GLP-1

maker-of-weight-loss-drugs-to-ask-trump-to-pause-price-negotiations:-report

Maker of weight-loss drugs to ask Trump to pause price negotiations: Report

Popular prescriptions

For now, Medicare does not cover drugs prescribed specifically for weight loss, but it will cover GLP-1 class drugs if they’re prescribed for other conditions, such as Type 2 diabetes. Wegovy, for example, is covered if it is prescribed to reduce the risk of heart attack and stroke in adults with either obesity or overweight. But, in November, the Biden administration proposed reinterpreting Medicare prescription-coverage rules to allow for coverage of “anti-obesity medications.”

Such a move is reportedly part of the argument Lilly’s CEO plans to bring to the Trump administration. Rather than using drug price negotiations to reduce health care costs, Ricks aims to play up the potential to reduce long-term health care costs by improving people’s overall health with coverage of GLP-1 drugs now. This argument would presumably be targeted at Mehmet Oz, the TV presenter and heart surgeon Trump has tapped to run the Centers for Medicare and Medicaid Services.

“My argument to Mehmet Oz is that if you want to protect Medicare costs in 10 years, have [the Affordable Care Act] and Medicare plans list these drugs now,” Ricks said to Bloomberg. “We know so much about how much cost savings there will be downstream in heart disease and other conditions.”

An October report from the Congressional Budget Office strongly disputed that claim, however. The CBO estimated that the direct cost of Medicare coverage for anti-obesity drugs between 2026 and 2034 would be nearly $39 billion, while the savings from improved health would total just a little over $3 billion, for a net cost to US taxpayers of about $35.5 billion.

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Biased AI in health care faces crackdown in sweeping Biden admin proposals

Prior authorization

Elsewhere in the over 700-page proposal, the administration lays out policy that would bar Medicare Advantage plan providers from reopening and reneging on paying claims for inpatient hospital admission if those claims had already been granted approval through prior authorization. The proposal also wants to make criteria for coverage clearer and help ensure that patients know they can appeal denied claims.

The Department of Health and Human Services notes that when patients appeal claim denials from Medicare Advantage plans, the appeals are successful 80 percent of the time. But, only 4 percent of claim denials are appealed—”meaning many more denials could potentially be overturned by the plan if they were appealed.”

AI guardrails

Last, the administration’s proposal also tries to shore up guardrails for the use of AI in health care with edits to existing policy. The goal is to make sure Medicare Advantage insurers don’t adopt flawed AI recommendations that deepen bias and discrimination or exacerbate existing inequities.

As an example, the administration pointed to the use of AI to predict which patients would miss medical appointments—and then recommend that providers double-book the appointment slots for those patients. In this case, low-income patients are more likely to miss appointments, because they may struggle with transportation, childcare, and work schedules. “As a result of using this data within the AI tool, providers double-booked lower-income patients, causing longer wait times for lower-income patients and perpetuating the cycle of additional missed appointments for vulnerable patients.” As such, it should be barred, the administration says.

In general, people of color and people of lower socioeconomic status tend to be more likely to have gaps and flaws in their electronic health records. So, when AI is trained on large data sets of health records, it can generate flawed recommendations based on that spotty and incorrect information, thereby amplifying bias.

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shady-drugmaker-used-code-words-to-sell-knockoff-weight-loss-drug:-lawsuit

Shady drugmaker used code words to sell knockoff weight-loss drug: lawsuit

Starts with a T

Pivotal Peptides—which is not a licensed pharmacy or dispensary—did not respond to the letter. Instead, its website was modified to indicate that it was “down for maintenance,” and the company instructed customers to email directly. About 10 days later, Pivotal Peptides’ registered agent, Elizabeth Gately, then sent an email (which Lilly obtained) instructing customers to place tirzepatide orders using coded language.

“Good News,” the email read, “Pivotal Peptides … is still in business!”

“If a favorite product (starting with T) was your go-to, that name can’t be used in any correspondence with me or listed on my price sheet anymore,” Gately allegedly wrote. “Therefore, I need another identifier and decided (for now) to call this peptide ’11mg.'”

Gately went on to say that the codenamed product “is Pivotal Peptide’s [sic] bestseller,” and “it is the only T size available from PP right now except by special order.” The letter ended with: “Remember to order ’11 mg’ with the latest price to identify the product you want, if applicable, and no longer use T in our communication.”

Pivotal Peptides did not respond to Ars’ request for comment.

In a statement emailed to Ars, a Lilly spokesperson said Pivotal Peptides and the other companies Lilly is suing are engaging in “conduct that poses serious risks to patient safety.” In the lawsuit, Lilly notes that even children could be ordering this DIY, research-grade drug.

“No one should ever be allowed to sell these untested, non-human grade or manipulated drugs to American consumers,” the statement continued.

Lilly’s lawsuits come amid a legal storm over compounded versions of the tirzepatide, which can be legally made by licensed pharmacies as long as tirzepatide is in shortage. On October 2, the Food and Drug Administration announced that the shortage had ended but then decided to reconsider the decision after being sued by compounding pharmacies.

On several occasions, the FDA has warned of safety concerns related to compounded versions of GLP-1 weight-loss drugs.

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drugmakers-can-keep-making-off-brand-weight-loss-drugs-as-fda-backpedals

Drugmakers can keep making off-brand weight-loss drugs as FDA backpedals

The judge in the case, District Judge Mark Pittman, granted the FDA’s request, canceling an October 15 hearing, and ordering the parties to submit a joint status report on November 21.

Drugmakers respond

The move was celebrated by the Outsourcing Facilities Association (OFA), which filed the lawsuit.

“We believe that this is a fair resolution in light of the agency’s rash decision to take the drug off of the list at a time when the agency has acknowledged ‘supply disruptions,’ which immediately created a major access issue for patients everywhere,” OFA Chairperson Lee Rosebush said in a statement. “Most important, should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”

The move is also likely to please patients who have come to rely on cheaper, more readily available compounded versions of the drugs. For some, compounded products may have been their only access to tirzepatide.  Still, those drugs are not without risk. The FDA has repeatedly emphasized that compounded drugs are not FDA-approved and do not go through the same safety, efficacy, and quality reviews. And the agency has warned of dosing errors and other safety concerns with compounded versions.

The one party that is certainly unhappy with the FDA’s move is Eli Lilly, which had reportedly sent cease-and-desist letters to compounders. In an emailed statement to Ars, a spokesperson for Lilly said that there was sufficient supply of the company’s drug and continued use of compounded versions is unwarranted. “Nothing changes the fact that, as FDA has recognized, Mounjaro and Zepbound are available and the shortage remains ‘resolved,'” the spokesperson said.

Lilly also noted the FDA’s safety concerns about the compounded versions, adding that its own examination of some compounded products found impurities, bacteria, strange coloring, incorrect potency, puzzling chemical structures, and, in one case, a product that was just sugar alcohol.

“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.

In terms of the supply “disruptions” the FDA mentioned and that some patients and pharmacies have reportedly experienced, Lilly said that the supply chain was complex and there are many reasons why a given pharmacy may not have a specific dose at hand, such as limited refrigerated storage space.

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Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

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eli-lilly-raises-price-of-zepbound-while-trumpeting-discount-on-starter-vials

Eli Lilly raises price of Zepbound while trumpeting discount on starter vials

Pharma misdirection —

Cost for insured patients without coverage for the drug rises from $550 to $650 a month.

An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company’s press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month’s supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month’s supply of vials with the 2.5 mg doses will cost $399, while a month’s supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

“This new option helps millions of adults with obesity access the medicine they need,” Lilly said in its announcement of the vials and their prices.

The company also included a quote from James Zervos, chief operating officer of the nonprofit Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity,” Zervos said. “We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality.” Even President Biden chimed in on social media, saying he was “pleased” by the discount, though he urged drug companies to cut prices “across the board.”

“No rational reason, other than greed”

But, that wasn’t the end of the news. When Lilly released its press release, people noticed that the company had also increased the price of Zepbound pens for those who have insurance plans that don’t cover the drug. In the past, Lilly offered a “savings card” that allowed these patients to buy a month’s supply of any dosage of Zepbound pens for $550. Now the price is $650, a nearly 20 percent increase.

Lilly did not respond to Ars’ request for comment or questions about why the company increased the price for some patients.

Sen. Bernie Sanders (I-Vt.), a longtime critic of the pharmaceutical industry and their drug pricing, was quick to weigh in. He called the vial prices a “modest step forward” but noted that, even with the price reduction, millions of Americans still won’t be able to pay for the drug. At $549 a month, the price of the drug is a little over the average monthly payment for a used car, which was $523 in the first quarter of this year, according to Experian. As for the increase in pen pricing, Sanders called it “bad news.”

“In addition, Eli Lilly has still refused to lower the outrageous price of Mounjaro that Americans struggling with diabetes desperately need,” Sanders went on. “There is no rational reason, other than greed, why Mounjaro should cost $1,069 a month in the United States but just $485 in the United Kingdom and $94 in Japan.”

In May, a Senate committee report concluded that uptake of such weight-loss and diabetes drugs stands to “bankrupt our entire health care system,” given the high prices and large demand in the US. The report was produced by the Senate’s Health, Education, Labor, and Pensions (HELP) committee, which is chaired by Sanders.

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people-are-overdosing-on-off-brand-weight-loss-drugs,-fda-warns

People are overdosing on off-brand weight-loss drugs, FDA warns

Dosage disarray —

Bad math and unclear directions are behind overdoses of up to 20 times the normal amount.

Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity.

Enlarge / Wegovy is an injectable prescription weight-loss medicine that has helped people with obesity.

The US Food and Drug Administration has approved two injectable versions of the blockbuster weight-loss and diabetes drug, semaglutide (Wegovy and Ozempic). Both come in pre-filled pens with pre-set doses, clear instructions, and information about overdoses. But, given the drugs’ daunting prices and supply shortages, many patients are turning to imitations—and those don’t always come with the same safety guardrails.

In an alert Friday, the FDA warned that people are overdosing on off-brand injections of semaglutide, which are dispensed from compounding pharmacies in a variety of concentrations, labeled with various units of measurement, administered with improperly sized syringes, and prescribed with bad dosage math. The errors are leading some patients to take up to 20 times the amount of intended semaglutide, the FDA reports.

Though the agency doesn’t offer a tally of overdose cases that have been reported, it suggests it has received multiple reports of people sickened by dosing errors, with some requiring hospitalizations. Semaglutide overdoses cause nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the agency reports.

Bad math

In typical situations, compounding pharmacies provide personalized formulations of FDA-approved drugs, for instance, if a patient is allergic to a specific ingredient, requires a special dosage, or needs a liquid version of a drug instead of a pill form. But, when commercially available drugs are in short supply—as semaglutide drugs currently are—then compound pharmacies can legally step in to make their own versions if certain conditions are met. However, these imitations are not FDA-approved and, as such, don’t come with the same safety, quality, and effectiveness assurances as approved drugs.

In the warning Friday, the FDA said that some patients received confusing instructions from compounding pharmacies, which indicated they inject themselves with a certain number of “units” of semaglutide—the volume of which may vary depending on the concentration—rather than milligrams or milliliters. In other instances, patients received U-100 (1-milliliter) syringes to administer 0.05-milliliter doses of the drug, or five units. The relatively large syringe size compared with the dose led some patients to administer 50 units instead of five.

The figure demonstrates how syringe size could lead some to an incorrect dosage.

Enlarge / The figure demonstrates how syringe size could lead some to an incorrect dosage.

FDA-approved semaglutide drugs, meanwhile, are dosed in milligrams and come in standardized concentrations. The agency received several reports of health care providers incorrectly converting from milligrams to units or milliliters, leading them to calculate the wrong dosages. With these math errors, some patients administered five to 10 times more semaglutide than intended.

“FDA recognizes the substantial consumer interest in using compounded semaglutide products for weight loss,” the agency wrote. “However, compounded drugs pose a higher risk to patients than FDA-approved drugs.” The agency urged patients and prescribers to only use compounded versions when absolutely necessary.

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new-weight-loss-and-diabetes-drugs-linked-to-lower-risk-of-10-cancers

New weight-loss and diabetes drugs linked to lower risk of 10 cancers

Secondary benefits —

For diabetes patients, GLP-1 drugs linked to lower cancer risks compared to insulin.

Ozempic is a GLP-1 drug for adults with type 2 diabetes.

Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes.

For patients with Type 2 diabetes, taking one of the new GLP-1 drugs, such as Ozempic, is associated with lower risks of developing 10 out of 13 obesity-associated cancers as compared with taking insulin, according to a recent study published in JAMA Network Open.

The study was retrospective, capturing data from over 1.6 million patients with Type 2 diabetes but no history of obesity-associated cancers prior to the study period. Using electronic health records, researchers had follow-up data for up to 15 years after the patients started taking either a GLP-1 drug, insulin, or metformin between 2008 and 2015.

This type of study can’t prove that the GLP-1 drugs caused the lower associated risks, but the results fit with some earlier findings. That includes results from one trial that found a 32 percent overall lower risk of obesity-associated cancers following bariatric surgery for weight loss.

In the new study, led by researchers at Case Western Reserve University School of Medicine, some of the GLP-1-associated risk reductions were quite substantial. Compared with patients taking insulin, patients taking a GLP-1 drug had a 65 percent lower associated risk of gall bladder cancer, a 63 percent lower associated risk of meningioma (a type of brain tumor), a 59 percent lower associated risk for pancreatic cancer, and a 53 percent lower associated risk of hepatocellular carcinoma (liver cancer). The researchers also found lower associated risks for esophageal cancer, colorectal cancer, kidney cancer, ovarian cancer, endometrial cancer, and multiple myeloma.

Compared with insulin, the researchers saw no lowered associated risk for thyroid and breast cancers. There was a lower risk of stomach cancer calculated, but the finding was not statistically significant.

Gaps and goals

The GLP-1 drugs did not show such promising results against metformin in the study. Compared with patients taking metformin, patients on GLP-1 drugs saw lower associated risks of colorectal cancer, gall bladder cancer, and meningioma, but those calculations were not statistically significant. The results also unexpectedly indicated a higher risk of kidney cancer for those taking GLP-1 drugs, but the cause of that potentially higher risk (which was not seen in the comparison with insulins) is unclear. The researchers called for more research to investigate that possible association.

Overall, the researchers call for far more studies to try to confirm a link between GLP-1 drugs and lower cancer risks, as well as studies to try to understand the mechanisms behind those potential risk reductions. It’s unclear if the lower risks may be driven simply by weight loss, or if insulin resistance, blood sugar levels, or some other mechanisms are at play.

The current study had several limitations given its retrospective, records-based design. Perhaps the biggest one is that the data didn’t allow the researchers to track individual patients’ weights throughout the study period. As such, researchers couldn’t examine associated cancer risk reductions with actual weight loss. It’s one more aspect that warrants further research.

Still, the study provides another promising result for the blockbuster, albeit pricy, drugs. The researchers suggest extending their work to assess whether GLP-1 drugs could be used to improve outcomes in patients with Type 2 diabetes or obesity who are already diagnosed with cancer, in addition to understanding if the drugs can help prevent the cancer.

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the-next-food-marketing-blitz-is-aimed-at-people-on-new-weight-loss-drugs

The next food marketing blitz is aimed at people on new weight-loss drugs

GLP-1 friendly —

Taking a weight-loss drug? Food makers have just the new food for you.

The next food marketing blitz is aimed at people on new weight-loss drugs

As new diabetes and weight-loss drugs help patients curb appetites and shed pounds, food manufacturers are looking for new ways to keep their bottom lines plump.

Millions of Americans have begun taking the pricey new drugs—particularly Mounjaro, Ozempic, Wegovy, and Zepbound—and millions more are expected to go on them in the coming years. As such, food makers are bracing for slimmer sales. In a report earlier this month, Morgan Stanley’s tobacco and packaged food analyst Pamela Kaufman said the drugs are expected to affect both the amounts and the types of food people eat, taking a bite out of the food and drink industry’s profits.

“In Morgan Stanley Research surveys, people taking weight-loss drugs were found to eat less food in general, while half slashed their consumption of sugary drinks, alcohol, confections and salty snacks, and nearly a quarter stopped drinking alcohol completely,” Kaufman said. Restaurants that sell unhealthy foods, particularly chains, may face long-term business risks, the report noted. Around 75 percent of survey respondents taking weight-loss drugs said they had cut back on going to pizza and fast food restaurants.

Some food makers aren’t taking the threat lightly. On Tuesday, the massive multinational food and beverage conglomerate Nestlé announced a new line of frozen foods, called Vital Pursuit, aimed directly at people taking GLP-1 weight-loss drugs (Wegovy and Ozempic). Nestlé—maker of DiGiorno frozen pizzas and Stouffer’s frozen entrées—said the new product line will include frozen pizzas, sandwich melts, grain bowls, and pastas that are “portion-aligned to a weight loss medication user’s appetite.” The frozen fare is otherwise said to contain fiber, “essential nutrients,” and high protein, food features not specific for people on GLP-1 drugs.

“As the use of medications to support weight loss continues to rise, we see an opportunity to serve those consumers,” Steve Presley, CEO of Nestlé North America, said in the product line announcement. “Vital Pursuit provides accessible, great-tasting food options that support the needs of consumers in this emerging category.”

Nestlé isn’t alone. At the end of last year, WeightWatchers began offering a membership program for people taking GLP-1 drugs. In January, meal delivery service Daily Harvest announced its “GLP-1 Companion Food Collection.” And last month, GNC announced a “GLP-1 support program” for people on the drugs, which includes a collection of various supplements, coaching, and consultations.

The companies seem to be heeding the advice of analysts. Morgan Stanley’s report noted that food makers can adapt to people’s changing diets by “raising prices, offering ‘better for you’ or weight-management products, or catering to changing trends with vegan or low-sugar options.” Kaufman noted that some companies are already adjusting by selling smaller packages and portions.

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“Outrageously” priced weight-loss drugs could bankrupt US health care

Collision course —

Prices would need to be dramatically slashed to avoid increasing the national deficit.

Packaging for Wegovy, manufactured by Novo Nordisk, is seen in this illustration photo.

Enlarge / Packaging for Wegovy, manufactured by Novo Nordisk, is seen in this illustration photo.

With the debut of remarkably effective weight-loss drugs, America’s high obesity rate and its uniquely astronomical prescription drug pricing appear to be set on a catastrophic collision course—one that threatens to “bankrupt our entire health care system,” according to a new Senate report that modeled the economic impact of the drugs in different uptake scenarios.

If just half of the adults in the US with obesity start taking a new weight-loss drug, such as Wegovy, the collective cost would total an estimated $411 billion per year, the analysis found. That’s more than the $406 billion Americans spent in 2022 on all prescription drugs combined.

While the bulk of the spending on weight-loss drugs will occur in the commercial market—which could easily lead to spikes in health insurance premiums—taxpayer-funded Medicare and Medicaid programs will also see an extraordinary financial burden. In the scenario that half of adults with obesity go on the drug, the cost to those federal programs would total $166 billion per year, rivaling the programs’ total 2022 drug costs of $175 billion.

In all, by 2031, total US spending on prescription drugs is poised to reach over $1 trillion per year due to weight-loss drugs. Without them, the baseline projected spending on all prescription drugs would be just under $600 billion.

The analysis was put together by the Senate’s Health, Education, Labor, and Pensions (HELP) committee, chaired by staunch drug-pricing critic Bernie Sanders (I-Vt). And it’s quick to knock down a common argument about the high prices for smash-hit weight-loss drugs. That is, with their high effectiveness, the drugs will improve people’s health in wide-ranging ways, including controlling diabetes, improving cardiovascular health, and potentially more. And, with those improvements, people won’t need as much health care, generally, lowering health care costs across the board.

But, while the drugs do appear to have wide-ranging, life-altering benefits for overall health, the prices of the drugs are still set too high to be entirely offset by any savings in health care use. The HELP committee analysis cited a March Congressional Budget Office (CBO) report that found: “at their current prices, [anti-obesity medicines] would cost the federal government more than it would save from reducing other health care spending—which would lead to an overall increase in the deficit over the next 10 years.” Moreover, in April, the head of the CBO said that the drugmakers would have to slash prices of their weight-loss drugs by 90 percent to “get in the ballpark” of not increasing the national deficit.

The HELP committee report offered a relatively simple solution to the problem: Drugmakers should set their US prices to match the relatively low prices they’ve set in other countries. The report focused on Wegovy because it currently accounts for the most US prescriptions in the new class of weight-loss drugs (GLP-1 drugs). Wegovy is made by Denmark-based Novo Nordisk.

In the US, the estimated net price (after rebates) of Wegovy is $809 per month. In Denmark, the price is $186 per month. A study by researchers at Yale estimated that drugs like Wegovy can be profitably manufactured for less than $5 per month.

If Novo Nordisk set its US prices for Wegovy to match the Danish price, spending to treat half of US adults with obesity would drop from $411 billion to $94.5 billion, a roughly $316.5 billion savings.

Without a dramatic price cut, Americans will likely face either losing access to the drugs or shouldering higher overall health care costs, or some of both. The HELP committee report highlighted how this recently played out in North Carolina. In January, the board of trustees for the state employee health plan voted to end all coverage of Wegovy and other GLP-1 drugs due to the cost. Estimates found that if the plan continued to cover the drugs, the state would need to nearly double health insurance premiums to offset the costs.

“Outrageously” priced weight-loss drugs could bankrupt US health care Read More »

blockbuster-weight-loss-drugs-slashed-from-nc-state-plan-over-ballooning-costs

Blockbuster weight-loss drugs slashed from NC state plan over ballooning costs

Patients vs. profits —

The plan spent $102M on the weight-loss drugs last year, 10% of total drug costs.

Wegovy is an injectable prescription weight loss medicine that has helped people with obesity.

Enlarge / Wegovy is an injectable prescription weight loss medicine that has helped people with obesity.

The health plan for North Carolina state employees will stop covering blockbuster GLP-1 weight-loss drugs, including Wegovy and Zepbound, because—according to the plan’s board of trustees—the drugs are simply too expensive.

Last week, the board voted 4-3 to end all coverage of GLP-1 medications for weight loss on April 1. If the coverage is dropped, it is believed to be the first major state health plan to end coverage of the popular but pricey weight-loss drugs. The plan will continue to pay for GLP-1 medications prescribed to treat diabetes, including Ozempic.

The North Carolina State Health Plan covers nearly 740,000 people, including teachers, state employees, retirees, and their family members. In 2023, monthly premiums from the plan ranged from $25 for base coverage for an individual to up to $720 for premium family coverage. Members prescribed Wegovy paid a co-pay of between $30 and $50 per month for the drug, while the plan’s cost was around $800 a month.

In 2021, just under 2,800 members were taking the drugs for weight loss, but in 2023, the number soared to nearly 25,000 members, costing the plan $102 million. That’s about 10 percent of what the plan pays for all prescription drugs combined. If the current coverage continued, the plan’s pharmacy benefit manager, CVS Caremark, estimated that by 2025, the plan’s premiums would have to rise $48.50 across the board to offset the costs of the weight-loss drugs.

Without insurance, the list price of Wegovy is $1,349 per month, totaling $16,188 for a year of treatment. The average reported salary for members of North Carolina’s health plan is $56,431.

Last October, the board voted to grandfather the 25,000 or so current users, maintaining coverage for them moving forward, but then to stop offering new coverage to members. However, according to CVS Caremark, the move would mean losing a 40 percent rebate from Wegovy’s maker, Novo Nordisk. This would be a loss of $54 million, bringing projected 2024 costs to $139 million.

A spokesperson for Novo Nordisk called the vote to end coverage entirely “irresponsible,” according to a statement given to media. “We do not support insurers or bureaucrats inserting their judgment in these medically driven decisions,” the statement continued.

While the costs of weight-loss drugs are high everywhere, the pricing is particularly bitter for North Carolinians—Novo Nordisk manufactures Wegovy in Clayton, North Carolina, southeast of Raleigh.

“It certainly adds insult to injury,” Ardis Watkins, executive director of the State Employees Association of North Carolina, a group that lobbies on behalf of state health plan members, according to The New York Times. “Our economic climate that has been made so attractive to businesses to locate here is being used to manufacture a drug that is wildly marked up.”

While it appears to be the first time such a large state health plan has dropped coverage of the weight-loss drugs, North Carolina is not alone in wrestling with the costs. The University of Texas’ employee plan ceased coverage of Wegovy and Saxenda, another weight-loss drug, in September. Connecticut’s state health plan, meanwhile, added restrictions on how members could get a prescription covered. Some state health plans that cover GLP-1 medications for weight-loss have prior authorization procedures to try to limit use.

“Every state has been wrestling with it, every professional association that my staff is a part of has had some discussion about it,” Sam Watts, director of the North Carolina State Health Plan, told Bloomberg. “But to our knowledge, we’re the first major state health plan to act on it.”

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