For these drugs, Medicare will set a “maximum fair price” based on several factors, including manufacturer costs of research, development, and distribution; comparative drug effectiveness and therapeutic alternatives; and how much the government supported research and development related to the drug.

The first ten drugs for potential negotiation were selected last month (see below). In total, these drugs cost Medicare about $50 billion last year, and accounted for $3.4 billion in out of pocket costs for Medicare recipients.

If some of these names look familiar, it’s because these brand name drugs have been in the news over the past few years. Here’s a rundown of our previous blogs related to these drugs…

Blood thinner boondoggle

Eliquis and Xarelto are blood thinners that cost Medicare a combined $22.5 billion last year, according to CMS. This high cost to Medicare may be related to the companies’ pricing strategy. The Lown Institute gave the manufacturers of these drugs a “dishonorable mention” in the 2022 Shkreli Awards for allegedly raising their prices in concert. From the blog:

Anticoagulant drugs Eliquis and Xarelto were revolutionary when they hit the market in 2011 because they were safer than the previous standard of care. But as their popularity has grown over the past decade, so has their price, reported advocacy group Patients for Affordable Drugs. PAD’s 2022 report alleges that drug companies Pfizer and Johnson & Johnson have increased the prices of their drugs in lockstep, a practice known as “shadow pricing.” The prices for both of these drugs have more than doubled since 2011, and Eliquis and Xarelto are now the #1 and #3 most costly Medicare drugs, respectively.

25x price increases

A 2021 report from the Congressional Committee on Oversight and Reform called out Enbrel (a drug for rheumatoid arthritis) for increasing their price more than 25 times since its initial market launch.

The report, which utilized 1.5 million pages of internal documents and took three years to compile, found that pharma companies target the US for price increases because Medicare can’t negotiate, even as they keep prices flat or lowering them in the rest of the world. The report examined 12 drug prices and found that ten had increased in price 20 times of more since they came to market. Amgen in particular increased the price of Enbrel more than 25 times, for a total price increase of 486% since market launch. Amgen made more than $5 billion in revenue from this drug in 2019.

Another drug on the Medicare price negotiation list was also investigated in the congressional report. Imbruvica, a drug for blood cancers, was one of the few drugs that didn’t have 20 or more price increases– but they did increase the price more than five times for an 82% overall price increase. The drug made AbbVie $3.83 billion in revenue in 2019.

Drug ads that scare

Here’s a throwback from the Lown Institute blog archives. We included Entresto, a heart failure drug, and Eliquis in our Halloween series on scary pharma advertisements. Here’s an excerpt from our 2017 blog about the ominous “Keep it Pumping” ad campaign from Entresto manufacturer Novartis:

Novartis’ 2016 ad campaign called “Keep it Pumping” featured a TV advertisement warning that “with heart failure, danger is always on the rise.” As a man ignores the water rising around him, a voice-over says, “About 50% of people die within five years of being diagnosed [with heart failure].” Although the Novartis drug Entresto wasn’t explicitly mentioned, viewers were told to “talk to their doctor about heart failure treatment options.” Many doctors and researchers, including the head researcher on an Entresto study, criticized the ad for fear-mongering.

How are stakeholders responding?

Several pharmaceutical manufacturers, including Merck, J&J, and AstraZeneca have filed lawsuits to try and block the price negotiation (Astellas recently dropped their suit). Trade groups like the pharmaceutical lobbying group PhRMA and the National Infusion Center Association are also suing.

Given that pharma companies stand to lose billions each year from price reductions to their blockbuster drugs, it’s not surprising that they’re pushing back. What’s more interesting is the lack of response from hospitals on the negotiations. Large hospital and medical organizations like the American Hospitals Association have not publicly commented, noted Bob Herman in Stat News. Why not? One would think that hospitals would want lower drugs prices, but hospitals can make a hefty profit by passing along drug price markups to insurers (particularly if they are getting a discount on the drugs). Herman also points out that hospitals might not want to endorse price negotiations for drugs if they could later be subject to price negotiations on reimbursements for medical services.

The fact that Medicare may be negotiating drug prices soon is a historic win for patients. A successful first round of negotiations could put America closer to where other countries stand on drug price affordability, so we’ll be following this issue as we get closer to implementation.

The post Medicare drug price negotiations: The first drug list is here! appeared first on Lown Institute.

What is the 340B program?

The 340B Drug Pricing Program, part of the 1992 Public Health Service Act, provides outpatient drugs at a high discount to safety net providers. These discounts help keep hospitals afloat financially so they can continue delivering needed services to their communities. Hospitals say that the savings from 340B allow them to do things like “provide free care for uninsured patients, offer free vaccines, provide services in mental health clinics, and implement medication management and community health programs.” Hospitals can do these things with their 340B savings…but there’s no regulation that says they have to.

As the prices of cancer medications and other drugs used in the outpatient setting have skyrocketed, it makes sense that hospitals on thin margins deserve a discount. And it’s not like pharmaceutical companies — whose profits are nearly double that of other large companies make — need even more money. But at the same time, it’s important to ask whether the 340B program is actually serving its intended purpose.

340B and safety nets

If the 340B program worked perfectly, it would primarily help struggling hospitals that serve more low-income patients. However, the definition of “safety net” hospital when it comes to 340B eligibility is murky. Critical access hospitals (very small rural hospitals) and sole community providers, which typically operate on thin margins, are eligible for 340B. But so are “Disproportionate Share Hospitals,” a designation that ironically applies to half of all nonprofit hospitals and is not based on uncompensated care spending. Because eligibility is broad, an estimated 55% of nonprofit hospitals in urban areas receive 340B discounts.

Ideally, 340B would lead to more provision of financial assistance and care for underserved communities. However, research on whether 340B participation increases this kind of care is mixed. A 2021 study compared spending on uncompensated care at hospitals after they entered the 340B program compared to those that did not participate, and found that hospitals that participated did not spend more on uncompensated care compared to those not in 340B. However, a similar study from 2020 found that 340B hospitals did increase their spending on financial assistance specifically, although their overall community benefit spending and provision of low-profit services did not change.

The lack of regulation around how hospitals and systems spend their 340B savings can lead to cases like Bon Secours. According to a 2022 New York Times investigation, Bon Secours health system made a $100 million profit off of 340B discounts from their Richmond hospital, which serves mostly Black patients, but reinvested this money into its hospitals that serve a wealthier, whiter clientele. As a result, Bon Secours Richmond did not have an intensive care unit, maternity ward, or even a consistently-working MRI machine in 2022, despite a high need in the community for more services. Unfortunately, this may not be a unique example, as one study found that disproportionate share hospitals that participated in 340B after 2004 tended to be in higher-income communities, compared to hospitals that joined the 340B program earlier.

The 340B “remedy”

If 340B hospitals passed along the drug discounts they receive to patients, that would be another good use of these funds. However, there’s no requirement for hospitals to do so. In fact, one recent study found that commercially-insured patients spent more on certain cancer drugs at newly-participating 340B hospitals, compared to hospitals that didn’t participate in 340B. For cancer patients with high-deductible plans or other cost sharing, these increased charges can contribute to financial toxicity.

State Medicaid agencies reimburse 340B hospitals at the discounted price at which the drugs were acquired, but Medicare and commercial insurers can’t do the same. When Medicare cut their reimbursement rates in 2018 to match hospitals’ discounted price, hospitals went to court and had the cuts overturned. Now CMS has to pay back these hospitals to the tune of $9 billion, what is being called the “340B remedy.” According to a recent Modern Healthcare analysis, the 340B hospitals that will benefit the most from the proposed remedy provided less in uncompensated care as a share of expenses than other hospitals, while the hospitals spending the most in uncompensated care stand to gain the least from the remedy.

Fixing 340B

You might be thinking that given the issues with 340B, we should get rid of this designation altogether. But that’s a solution that only helps pharma. Let’s not forget, there wouldn’t be such a big problem with 340B if drug prices weren’t so high in the first place. At the same time that pharmaceutical companies are looking to restrict or get rid of 340B, they’re also brazenly suing the US government for trying to negotiate the highest-cost drug prices for Medicare patients.

But there are ways that 340B could be tweaked to optimize the benefit for low-income patients and the hospitals that serve them. In a recent Viewpoint article in JAMA, Dr. Sanjay Kishore at The University of Alabama, Dr. Rahul K. Nayak at the Emory University School of Medicine, and Dr. Aaron S. Kesselheim at Harvard Medical School explore policy solutions to improve oversight and eligibility for the 340B program. Here are a few of their proposals:

• Alter eligibility requirements for hospitals to redefine “safety net” hospitals beyond disproportionate share percentage, to include other criteria such as “measures of uncompensated care and area socioeconomic disadvantage.”
• Offer 340B discounts on a sliding scale based on hospitals with the neediest patients, rather than having 340B eligibility be “all or nothing.”
• Add more reporting requirements and utilize audits to better understand how 340B hospitals are using their discounts and gain more data around whether these discounts are being passed along to patients.

“Instead of heeding calls to cancel the program amid growth, policymakers should consider reforms that better ensure 340B benefits are targeted toward people with the most need. It is the least patients, clinicians, and health care facilities deserve.”

Dr. Sanjay Kishore et al, JAMA Viewpoint

The post What’s the tea on 340B? appeared first on Lown Institute.

Statistical vs clinical significance

Dr. Susan Molchan and Dr. Adriane Fugh-Berman, researchers from the PharmedOut project at Georgetown University Medical Center, explain why they’re skeptical of the new crop of Alzheimer’s drugs, in a recent Viewpoint in JAMA Internal Medicine. They write, “A statistically significant change on a test or scale does not mean that the change is clinically significant, such that patients or their families would see a benefit in their daily lives.” 

According to the clinical trial of Leqembi published in the New England Journal of Medicine, the drug actually shows a statistically significant impact on measures of cognitive decline (not just a reduction of beta amyloid like Aduhelm). However, we don’t yet know whether the result is clinically significant (a big enough difference to improve patients’ quality of life), given that the differences in cognitive decline between the two groups was small. Leqembi users showed a 0.45 point difference on the Clinical Dementia Rating compared to the placebo group, which previous research has not found enough to be a “meaningful” clinical change. 

If the patient or their families don’t see an improvement in their daily lives, if there is no meaningful change in retaining cognitive function or how they interact with loved ones, are they really doing “better”? 

“A statistically significant change on a test or scale does not mean that the change is clinically significant, such that patients or their families would see a benefit in their daily lives.”

-Susan Molchan, MD and Adriane Fugh-Berman, MD, of PharmedOut at Georgetown University Medical Center

This isn’t the first time a class of drugs for Alzheimer’s produced promising results but failed to deliver on clinical significance. While the beta-amyloid hypothesis remains dominant today, the cholinergic hypothesis ruled up until the 90s. Molchan and Fugh-Berman remind readers that drugs cholinesterase inhibitors like donepezil, which were approved to treat Alzheimer’s in 1996, had similar results in clinical trials as this new class of drugs that target beta-amyloid. They showed a reduced decline in cognitive function that passed the test for statistical significance, but did not meet the threshold for clinical significance. Cholinesterase inhibitors are rarely prescribed for Alzheimer’s today, and yet lecanemab, with similar results, is being hailed as something revolutionary. Is this real innovation, or just history repeating? 

New drugs aren’t risk-free

There are other reasons to be cautious about lecanemab and other new Alzheimer’s medications. Some physicians and patient advocates have remained wary of the newly-approved drugs due to their concerning side effects ranging from brain atrophy to death, especially given the dearth of evidence showing clinical significance.

These treatments are also expensive. A recent report by UCLA estimated that lecanemab could cause a $2-5 billion increase in annual Medicare spending. Out-of-pocket costs for patients lacking coverage could reach up to $6,600 per year, or about 20% of the median income of Medicare beneficiaries. As the report notes, additional costs likely lead to increased premiums, and many Americans are already living close to the edge financially as is. 

Molchan and Fugh-Berman point out that the resources directed towards biochemical interventions might have more impact if applied towards preventative measures. “Focusing on drugs for Alzheimer disease with at best marginal efficacy distracts from the use of drugs with clear benefits for diabetes, hypertension, and depression. The treatment of these diseases is associated with a substantially decreased risk of developing Alzheimer disease and other dementias (as well as many other diseases).”

“At present, drugs for Alzheimer disease have unproven clinical benefits and proven harms. Billions of dollars spent on hearing aids, smoking cessation, encouragement of healthy lifestyles, and treatment of hypertension, diabetes, and other modifiable risk factors may benefit patients more than spending on these drugs.” 

-Susan Molchan, MD and Adriane Fugh-Berman, MD, of PharmedOut at Georgetown University Medical Center

Given the haziness around whether lecanemab can meaningfully improve quality of life – the ultimate goal of any health intervention – it may be time to invest more into other interventions with proven, positive, tangible results.

The post Defining “better”: A look at the new Alzheimer’s drugs appeared first on Lown Institute.

Is lecanemab cost effective?

We previously wrote about the new drug for Alzheimer’s Disease lecanemab (brand name Lequembi). While the drug shows some promise to slow the progression of cognitive decline, it’s still unclear whether the safety issues outweigh the clinical benefits, and whether Biogen’s list price of $26,500 per year is reasonable.

A recent report by The Institute for Clinical and Economic Review (ICER) evaluated the cost-effectiveness of the current list price of lecanemab and concluded that the current price doesn’t accurately reflect the clinical value of the drug. ICER’s estimated cost-effective pricing of it falls between $8,900 and $21,500, which means that manufacturers would need to discount the drug by at least 19% to fall within that range. 

Evaluating the cost-effectiveness of lecanemab is difficult because the effectiveness of the drug itself is unclear. On the one hand, clinical trials have showed a slowing in cognitive decline; on the other hand, those same trials showed serious and concerning side effects. The theory behind the drug is shaky as well. Lecanemab is designed to remove amyloid plaques, but the study identifying amyloid plaques as the primary source of Alzheimer’s has been called into question as fraudulent. Thus, ICER classifies the evidence for benefit of lecanemab as “promising but inconclusive.”

The price of lecanemab is a serious one, because if all eligible patients receive it, that could put an enormous strain on Medicare’s finances. ICER calculated that if more than 5% of eligible patients received the drug over five years, Medicare spending would surpass $777 million, ICER’sl budgetary impact threshold of sustainable government spending.. 

Medicare spends too much for ineffective drugs

Aside from lecanemab, there is evidence showing that Medicare already spends too much on drugs that offer little clinical benefit compared to what’s already on the market. A day after ICER released their report, JAMA published an investigation of the added therapeutic benefit of top-selling brand-name drugs in Medicare. Researchers looked at the drugs Medicare spent the most on in 2020 and assessed their added therapeutic benefit using ratings from national assessment organizations in Canada, France, and Germany. 

Of the 49 drugs examined, 27 (55%) had received at least one rating of “low added therapeutic benefit” from another country. This means that compared to existing treatment options, the drugs added little or no benefit for patients. These 27 drugs together made up $19.3 billion in Medicare spending–more than 10% of all Medicare’s prescription drug spending. 

The Inflation Reduction Act of 2022 allows Medicare to negotiate the pricing of top-selling drugs, so reform is likely coming. While pharmaceutical manufacturers will push back with claims that lowering drug prices will “stifle innovation,” it’s important to point out that some of these “innovations” aren’t really helping patients. It’s time to negotiate these prices in accordance with their proven therapeutic benefit. 

The post When it comes to prescription drugs, are we getting what we pay for? appeared first on Lown Institute.

An overview

The price of insulin has been a hotly-debated topic for decades, as prices rose exorbitantly and patients’ ability to pay dropped. In 1999, a vial of Humalog cost $21. Just twenty years later, the same vial costs $332. That’s a 1000% increase. Given that patients can die without it, it should be easier to access. Instead, some Americans have been rationing or foregoing their medication.

For years, advocates have been demanding reasonable pricing from the “big three” insulin manufacturers Eli Lilly, Sanofi, and Novo Nordisk. In 2018, the Right Care Alliance organized a coalition of patients and healthcare workers to protest the price of insulin. They showed up at the doors of Sanofi’s offices in Cambridge, MA with two mothers carrying the ashes of their children who died because they couldn’t afford insulin. In November of last year, a journalist trolled Eli Lilly by impersonating their Twitter account and tweeting “We are excited to announce insulin is free now,” sparking deep public discussion on the unreasonable drug pricing. 

While the Inflation Reduction Act capped insulin prices at $35 a month for those covered by Medicare, it didn’t help those with Medicaid, private insurance, or no insurance. Just a few weeks ago, President Biden called for insulin price caps for all in his State of the Union speech.

The basics

Eli Lilly is the first of the major insulin manufacturers to willingly cap their insulin prices. Their new pricing policy drops a vial of insulin from $82 to $25 and is capping monthly out-of-pocket costs at $35. The company also announced a new insulin product intended to compete with a version of Sanofi’s insulin. It will be listed at a 78% discount compared to Sanofi’s pricing.

For those with commercial insurance, the $35-per-month cap will be implemented automatically when they fill their prescriptions at participating pharmacies.

For those with public insurance: Medicare members will see their prices capped at $35 a month due to the Inflation Reduction Act. However, this only applies to plans like Part D and Medicare Advantage. Right now, vials and injection pens qualify for this price reduction. This will be extended to include insulin pumps beginning in July.

For those without insurance: Costs can be capped at $35 monthly IF you acquire a savings card online.

It’s about damn time

Activists, patients, and clinicians have all been begging insulin manufacturers for decades to drop their prices. But prices kept rising despite their pleas. Over the last 20 years, overall insulin prices have risen an estimated 600%. Some patients who couldn’t afford the rising prices rationed their drugs, used expired medication, crossed country borders, and died trying to get the medication they needed. Meanwhile, the Eli Lilly CEO raked in $21.3 million in a single year. 

Excessively high pricing is not unique to insulin. According to recent data, drugmakers raised prices on nearly 1,000 drugs in just January of this year. This includes top-selling drugs that haven’t changed in years, but will now cost patients more money. Drug pricing is based on what the market will bear, regardless of the cost to patients. With insulin, it may just be the case that manufacturers sense impending regulations and would rather set their own pricing than fall subject to more governmental regulations. Another factor is state action; some states have been pushing for importing insulin, and California is even trying to manufacture and sell insulin to undercut Big Pharma.

It’s clear that insulin manufacturers could’ve lowered these prices all along. After all, insulin was always intended to be accessible and affordable. By enacting these aggressive price reductions, Eli Lilly is admitting to abuse and profiteering at the expense of people’s lives. If they could make this change today, why couldn’t they do it last week? Last year? Why did they continue to raise prices and prioritize excessive profits when it is evidently feasible to have a reasonable price and still maintain a profit margin? If they’d lowered prices sooner, how many lives could’ve been saved?

The post <strong>After decades of profiteering, insulin manufacturer finally cuts the price</strong> appeared first on Lown Institute.

Unfortunately, the tweet wasn’t real. A policy change at Twitter initiated by the new owner Elon Musk made it easy for tricksters to impersonate corporate accounts, and Eli Lilly was one of many to face the consequences. The company’s real account sent out a tweet hours later reading, “We apologize to those who have been served a misleading message from a fake Lilly account. Our official Twitter account is @LillyPad.” 

Days later, the fake-tweeter revealed himself to be Sean Morrow of the nonprofit media organization More Perfect Union. “I thought, hey, I feel like this is an opportunity to speak to corporate greed. I was not expecting it to blow up as much as it did,” Morrow told CBC. Here’s why his targeted trolling sent shockwaves throughout healthcare activism.

“We can do this whenever we want and there’s nothing you can do about it.”

Twitter’s past few weeks have been tumultuous, resulting in a mass exodus of employees and a significant shift in the business model of the company. When Elon Musk acquired Twitter, his stated goal was to make the company profitable.

Musk’s initial business plan was to turn Twitter into a subscription-based service in order to make it profitable. Users could now pay $8 per month for their verified badge–even if they were not an influencer, celebrity, or company account (credibility be damned!)

This went as well as expected. For just $8, individuals could suddenly impersonate accounts with virtually no way to identify the frauds without looking closely. Internet trolls–or vigilantes, depending on how you look at it–immediately spotted the opportunity to cause chaos. The consequences have been wide-ranging and in some cases, even satisfying to watch.

The biggest healthcare loser in all of this may be the pharmaceutical company Eli Lilly, one of the big three manufacturers of insulin. With nine words, an impersonator sent the internet into a frenzy. “We are excited to announce insulin is free now.” Due to the pandemonium of Twitter’s restructuring, there were no staff available to respond to the real Eli Lilly’s request to take the tweet down. The real Eli Lilly took to their own account to remedy the situation, issuing the statement “We apologize to those who have been served a misleading message from a fake Lilly account. Our official Twitter account is @LillyPad.”

That didn’t solve the problem. The impersonator came back in under an hour, tweeting out, “We apologize to those who were served a misleading message from a fake Lilly account about the cost of diabetic care. Humalog is now $400. We can do this whenever we want and there’s nothing you can do about it. Suck it. Our official Twitter account is @LillyPadCo.” Minutes later, they followed up with “$500 now. You want to keep going?” 

One tweet, billions of dollars

As individual users take shots at multi-billion dollar corporations, viewers are left wondering how this power imbalance came to be in the first place. The fight for affordable insulin has been raging since the drug’s discovery, and recently a study found that up to 1.3 million insulin users nationwide are rationing their medication. Given the company’s multibillion-dollar status and the manufacturing costs of insulin only reaching $10, it’s unclear why the cost of insulin has to be so high. 

The consequences of this scandal hit Eli Lilly hard. Eli Lilly’s shares dropped 4.5% in one single day, equivalent to billions of dollars. The financial impacts forced the hand of Eli Lilly’s C-suite – they had to address the controversy. 

“It probably highlights that we have more work to do to bring down the cost of insulin.”

– Eli Lilly CEO David Ricks at the 2022 STAT Summit

Eli Lilly wasn’t the only one to feel the heat. A fake Nestle account tweeted “we steal your water and sell it back to you lol” causing thousands of previously-unaware individuals to look deeper into the real Nestle’s production. Lockheed Martin reportedly lost billions after an impersonator tweeted, “We will begin halting all weapons sales to Saudi Arabia, Israel, and the United States until further investigation into their record of human rights abuses.” Even Elon Musk’s own company Tesla got caught up in the mess, with an impersonator tweeting “Our analysis engineers simulate hundreds of impact scenarios before ever killing a child in real life,” in reference to the car company’s failure to design a safe automated driving system.

Turning satire into success

Somewhere along the way of laughing at these companies’ misfortune, people started to reflect on what this chaos actually means and represents. It’s funny that “Eli Lilly” tweeted that insulin is free because we know that would never happen. We laugh at the follow-up tweet raising the price of insulin and the line “We can do this whenever we want and there’s nothing you can do about it” rings true. But the humor eventually gives way to the question, “but why does it have to be this way?”

“No one believed it, because no pharmaceutical company would ever do this in the United States…a pharmaceutical company saying their product is free or even cheaper is absurd. And that’s the trademark of satire.”

– Sean Morrow, the writer behind the infamous fake Eli Lilly tweet

This moment presents a unique opportunity to reflect on our values and how we live by them – or don’t. Do we really want to allow Nestle to drain our freshwater supply so they can profit off the sales of plastic bottles, another environmental problem? Are we okay with selling arms to Saudi Arabia knowing full well that those weapons will be used to carry out heinous human rights abuses? Can we swallow letting millions of Americans suffer so that Eli Lilly can charge $274.70 for a vial that only cost them $10 to make?

Internet activists were able to force these corporations to face real monetary consequences by spending $8 and taking their shots in the public square. It sparked the debate back up around insulin pricing and highlighted yet again how pharmaceutical companies are overpricing life-saving medication to reap bigger profits. We deserve a better system than this.

The post Power to the People: How a single tweet could reignite a movement appeared first on Lown Institute.

Racial equity and drug approvals

Racial equity has been a growing topic of conversation regarding drug approvals. Confronting structural racism requires dialogue with all actors in the healthcare system. However, what could be a fruitful conversation has been largely co-opted by pharmaceutical companies and pharma-funded groups as a method for trying to get drugs with unclear benefits approved.

At the recent Makena hearing, one of Covis pharmaceuticals’ key arguments was that Makena should remain on the market as a health equity intervention, because the drug may benefit Black women. This claim is based on the fact that a 2003 trial of Makena was positive, and this trial was conducted in the US with a majority Black women in the trial. However, there were some serious methodological flaws that called the results into question.

Makena’s manufacturer was required to conduct another trial, called PROLONG. This trial had a larger international cohort (since Makena was already on the market in the US, it was harder to recruit American women for the trial) and participants were mostly white women. This trial did not find a significant effect on preterm birth, regardless of the participants’ race, risk level, or other characteristic. The FDA wrote they were “unable to identify a group of women for whom Makena had an effect” in the confirmatory trial.

The differences between the two trials does not mean that the drug is effective in Black women. Neither trial showed a difference between drug effectiveness by race. The PROLONG trial had three times more participants than the previous trial and did not have the methodological problems as in the previous trial. PROLONG was designed to confirm that Makena decreased preterm birth-related health issues for infants, and not only was there no difference in infant health, but there was no different in the surrogate outcome of preterm birth at 37 weeks.

Given these findings, keeping Makena on the market would be a deeply inequitable decision. Because Black women are more likely to be at high risk for preterm birth, they would be more likely to be prescribed this unproven drug, and thereby exposed to unnecessary risk of drug side effects including headaches, depression, and cancer.

Let’s not forget, drug companies did not rush to get Makena approved because they cared so much about racism. Makena is a branded form of a very old $10 drug that was repackaged by a drug company and sold for $1500. Medicaid has spent $700 million on Makena in the past three years alone.

Pharma-funded claims

The FDA was not swayed by Covis Pharmaceuticals’ claim that the drug should stay on the market for purposes of racial equity. But it is concerning to see the crucial topic of racial equity being used to advocate for ineffective drugs. Covis did a great job spreading their message (read: money) around to specialty and advocacy groups to get their support. In many cases, pharma-funded groups brought up the issue of racial disparities in Makena’s defense.

For example, the senior advisor for HealthyWomen (Covis is on their corporate advisory council) wrote in a comment to the FDA, “Now is not the time for the FDA to exacerbate an ever increasing maternal health disparity in maternal and infant health outcomes between Black, Indigenous, and women of color and their white counterparts.”

Other specialty groups including the Society for Maternal-Fetal Medicine and the American College of Gynecology received funding from AMAG Pharmaceuticals, the previous owner of Makena. These and many other organizations belong to the Coalition to Advance Maternal Therapeutics, which is funded by Covis and other pharmaceutical companies. Covis also funded the creation of a group by the National Consumers League called the Preterm Birth Prevention Alliance to share patient stories about preterm birth at the FDA hearing.

Next in a pattern

Covis Pharmaceuticals isn’t the first to argue that an unproven drug should kept on the market for the sake of racial equity. Drug company Biogen used a similar argument to urge Medicare to cover their Alzheimer’s drug Aduhelm. Biogen and pharma-backed patient organizations called CMS’ decision to restrict access to the drug “discrimination” since people of color are at greater risk for Alzheimer’s.

Biogen, the makers of Aduhelm, claimed the CMS decision would “exacerbate health inequity in dementia care.” And the Alzheimer’s Association, a patient organization that receives funding from Biogen, called the decision “shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics.” This argument ignores the fact that we don’t know if Aduhelm actually works to reduce Alzheimer’s symptoms or progression, and that Biogen did not recruit enough people of color in their trials to match the levels of Alzheimer’s seen these groups.

And again very recently, the head of a pharma-funded advocacy group penned an op-ed in StatNews arguing for more access to PET scans for the sake of health equity — so that Black people could more easily access Alzheimer’s drugs that haven’t been proven to work.

What we need to talk about

Achieving racial health equity is incredibly difficult. It will require all actors in our health system — doctors, patients, hospitals, insurers, government agencies, pharmaceutical companies, etc. — to tackle structural racism at its core and to put power into the hands of communities most impacted by racism. The idea that unproven drugs like Makena and Aduhelm can solve racial disparities is a tempting shortcut, but a very misguided one.

Imagine that we did uncover a drug that cured Alzheimer’s disease, preterm birth, or another of the many health conditions more likely to impact people of color. Black, Hispanic, and Indigenous Americans would still be less likely to access this hypothetical miracle pill because of factors created by structural racism. People of color are less likely to have health care coverage than white Americans, less likely to be able to afford out-of-pocket costs for drugs, and less likely to be prescribed drugs that work.

The idea that unproven drugs like Makena and Aduhelm can solve racial disparities is a tempting shortcut, but a very misguided one.

Many people of color already have trouble accessing medications that already exist. Black individuals with atrial fibrillation are significantly less likely to receive direct-acting blood thinners (the safest, most effective type of blood thinner) than white patients. People of color are also less likely to receive buprenorphine for opioid addiction and more likely to report underuse of diabetes medications because of cost. And during Covid-19, Black and Hispanic/Latinx individuals were less likely to have access to antibody therapy or other novel treatments.

Racial health equity will not be attained through spending hundreds of millions on unproven drugs. We have to address the structural racism that leads to these disparities. That means implementing universal coverage, addressing provider unconscious bias, tackling residential segregation and hospital segregation, improving the social conditions in communities of color, and a myriad of other policies.

For their part, drug companies can ensure they represent all Americans in clinical trials, invest more in research for underfunded conditions that predominantly impact people of color like sickle cell anemia, and stop raising their prices unnecessarily (discounts through charities don’t count).

Racial equity is a real goal that we all need to work together to strive for — not a talking point to market unproven drugs.

The post Debunking pharma’s spin on racial equity appeared first on Lown Institute.

Unequitable access

By reviewing the 2021 National Health Interview Survey, researchers were able to look at data from nearly 30,000 adults in every state. Clear trends emerged among participants who are rationing their insulin. Individuals with Type 1 Diabetes were more likely to ration, as were Black Americans, and middle-income Americans. There was a significant difference in the likelihood of rationing insulin amongst individuals under the age of 65, with rates of rationing nearly doubling as compared to their older counterparts. Nearly all of those rationing and aged 65 or older were covered by Medicare. Nearly one-third of respondents without health insurance reported rationing their insulin in the past year.

Nearly one-third of respondents without health insurance reported rationing their insulin in the past year.

How rationing plays out

This study asked respondents if they “skipped insulin doses,” “took less insulin than needed,” or “delayed buying insulin,” though there are other ways individuals may strategize to save money. Right Care Alliance member Deidre Waxman shared how she got by with the Boston Globe, saying “I don’t use tons of insulin like other people do, so I’d have some left over, and instead of getting a whole new script, I would use the insulin out of date.”

Instead of getting a whole new script, I would use the insulin out of date.

Deidre Wexman to the Boston Globe

Individuals who ration insulin have also resorted to methods such as not eating, skipping other medical appointments necessary for diabetes management, and rationing test strips leaving the required insulin dosage unknown. The impacts of the actions can be immense; diabetic ketoacidosis is a life-threatening condition that requires emergency care. Diabetic ketoacidosis is preventable when diabetes is managed properly – but if someone can’t afford their insulin, they can’t afford to manage their diabetes properly. It’s a systems failure that leaves grieving families asking, “how many more?”

Intentions vs Reality

Insulin is a notable case of good intentions being corrupted by reality. When the drug was discovered in the early 1920s, its patent was sold for just $1. One of the scientists who sold the patent, Frederick Banting,  famously said, “Insulin does not belong to me, it belongs to the world.” 

Insulin does not belong to me, it belongs to the world.

Frederick Banting, co-discoverer of insulin

100 years later and the drug can cost patients hundreds of dollars per month. Eli Lilly, one of the first manufacturers of insulin, still controls a vast majority of the global market alongside Sanofi and Novo Nordisk. 

Despite the good intentions of the patent, insulin is still not truly accessible due to its high cost. Rationing insulin has its own price though. In 2018, the Right Care Alliance organized a coalition of patients and healthcare workers to protest the price of insulin. They showed up at the doors of Sanofi’s offices in Cambridge, MA with two mothers carrying the ashes of their children- they say their children died while rationing insulin.

Try and Try Again

The 2022 Inflation Reduction Act has the potential to alleviate some of the insulin pricing pressure through its monthly cap on insulin cost sharing in Medicare, set to take effect next year. This is a win for Medicare patients but does nothing for those who are privately insured or uninsured. We must keep pushing for insulin pricing reform; where we are is simply not good enough.

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Which mistake would you rather make?

The controversy stems from the lack of strong evidence regarding Relyvrio’s effectiveness. Despite a lack of sufficient support that the drug can extend patients’ lives or slow the rate of deterioration according to their own reviewers, the F.D.A. granted the drug Priority Review and orphan drug designation at the end of last month.

The reasoning behind this decision has to do with a complex bioethical question – if there is the potential to treat a previously untreatable disease with a new pharmaceutical, but the consequences are unknown, do you prescribe the drug? Is the unknown enough to deny patients hope? In this case, the F.D.A. says the uncertainty is acceptable. 

This move comes after patient advocacy groups and physicians had been pushing for approval, securing funding through the viral “Ice Bucket Challenge,” and writing letters to the F.D.A and testifying before their advisory committee. One of the physicians who signed the letter summed up the emotions behind the push for drug approval.

“In your difficult job, there’s always going to be a chance of making a mistake; it comes down to which mistake you would rather make…Can you imagine the mistake of saying no and then getting confirmatory evidence in two years that this really did work? And realizing all those patients were much more disabled or even dead when they didn’t need to be? I don’t know how you’ll be able to live with yourself if you make that mistake.”

– Dr. Richard Bedlack to the New York Times

A.L.S., Alzheimer’s, and Aduhelm

Critics, however, say approval of Relyvrio is yet another point in a concerning trend. The obvious comparison is to Aduhelm. Back in 2021, the F.D.A. approved the drug Aduhelm to treat Alzheimer’s in a move similar to this latest one. With limited evidence of effectiveness, Aduhelm sped through accelerated approval due to the serious and life-threatening nature of the disease it was supposed to treat. Some patient advocates and physicians rejoiced, taking more issue with the absurdly high price for the treatment than with its questionable efficacy. Others protested the decision, and the Centers for Medicare & Medicaid Services (CMS) refused to cover the drug until it was proven effective in a clinical trial. Aduhelm took another blow months later when it was revealed the research that served as the primary basis for the theory of treatment had been fabricated, calling into question our entire understanding of Alzheimer’s and its development.

There are key differences that distinguish Relyvrio from Aduhelm. Whereas Aduhelm had concerning side effects, Relyvrio was shown to be safe in its trial. Alzheimer’s is also much more common than ALS, meaning that Aduhelm was far more likely to raise Medicare premiums. Still, the high price tag of the still-unproven Relyvrio is controversial – drug pricing this high inevitably impacts us all. 

Evidence-based medicine is harder than it sounds

Every physician and scientist strives to make evidence-based decisions. But in the case of Relyvrio, as with Aduhelm, the evidence is unclear and does not justify the high price. An additional factor is the long process for fixing mistakes. Removing drugs from the market takes years – as evidenced by the fight to remove the pregnancy drug Makena from the market – allowing patients across the nation to be exposed to potentially dangerous drugs. Consequences can range from biological, in which someone has bodily harm from a bad drug, to financial, in which a patient bankrupts themselves for a drug that doesn’t work. 

Some policy action is being taken to remedy this situation. The Accelerated Approval Integrity Act outlines new authority and guidelines for the F.D.A., like outlining expedited procedures for withdrawing approval for drugs that don’t show efficacy in later trials. Given the controversy and nuance in the debate around drug development and sales, it’s clear that we need a better process for determining what exactly is required when we say “evidence-based medicine.”

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The primary accomplishments of this bill are allowing Medicare to negotiate certain drug prices and capping the price of insulin for Medicare patients. These changes have been in the works for over a decade, with politicians going back and forth over their impacts despite them having strong and steady public support. 

The major fault of this bill, however, is the exclusion of privately insured and uninsured patients. Given that the majority of Americans are privately insured and  10% of the US population is uninsured, a huge chunk of the population does not stand to benefit from these changes. Critics are right to point out that the uninsured face the steepest financial burdens to accessing care and yet this bill will not help them.

The Inflation Reduction Act allows Medicare to negotiate prices

Starting in 2026, Medicare can negotiate pricing for 10 drugs, set to grow in number in the following years. The targeted drugs have not yet been named, but based on the highest-priced drugs in 2020, potential candidates could be blood thinners Eliquis and Xarelto, cancer immune therapies Keytruda and Rituxan, diabetes drug Januvia, and others.

Price negotiation is restricted to these specific, high-spending drugs with limited generic options but will likely be impactful – a recent study in Health Affairs revealed that over a third of adults enrolled in Medicare did not fill prescriptions for drugs to treat cancer, hepatitis C, and immune disorder primarily because of the cost.  

If a drug is selected, this bill directs a minimum price reduction of 25%. If the drug has been on the market for a while and it is not new, the manufacturers may be required to drop their prices by up to 60%. Non-compliance results in a financial penalty between 65-95% of a drug’s sales. Should the manufacturer raise prices higher than inflation, they must pay a rebate to the government.

Another crucial feature of this bill is capping out-of-pocket spending for Part D Medicare enrollees. This is a victory for patient advocates across the nation, as it eliminates the so-called “coverage gap” that has been sinking patients into financial troubles with surprise billing. Starting in 2025, out-of-pocket spending is capped at $2,000 annually, potentially benefiting millions of seniors enrolled. 

As with most things in healthcare policy, though, this bill is not perfect. For starters, it only applies to Medicare, meaning citizens under the age of 65 do not benefit. Critiques have been made regarding how this all applies to residents of Puerto Rico. The pharmaceutical industry is not thrilled about these changes, saying that Medicare price negotiation will lead to reduced innovation and fewer new cures. Given that high prices don’t buy us better drugs now, their claim that lower drug prices will stifle innovation is shaky at best. 

The Insulin Cap: Progress, not perfection

Another impactful feature of the Inflation Reduction Act is the new cap on insulin prices. Insulin has a unique backstory in that the original patent in the 1920s was sold for just a dollar, specifically with the intention of saving lives without profiteering. Today, the cost can be so absurdly high that many people with type 1 diabetes ration their insulin because of the cost. More than a dozen people have died from insulin rationing in the past few years.   

Between 2007 and 2020, total out-of-pocket spending on insulin in the United States quadrupled from $236 million to $1.03 billion. Much of the problem can be traced back to monopoly pricing between the three largest insulin manufacturers, Eli Lilly, Sanofi, and Novo Nordisk, who have repeatedly been accused of intentionally driving up the cost of the drug by raising prices in lockstep.

The insulin cap included in the Inflation Reduction Act takes aim at these practices, capping the price at $35 per month. Targeted only for Medicare patients, the privately insured and (more concerningly) the uninsured will be left on their own. It is possible that insurance corporations will compensate for lost profits by raising prices for the privately insured and uninsured. Senior patient advocacy groups are still thrilled with victory, and they should be – pharmaceutical companies blew them out of the water in terms of lobbying funds, but they managed to prevail.

The pharmaceutical industry is, of course, unhappy with this outcome. Again they argue that this will harm innovation and is an overreach of government power, instead pointing the finger at pharmacy benefit managers.  A generic version of insulin is set to hit the market in 2024 and would be priced around $35, which may also add pressure on the pharmaceutical industry to stop price-gouging. 

While the healthcare provisions in the Inflation Reduction Act are not above critique, they are a strong step forwards towards accessible, affordable healthcare and should be counted as a win for patient advocates across the nation. There is potential for this to open the door to more change. The exclusion of private insurance may motivate private insurers to demand the lower prices set for Medicare. Perhaps the population will be louder in its demands for Medicare for All, desperate to also have affordable medication. Leveraging the collective power of the people – in this case, patients – is a part of building a better future. These provisions open the door for future reforms and show that impactful change is possible.

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