverage at work. Some of them are getting coverage at work. One of the things that I wrote about recently was the role of providers. States are really uneven. Some states are doing a much better job. You know, we’ve seen the numbers out of Florida. They’re really huge disenrollment numbers. Some states are doing a better job. Georgetown Center on Health Insurance — what’s the right acronym? — Children’s and Family. They’re tracking, they have a state tracker, but providers can step up, and there’s a lot of variability. I interviewed a health system, a safety net in Indiana, which is a red state, and they have this really extensive outreach system set up through mail, phone, texts, through the electronic health records, and when you walk in. And they have everybody in the whole system, from the front desk to the insurance specialists, able to help people sort this through. So some of the providers are quite proactive in helping people connect, because there’s three things: There’s understanding you’re no longer eligible, there’s understanding what you are eligible for, and then actually signing up. They’re all hard. You know, if your government’s not going to do a good job, are your providers or your community health clinics or your safety net hospitals — what are they doing in your state? That’s an important question to ask.
Rovner: Providers have an incentive because they would like to be paid.
Kenen: Paid.
Weber: Well, the thing about Indiana too, Joanne, I mean — so that was one of the states that Hannah got the data from. They had I think it was 53,000 residents that have lost coverage in the first amount of unwinding. 89% of them were for paperwork. I mean, these are not small fractions. I mean, it is the vast majority that is being lost for this reason. So that’s really interesting to hear that the providers there are stepping up to face that.
Kenen: It’s not all of them, but you can capture these people. I mean, there’s a lot that can go wrong. There’s a lot that — in the best system, you’re dealing with [a] population that moves around, they don’t have stable lives, they’ve got lots of other things to deal with day to day, and dealing with a health insurance notice in a language you may not speak delivered to an address that you no longer live at — that’s a lot of strikes.
Rovner: It is not easy. All right. Well, because we’re in Washington, D.C., we have to talk about climate change this week. My mother, the journalist, used to say whenever she would go give a speech, that news is what happens to or in the presence of an editor. I have amended that to say now news is what happens in Washington, D.C., or New York City. And since Washington, D.C., and New York City are both having terrible air quality — legendary, historically high air quality — weeks, people are noticing climate change. And yes, I know you guys on the West Coast are saying, “Uh, hello. We’ve been dealing with this for a couple of years.” But Joanne and Lauren, both of your extra credits this week have to do with it. So I’m going to let you do them early. Lauren, why don’t you go first?
Weber: Yeah, I’ve highlighted a piece by my colleague Dan Diamond and a bunch of other of my colleagues, who wrote all about how this is just a sign of what’s to come. I mean, this is not something that is going away. The piece is titled “Smoke Brings a Warning: There’s No Escaping Climate’s Threat to Health.” I think, Julie, you hit the nail on the head. You know, we all live here in Washington, D.C. A lot of other journalist friends live in New York. There’s been a lot of grousing on Twitter that everyone is now covering this because they can see it. But the reality is, when people can see it, they pay attention. And so the point of the story is, you know, look, I mean, this is climate change in action. We’re watching it. You know, it’s interesting; this story includes a quote from Mitch McConnell saying [to] follow the public health authorities, which I found to be quite fascinating considering the current Republican stance on some public health authorities during the pandemic. And I’m just very curious to see, as we continue to see this climate change in reality, how that messaging changes from both parties.
[Editor’s note: The quote Weber referenced did not come from McConnell but from Senate Majority Leader Chuck Schumer, a Democrat, and would not have warranted as much fascination in this context.]
Kenen: But I think that you’ve seen, with the fires on the West Coast, nobody is denying that there’s smoke and pollutants in the air — of either party. You know, we can look out our windows and see it right now, right? But they’re not necessarily accepting that it’s because of climate change, and that — I’m not sure that this episode changes that. Because many of the conservatives say it’s not climate change; it’s poor management of forests. That’s the one you hear a lot. But there are other explain — or it’s just, you know, natural variation and it’ll settle down. So it remains to be seen whether this creates any kind of public acknowledgment. I mean, you have conservative lawmakers who live in parts of the country that are already very — on coasts, on hurricane areas, and, you know, forest fire areas there. You have people who are already experiencing it in their own communities, and it does not make them embrace the awareness of poor air quality because of a forest fire. Yes. Does it do what Julie was alluding to, which is change policy or acknowledging what, you know, the four of us know, and many millions of other people, you know, that this is related to climate change, not just — you know, I’m not an expert in forestry, but this is not just — how many fires in Canada, 230?
Rovner: Yeah. Nova Scotia and Quebec don’t tend to have serious forest fire issues.
Kenen: Right. This is across — this is across huge parts of the United States now. It’s going into the South now. I was on the sixth floor of a building in Baltimore yesterday, and you could see it rolling in.
Rovner: Yeah. You have a story about people trying to do something about it. So why don’t you tell us about that.
Kenen: Well it was a coincidence that that story posted this week, because I had been working on it for a couple of months, but I wrote a story. The headline was — it’s in Politico Magazine — it’s “Can Hospitals Turn Into Climate Change Fighting Machines?” Although one version of it had a headline that I personally liked more, which was “Turn Off the Laughing Gas.” And it’s about how hospitals are trying to reduce their own carbon footprint. And when I wrote this story, I was just stunned to learn how big that carbon footprint is. The health sector is 8.5% of greenhouse gas emissions in the United States, and that’s twice as high as the health sector in comparable industrial countries, and —
Rovner: We’re No. 1!
Kenen: Yes, once again, and most of it’s from hospitals. And there’s a lot that the early adopters, which is now, I would say about 15% of U.S. hospitals are really out there trying to do things, ranging from changing their laughing gas pipes to composting to all sorts of, you know, energy, food, waste, huge amount of waste. But one of the — you know, everything in hospitals is use once and throw it out or unwrap it and don’t even use it and still have to throw it out. But one of the themes of the people I spoke to is that hospitals and doctors and nurses and everybody else are making the connection between climate change and the health of their own communities. And that’s what we’re seeing today. That’s where the phenomenon Laura was talking about is connected. Because if you look out the window and you can see the harmful air, and some of these people are going to be showing up in the emergency rooms today and tomorrow, and in respiratory clinics, and people whose conditions are aggravated, people who are already vulnerable, that the medical establishment is making the connection between the health of their own community, the health of their own patients, and climate. And that’s where you see more buy-in into this, you know, greening of American hospitals.
Rovner: Speaking of issues that that seem insoluble but people are starting to work on, drug prices. In drug price news, drug giant Merck this week filed suit against the federal government, charging that the new requirements for Medicare price negotiation are unconstitutional for a variety of reasons. Now, a lot of health lawyers seem pretty dubious about most of those claims. What’s Merck trying to argue here, and why aren’t people buying what they’re selling?
Hellmann: So there’s two main arguments they’re trying to make. The primary one is they say this drug price negotiation program violates the Fifth Amendment, which prohibits the government from taking private property for public use without just compensation. So they argue that under this negotiation process they would basically be coerced or forced into selling these drugs for a price that they think is below its worth. And then the other argument they make is it violates their First Amendment rights because they would be forced to sign an agreement they didn’t agree with, because if they walk away from the negotiations, they have to pay a tax. And so it’s this coercive argument that they are making. But there’s been some skepticism. You know, Nick Bagley noted on Twitter that it’s voluntary to participate in Medicare. Merck doesn’t have a constitutional right to sell its drugs to the government at a price that they have set. And he also noted — I thought this was interesting — I didn’t know that there was kind of a similar case 50 years ago, when Medicare was created. Doctors had sued over a law Congress passed requiring that a panel review treatment decisions that doctors were making. The doctors sued also under the Fifth Amendment in the courts, and the Supreme Court sided with the government. So he seems to think there’s a precedent in favor of the government’s approach here. And there just seems to be a lot of skepticism around these arguments.
Rovner: And Nick Bagley, for those of you who don’t know, is a noted law professor at the University of Michigan who specializes in health law. So he knows whereof he speaks on this stuff. I mean, Joanne, you were, you were mentioning, I mean, this was pretty expected somebody was going to sue over this.
Kenen: It’s probably not the last suit either. It’s probably the first of, but, I mean, the government sets other prices in health care. And, you know, it sets Medicare Advantage rates. It sets rates for all sorts of Medicare procedures. The VA [U.S. Department of Veterans Affairs] sets prices for every drug that’s in its formulary or, you know, buys it at a negotiated —
Rovner: Private insurers set prices.
Kenen: Right. But that’s not government. That’s different.
Rovner: That’s true.
Kenen: They’re not suing private insurers. So, you know, I’m not Nick Bagley, but I usually respect what Nick Bagley has to say. On the other hand, we’ve also seen the courts do all sorts of things we have not expected them to do. There’s another Obamacare case right now. So, precedent, schmecedent, you know, like — although on this one we did expect the lawsuits. Somebody also pointed out, I can’t remember where I read it, so I’m sorry not to credit it, maybe it was even Nick — that even if they lose, if they buy a extra year or two, they get another year or two of profits, and that might be all they care about.
Rovner: It may well be. All right. Well, let us turn to abortion. It’s actually been relatively quiet on the abortion front these last couple of weeks as we approach the one-year anniversary of the Supreme Court striking down Roe v Wade. I did want to mention something that’s still going on in Indiana, however. You may remember the case last year of the 10-year-old who was raped in Ohio and had to go to Indiana to have the pregnancy terminated. That was the case that anti-abortion activists insisted was made up until the rapist was arraigned in court and basically admitted that he had done it. Well, the Indiana doctor who provided that care is still feeling the repercussions of that case. Caitlin Bernard, who’s a prominent OB-GYN at the Indiana University Health system, was first challenged by the state’s attorney general, who accused her of not reporting the child abuse to the proper state authorities. That was not the case; she actually had. But the attorney general, who’s actually a former congressman, Todd Rokita, then asked the state’s medical licensing board to discipline her for talking about the case, without naming the patient, to the media. Last month, the majority of the board voted to formally reprimand her and fine her $3,000. Now, however, lots of other doctors, including those who don’t have anything to do with reproductive health care, are arguing that the precedent of punishing doctors for speaking out about important and sometimes controversial issues is something that is dangerous. How serious a precedent could this turn out to be? She didn’t really violate anybody’s private — she didn’t name the patient. Lauren, you wanted to respond.
Weber: Yeah, I just think it’s really interesting. If you look at the context, the number of doctors that actually get dinged by the medical board, it’s only a couple thousand a year. So this is pretty rare. And usually what you get dinged for by the medical board are really severe things like sexual assault, drug abuse, alcohol abuse. So this would seem to indicate quite some politicization, and the fact that the AG was involved. And I do think that, especially in the backdrop of all these OB-GYN residents that are looking to apply to different states, I think this is one of the things that adds a chilling effect for some reproductive care in some of these red states, where you see a medical board take action like this. And I just think in general — it cannot be stated enough — this is a rare action, and a lot of medical board actions will be, even if there is an action, will be a letter in your file. I mean, to even have a fine is quite something and not it be like a continuing education credit. So it’s quite noteworthy.
Rovner: Well, meanwhile, back in Texas, the judge who declared the abortion pill to have been wrongly approved by the FDA, Trump appointee Matthew Kacsmaryk, is now considering a case that could effectively bankrupt Planned Parenthood for continuing to provide family planning and other health services to Medicaid patients while Texas and Louisiana were trying to kick them out of the program because the clinics also provided abortions in some cases. Now, during the time in question, a federal court had ordered the clinics to continue to operate as usual, banning funding for abortions, which always has been the case, but allowing other services to be provided and reimbursed by Medicaid. This is another of those cases that feels very far-fetched, except that it’s before a judge who has found in favor of just about every conservative plaintiff that has sought him out. This could also be a big deal nationally, right? I mean, Planned Parenthood has been a participant in the Medicaid program in most states for years — again, not paying for abortion, but for paying for lots of other services that they provide.
Kenen: The way this case was structured, there’s all these enormous number of penalties, like 11,000 per case or something, and it basically comes out to be $1.8 billion. It would bankrupt Planned Parenthood nationally, which is clearly the goal of this group, which has a long history that — we don’t have time to go into their long history. They’re an anti-abortion group that’s — you know, they were filming people, and there’s a lot of history there. It’s the same people. But, you know, this judge may in fact come out with a ruling that attempts to shut down Planned Parenthood completely. It doesn’t mean that this particular decision would be upheld by the 5th Circuit or anybody else.
Rovner: Or not. The same way the mifepristone ruling finally woke up other drugmakers who don’t have anything to do with the abortion fight because, oh my goodness, if a judge can overturn the approval of a drug, what does the FDA approval mean? This could be any government contractor — that you can end up being sued for having accepted money that was legal at the time you accepted it, which feels like not really a very good business partner issue. So another one that we will definitely keep an eye on.
Kenen: I mean, that’s the way it may get framed later, is that this isn’t really about Planned Parenthood; this is about a business or entity obeying the law, or court order. I mean, that’s how the pushback might come. I mean, I think people think Planned Parenthood, abortion, they equate those. And most Planned Parenthood clinics do not provide abortion, while those that do are not using federal funds, as a rule; there are exceptions. And Planned Parenthood is also a women’s health provider. They do prenatal care in some cases; they do STD [sexually transmitted disease] treatment and testing. They do contraception. They, you know, they do other things. Shutting down Planned Parenthood would mean cutting off many women’s access to a lot of basic health care.
Rovner: And men too, I am always reminded, because, particularly for sexually transmitted diseases, they’re an important provider.
Kenen: Yeah. HIV and other things.
Rovner: All right. Well, that is this week’s news. Now we will play my “Bill of the Month” interview with Sarah Jane Tribble, and then we will be back with our extra credits. We are pleased to welcome back to the podcast Sarah Jane Tribble, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” story. Sarah, thanks for coming in.
Sarah Jane Tribble: Thanks for having me.
Rovner: So this month’s patient is a former American who now lives in Switzerland, a country with a very comprehensive health insurance system. But apparently it’s not comprehensive enough to cover the astronomical cost of U.S. health care. So tell us who the patient is and how he ended up with a big bill.
Tribble: Yeah. Jay Comfort is an American expatriate, and he has lived overseas for years. He’s a former educator. He’s 66 years old. And he decided to retire in Switzerland. He has that country’s basic health insurance plan. He pays his monthly fee and gets a deductible, like we do here in the U.S. He traveled last year for his daughter’s wedding and ended up with an emergency appendectomy in the ER [emergency room] at the University of Pittsburgh in Williamsport.
Rovner: And how big was the ultimate bill?
Tribble: Well, he was in the hospital just about 14 hours, and he ended up with a bill of just over $42,000.
Rovner: So not even overnight.
Tribble: No.
Rovner: That feels like a lot for what was presumably a simple appendectomy. Is it a lot?
Tribble: We talked to some experts, and it was above what they had predicted it would be. It did include the emergency appendectomy, some scans, some laboratory testing, three hours in the recovery room. There was also some additional diagnostic testing. They had sent off some cells for a diagnostics and did find cancer at the time. Still, it didn’t really explain all the extra cost. Healthcare Bluebook, which you can look up online, has this at about $14,000 for an appendectomy. One expert told me, if you look at Medicare prices and average out in that region, it would be between $6,500 and $18,000-ish. So, yeah, this was expensive compared to what the experts told us.
Rovner: So he goes home and he files a claim with his Swiss insurance. What did they say?
Tribble: Well, first let me just say, cost in the U.S. can be two to three times that in other countries. Switzerland isn’t known as a cheap country, actually. Its health care is —
Rovner: It’s the second most expensive after the U.S.
Tribble: Considered the most expensive in Europe, right. So this is pretty well known. So he was still surprised, though, when he got the response from his Swiss insurance. They said they were willing to pay double because it was an emergency abroad. Total, with the appendectomy and some extra additional scans and so forth: About $8,000 is what they were willing to pay.
Rovner: So, double what they would have paid if he’d had it done in Switzerland.
Tribble: Yeah.
Rovner: So 42 minus 8 leaves a large balance left. Yeah. I mean, he’s stuck with — what is that — $34,000. He’s on the hook for that. I mean, it’s better than having nothing, obviously, but it’s a lot of money and it’s really striking, the difference, because, you know, in Switzerland, they’re very much like, we would pay this amount, then we’ll double it to pay you back. And he still has this enormous bill he’s left paying. He’s on a fixed income. He’s retired. So it’s quite the shock to his system.
Rovner: So what happened? Has this been resolved?
Tribble: Let me first tell you what happened at the ER, because Jay was very diligent about providing documents and explaining everything. We had multiple Zoom calls. Jay’s wife was with him, and she provided the Swiss insurance card to UPMC. Now, UPMC had confirmed that there was some confusion, and it took months for Jay to get his bill. He had to call and reach out to UPMC to get his bill. He wants to pay his bill. He wants to pay his fair share, but he doesn’t consider $42,000 a fair share. So he wants to now negotiate the bill. We’ve left it at that, actually. UPMC says they are charging standard charges and that he has not requested financial assistance. And Jay says he would like to negotiate his bill.
Rovner: So that’s where we are. What is the takeaway here? Obviously, “don’t have an emergency in a country where you don’t have insurance” doesn’t feel very practical.
Tribble: Well, yeah, I mean, this was really interesting for me. I’ve been a health care reporter a long time. I’ve heard about travel insurance. The takeaway here for Jay is he would have been wise to get some travel insurance. Now, Jay did tell me previously he had tried to get Medicare. He is a U.S. citizen residing in Switzerland. He does qualify. He had worked in the U.S. long enough to qualify for it. He had gone through some phone calls and so forth and didn’t have it before coming here. He told me in the last couple of weeks that he now has gotten Medicare. However, that may not have helped him too much because it was an outpatient procedure. And it’s important to note that if you have Medicare and you’re 65 in the U.S., when you go overseas, it’s not likely to cover much. So the takeaway: Costs in the U.S. are more expensive than most places in the world, and you should be prepared if you’re traveling overseas and you find yourself in a situation, you might consider travel insurance anyway.
Rovner: So both ways.
Tribble: Yeah.
Rovner: Americans going somewhere else and people from somewhere else coming here.
Tribble: Well, if you’re a contract worker or a student on visa or somebody visiting the U.S., you’re definitely [going to] want to get some insurance because, wherever you’re coming from, most likely that insurance isn’t going to pay the full freight of what the costs are in the U.S.
Rovner: OK. Sarah Jane Tribble, thank you very much.
Tribble: Thanks so much.
Rovner: OK, we’re back, and it’s time for our extra credit segment. That’s where we each recommend a story we read this week that we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Lauren and Joanne, you’ve already given us yours, so Jessie, you’re next.
Hellmann: Yeah. My extra credit is from MLive.com, an outlet in Michigan. It’s titled “During the Darkest Days of COVID, Some Michigan Hospitals Made 100s of Millions.” They looked at tax records, audited financial statements in federal data, and found that some hospitals and health systems in Michigan actually did really well during the pandemic, with increases in operating profits and overall net assets. A big part of this was because of the covid relief funding that was coming in, but the article noted that, despite this, hospitals were still saying that they were stretched really thin, where they were having to lay off people. They didn’t have money for PPE [personal protective equipment], and they were having to institute, like, other cost-saving measures. So I thought this was a really interesting, like, a local look at how hospitals are kind of facing a backlash now. We’ve seen it in Congress a little bit, just more of an interest in looking at their finances and how they were impacted by the pandemic, because while some hospitals really did see losses, like small, rural, or independent hospitals, some of the bigger health systems came out on top. But you’re still hearing those arguments that they need more help, they need more funding.
Rovner: Well, my story is also about a hospital system. It’s yet another piece of reporting about nonprofit hospitals failing to live up to their requirement to provide, quote, “community benefits,” by our podcast panelist at The New York Times Sarah Kliff and Jessica Silver-Greenberg. It’s called “This Nonprofit Health System Cuts Off Patients With Medical Debt.” And it’s about a highly respected and highly profitable health system based in Minnesota called Allina and its policy of cutting off patients from all nonemergency services until they pay back their debts in full. Now, nonemergency services because federal law requires them to treat patients in emergencies. It’s not all patients. It’s just those who have run up debt of at least $1,500 on three separate occasions. But that is very easy to do in today’s health system. And the policy isn’t optional. Allina’s computerized appointment system will actually block the accounts of those who have debts that they need to pay off. It is quite a story, and yet another in this long list of stories about hospitals behaving badly. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for now. I’m still there. I’m @jrovner. Joanne?
Kenen: @JoanneKenen
Rovner: Jessie.
Hellmann: @jessiehellmann
Rovner: Lauren.
Weber: @LaurenWeberHP
Rovner: We will be back in your feed next week. Until then, be healthy.
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STAT+: Coherus works with Mark Cuban to sell biosimilar Humira at steep discounts
In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.
In a bold move, Coherus BioSciences plans to sell a biosimilar version of Humira — one of the world’s best-selling medicines — at a steep discount, and will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less.
Specifically, the Coherus medicine will carry a $995 list price for a carton of two autoinjectors, an 85% discount from the $6,922 that AbbVie charges for Humira, which is used to treat rheumatoid arthritis and other conditions. At the same time, Coherus will sell its drug at a discount to the Mark Cuban Cost Plus Drug Company, which will market the treatment for about $579.
The lowball pricing for the drug, which will become available in July, has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years. After enjoying a monopoly that yielded billions of dollars in annual sales, AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.
1 year 10 months ago
Pharma, Pharmalot, Biosimilars, finance, Pharmaceuticals, STAT+
When an Anti-Vaccine Activist Runs for President
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Julie Rovner
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Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
How should journalists cover political candidates who make false claims about the safety and effectiveness of vaccines? That question will need to be answered now that noted anti-vaccine activist Robert F. Kennedy Jr. has officially entered the 2024 presidential race.
Meanwhile, South Carolina has become one of the last states in the South to pass an abortion ban, making the procedure all but impossible to obtain for women across a broad swath of the country.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.
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Rachel Cohrs
Stat News
Sarah Karlin-Smith
Pink Sheet
Alice Miranda Ollstein
Politico
Among the takeaways from this week’s episode:
- Republican lawmakers and President Joe Biden continue to bargain over a deal to avert a debt ceiling collapse. Unspent pandemic funding is on the negotiating table, as the White House pushes to protect money for vaccine development — though the administration has drawn criticism for a lack of transparency over what would be included in a clawback of unspent dollars.
- In abortion news, South Carolina is the latest state to vote to restrict access to abortion, passing legislation this week that would ban abortion after six weeks of pregnancy — shortly after pregnant people miss their first period. And Texas is seeing more legal challenges to the state law’s exceptions to protect a mother’s life, as cases increasingly show that many doctors are erring on the side of not providing care to avoid criminal and professional liability.
- Congress is scrutinizing the role of group purchasing organizations in drug pricing as more is revealed about how pharmacy benefit managers negotiate discounts. So-called GPOs offer health care organizations, like hospitals, the ability to work together to leverage market power and negotiate better deals from suppliers.
- Lawmakers are also exploring changes to the way Medicare pays for the same care performed in a doctor’s office versus a hospital setting. Currently, providers can charge more in a hospital setting, but some members of Congress want to end that discrepancy — and potentially save the government billions.
- And our panel of health journalists discusses an important question after a prominent anti-vaccine activist entered the presidential race last month: How do you responsibly cover a candidate who promotes conspiracy theories? The answer may be found in a “truth sandwich.”
Also this week, Rovner interviews KFF Health News senior correspondent Aneri Pattani about her project to track the money from the national opioid settlement.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: KFF Health News’ “Remote Work: An Underestimated Benefit for Family Caregivers,” by Joanne Kenen
Alice Miranda Ollstein: Reuters’ “How Doctors Buy Their Way out of Trouble,” by Michael Berens
Rachel Cohrs: ProPublica’s “In the ‘Wild West’ of Outpatient Vascular Care, Doctors Can Reap Huge Payments as Patients Risk Life and Limb,” by Annie Waldman
Sarah Karlin-Smith: The New York Times’ “Heat Wave and Blackout Would Send Half of Phoenix to E.R., Study Says,” by Michael Levenson
Also mentioned in this week’s episode:
- KFF Health News’ “Abortion Bans Are Driving Off Doctors and Closing Clinics, Putting Basic Health Care at Risk,” by Julie Rovner.
- Stat’s “House Panel Takes First Steps Toward Reining In Hospitals With ‘Site-Neutral’ Changes,” by Rachel Cohrs.
- Vice’s “ABC News and CNN Manage to Demonstrate Exactly What Not to Do With Robert F. Kennedy Jr.,” by Anna Merlan.
click to open the transcript
Transcript: When an Anti-Vaccine Activist Runs for President
KFF Health News’ ‘What the Health?’
Episode Title: When an Anti-Vaccine Activist Runs for President
Episode Number: 299
Published: May 25, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?”. I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, May 25, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. Today we are joined via video conference by Rachel Cohrs of Stat News.
Rachel Cohrs: Hi, everybody.
Rovner: Sarah Karlin-Smith of the Pink Sheet.
Sarah Karlin-Smith: Hi, Julie.
Rovner: And Alice Miranda Ollstein of Politico.
Alice Miranda Ollstein: Hello.
Rovner: Later in this episode we’ll have my interview with KFF Health News’ Aneri Pattani about her project tracking where all of that opioid settlement money is going. But first, this week’s news. I suppose we have to start with the debt ceiling again, because how this all eventually plays out will likely impact everything else that happens in Washington for the rest of the year. First of all, as of this taping, at 10 o’clock on Thursday morning, there’s still no settlement here, right?
Ollstein: There is not. And depending who you listen to, we are either close or not close at all, on the brink of disaster or on the brink of being all saved from disaster. There’s a lot of competing narratives going around. But yes, as of this taping, no solution.
Rovner: I want to do a spreadsheet of how often the principals come out and say, “It was productive,” “It’s falling apart,” “It was productive,” “It’s falling apart.” I mean, it seems like literally every other time, particularly when Speaker [Kevin] McCarthy comes out, it was either “very productive” or “we’re nowhere near.” That seems to have been the gist for the past two weeks or so. Meanwhile, it seems like one thing Republicans and Democrats have at least tentatively agreed to do is claw back something like $30 billion in unspent covid funds. But, not so fast. The New York Times reports that the Biden administration wants to preserve $5 billion of that to fund the next generation of covid vaccines and treatment and another $1 billion to continue giving free covid vaccines to people without insurance. I feel like this is the perfect microcosm of why these talks are almost impossible to finish. They’re trying to negotiate a budget resolution, an omnibus spending bill, and a reconciliation bill all at the same time, with the sword of Damocles hanging over their head and a long holiday weekend in between. Somebody please tell me that I’m wrong about this.
Ollstein: Well, Congress never does anything unless there’s a sword of Damocles hanging over them and a vacation coming up that they really want to go on. I mean, do they ever make it happen otherwise? Not — not in our experience. But I do want to note that it is interesting that the Biden administration is trying to fight for some of that covid funding. Meanwhile, what they’re not reportedly fighting for is some of the other public health funding that’s at risk in that clawback, and I reported last week that some of Biden’s own health officials are warning that losing those tens of billions of dollars could undermine other public health efforts, including the fight against HIV and STDs [sexually transmitted diseases]. We have syphilis at record rates right now, and public health departments all around the country are counting on that money to preserve their workforces and do contact tracing, etc. And so that is another piece of this that isn’t getting as much attention.
Cohrs: There has been this ongoing fight between the White House and Republicans over covid money and how it’s being spent, for years at this point. And the White House has never really been fully transparent about exactly what was going to get clawed back. The Appropriations Committee was the one who actually put out some real information about this. And I think that trust has just been broken that the money is used where it’s supposed to be. I mean, even for the next-generation research project [Project NextGen] — I mean, they launched that like a couple of months ago, after Republicans had already threatened to take the money back. So I think there are some questions about the timing of the funding. [White House COVID-19 Response Coordinator] Ashish Jha said they didn’t know they had leftovers until recently, but I think this has just really turned into a mess for the White House, and I think the fact that they’re willing to offer some of this money up is just kind of a symbol and just a “ending with a whimper” of this whole fight that’s been going on for two years where they’ve been unsuccessful in extracting any more money.
Rovner: And yeah, I was just going to say, the White House keeps asking for more money and then they keep, quote-unquote, “finding money” to do things that are really important. Sarah, I wanted to ask you, how freaked out is the research establishment and the drug industry at whether, you know, will they or won’t they actually pony up money here?
Karlin-Smith: I think this could be pretty problematic because some of the type of companies that get this funding — some of them might be in a position to do this on their own, but others would essentially — you know, there isn’t necessarily a market for this without the government support, and that’s why they do it. That’s why the U.S. created this BARDA [Biomedical Advanced Research and Development Authority], which kind of funds this type of pandemic and other threats research. And so I think there are companies that definitely wouldn’t be able to continue without this money, because some of it is for things that we think we might need but don’t know if we definitely will. And so you don’t necessarily want to make the investment in the same way you know you need cancer drugs or something like that.
Rovner: We will see how this plays out. Perhaps it will be played out by next week or perhaps they will find some sort of short-term patch, which is another tried-and-true favorite for Congress. All right. Let’s turn to abortion. Last week, the North Carolina Legislature overrode the Democratic governor’s veto to pass a 12-week ban. This week was the South Carolina Legislature’s chance to say, “Hold my beer.” Alice, what happened in South Carolina, and what does it mean for availability of abortion in the whole rest of the South?
Ollstein: The governor is expected to sign this new restriction into law. Like many other GOP-led states. South Carolina was expected to quickly pass restrictions last year as soon as Roe v. Wade was overturned, but they got into fights within the Republican Party over how far to go, whether to have exceptions, what kind of exceptions, etc. It was the classic story we’ve seen play out over and over and over where, while Roe v. Wade was still in place, it was very easy for people to say, “I’m pro-life, I’m against abortion,” and not have to make those difficult, detailed decisions. So, yes, this could have a big impact, you know, especially with Florida moving for a much stricter ban. You know, the whole region is becoming more and more unavailable, and people are going to have to travel further and further.
Rovner: And South Carolina ended up with one of these six-week, quote-unquote, “heartbeat bills,” right?
Ollstein: That’s right.
Rovner: So it’s sort of shutting off yet another state where abortion is or really could be available. There’s more abortion-related court action, too. This week, in Texas, eight more women who experienced dangerous pregnancy complications joined a lawsuit seeking to force just a clarification of that state’s abortion ban that they say threatened their lives. One of them, Kiersten Hogan, had her water break prematurely, putting her at risk of infection and death, but says she was told by the hospital that if she tried to leave to seek care elsewhere, she could be arrested for trying to kill her baby. Four days later, the baby was born stillborn. Yet sponsors of the state’s abortion bill say it was never intended to bar, quote, “medically necessary abortions.” Why is there such a disconnect? And Texas is hardly the only place this is happening, right?
Ollstein: Yeah. Situations like this are why people are arguing that the whole debate over exceptions is sort of a fig leaf. It’s papering over how these work in practice. You can have exceptions on the book that say “life-threatening situations, medical emergencies,” etc. But because doctors are so afraid of being charged with a crime or losing their license or other professional repercussions, that’s just creating a huge chilling effect and making them afraid to provide care in these situations. A lot of times the state law also contradicts with federal law when it comes to medical emergencies, and so doctors feel caught in the middle and unsure what they’re supposed to do. And as we’re seeing, a lot of them are erring on the side of not providing care rather than providing care. So this is playing out in a lot of places. So I’m interested to see if this informs the debate in other states about whether to have these exceptions or not.
Rovner: And I get to promote my own story here, which is that we’re seeing in a lot of states either doctors leaving or doctors deciding not to train in states with abortion bans because they’re afraid of exactly those restrictions that could land them, you know, either in court or, even worse, in jail. We’ve long had abortion care deserts. Now we could see entire women’s health care deserts in a lot of these states, which would, you know, hurt not just the people who want to have abortions, but the people who want to get pregnant and have babies. We will continue to watch that space. Well, meanwhile, in West Virginia, another court case, filed by the maker of the generic version of the abortion pill mifepristone, could turn on a recent Supreme Court decision about pork products in California. Can somebody explain what one has to do with the other?
Karlin-Smith: There is basically a ruling that the Supreme Court issued the other week in a California case where the state was regulating how pigs were treated on farms in California. And the court basically allowed the law to stand, saying, you know, it didn’t interfere with interstate commerce. And the people who are protesting GenBioPro’s suit in West Virginia are basically saying that this, again, is an example where West Virginia’s regulation of the abortion drug, again, doesn’t really impact the distribution of the drug outside of the state or the availability of the drug outside of the state, and so this should be allowable. Of course, GenBioPro and the folks who are protesting how West Virginia is curtailing access to the suit are trying to argue the same ruling helps their cause. To me, what I read — and it seems like the comparison works better against the drug company, but it always is interesting to see this overlapping — you know, the cases you don’t expect. But I also, I think, when this ruling came out, saw somebody else making another argument that this should help GenBioPro. So it’s very hard to know.
Rovner: If it’s not confusing enough, I’m going to add another layer here: While we’re talking about the abortion pill, a group of House Democrats are reaching out to drug distribution company AmerisourceBergen, following reports that it would decline to deliver the pill to pharmacies in as many as 31 states, apparently fearing that they would be drawn into litigation between states and the federal government, the litigation we’ve talked about now a lot. So far, the company has only said that it will distribute the drug in states, quote, “where it is consistent with the law.” In the end, this could end up being more important than who wins these lawsuits, right? If — I think they’re the sole distributor — is not going to distribute it, then it’s not going to be available.
Ollstein: It also depends on the — at the 5th Circuit, and that will go back to the Supreme Court, because if it’s not an FDA-approved drug, then nobody can distribute it. That’s the ultimate controlling factor. But yes, since they are the sole distributor, they will have a lot of power over where this goes. And when I was reporting on Walgreens’ decision, they were pointing to this and saying that their decisions, you know, depend on other factors as well.
Karlin-Smith: And there’s a lot of nuance to this because my understanding is AmerisourceBergen, they’re particularly talking about distributing it to pharmacies where you could — under this new FDA permission to let pharmacies distribute the drug, which in the past they hadn’t.
Rovner: And which hasn’t happened yet.
Karlin-Smith: Right. They haven’t actually gone through the process of certifying the pharmacies. So it’s like a little bit premature, which is why I think Walgreens realized they probably jumped the gun on making any decision because it couldn’t happen yet anyway. But AmerisourceBergen is still saying, “Oh, we’re giving it to providers and other places that can distribute the drug in some of these states.” So it’s not necessarily like the drug is completely unavailable. It’s just about ease of access, I think, at this point.
Rovner: Yeah, we’re not just in “watch that space”; now we’ve progressed to “watch all those spaces,” which we will continue to do. Well, while we were on the discussion of drug middlepeople, there’s a story in Stat about the Federal Trade Commission widening its investigation of pharmacy benefit managers to include group purchasing organizations. Sarah, what are group purchasing organizations and how do they impact the price of prescription drugs?
Karlin-Smith: So group purchasing organizations are basically where you sort of pool your purchasing power to try and get better deals or discounts. So like, in this case, one of the GPOs FTC is looking at negotiates drug rebates on behalf of a number of different PBMs, not just one PBM. And so, again, you know, the idea is the more people you have, the more marketing you have, the better discount you should be able to get, which is — I think some people have been a little shocked by this because they’re like, “Wait, we thought the PBMs were the ones that did the negotiation. Why are they outsourcing this? Isn’t that the whole purpose of why they exist?” Yeah, so FTC has sort of a broader investigation into PBMs, so this is kind of the next step in it to kind of figure out, OK, what is the role of these companies? How are they potentially creating bad incentives, contributing to increased drug pricing, making it harder for people to perhaps, like, get their drug at particular pharmacies or more expensive at particular pharmacies? Again, because there’s been a lot of integration of ownership of these companies. So like the PBMs, the health insurance, some of these pharmacy systems are sort of all connected, and there’s a lot of concern that that’s led to incentives that are harming consumers and the prices we’re paying for our health care.
Rovner: Yeah, there’s all that money sloshing around that doesn’t seem to be getting either to the drug companies or to the consumers. Rachel, you wanted to add something?
Cohrs: Sure. I think GPOs are more used with hospitals when they buy drugs, because I think PBMs — you think of, like, going to pick up your drug at the pharmacy counter. But obviously hospitals are buying so many drugs, too. And their, you know, market power is pretty dispersed across the country. And so they also are a big customer of GPOs. So I think they’re also trying to get at this, like, different part of the drug market where, you know, a lot of these really expensive medications are administered in hospitals. So it will be interesting. They’re certainly not very transparent either. So, yeah, interesting development as to how they relate to PBMs, but also the rest of — you know, encompassing a larger part of the health care system.
Karlin-Smith: Yeah, I have seen complaints from hospital systems that the GPOs require them to enter into contracts that make it very difficult for the hospital to pivot if, say, the GPO can’t supply them with a particular product or maybe it’s … [unintelligible] … and then they end up stuck in a situation where they should, in theory, be able to get a product from another supplier and they can’t. So there’s lots of different levels of, again, concern about potential bad behavior.
Rovner: Well, while we are on the topic of nerdy practice-of-medicine stuff, Rachel, you had a story on the latest on the, quote, “site-neutral” Medicare payment policy. Remind us what that is and who’s on which side, and wasn’t that one of the bills — or I guess that wasn’t one of the bills that was approved by the House Energy and Commerce Committee yesterday, right?
Cohrs: No, so “site neutral” is basically hospitals’ worst nightmare. It essentially makes sure that Medicare is paying the same amount for a service that a doctor provides, whether it’s on a hospital campus or provided in a doctor’s office. And I think hospitals argue that they need to charge more because they have to be open 24/7. You know, they don’t have predictable hours. They have to serve anyone, you know, regardless of willingness to pay. It costs more overhead. That kind of thing. But I think lawmakers are kind of losing patience with that argument to some degree, that the government should be paying more for the same service at one location versus another. And it’s true that House Republicans had really wanted an aggressive form of this policy, and it could save like tens of billions of dollars. I mean, this is a really big offset we’re talking about here, if they go really aggressively toward this path, but instead they weren’t able to get Democrats on board with that plan yet. I think the chair, Cathy McMorris Rodgers, and the ranking member, Frank Pallone, have said they want to keep working on this. But what they did do this week is took a tiny little part out of that and advanced it through the committee. And it would equalize payment for, like, drug administration in physician’s offices versus a physician doing it in the hospital, and the savings to the federal government on that policy was roughly $3 billion. So, again, not a huge hit to industry, but it’s, you know, significant savings, certainly, and a first step in this direction as they think about how they want to do this, if they want to go bigger.
Rovner: So while we’re talking about the Energy and Commerce Committee, those members, in a fairly bipartisan fashion, are moving a bunch of other bills aimed at price transparency, value-based care, and a lot of other popular health buzzwords. Sarah, I know you watched, if not all, then most of yesterday’s markup. Anything in particular that we should be watching as it perhaps moves through the House and maybe the Senate?
Karlin-Smith: Yeah. So there was — probably the most contentious health bill that cleared yesterday was a provision that basically would codify a Trump-era rule in Medicaid that the Biden administration has sort of tweaked a bit but generally supported that basically tweaks Medicaid’s “best price” rule. So Medicaid is kind of guaranteed the best price that the private sector gets for drugs. But drugmakers have argued this prevents them from doing these unique value-based arrangements where we say, “OK, if the patient doesn’t perform well or the drug doesn’t work well for the patient, we’ll kind of give you maybe even all your money back.” Well, they don’t want the Medicaid best price to be zero. So they came up with a kind of a very confusing way to tweak that and also as part of that to, you know, hopefully allow Medicaid to maybe even take advantage of these programs. And Rep. [Brett] Guthrie [(R-Ky.)], Rep. [Anna] Eshoo [(D-Calif.)] on the Democratic side, want to codify that. But a number of the Democrats pushed back and over worries this might actually raise prices Medicaid pays for drugs and be a bit more problematic. And the argument from the Democrats, the majority of Democrats on the committee who oppose it, were not completely against this idea but let it play out in rulemaking, because if it stays in rulemaking, it’s a lot easier to —er, sorry — as a rule, it’s already made.
Rovner: To fix it if they need to.
Karlin-Smith: Right. It’s a lot easier to fix it, which, as anybody who follows health policy knows, it’s not actually as easy as you would think to fix a rule, but it’s definitely a lot easier to fix a rule than it is to fix something codified in law. So that’s sort of a very wonky but meaningful thing, I think, to how much drugs cost in Medicaid.
Rovner: Last nerdy thing, I promise, for this week: The Biden administration says it plans to conduct an annual audit of the cost of the most expensive drugs covered by Medicaid and make those prices public in what one of your colleagues, Alice, described as a “name and shame” operation? I mean, could this actually work, or could it end up like other HHS [Department of Health and Human Services] transparency rules, either not very followed or tied up in court?
Karlin-Smith: Experts that my colleague Cathy Kelly talked to to write about this basically were not particularly optimistic it would lead to big changes in savings to Medicaid, basically. One of the reasons is because Medicaid actually gets pretty good deals on drugs to begin with. But that said, even, again, like I said, they’re guaranteed these really large rebates are the best price. But in exchange for that, they have to cover all drugs. So that’s where you start to lose some of your leverage. So the hope with some of this extra transparency is they’ll get more information to have, like, a little bit of additional leverage to say, “Oh, well your manufacturing costs are only this, so you should be able to give us an additional rebate,” which they can negotiate that. Again, I think people think there’ll be sort of maybe some moderate, if any, benefits to that. But some states have actually tried similar things in kind of similar “name, shame” affordability boards. And the drugmakers have basically just said, “No, we’re not going to give you any more discounts.” And they’re kind of stuck.
Rovner: “And we’re not ashamed of the price that we’re charging.”
Karlin-Smith: Right.
Rovner: “Or we wouldn’t be charging it.”
Karlin-Smith: So it’s a tough one, but there’s, like, an argument to be made that drugmakers just don’t want to be on this list. So maybe some of them will more proactively figure out like how to get their price point and everything discounts to a point where they at least won’t get on the list. So maybe, again, it might tweak things around the edges, but it’s not a big price savings move.
Rovner: And we shall see. All right. Well, this is — finally this week, it’s something I’ve wanted to talk about for a couple of weeks. I’m calling it the “How do you solve a problem like RFK Jr.?” For those of you who don’t already know, the son of the former senator and liberal icon Robert Kennedy has declared his candidacy for president. He’s an environmental lawyer, but at the same time, he’s one of the most noted anti-vaxxers, not just in the country but in the world. Vice has a provocative story — this actually goes back a couple of weeks — about how the media should cover this candidacy or, more specifically, how it shouldn’t. According to the story, ABC did an interview with RFK Jr. and then simply cut out what they deemed the false vaccine claims that he made. CNN, on the other hand, did an interview and simply didn’t mention his anti-vaccine activism. I am honestly torn here about how should you cover someone running for president who traffics in conspiracy theories that you know are not true? I realize here I am now speaking of a wider — wider universe than just RFK Jr. But as a journalist, I mean, how do you handle things that — when they get repeated and you know them to be untrue, at least in the health care realm?
Karlin-Smith: I mean, I really like the thing that Vice mentioned, and I think maybe Jay Rosen, who’s a journalism professor at NYU [New York University], he might be the person that sort of coined this, I’m not sure — this, like, “truth sandwich” idea, where you make sure you sort of start with what is true, in the middle you put the sort of — this is what the false claim of X person — and then you go back to the truth. Because I think that really helps people grasp onto what’s true, versus a lot of times you see the coverage starts with the lie or the falsehood. And I think sometimes people might even just see that headline or just see the little bit of what’s correct and never make it to the truth. And I understand some of the decisions by the news outlets that decided not to air these segments and just didn’t want to deal with the topic. But then I guess I thought they did make a good point that then you let somebody like Kennedy say, “Oh, they’re suppressing me, they’re deliberately hiding this information.” So the Vice argument was that this truth sandwich idea kind of gets you in a better … [unintelligible]. And again, as journalists, our job is not to suppress what politicians are saying. People should know what these people claim, because that is what the positions they stand for. But it’s figuring out how to add the context and be able to, you know, in real time if you need to, fact-check it.
Rovner: I confess, over the years I have been guilty of the CNN thing of just not bringing it up and hoping it doesn’t come up. But then, I mean, it’s true, the worst-case scenario — probably not going to happen with somebody running for president — but I think we’ve discovered all these people running for lower offices, that they get elected, you don’t talk about the controversial things and then you discover that you have a legislator in office who literally believes that the Earth is flat. There are — can Google that. So if these things aren’t aired, then there’s no way for voters to know. Anybody else have a personal or organizational rule for how to handle this sort of stuff?
Ollstein: I think there can be smart decisions about when to let someone say in their own voice what they believe versus saying as the news organization, “In the speech, he spent X minutes advancing the discredited assertion of blah, blah, blah, blah, blah,” and not just handing over the platform for them to share the misinformation.
Rovner: Yeah, I just want the audience to know that we do think seriously about this stuff. We are not just as sort of blithe as some may believe. All right. Well, that is this week’s news. Now, we will play my interview with Aneri Pattani, and then we will come back with our extra credits. I am pleased to welcome back to the podcast my colleague Aneri Pattani, who is here to talk about her investigation into where those billions of dollars states are getting in pharmaceutical industry settlements for the opioid crisis are actually going. Aneri, I am so glad to have you back.
Aneri Pattani: Thanks so much for having me.
Rovner: So let’s start at the beginning. How much money are we talking about? Where’s it coming from, and where is it supposed to be going?
Pattani: So the money comes from companies that made, distributed, or sold opioid painkillers. So these are places like Purdue Pharma, AmerisourceBergen, Walgreens, and a bunch of others. They were all accused of aggressively marketing the pills and falsely claiming that they weren’t addictive. So thousands of states and cities sued those companies. And rather than go through with all the lawsuits, most of the companies settled. And as a result, they’ve agreed to pay out more than $50 billion over the next 15 or so years. And the money is meant to be used on opioid remediation, which is a term that means basically anything that addresses or fixes the current addiction crisis and helps to prevent future ones.
Rovner: So the fact is that many or most states — we don’t actually know where this money is going or will go in the future because that information isn’t being made public. How is that even legal, or, I guess it’s not public funds, but it’s funds that are being obtained by public entities, i.e., the attorneys general.
Pattani: Yeah, a lot of people feel this way. But the thing is, the national settlement agreements have very few requirements for states to publicly report how they use the money. In fact, the only thing that’s in there that they’re required to report is when they use money for non-opioid purposes. And that can be at most 15% of the total funds they’re getting. And that reporting, too, is on an honor system. So if a state doesn’t report anything, then the settlement administrators are supposed to assume that the state used all of its money on things related to the opioid crisis. Now, states and localities can enact stricter requirements. For example, North Carolina and Colorado are two places that have created these public dashboards that are supposed to show where the money goes, how much each county gets, how the county spends it. But honestly, the vast majority of states are not taking steps like that.
Rovner: So for people of a certain age, this all feels kind of familiar. In the late 1990s, a group of state attorneys general banded together and sued the tobacco companies for the harm their products had done to the public. They eventually reached a settlement that sent more than $200 billion to states over 25 years, so that money is only just now running out. But it didn’t all get used for tobacco cessation or even public health, did it?
Pattani: No. In fact, most of it didn’t get used for that. The Campaign for Tobacco-Free Kids, which has been tracking that tobacco settlement money for years, found that about only 3% of the money goes to anti-smoking programs a year. The rest of it has gone towards plugging state budget gaps, infrastructure projects like paving roads, or, in the case of North Carolina and South Carolina, the money even went to subsidizing tobacco farmers.
Rovner: Great. Given the lessons of the tobacco settlement, how do the attorneys general in this case try to make sure that wasn’t going to happen? I mean, was it just by requiring that that non-opioid-related money be made public?
Pattani: So they have added some specific language to the settlements that they point to as trying to avoid, you know, the, quote, “tobacco nightmare.” Essentially, the opioid settlements say that at least 85% of the money must be spent on opioid remediation. Again, that term — that’s like things that stop and prevent addiction. And there’s also a list included at the end of the settlement, called Exhibit E, with potential expenses that fall under opioid remediation. That’s things like paying for addiction treatment for people who don’t have insurance or building recovery housing or funding prevention programs in schools. But the thing is, that list is pretty broad and it’s nonexhaustive, so governments can choose to do things that aren’t on that list, too. So there are guidelines, but there’s not a lot of hard enforcement to make sure that the money is spent on these uses.
Rovner: So, as you’ve pointed out in your reporting, it’s not always simple to determine what is an appropriate or an inappropriate use of these settlement funds, particularly in places that have been so hard-hit by the opioid crisis and that it affects the entire economy of that state or county or city. So tell us what you found in Greene County, Tennessee. That was a good example, right?
Pattani: Yeah, Greene County is an interesting place. And what I learned is happening there is actually, you know, repeating in a lot of places across the country. So Greene County, it’s an Appalachian county, it’s been hard-hit. It has a higher rate of overdose deaths than the state of Tennessee overall or even the country. But when the county got several million dollars in opioid settlement funds, it first put that money towards paying off the county’s debt. And that included putting some money into their capital projects fund, which was then used to buy a pickup truck for the sheriff’s office. So a lot of folks are looking at that, saying, “That’s not really opioid-related.” But county officials said to me, you know, this use of the money makes sense, because the opioid epidemic has hurt their economy for decades; it’s taken people out of the workforce, it’s led to increased costs for their sheriff’s office and their jail with people committing addiction-related crimes, it’s hurt the tax base when people move out of the county. So now they need that money to pay themselves back. Of course, on the other hand, you have advocates and people affected by the crisis saying, “If we’re using all the money now to pay back old debts, then who’s addressing the current crisis? People are still dying of overdoses, and we need to be putting the opioid settlement money towards the current problem.”
Rovner: So I suppose ideally they could be doing both.
Pattani: I think that’s the hard thing. Although $54 billion sounds like a lot of money, it’s coming over a long period of time. And so at the end of the day, it’s not enough to fund every single thing people want, and there is a need for prioritization.
Rovner: So I know part of your project is helping urge local reporters to look into where money is being used in their communities. How is that going?
Pattani: It’s going well. I think it’s important because the money is not only going to state governments, but to counties and cities too. So local reporters can play a really big role in tracking that money and holding local officials accountable for how they use it. So I’m trying to help by sharing some of the national data sets we’re pulling together that can be used by local reporters. And I’ve also hopped on the phone with local reporters to talk about where they can go to talk to folks about this or finding story ideas. Some of the reporters I’ve spoken with have already published stories. There was one just a week ago in the Worcester Telegram from a student journalist, actually, in that area —
Rovner: Cool.
Pattani: — so there’s a lot of good coverage coming.
Rovner: I’m curious: What got you interested in pursuing this topic? I know you cover addiction, but this is the kind of reporting that can get really frustrating.
Pattani: It definitely can. But I think it’s what you said: As someone who’s been covering addiction and mental health issues for a while, kind of focusing on some of the problems and the systemic gaps, when I learned that this money was coming in, it was exciting to me too, like, maybe this money will be used to address the issues that I’m often reporting on, and so I want to follow that and I want to see if it delivers on that promise.
Rovner: So what else is coming up in this project? I assume it’s going to continue for a while.
Pattani: Yes. So this will be a yearlong project, maybe even more, because, as I said, the funds are coming for a long time. But essentially the next few things I’m looking at, I have a big data project looking at who sits on opioid settlement councils. These are groups that advise or direct the money in different states and, you know, may represent different interests. And then we’re going to be looking at some common themes in the ways different states are using this money. So a lot of them are putting it towards law enforcement agencies, a lot of them are putting them toward in-school prevention programs, and taking a look at what the research tells us about how effective these strategies are or aren’t.
Rovner: Well, Aneri Pattani, thank you so much, and we will post links to some of Aneri’s work on the podcast homepage at kffhealthnews.org and in this week’s show notes. Thanks again.
Pattani: Thank you so much.
Rovner: OK, we’re back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?
Karlin-Smith: Sure. I looked at a piece in The New York Times called “Heat Wave and Blackout Would Send Half of Phoenix to E.R., Study Says,” by Michael Levenson. And it’s just really sort of a horrifying piece where researchers were sort of able to model the impact of the growing frequency of heat waves due to climate change, and obviously, the U.S. had some electric grid stability issues, and just the disconnect between the amount of hospital beds and people that would be able to care for people in a very hot city due to, you know, heat waves without being able to access air conditioning and other cooling methods. And the amount of people that would be hospitalized or die or just wouldn’t have a hospital bed. The one thing I did think was sort of positive is the piece does have some suggestions, and some of them are fairly simple that could really change the degrees in cities in relevant ways, like planting more trees in particular areas, and often this affects sort of — the poorest areas of cities tend to be the ones with less trees — or, you know, changing colors or the material on roofing. So as much as sometimes I think climate change becomes sort of such an overwhelming topic where you feel like you can’t solve it, I think the one nice thing here is it does sort of show, like, we have power to make the situation better.
Rovner: We can perhaps adapt. Alice.
Ollstein: I picked a upsetting piece but really good investigation from Reuters by Michael Berens. It’s called “How Doctors Buy Their Way out of Trouble.” It’s about doctors who are charged federally with all kinds of wrongdoing, including operating on patients who don’t need to be operated on for profit and having a pattern of doing so. And it’s about how often these cases settle with federal prosecutors and the settlement allows them to keep practicing, and the settlement money goes to the government, not to the victims. And often the victims aren’t even aware that the settlement took place at all. And new patients are not aware that the doctor they may be going to has been charged. And so it’s a really messed up system and I hope this shines a light on it.
Rovner: Rachel.
Cohrs: All right. So mine is from ProPublica, and the headline is, “In the ‘Wild West’ of Outpatient Vascular Care, Doctors Can Reap Huge Payments as Patients Risk Life and Limb,” by Annie Waldman. And I think I found this story timed really well kind of as lawmakers do start to talk a little bit more about incentives for patients to be seen in a hospital versus in more physician offices. And certainly there are cost reasons that that makes sense for some procedures. But I think this story does a really good job of kind of following one doctor, who I think, similar to kind of the story Alice was talking about, you know, was taking advantage of these inflated payments that were supposed to incentivize outpatient treatment to perform way more of these procedures than patients needed. And so I think it’s just important, a cautionary tale about the safeguards that could be necessary, you know, if more of this care is provided elsewhere.
Rovner: Yeah, I think these two stories are very good to be read together. My story this week is from our fellow podcast panelist Joanne Kenen for KFF Health News. It’s called “Remote Work: An Underestimated Benefit for Family Caregivers,” and it’s about how the U.S., still one of the few countries without any formal program for long-term care, that most of us will need at some point, has accidentally fallen into a way to make family caregiving just a little bit easier by letting caregivers do their regular jobs from home, either all the time or sometimes. While many, if not most, employers have policies around childbirth and child care, relatively few have benefits that make it easier for workers to care for other sick family members, even though a fifth of all U.S. workers are family caregivers. More flexible schedules can at least make that a little easier and possibly prevent workers from quitting so that they can provide care that’s needed. It’s no substitute for an actual national policy on long-term care, but it’s a start, even if an accidental one. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our ever-patient producer, Francis Ying. And next week is our 300th episode. If all goes as planned, we’ll have something special, so be sure to tune in. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m @jrovner. Sarah?
Karlin-Smith: I’m @SarahKarlin.
Rovner: Alice.
Ollstein: @AliceOllstein.
Rovner: Rachel.
Cohrs: @rachelcohrs.
Rovner: We will be back in your feed next week. Until then, be healthy.
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This Panel Will Decide Whose Medicine to Make Affordable. Its Choice Will Be Tricky.
Catherine Reitzel’s multiple sclerosis medication costs nearly $100,000 a year. Kris Garcia relies on a drug for a blood-clotting disorder that runs $10,000 for a three-day supply. And Mariana Marquez-Farmer would likely die within days without her monthly $300 vial of insulin.
At best, a Colorado panel of medical and pharmacy experts seeking to cut the costs of expensive drugs will be able to help only one of them.
Starting this summer, the state’s Prescription Drug Affordability Board will choose up to 18 high-cost drugs for review over the next three years to determine if the medications are unaffordable and whether to cap what health plans and consumers pay for them.
But with hundreds of expensive drugs to choose from, the board members face tough decisions about who will get help now and who will have to wait.
Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers, such as for insulin, whose copays Colorado caps at $50 a month, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?
And what does “affordable” even mean?
“That question alone is a lot harder to answer than it might seem at face value,” said Jennifer Reck, project director for the National Academy for State Health Policy’s Center for State Prescription Drug Pricing. “You immediately get into how utterly complex our drug supply chain is, how opaque it is, how many different prices there are,” she said.
Maryland was the first state to establish a drug affordability board in 2019, but funding challenges and the pandemic have slowed its progress. Colorado passed a bill creating its board in 2021 and has already moved ahead of Maryland in the process. Washington followed in 2022 but is still in its early phases of implementation.
Maine, New Hampshire, Ohio, and Oregon have also established boards, but they lack the power to limit drug payments. And at the federal level, the Inflation Reduction Act of 2022 included a provision requiring the Health and Human Services secretary to negotiate prices with drug companies for a small number of the most costly medications covered by Medicare.
It’s taken years for the Colorado and Maryland board members to create all the rules and regulations to govern their work before getting to the point of looking at specific drugs.
“It’s just a long, tortuous government process to get things up and running,” said Gerard Anderson, a professor of health policy and management at Johns Hopkins University, and a member of Maryland’s board. “You basically have to dot every ‘i’ and cross every ‘t’ in order not to get sued.”
Setting Priorities
On May 12, Colorado released its first list of hundreds of drugs eligible for review, mostly because they each cost more than $30,000 for a course of treatment. Next month, they’ll release a dashboard ranking those drugs according to the board’s priorities. The dashboard can also be used to examine which drugs have the highest price tags, which have had the largest increases in price, and which the state spends the most on. That would allow the board to begin affordability reviews this summer and set payment limits for the first four to eight drugs sometime in 2024. But board members will first have to set their priorities, and those could change from year to year.
“Maybe one year we focus on the impact to the system, and another year we focus on out-of-pocket costs, and one year we focus on a lifesaving drug that has smaller utilization,” said Lila Cummings, director of the Colorado board.
Such approaches could pit one group of patients against others looking for cost relief. But Cummings said not all groups are eager to see payment limits.
“Some of them said, ‘We want the board to focus on our drugs,’ and others said, ‘Please leave us alone,’” she said.
That reluctance likely reflects the close ties that some patient groups have with the manufacturers of their medications, including receiving funding from the drugmakers.
“We have seen cases in public hearings — it seems counterintuitive or surprising — where a patient group, instead of being thrilled that they might have access to the drugs at a lower price, instead are arguing against upper payment limits,” Reck said. “But in most cases, there’s a pretty clear financial connection to drug manufacturers.”
Maryland has also received input from patient groups as it finalizes its regulations.
“So far it has not been, ‘Pick me! Pick me! Pick me!’” Anderson said. But that could change once the Maryland board begins its affordability reviews this fall.
The drug that Garcia, 47, of Denver, takes did not make the board’s list. Diagnosed with four bleeding disorders, including von Willebrand disease, he needs the medication Humate-P, made by CSL Behring, to replace one of the clotting factors missing in his blood. This winter, driving home from his job at the airport, Garcia hit a patch of black ice, spun out, and careened into a concrete barrier at 75 mph. He needed the expensive medication every day for the first five days after the accident, and then every other day for a full month.
“It’s not like I can just sit there and say no to this medication, because my bleeds get so bad,” he said.
According to Perry Jowsey, executive director of the National Hemophilia Foundation’s Colorado chapter, about 300 to 400 individuals are being treated for von Willebrand disease in Colorado. That’s far fewer than the roughly 10,000 Coloradans with MS or the 74,000 who manage their diabetes with insulin.
“In my shoes, I would target what would help the most people,” Garcia said. “You have to find a balance, especially starting out. You’re not going to be able to help everyone.”
The Colorado and Maryland boards will rely on data from state databases that show how much various public and private health plans pay for drugs. That data, however, doesn’t capture what uninsured patients pay, and it doesn’t give any insight into how much manufacturers pay for research and development.
“The goal is not to stifle innovation,” Anderson said. “But we can’t get any public data, so we have to ask the pharmaceutical industry, and they’re not required to give us the data.”
The boards want to ensure that patients like Reitzel still have access to new and better therapies. Reitzel, 38, of Highlands Ranch, was diagnosed with multiple sclerosis in 2008 and has switched medications several times seeking one whose side effects she could tolerate. “They’re all terrible in their own special way,” she said.
In 2021, she began taking a relatively new drug from Biogen and Alkermes called Vumerity, which was included on Colorado’s list of eligible drugs. But the cost of a three-month supply was nearly $24,000, including a copay of more than $7,000. Biogen provides up to $20,000 in annual copay assistance through a debit card she can use at the pharmacy. But now her health plan no longer credits those payments toward her deductible. It makes it almost impossible for her to meet the $25,000 out-of-pocket maximum under her plan.
“Primarily for this reason, I am no longer taking any medication,” Reitzel said, “and have to only hope my disease does not progress.”
Colorado legislators passed a bill to require health plans to count copay assistance programs toward patients’ deductibles for drugs with no generic equivalents, but that provision does not take effect until 2025.
Insulin as an Outlier?
Just a couple of years ago, insulin may have been a higher priority for drug affordability boards, but now it’s not so clear. Both Colorado and Maryland have established insulin copay caps that provide pocketbook relief, at least for patients with coverage. And manufacturers are making their own moves to lower insulin prices. That could prompt the boards to bypass insulin and concentrate their limited resources on other high-cost drugs.
Copay caps do not lower the actual cost of insulin but instead spread it among members of the health plan through higher premiums. The Colorado copay caps don’t help new state residents and initially did not help those without insurance, either. Both of those hurdles would have applied to Marquez-Farmer when she moved from California to Colorado Springs a couple of years ago.
“I got married to my husband during covid because I didn’t have insurance,” she said. “I loved him, and it all worked out, but a big reason for me to marry him was because I would not be able to afford insulin.”
Marquez-Farmer, 34, said that while insulin may not be the most expensive drug on the market, many Coloradans, particularly those from marginalized communities who have higher rates of diabetes, struggle to afford it.
“I’m not saying the other medicines are not important, because obviously they are,” she said. “The reality is there’s more people who are being affected by not being able to afford their insulin and a lot of people who are dying because of them rationing insulin.”
Andrew York, executive director of the Maryland board, said the payment limits should be viewed as a last resort, a tool that can be used when other cost-control measures haven’t worked.
“The goal is for folks to never be able to say that they can’t afford their insulin. And I think we may get there soon enough just because of how much is happening in that space,” he said. “So if that’s the case, then maybe boards don’t need to use the upper payment limit tool.”
At least one form of insulin was included on Colorado’s list of drugs eligible for review, but not the most commonly taken brand-name insulins. That precludes the Colorado board from addressing insulin costs more broadly.
The pharmaceutical industry has pushed back against the concept of payment limits, warning that drugmakers could pull out of states that set payment limits.
“The boards are acutely aware of this discussion point. The interest and the purpose of these boards is to increase access to the drugs, not decrease it,” York said. “But there’s kind of this game theory element of: How will manufacturers react?”
Reck discounted the notion that a payment limit would prompt a manufacturer to abandon a profitable market.
“Unfortunately, it’s kind of a scary message and it can be impactful on patients,” she said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 10 months ago
Health Care Costs, Pharmaceuticals, States, Colorado, Drug Costs, Maine, Maryland, New Hampshire, Ohio, Oregon, Prescription Drugs, Washington
A More Aggressive FTC Is Starting to Target Drug Mergers and Industry Middlemen
Under the leadership of an aggressive opponent of anti-competitive business practices, the Federal Trade Commission is moving against drug companies and industry middlemen as part of the Biden administration’s push for lower drug prices at the pharmacy counter.
On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals.
In its lawsuit, the FTC said that if it allowed Amgen’s $27.8 billion purchase to go through, Amgen could pressure the companies that manage access to prescription drugs — pharmacy benefit managers, or PBMs — to boost the two extremely expensive Horizon products in a way that would inhibit any competition.
The suit, the first time since 2009 that the FTC has tried to block a drug company merger, reflects Chair Lina Khan’s strong interest in antitrust action. In announcing the suit, the agency said that by fighting monopoly powers it aimed to tame prices and improve patients’ access to cheaper products.
The FTC’s action is a “shot across the bow for the pharmaceutical industry,” said Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco. David Balto, a former FTC official and attorney who fought the 2019 Bristol-Myers Squibb-Celgene and 2020 AbbVie-Allergan mergers, said FTC’s action was long overdue.
The Horizon-Amgen merger would “cost consumers in higher prices, less choice, and innovation,” he said. “The merger would have given Amgen even more tools to exploit consumers and harm competition.”
The FTC also announced an expansion of a yearlong investigation of the PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services. Critics claim the PBMs set up these companies to conceal profits.
When Amgen announced its purchase of Horizon in December — the biggest biopharma transaction in 2022 — it showed particular interest in Horizon’s drugs for thyroid eye disease (Tepezza) and severe gout (Krystexxa), for which the company was charging up to $350,000 and $650,000, respectively, for a year of treatment. The complaint said the merger would disadvantage biotech rivals that have similar products in advanced clinical testing.
Amgen could promote the Horizon drugs through “cross-market bundling,” the FTC said. That means requiring PBMs to promote some of Amgen’s less popular drugs — the Horizon products, in this case — in exchange for Amgen offering the PBMs large rebates for its blockbusters. Amgen has nine drugs that each earned more than $1 billion last year, according to the complaint, the most popular being Enbrel, which treats rheumatoid arthritis and other diseases.
The three biggest PBMs negotiate prices and access to 80% of prescription drugs in the U.S., giving them enormous bargaining power. Their ability to influence which drugs Americans can get, and at what price, enables the PBMs to obtain billions in rebates from drug manufacturers.
“The prospect that Amgen could leverage its portfolio of blockbuster drugs to gain advantages over potential rivals is not hypothetical,” the FTC complaint states. “Amgen has deployed this very strategy to extract favorable terms from payers to protect sales of Amgen’s struggling drugs.”
The complaint noted that biotech Regeneron last year sued Amgen, alleging that the latter’s rebating strategy harmed Regeneron’s ability to sell its competing cholesterol drug, Praluent. Amgen’s Repatha generated $1.3 billion in global revenue in 2022.
It “may be effectively impossible” for smaller rivals to “match the value of bundled rebates that Amgen would be able to offer” as it leverages placement of the Horizon drugs on health plan formularies, the complaint states.
Business analysts were skeptical that the FTC action would succeed. Until now the commission and the Department of Justice have shied away from challenging pharmaceutical mergers, a precedent that will be hard to overcome.
Research on the impact of mergers has shown that they often benefit shareholders by increasing stock prices, but hurt innovation in drug development by trimming research projects and staffing.
Waves of consolidation shrank the field of leading pharma companies from 60 to 10 from 1995 to 2015. Most of the mergers in recent years have involved “big fish buying up lots of little fish,” such as biotech companies with promising drugs, Feldman said.
The giant Amgen-Horizon merger is an obvious exception, and therefore a good opportunity for the FTC to demonstrate a “theory of harm” around drug industry bundling maneuvers with PBMs, said Aaron Glick, a mergers analyst with Cowen & Co.
But that doesn’t mean the FTC will win.
Amgen may or may not engage in anti-competitive practices, but “a separate question is, how does this lawsuit fit under current antitrust laws and precedent?” Glick said. “The way the law is set up today, it seems unlikely it will hold up in court.”
The FTC’s argument about Amgen’s behavior with Horizon products is hypothetical. The pending Regeneron suit against Amgen, as well as other, successful lawsuits, suggests that rules are in place to suppress this kind of anti-competitive behavior when it occurs, Glick said.
The judge presiding over the case in U.S. District Court in Illinois is John Kness, who was appointed by then-President Donald Trump and is a former member of the Federalist Society, whose membership tends to be skeptical of antitrust efforts. The case is likely to be settled by Dec. 12, the deadline for the merger to go through under current terms.
Amgen sought to undercut the government’s case by agreeing not to bundle Horizon products in future negotiations with pharmacy benefit managers. That promise, while hard to enforce, might get a sympathetic hearing in court, Glick said.
Still, even a loss would enable the FTC to shed light on a problem in the industry and what it sees as a deficiency in antitrust laws that it wants Congress to correct, he said.
The day after suing to stop the merger, the FTC announced it was pushing further into an investigation of pharmacy benefit managers that it began last June. The agency demanded information from Ascent and Zinc, the two so-called rebate aggregators — drug purchasing organizations set up by PBMs Express Scripts and CVS Caremark.
At a May 10 hearing, Eli Lilly & Co. CEO Dave Ricks said that most of the $8 billion in rebate checks his company paid last year went to rebate aggregators, rather than to the PBMs directly. A “big chunk” of the $8 billion went overseas, he said. Ascent is based in Switzerland, while Emisar Pharma Services, an aggregator established by PBM OptumRx, is headquartered in Ireland. Zinc Health Services is registered in the U.S.
Critics say the aggregators enable PBMs to obscure the size and destination of rebates and other fees they charge as intermediaries in the drug business.
The PBMs say their efforts reduce prices at the pharmaceutical counter. Testimony in Congress and in FTC hearings over the past year indicate that, at least in some instances, they actually increase them.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 10 months ago
Courts, Health Industry, Pharmaceuticals, Drug Costs, Prescription Drugs
Una FTC más agresiva persigue las fusiones en la industria farmacéutica y a los intermediarios del sector
Bajo la dirección de una agresiva opositora al comportamiento empresarial que menoscaba la competencia, la Comisión Federal de Comercio (FTC) está actuando contra las empresas farmacéuticas y los intermediarios del sector, como parte de la campaña de la administración Biden para reducir los precios de los medicamentos en las farmacias.
El 16 de mayo, la FTC interpuso una demanda para bloquear la fusión de las farmacéuticas Amgen y Horizon Therapeutics, alegando que la enmarañada red de acuerdos de la industria permitiría a Amgen aprovechar el poder monopolístico de dos de los principales medicamentos de Horizon que no tienen rivales.
En su demanda, la FTC alegó que si se permitía la compra que pretende Amgen por $27,800 millones, Amgen podría presionar a las empresas que gestionan el acceso a los medicamentos con receta —los gestores de beneficios de farmacia, o PBM— para que impongan los dos productos extremadamente caros de Horizon de una manera que eliminaría cualquier competencia.
Es la primera vez desde 2009 que la FTC intenta bloquear una fusión de empresas farmacéuticas, y esta demanda refleja el gran interés de la presidenta Lina Khan por las medidas antimonopolio. Al anunciar la demanda, la agencia declaró que al luchar contra los poderes monopolísticos pretendía controlar los precios y mejorar el acceso de los pacientes a productos más baratos.
Para Robin Feldman, profesor y experto en la industria farmacéutica de la Facultad de Derecho de la Universidad de California en San Francisco, la actuación de la FTC es “un golpe frontal a la industria farmacéutica”. David Balto, ex funcionario de la FTC y abogado que luchó contra las fusiones Bristol-Myers Squibb-Celgene en 2019 y AbbVie-Allergan en 2020, dijo que la acción de la FTC era necesaria desde hace mucho tiempo.
La fusión Horizon-Amgen “costaría a los consumidores precios más altos, menos opciones e innovación”, señaló. “La fusión habría dado a Amgen aún más herramientas para explotar a los consumidores y dañar la competencia”.
La FTC también anunció la ampliación de una investigación de un año sobre los PBM, indicando que se investigaban dos gigantescas empresas de compra de medicamentos, Ascent Health Services y Zinc Health Services. Los críticos afirman que los PBM crearon estas empresas para ocultar beneficios.
Cuando Amgen anunció la compra de Horizon en diciembre —la mayor operación biofarmacéutica de 2022— mostró especial interés por los medicamentos de Horizon para la enfermedad tiroidea ocular (Tepezza) y la gota grave (Krystexxa), por los que la empresa cobraba hasta $350,000 y $650,000, respectivamente, por un año de tratamiento. Según la demanda, la fusión perjudicaría a rivales biotecnológicos que tienen productos similares en fase avanzada de pruebas clínicas.
Según la FTC, Amgen podría promocionar los fármacos de Horizon a través de la “venta cruzada”. Esto significa exigir a los PBM que promocionen algunos de los medicamentos menos populares de Amgen —los productos Horizon, en este caso— a cambio de que Amgen ofrezca a los PBM grandes descuentos por sus superventas. Según la denuncia, Amgen tiene nueve medicamentos que el año pasado generaron más de $1,000 millones cada uno. El más popular es Enbrel, que trata la artritis reumatoide y otras enfermedades.
Los tres mayores PBM negocian los precios y el acceso al 80% de los medicamentos recetados en Estados Unidos, lo que les confiere un enorme poder de negociación. Su capacidad para influir en los medicamentos a los que tienen acceso los estadounidenses, y a qué precio, les permite obtener miles de millones en descuentos de los fabricantes.
“La posibilidad de que Amgen pudiera aprovechar su cartera de medicamentos superventas para obtener ventajas sobre sus rivales potenciales no es hipotética”, afirma la denuncia de la FTC. “Amgen ha desplegado esta misma estrategia para conseguir condiciones favorables de los pagadores y proteger así las ventas de los medicamentos de Amgen en dificultades”.
La denuncia señaló que la biotecnológica Regeneron demandó el año pasado a Amgen, alegando que la estrategia de reembolso de esta última perjudicó la capacidad de Regeneron para vender su medicamento competidor contra el colesterol, Praluent. Repatha, de Amgen, generó unos ingresos mundiales de $1,300 millones en 2022.
Según la demanda, “puede resultar completamente imposible” para los rivales más pequeños “igualar el valor de los reembolsos agrupados que Amgen podría ofrecer”, ya que aprovecha la colocación de los medicamentos de Horizon en los formularios de los planes de salud.
Los analistas de la industria se mostraron escépticos sobre el éxito de la acción de la FTC. Hasta ahora, la Comisión y el Departamento de Justicia han evitado cuestionar las fusiones farmacéuticas, un precedente difícil de superar.
Las investigaciones sobre el impacto de las fusiones han demostrado que a menudo benefician a los accionistas al aumentar el precio de las acciones; pero perjudican la innovación en el desarrollo de fármacos al recortar los proyectos de investigación y el personal.
Las olas de consolidación redujeron el número de empresas farmacéuticas líderes de 60 a 10 entre 1995 y 2015. Según Feldman, la mayoría de las fusiones de los últimos años se han producido entre “peces gordos que adquieren muchos peces pequeños”, como empresas de biotecnología con fármacos prometedores.
La gigantesca fusión Amgen-Horizon es una excepción obvia y, por tanto, una buena oportunidad para que la FTC demuestre la “teoría del daño” en las maniobras de consolidación de la industria farmacéutica con los PBM, dijo Aaron Glick, analista de fusiones de Cowen & Co.
Pero eso no significa que la FTC vaya a ganar.
Amgen puede incurrir o no en prácticas anticompetitivas, pero “otra cuestión es cómo encaja esta demanda en las leyes antimonopolio y los precedentes actuales”, señaló Glick. “Tal y como está configurada la ley hoy, parece poco probable que se sostenga en los tribunales”.
El argumento de la FTC sobre el comportamiento de Amgen con los productos Horizon es hipotético. La demanda pendiente de Regeneron contra Amgen, así como otras demandas que han prosperado, sugiere que existen normas para suprimir este tipo de comportamiento anticompetitivo cuando se produce, añadió Glick.
El juez que preside el caso en el Tribunal de Distrito de Estados Unidos en Illinois es John Kness, quien fue nombrado por el entonces presidente Donald Trump y es un ex miembro de la Federalist Society, cuyos miembros tienden a ser escépticos sobre los esfuerzos antimonopolio.
Es probable que el caso se resuelva antes del 12 de diciembre, fecha límite para que la fusión se lleve a cabo en los términos actuales.
Amgen trató de socavar los argumentos del Gobierno comprometiéndose a no agrupar los productos de Horizon en futuras negociaciones con los gestores de beneficios farmacéuticos (PBM). Esta promesa, aunque difícil de hacer cumplir, podría obtener una audiencia favorable en corte, apuntó Glick.
Sin embargo, incluso una derrota permitiría a la FTC arrojar luz sobre un problema en la industria y lo que considera una deficiencia en las leyes antimonopolio que quiere que el Congreso corrija, explicó.
Al día siguiente de ir a corte para detener la fusión, la FTC anunció que profundizaba en una investigación sobre los gestores de beneficios farmacéuticos que inició el pasado mes de junio. La agencia solicitó información a Ascent y Zinc, los dos llamados agregadores de reembolsos, organizaciones de compra de medicamentos creadas por los PBM Express Scripts y CVS Caremark.
En una audiencia celebrada el 10 de mayo, el CEO de Eli Lilly & Co., Dave Ricks, afirmó que la mayor parte de los $8,000 millones en cheques de reembolso que su empresa pagó el año pasado fueron a parar a los agregadores de reembolsos, en lugar de directamente a los PBM. Una “gran parte” de los $8,000 millones fue a parar al extranjero, indicó Ricks. Ascent tiene su sede en Suiza, mientras que Emisar Pharma Services, un agregador establecido por PBM OptumRx, tiene su sede en Irlanda. Zinc Health Services está registrada en Estados Unidos.
Los críticos afirman que los agregadores permiten a los PBM ocultar la cuantía y el destino de los reembolsos y otras comisiones que cobran como intermediarios en el negocio de los medicamentos.
Por su parte, los PBM aseguran que sus esfuerzos reducen los precios en el mostrador de la farmacia. Los testimonios en el Congreso y en las audiencias de la FTC del año pasado indican que, al menos en algunos casos, en realidad los aumentan.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 10 months ago
Courts, Health Industry, Noticias En Español, Pharmaceuticals, Drug Costs, Prescription Drugs
AstraZeneca is third member to leave PhRMA in five months
WASHINGTON — AstraZeneca has decided to leave the brand drug lobbying powerhouse PhRMA halfway through the year, the organization said.
The exit is the group’s third in five months, as AbbVie exited PhRMA in December and Teva Pharmaceuticals left in February.
1 year 11 months ago
Pharma, Politics, Advocacy, biotechnology, Congress, drug pricing, life sciences, Pharmaceuticals, policy