Why millions are trying FDA-authorized alternatives to Big Pharma’s weight-loss drugs, exceedingly popular in Kentucky

Editor's note: Last year Kentucky led the nation in the percentage of population that had received these weight-loss druges by prescription.

By Arthur Allen

Britannica image

KFF Health News

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mikhael, CEO of Orlando, Florida-based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them.

The U.S. Food and Drug Administration, too, has cautioned about the potential danger of the compounds, and leading obesity-medicine groups starkly warn patients against their use. But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the U.S. health-care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent, so they earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight-loss drugs this year made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100 to $450 a month, compared with list prices of roughly $1,000 to $1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 co-inventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mikhael said. “When you have an airline crash, it hurts everybody.”

Warnings from the past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30 percent of the semaglutide sold in the U.S., Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, N.C. site. The FDA last year issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.

Compounding for dummies

At least 28 companies mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Va.

Compounders can buy powdered semaglutide from some U.S. distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. Last July, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Wash., found an online clinic that charged her $1,000 for three months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta of Manhattan Beach, Calif. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Gupta said.

There’s some risk in using the non-FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA-approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.

Corporate battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, N.J., who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

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. 

Some Ky. counties using settlement money to make new opioid-withdrawal treatment available to a small number of residents

The device uses low-intensity electrical pulses to reduce withdrawal symptoms. (WDRB photo, from NET Recovery Corp.)

The device uses low-intensity electrical pulses to reduce

withdrawal symptoms. (WDRB photo, from NET Recovery Corp.)

This story has been updated.

By Melissa Patrick

Kentucky Health News

four Kentucky counties are making a new treatment to reduce opioid-withdrawal symptoms available free to a few of their residents, using money from the state's settlements with drug manufacturers and distributors.

Three more counties are in the queue, and others are in discussion. Counties and most Kentucky cities get half the settlement money, more than $900 million over the next 15 years.

Meade, Scott, Bullitt and Franklin counties have committed settlement money for the treatment of limited numbers of residents with opioid-use disorder. Letcher and Shelby counties are in the process of final approval, and Bell County is in discussions with NET Recovery Corp.

The company is named for the "neuro-electric therapy" that its non-invasive "NET Device" delivers. Asked about the device's success rate, company spokesman Jeff Lott said, "A person treated with the NET Device for more than one day is significantly more likely to remain opioid-free without medication."

The amount of money committed to NET Recovery for treatment from each county varies. 

Company spokesman Jeff Lott said since the NET Device gained U.S. Food and Drug Administration approval, the cost for a treatment is $5,500. He said in an email that some counties received a discount if they started negotiations before FDA approval. 

"If we had already started negotiations with an amount for less than $5,500, we are still honoring that price for the first contract," Lott said. 

In Bullitt County, CFO and Community Development Director Keith Griffee said the county has signed a service contract for $50,000 to provide treatment services for 15 residents, or $3,333 per person.

The same per-person figure applies in Meade County, where Treasurer Tammy Graham said the county had allocated $60,000 of its opioid-abatement money for services to 18 residents.

Scott County Court Clerk Stacy Hamilton said Scott County had approved $110,000 for 34 residents. That amounts to $3,235 per person.

Franklin County's $75,000 contract is for 15 patients at $5,000 each, The State Journal reports.  

Lott said Shelby County plans to vote on its contract Tuesday, July 2. He said the county is looking to commit $100,000 to the program. He did not say how many residents this contract would serve. 

He said Franklin County had voted to approve a service agreement for $75,000 to cover 15 patients, but the contract has not been signed. That amounts to $5,000 per person.

Lott said NET Recovery is still in talks with Letcher County, which had backed out of its initial $125,000 contract with NET Recovery.  Lott said the two-year contracts allow either party to terminate the contract. 

"It is my understanding that they still want to participate for a lesser amount," Lott said.

He said the company is working to get other counties "to help their people get a brand new FDA-cleared treatment that can change the lives of their residents."

"We are counting on the counties to help fund this," Lott said. "If anyone has a question about how they can get their county to sponsor it, they can email me. I'd love to talk them through it." (His email address is jeff.lott@netrecovery.net.)

Isaiah House lauds NET Device

The neuro-electric therapy to reduce withdrawal symptoms will be offered exclusively through Isaiah House, a Christian-based rehabilitation center based in Harrodsburg.

The NET Device (Photo from company website)

Mike Cox, chief operating officer of Isaiah House, said the treatment involves taping tiny electrodes behind the participant's mastoid process, behind the ear, to deliver a carefully programmed series of tiny electrical pulses that stimulate the production of the body's natural neurotransmitters, such as endorphins.

"We know that those neurotransmitters become depleted and replaced by the drug" chosen by those with opioid-use disorder, Cox said. "When a person tries to stop taking the drug, then he or she begins to experience intense cravings and the body goes into withdrawal. It is that terrible experience of intense cravings, that horrible sickness that keeps people from stopping using the substance that keeps them using. Not for the euphoria of it, but just to survive." 

He said they will have 30 reusable units on hand for the treatment, which lasts five to seven days.

While the device will be helpful, Cox said, it is not the single solution. 

"We see it as a tool to help them on the front end of treatment," he said. "This device is a new tool in the toolbox to really help people overcome the fear and experience of being sick from withdrawal and the intense cravings, which are . . . really the reasons why many people are afraid to get treatment." 

According to state data, in 2023, nearly 80% of Kentucky's overdose deaths involved opioids.

Medications are available to treat opioid-use disorder, but Cox noted that many people use more than one substance. And while the clinical trial of the NET Device focused on opiates, he said it also helps with the withdrawal symptoms of other drugs, from nicotine to methamphetamine.

"We know the device to be effective for all drugs," Cox said. "They have specific programming for each type of drug, which makes this device unique. . . . The additional upside to this device over medications is that it addresses the concerns of abuse and diversion."

Later, he said, "We have witnessed, really the positive impact of this device on a lot of people without any negative side effects. And, FDA approval is further evidence of the efficacy of this device in reducing cravings and withdrawal symptoms."

Cox said Isaiah House will only be paid a "small amount" for the additional work required by his staff to offer the therapy.

Who qualifies for it? 

Cox said participants will be considered for the NET Device on a case-by-case basis. "We just want to help people," he said.

Because insurance does not pay for the treatment, Lott said, "At this time, we're only focusing on treating people from counties who have paid for it or anyone can choose to pay and be treated." 

Bullitt County's contract says the participant must be diagnosed with opioid-use disorder, be admitted on a separately paid basis into a participating service program with a residential drug-addiction treatment facility, be a resident of the contracted county, and meet the clinical eligibility for the treatment, including a desire to participate in the program. 

Lott added that a participant must also be 18, and cannot be pregnant or have a pacemaker.

Cox said Isaiah House is starting the program in one of its men's facilities in Washington County and one of its women's facilities in Mercer County. Eventually, he said the treatment would be offered at all of their residential facilities.

Curious about new, popular weight-loss drugs? Here's a lowdown

Axios Visuals map adapted by Ky. Health News; click to enlarge

Editor's note: At the end of 2023 Kentucky led the nation in the percentage of state residents, 2.1%, who had received the new class of diabetes and weight-loss drugs.

By Katelyn Jetelina
Your Local Epidemiologist

You’ve probably heard of Ozempic by now. It is everywhere. Sales are up more than 300% and research studies are coming out like a firehose, but future population-level implications are unknown. Here, we catch you up on the science and what it may mean for you.

Ozempic (one brand name for the substance semaglutide) is one of many medications under the umbrella of “GLP-1 receptor agonists.” Others are Trulicity (dulaglutide), Wegovy (semaglutide) and Mounjaro (tirzepatide).

GLP stands for glucagon-like peptide 1. GLP-1 is a hormone produced in the intestinal system and released when you eat food. It is a natural signal saying you have eaten enough food. Naturally occurring GLP-1 comes and goes in a few minutes.

These medications mimic this natural process but for longer. Ozempic, for example, stays in our system for an entire week. It also slows down gastric emptying, thereby slowing down digestion.

How effective are these drugs? Very. The original clinical trials that supported initial FDA approval for patients with diabetes blew expectations out of the water. It improved:

• Blood sugar control (A1c reduction)
• Weight loss (average 15 pounds)
• Unexpected positives, like reduced kidney disease (24% less likely to experience kidney failure and death due to kidney complications)

Since the first clinical trials, studies have tested its use in non-diabetic individuals, and its is effective in weight loss. A meta-analysis of eight studies found a significant decrease (about 10% of body weight). None saw an increase. Also, it has protective effects on the heart, such as reduced blood pressure and triglycerides.

 
What happens if you stop taking it? Unfortunately, weight (and other outcomes) rebound. As shown below, after the original clinical trial (68 weeks), people who stopped taking it regained their weight.

The use of GLP-1’s as a motivating tool for sustained change has been less studied. Will these be lifetime drugs like other medications (e.g., statin drugs for heart disease) or a tool to titer up or down in times of need? This is a big unanswered question.

While obesity often involves an energy imbalance where calories consumed exceed those expended, it’s influenced by genetics, socioeconomic status, environmental factors, and mental health. These factors contribute to a complex web of challenges that may extend beyond individual choices alone.

What about kids? Ozempic isn’t officially approved by the FDA for children (but can be used off-label), but Wegovy is approved. In 2023 alone, about 31,000 children aged 12 to 17 and 162,000 aged 18 to 25 used these medications.

A recent meta-analysis found treatments led to modest reductions in body weight and improved glycemic control in children with insulin resistance.

Ozempic babies? The term refers to a recent phenomenon where women are reporting unplanned pregnancies. This has sparked discussions on social media and in the medical community about the potential impact of these drugs on fertility. Why could this be happening? Two hypothesized pathways:

• 1. These drugs delay gastric emptying, which can impact the effectiveness of oral birth control by slowing down the rate of absorption
• 2. Weight loss enhances fertility, making it easier for women to become pregnant. This is particularly true for women with Polycystic Ovarian Syndrome, in which weight loss is known to boost fertility significantly.

However, it’s recommended to stop the medication two months before trying to get pregnant (see more below).

 

Datawrapper graph by YLE; data from Ghusn et al., JAMA

Are there downsides to the meds?

Like any medication, there are side effects and risks, some known and some theoretical, and many with mixed study results. Individuals must weigh the risks of obesity with the small but meaningful risks of the medication.

 
Many people experience side effects, particularly nausea and diarrhea. A recent analysis from an insurance agency found that 6 in 10 people who start the drugs quit before they see benefits because of side effects. These tend to go away after a few weeks, but they can substantially impact the quality of life until then.

Muscle loss: Most (60-75%) weight loss is from fat, but some is from non-fat, including muscle. This could lead to a rare condition called sarcopenia—loss of muscle mass and strength where you can’t do much because you’re physically weak. Research is mixed, though, on how often this happens, and it may be minimal when combined with exercise and adequate protein intake.

 
Increased risk of thyroid cancer. A small French case-control study found an elevated risk of thyroid cancers (58% elevated relative risk) and medullary thyroid cancer (78% elevated relative risk) after GLP-1’s. However, another study in Scandinavia with more than 400,000 people found no risk of thyroid cancer after 3 years. Regardless, the potential increase in absolute risk is very small.

Mental health. There is a big debate on what is happening in the brain. GLP-1 is not only produced in the gut but in the brain as well. Some evidence has correlated the usage of GLP-1 medications with suicidal ideation. However, recent evaluations by regulatory agencies found no substantial evidence after extensive review. Some studies have even suggested a potential decrease in the likelihood of anxiety and depression.

Eating disorders. It is a growing concern that GLP-1s may increase the risk of disordered eating, particularly among those who are high-risk (e.g., prior history of eating disorders).

 
Pregnancy. Pre-clinical trials on rats found GLP-1s are more likely to have offspring with birth deformities, so it’s not recommended to take during pregnancy.

While these new drugs have a strong safety profile based on available data, human studies are only about 5 years old. This means the long-term effects are not yet fully understood. However, we do have data from drugs in the same class that started testing in 2006, showing a consistent safety profile. Continued monitoring and research are essential to determine whether theoretical risks are real in light of new data.

This means decisions today must be made based on what is available and in the context of individual risk factors. For example, if you have a history of eating disorders, the risks of taking the medication may outweigh the benefits.

What does the future look like? After a century of fad diets and weight loss gimmicks, people are tired: some from fighting stigma and others from trying to lose weight unsuccessfully. These medications have proven to work, and the market shows it: GLP-1 prescriptions have increased by over 300% since 2020. A recent poll indicates that nearly half of adults express interest. But there’s no sugarcoating it: It’s expensive, about $1,000 per month without insurance. The price should decrease dramatically in about 8 years once the patent expires and the generic version comes to market.

On a population level, these drugs will likely have widespread impacts, just like the iPhone, which can be good or bad, depending on who you ask. Given the massive impact obesity has had on health in the past two decades, this could be extraordinary for lifespan and quality of life. It could also have ripple effects on the fast-food industry and save millions of dollars in health care costs.

But it could further widen health disparities, given the cost, and hurt body positivity, losing much ground gained. We also cannot ignore that these drugs benefit a billion-dollar pharmaceutical industry when underlying societal causes should be addressed for prevention. And, the fact there are numerous other benefits to a healthy lifestyle.
Bottom line

GLP-1 drugs offer much-needed hope to individuals, and a flood of studies show their effectiveness. However, there are both demonstrated and theoretical risks to consider. Regardless, obesity deserves compassion, and perhaps 21st-century tools can help foster a supportive environment that promotes lasting progress.

First naxolone shipment under settlement with drug maker arrives

Teva Pharmaceuticals' generic naloxone

Kentucky Health News

Nearly 8,000 doses of naloxone, which reverses the effects of drug overdose, were delivered to Kentucky this week as part of a settlement with Teva Pharmaceuticals, Attorney General Russell Coleman announced.

In October, Teva agreed to pay the state more than $71 million over 13 years, resolving allegations that the company’s marketing and promotional practices fueled the opioid-overdose crisis. In addition to the cash payments, Teva agreed to provide more than 23,000 units of naloxone.

The shipment, the first of four expected this year, went to facilities in Louisville, Florence, Ashland, Paducah and Frankfort. The Opioid Commission is partnering with the Cabinet for Health and Family Services as well as the Kentucky Pharmacists Association for distribution.

“Naloxone is a critical lifeline for Kentucky families struggling with addiction,” Coleman said in a news release. “Equipping first responders, health professionals and treatment providers with this all-important medication can help save lives for Kentuckians on the road to recovery.”

Half of all opoid-settlement funds go to local governments. The state's half is distribited by the Kentucky Opioid Abatement Advisory Commission is responsible for the distribution, part of the attorney general's office. On Tuesday, June 4,, the commission will award its next round of grants.

Kentuckians can find out how to get free naloxone near them at FindNaloxoneNowKY.org. Naloxone is also sold under the brand name Narcan by Emergent Solutions Inc.

High cost of new diabetes drugs, more popular in Ky. than any other state, deprives low-income people of effective treatment

Photo by George Frey, Bloomberg, via iStock/Getty Images, KFF Health News

Editor's note: At the end of 2023 Kentucky led the nation in the percentage of state population, 2.1%, who had received the new class of diabetes and weight-loss drugs.

By Renuka Rayasam
KFF Health News

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill prescriptions for medications they need to control their blood sugar.

Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The couple’s doctor has tried prescribing similar drugs, which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production, but those are also often out of stock. Even if they are available, their Affordable Care Act insurance burdens the couple with a lengthy approval process or an out-of-pocket cost they can’t afford.

“It’s like, I’m having to jump through hoops to live,” said Cooper Harris, 46, a resident of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to KFF poll results released this month. Patients with the lowest disposable incomes who are hit the hardest; they have few resources and often struggle to see doctors and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month’s supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month’s supply of different GLP-1 drugs range from $936 to $1,349 before insurance coverage, according to the Peterson-KFF Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs — Ozempic, Rybelsus, and Mounjaro — reached $5.7 billion in 2022, up from $57 million in 2018, according to research by KFF.

The “outrageously high” price has “the potential to bankrupt Medicare, Medicaid, and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, told Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They’re kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont Healthcare in Conyers, Georgia. Many of Rahman’s patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that help patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers’ requirements that patients receive prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman’s patients see her, their diabetes has gone unmanaged for years and they’re suffering from severe complications like foot wounds or blindness. “And that’s the end of the road,” Rahman said. “I have to pick something else that’s more affordable and isn’t as good for them.”

GLP-1 agonists — the category of drugs that includes Ozempic, Trulicity, and Mounjaro — were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs’ benefits become apparent.

In March, the FDA approved the weight-loss drug Wegovy, a version of Ozempic, to treat heart problems, which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company J.P. Morgan estimated.

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs’ popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines’ ability to help with weight loss.

It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it’s kind of not as many people as you think,” she said. “There just isn’t any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. State Medicaid plans vary in their coverage of the drugs for weight loss. (Kentucky's does not.) Medicare won’t cover the drugs if they are prescribed for obesity. And commercial insurers are tightening access due to the drugs’ cost.

Health-care providers cobble together care plans based on what’s available and what patients can afford. For example, Cooper Harris’s insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, Texas, had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher-retirement health plan with a high deductible, couldn’t afford to be on a GLP-1 agonist, Addison said.

“Until she reaches that deductible, that’s just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn’t have the same benefits. “Those patients who have a fixed income are going to be our more vulnerable patients.”

Comer and committee grill FDA chief about handling of vapes

U.S. Rep. James Comer, R-Ky.
(AP photo by Alex Brandon)

Kentucky Health News

Rep. James Comer of Kentucky and other House members "grilled FDA Commissioner Robert Califf about why the agency has failed to swiftly assess product applications for e-cigarettes while illicit products from China flood store shelves," Luke Zarzecki reports for Inside Health Policy. "Califf defended FDA's approach by saying the agency is not resourced to deal with the flood of millions of applications for vaping products."

Califf appeared Thursday at a hearing of the Comer-chaired House Committee on Oversight & Accountability that last almost five hours. "We covered topics from seafood inspection, all the way to every other topic that I think could be imaginable," Comer told Zoey Becker of FiercePharma.

"Multiple lawmakers blamed FDA’s failure to quickly approve e-cigarette and vaping products from the United States for the proliferation of illegal imports, Zarzecki reports, quoting Comer: “FDA’s failure to regulate has allowed unsafe and illicit products to proliferate.”

"Califf said FDA would be more equipped to deal with illicit products if Congress approved the agency’s request to require e-cigarette manufacturers to pay user fees," Zarzecki reports. "He said FDA will not approve applications for vaping products unless they demonstrate the product will not contribute to nicotine addiction among children and youth." He said no one expected 26 million applications, and FDA has requested more staff to address the backlog.

The agency has asked the Supreme Court to review an appeals court’s ruling that it consider every marketing application for flavored e-cigarette products individually, "rather than rejecting them en masse because of their impact on youth smoking," Zarzecki notes.

"Public health groups have also sued the FDA and HHS over delaying a ban on menthol cigarettes and flavored cigars, and a spokesperson for FDA noted the rule is pending at the White House Office of Management and Budget."

FDA Commissioner Robert Califf (AP photo)

Califf said that in 2023, FDA “issued warning letters to more than 120 manufacturers and distributors and more than 400 retailers; filed over 40 civil money penalty complaints against manufacturers and over 65 against retailers; and collaborated with our federal partners at the U.S. Customs and Border Protection to seize approximately 1.4 million units of unauthorized e-cigarette products with an estimated retail value of more than $18 million; among other actions.”

"Comer criticized FDA for not seizing more illegal products from retailers," Zarzecki reports, and said the agency's approach to e-cigarettes is not what Congress had in mind. Comer said, “Those seeking to play by the rules don’t even know what the rules are because FDA won’t tell them, or FDA won’t put information out, or they will put information out, but they change it.”

Califf said vaping and electronic cigarettes came along after Congress passed the Tiobacco Control Act, under which the FDA operates.

Comer, who represents the state's First Congressional Distict, also criticized FDA for “failing to do the bare minimum to carry out its core mission” under the Biden administration. He said “a pattern of issues” show the agency “appears consistently unprepared for crises.”

He noted that FDA inspections of foreign manufacturing plants, where many drugs sold in the U.S. are made, haven't returned to pre-pandemic levels. He said the agency inspected 79 percent fewer foreign plants in 2022 than it did in 2019.

Califf conceded, “We need to pick up the pace.” He said the FDA recently “completely" reworked its inspection system in India to address problems there. The agency is converting its Office of Regulatory Affairs into an Office of Inspections and Investigations, "reassigning some 1,500 staffers to related roles."

Database lists opioid-settlement payments to local governments

Screenshot of first page of KFF Health News database of settlement
payments in Kentucky through March 4 shows the top 15 recipients.

How much money are your local governments getting from the settlements of lawsuits filed against opioid manufacturers and distributors? You can track it with a new online database from KFF Health News.

Kentucky is getting $478 million from the settlements through 2038, and a like amount is being paid each year to local governments in the state. State government got $100.7 million in 2022 and $17.4 million in 2023. It will get $21.8 million this year and the same amount in 2025, and an average of $24 million a year after that.

The state's money is being allocated by the Kentucky Opioid Abatement Advisory Commission, operated out of the attorney general's office. Local governments' spending is up to their governing bodies.

"This database undercounts the amount of opioid settlement money most places have received and will receive," note Aneri Pattani and Lydia Zuraw and Holly K. Hacker of KFF Health News.

The database reflects only the largest settlement so far, $26 billion to be paid by pharmaceutical distributors AmerisourceBergen (now called Cencora), Cardinal Health, and McKesson, as well as opioid manufacturer Janssen (now known as Johnson & Johnson Innovative Medicine).

It does not include settlements with other drug manufacturers and retailers Walmart, Walgreens, and CVS. Data from these five companies will be added in July, according to BrownGreer, the settlement firm that gets the money and makes the payments. It is not handling some additional settlements such as the agreement between Kentucky and four Midwestern states with regional supermarket chain Meijer.

Other settlements, including with OxyContin manufacturer Purdue Pharma, are pending.

Anthem is among health insurers now covering anti-obesity drug if it is prescribed to reduce the risk of heart attack and stroke

One of Kentucky's major health insurers is among the first that have "agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions," The Wall Street Journal reports. Kentucky has the highest share (about 2.1%) of a state's population that have prescriptions for the new class of weight-loss drugs.

Elevance Health, the corporate parent of Anthem, joined CVS Health and Kaiser Permanente in covering Wegovy to reduce the risk of heart attacks and strokes in beneficiaries "who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan," report the Journal's Peter Loftus and Anna Wilde Mathews.

State table shows Medicaid coverage numbers for March. FFS
means "fee for service," which is separate from managed care.

"Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan" and would make the change in the next few weeks. "A committee of outside advisers to Elevance Health’s CarelonRx unit, which manages pharmacy benefits, has approved the use of Wegovy to reduce the risk of major cardiovascular events. . . . The company also is working with state-government agencies to determine Medicaid coverage of Wegovy." Anthem manages the Medicaid care of about 172,000 Kentuckians; county-level numbers are available.

"The insurers’ moves open up reimbursement of the coveted but costly class of weight-loss drugs, which had previously been excluded from Medicare coverage by a U.S. law and which many private health plans had resisted reimbursing because of the expense," the Journal notes. "The decisions will ease the financial burden on people who had been paying more than $1,000 out of pocket each month because their health plan wouldn’t cover the medicines, and spur use among people who couldn’t afford the heavy cost or didn’t want to pay for it. Other Medicare and commercial health plans might now feel pressure to follow suit and begin coverage. But the widening coverage could result in billions of dollars in additional drug spending by health insurers that have struggled to keep a lid on rising health costs. Wegovy lists for about $1,349 a month."

U.S. Sen. Bernie Sanders (I-Vt.), chair of the Senate's health committee, this week called on insurers to charge Americans no more than they charge in Canada for the drugs. That would lower their prices by about two-thirds.

"The insurers’ decisions arose from new guidance issued last week by the Centers for Medicare and Medicaid Services," the Journal notes. Medicare Part D plans, "which are administered by private insurers, might cover anti-obesity medications if the drugs receive approval for an additional use. Their use for weight-loss alone would still be excluded from coverage. That new guidance applies to Wegovy because the Food and Drug Administration this month approved the weight-loss drug’s use reducing the risk of heart attacks and strokes in people with a history of heart disease, and who have a body-mass index above certain thresholds. A study showed Wegovy reduced cardiovascular risk by about 20% versus a placebo."

Kentucky-based Humana, which manages the care of 155,000 Kentuckians on Medicaid and has a broad paying-customer base in the state, said it is reviewing the CMS guidance. UnitedHealth Group, which covers more than 91,000 Kentucky Medicaid beneficiaries and has many paying customers in the state, declined the Journal's request for comment.

Chair of U.S. Senate health committee demands maker of weight-loss drugs, most popular in Kentucky, cut their prices by two-thirds

Axios Visuals map, adapted by Kentucky Health News; click it to enlarge.

Sen. Bernie Sanders of Vermont, who chairs the U.S. Senate's Health, Education, Labor and Pensions Committee says the maker of two popular diabetes and weight-loss drugs Ozempic and Wegovy should lower their list prices of “to no more than what they charge for this drug in Canada,” The Washington Post reports.

Sanders, an independent who votes with Democrats, "is demanding that Novo Nordisk slash the prices of its blockbuster drugs Ozempic and Wegovy, citing a new study on the manufacturing costs of the diabetes and weight-loss medications," the Post reports.

Kentucky leads the nation in the percentage (about 2.1%) of residemts who have received a prescription for one of the new drugs created to fight obesity and diabetes, which can also aid weight loss.

"Researchers found that a month’s supply of semaglutide — the active ingredient in both drugs — could be manufactured for an estimated 89 cents to $4.73," the Post reports, but "Novo Nordisk charges $935.77 for four weekly injections of Ozempic in the United States, while it costs about $300 per month out-of-pocket in Canada."

In response, a Novo Nordisk spokesperson didn’t address manufacturing costs but said the Danish company offers several ways to help patients and "supports changes in policy to improve patient affordability and access for those living with chronic diseases," the Post reports.

Kentucky leads the nation in use of new class of drugs that fight diabetes and obesity; more than 2% of Kentuckians use them

Kentucky Health News

This story has been updated, as underlined.

Kentucky has the nation's highest rate of dispensed prescriptions for a new class of diabetes and obesity medications, according to the analytics company PurpleLab and published by Axios.

"For every 1,000 people in Kentucky, roughly 21 were prescribed a drug that belongs to a buzzy class of diabetes and anti-obesity medications last year," Tina Reed of Axios reports.

The drugs are GLP-1 agonists, which mimic a hormone that triggers the release of insulin, which lowers blood sugar; slows digestion; and increases the feeling of fullness after eating. They were developed to treat diabetes but have become popular in treating obesity, in which Kentucky ranks high.

"GLP-1 agonists alone can’t treat Type 2 diabetes or obesity," the Cleveland Clinic cautions. "Both conditions require other treatment strategies, like lifestyle and dietary changes." The drugs are costly, running between $900 and $1,300 a month, and most must be injected into fatty tissue.

Axios reports that after Kentucky, West Virginia had the next highest prescribing rate, at 18.9 prescriptions dispensed per 1,000 residents. That was followed by Alaska (17.5), Mississippi (16.1) and Louisiana (15.4). Rhode Island had the lowest rate (3.7), and Massachusetts was second lowest (4), followed by Wisconsin (4.3) and Hawai'i (4.3.)

The figures come from a collection of 1.9 billion claims to private insurers, Medicare (which only covers GLP-1s to treat diabetes) and Medicaid. "The data lumps the prescriptions together, so it's not possible to tease out how often these drugs are being prescribed for obesity versus diabetes," Axios notes. Kentucky Medicaid does not cover the drugs, but health insurance for state workers does.

In another story Reed reports, "Doctors are getting inundated with patients' requests . . . including from many who don't really need them. Primary-care doctors in particular, who typically have little training in obesity, have found themselves as gatekeepers for a class of injection drugs, including Novo Nordisk's Ozempic and Wegovy, that are effective but still face questions about who should take them."

Incoming attorney general replaces leading advocate of funding research aimed at legalizing psychedelic for addiction treatment

By Al Cross

Kentucky Health News

The main proponent of using state opioid-settlement money to fund research into a psychdelic drug as a treatment for addiction will soon be out of a job.

Bryan Hubbard, the chair and executive director of the state Opioid Abatement Advisory Commission under outgoing Attorney General Daniel Cameron, will be replaced when Russsell Coleman becomes attorney general Jan. 1. Coleman was elected in November, as his fellow Republican was losing the race for governor.

D. Christopher Evans

The commission's new chair and executive director will be Christoper Evans, a former Drug Enforcement Administration agent and leader who was acting administrator of the agency for more than five months in 2021, while President Biden's nominee, Anne Milgram, was being chosen and confirmed.

When Coleman announced his executive team in the state Senate chamber Tuesday, Kentucky Health News asked for his opinion and Evans's opinion of funding research on ibogaine, the African psychedelic that can suppress opioid-withdrawal symptoms but poses risks to the heart and is illegal everywhere but Mexico and New Zealand.

Coleman didn't give Evans an opportunity to respond, but said "We're gonna take a look at ibogaine," and would "make sure we look at that objectively." He said earlier that "Personnel is policy" and the change signals his belief that the "three-legged stool" of prevention, enforcement and treatment needs to focus more on prevention of drug use.

"We do not have a statewide prevention effort in the commonwealth," he said, adding later, "There's some great ideas out there on the prevention side. I want to see if we can scale those up. . .  I understand there's been a lot of ink spilled on ibogaine. My concern is we are not as focused as intently as we should be on the prevention piece of this."

The commission handles the state's half of the $900 million or so that the state will get in lawsuit settlements from opioid manufacturers and distributors. As chair and executive director, Hubbard promoted the idea of spending $42 million, about 5 percent of the money, on research aimed at getting Food and Drug Administration approval for use of ibogaine in addiction treatment.

At the commission's Nov. 14 meeting, Hubbard read several endorsements of ibogaine by experts, foundations and the American Legion. One foundation is supporting ibogaine research at Stanford University, which is awaiting publication, presumably in a peer-reviewed journal. Hubbard said the researcher had agreed to discuss his findings with the commission after they are published.

Bryan Hubbard

Hubbard noted that on Oct. 31 the National Institutes of Health and the Department of Health and Human Services issued a notice of funding opportunity for research on psychedelics including ibogaine as treatment for substance-use disorder. The notice says "There is an urgent need to develop novel treatments for SUD in light of the escalating rates of substance use, addiction, and overdose."

Several commission members spoke favorably of funding ibogaine research, but a non-voting member, state Rep. Danny Bentley, R-Russell (Greenup County), a pharmacist, called it "false hope," saying "It will take $2 billion and 10 years to get that product on the market."

Bentley said the drug's effect on the heart will put it in a "black box," meaning it will have one of the highest safety-related warnings assigned by the U.S. Food and Drug Administration. Other critics have said the heart effects would mean that treatment would be limited to hospitals, and thus expensive.

Bentley cautioned the commission to be aware of who is funding ibogaine research. Citing his education as a pharmacist and one of the earlier witnesses at the commission, he said he was taught that "If the people paying for the research own the company and the drug, it was invalid from the get-go."

Gov. Andy Beshear was also critical of the idea and the way it was promoted by Hubbard. His initial promotion of it was countenanced by Cameron, whom Beshear defeated for re-election.

Around the time Cameron implicitly endorsed the idea, a firm owned by a major national political contributor increased its investment in such research and gave Cameron a political boost, the Daily Beast reported.

Unlike Hubbard, Evans will have a deputy: Jessie Halladay, now a senior policy specialist with the Criminal Justice Institute. She has been special adviser to the Louisville Metro Police Department, senior policy adviser to the Kentucky Justice and Public Safety Cabinet, communications director for Jefferson County attorney and a public-safety and social-services reporter for the Louisville Courier Journal.

Evans, who will head the commission starting next month, was the first special agent in charge of the DEA's Louisville Field Division. In that job, he partnered with Coleman, then U.S. attorney for Western Kentucky, to create a DEA office in Paducah, a Coleman news release said.

Coleman said Evans rose to become chief of operations for DEA, which led to his stint as acting administrator. The release said he is a director of Christopher 2X Game Changers in Louisville and the Kentucky State Police Foundation.

5 things to know about new Medicare negotiations on drug prices

By Arthur Allen, Rachana Pradhan and David Hilzenrath

KFF Health News

The Biden administration has picked the first 10 high-priced prescription drugs subject to federal price negotiations, taking a swipe at the powerful pharmaceutical industry. It marks a major turning point in a long-fought battle to control ever-rising drug prices for seniors and, eventually, other Americans.

Under the 2022 Inflation Reduction Act, Congress gave the federal government the power to negotiate prices for certain high-cost drugs under Medicare. The list of drugs selected by the Centers for Medicare and Medicaid Services will grow over time.

The first eligible drugs treat diabetes, blood clots, blood cancers, arthritis, and heart disease — and accounted for about $50 billion in spending from June 2022 to May 2023.

The United States is clearly an outlier on drug costs, with drugmakers charging Americans many times more than residents of other countries “simply because they could,” Biden said Aug. 29. “I think it’s outrageous. That’s why these negotiations matter.”

Democratic lawmakers cheered the announcement, and the pharmaceutical industry, which has filed a raft of lawsuits against the law, condemned it.

The companies have until Oct. 2 to present data about their drugs to CMS, which will make initial price offers in February, starting negotiations set to end next August. The prices would take effect in January 2026.

Here are five things to know about the impact:

1. How important is this step? Medicare has long been in control of the prices for its services, setting physician payments and hospital payments for about 65 million Medicare beneficiaries. But it was previously prohibited from involvement in pricing prescription drugs, which it started covering in 2006.

Until now the drug industry has successfully fought off price negotiations with Washington, although in most of the rest of the world governments set prices for medicines. While the first 10 drugs selected for negotiations are used by a minority of patients — 9 million — CMS plans by 2029 to have negotiated prices for 50 drugs on the market.

“There’s a symbolic impact, but also Medicare spent $50 billion on these 10 drugs in a 12-month period. That’s a lot of money,” said Juliette Cubanski, deputy director of the Kaiser Family Foundation’s analysis of Medicare policy.

The long-term consequences of the new policy are unknown, said Alice Chen, vice dean for research at University of Southern California’s Sol Price School of Public Policy. The drug industry says the negotiations are essentially price controls that will stifle drug development, but the Congressional Budget Office estimated only a few drugs would not be developed each year as a result of the policy.

Biden administration officials say reining in drug prices is key to slowing the skyrocketing costs of U.S. health care.

2. How will the negotiations affect Medicare patients? In some cases, patients may save a lot of money, but the main thrust of Medicare price negotiation policy is to provide savings to the Medicare program — and taxpayers — by lowering its overall costs.

The drugs selected by CMS range from specialized, hyper-expensive drugs like the cancer pill Imbruvica (used by about 26,000 patients in 2021 at an annual price of $121,000 per patient) to extremely common medications such as Eliquis (a blood thinner for which Medicare paid about $4,000 each for 3.1 million patients).

While the negotiations could help patients whose Medicare drug plans require them to make large copayments for drugs, the relief for patients will come from another segment of the Inflation Reduction Act that caps drug spending by Medicare recipients at $2,000 per year starting in 2025.

3. What do the Medicare price negotiations mean for those not on Medicare? One theory is that reducing the prices drug companies can charge in Medicare will lead them to increase prices for the privately insured.

But that would be true only if companies aren’t already pricing their drugs as high as the private market will bear, said Tricia Neuman, executive director of KFF’s program on Medicare policy.

Another theory is that Medicare price negotiations will equip private health plans to drive a harder bargain. David Mitchell, president of the advocacy group Patients for Affordable Drugs, predicted that disclosure of negotiated Medicare prices “will embolden and arm private sector negotiators to seek that lower price for those they cover.”

Stacie B. Dusetzina, a professor of health policy at Vanderbilt University, said the effect on pricing outside Medicare isn’t clear: “I’d hedge my bet that it doesn’t change.”

Dusetzina described one way it could: Because the government will be selecting drugs for Medicare negotiations based partly on the listed gross prices for the drugs — distinct from the net cost after rebates are taken into account — the process could give drug companies an incentive to lower the list prices and narrow the gap between gross and net. That could benefit people outside Medicare whose out-of-pocket payments are pegged to the list prices, she said.

4. What are drug companies doing to stop this? Even though negotiated prices won’t take effect until 2026, drug companies haven’t wasted time turning to the courts to try to stop the new program in its tracks.

At least six drug companies have filed lawsuits to halt the Medicare drug negotiation program, as have the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, known as PhRMA.

The lawsuits include a variety of legal arguments. Merck & Co., Johnson & Johnson and Bristol Myers Squibb are among the companies arguing their First Amendment rights are being violated because the program would force them to make statements on negotiated prices they believe are untrue. Lawsuits also say the program unconstitutionally coerces drugmakers into selling their products at inadequate prices.

“It is akin to the government taking your car on terms that you would never voluntarily accept and threatening to also take your house if you do not ‘agree’ that the taking was ‘fair’,” Janssen, part of Johnson & Johnson, wrote in its lawsuit.

Nicholas Bagley, a law professor at the University of Michigan, predicted the lawsuits would fail because Medicare is a voluntary program for drug companies, and those wishing to participate must abide by its rules.

5. What if a drug suddenly gets cheaper by 2026? In theory, it could happen. Under guidelines CMS issued this year, the agency will cancel or adjourn negotiations on any drug on its list if a cheaper copycat version enters the market and finds substantial buyers.

According to company statements this year, two biosimilar versions of Stelara, a Johnson & Johnson drug on the list, are prepared to launch in early 2025. If they succeed, it would presumably scotch CMS’ plan to demand a lower price for Stelara.

Other drugs on the list have managed to maintain exclusive rights for decades. For example, Enbrel, which the FDA first approved in 1998 and cost Medicare $1.5 billion in 2021, will not face competition until 2029 at the earliest.