GLP-1: More Competition, Soaring Prices, and What Medicare Won’t Cover

Despite soaring prices, reported side effects (some serious), and the fact that many gain their weight back after stopping taking their weight loss medications, overweight adults are still very much interested in taking them. A recent poll from the University of Michigan found that more than 60% of overweight adults ages 50 to 80 are interested in taking one.

And many doctors are on board. “These are game-changing medications,” Shauna Levy, M.D., an obesity medicine physician at the Tulane University Medical Center and medical director of Tulane’s Bariatric and Weight Loss Center, was quoted as saying in a recent AAPR article detailing possible side effects of the new weight loss medications.

Let’s take a quick peek at last week’s headline to glimpse at what’s happening in the world of weight loss meds.

The competition heats up, and more pharma companies want in

Last week, CNBC Digital Reporter Annika Kim Constantino wrote about how the weight loss drug market is witnessing increased competition as drugmakers aim to tap into its potential worth of tens of billions in the next decade. Dominated by Novo Nordisk and Eli Lilly, the market is attracting both large and lesser-known players.

Some companies entering the race include Boehringer Ingelheim, in collaboration with Zealand Pharma, developing the drug survodutide targeting GLP-1 and glucagon, Constantino reported. The list of interested entities entering the game is growing. Consider this: Terns Pharmaceuticals is conducting early-stage trials for an oral weight-loss drug focusing on GLP-1. Viking Therapeutics and Structure Therapeutics are developing drugs targeting GLP-1 and other hormones. And Altimmune’s pemvidutide has shown promising results with a 15.6% weight loss.

Additionally, Sanofi and Bayer are considering entering the market with potential next-generation weight loss drugs. The demand is expected to rise, with Goldman Sachs projecting 15 million U.S. adults on obesity medications by 2030.

At the same time, the prices are soaring in 2024

Pharmaceutical companies have raised prices for over 700 medications, including popular drugs like Ozempic and Mounjaro, with an average increase of about 4.5% at the start of the year, slightly slower than in previous years. Notable increases include Ozempic (3.5% to $984.29) and Mounjaro (4.5% to $1,000), both GLP-1 agonists used for weight loss. CBS News reported that the analysis from 46 Brooklyn Research, a nonprofit that processes drug pricing data, found that the average price increase at year start was about 4.5%.

Why Ozempic and Mounjaro? These GLP-1 agonists, while designed to help diabetics regulate their blood sugar, also had been found to be effective weight loss drugs, prompting non-diabetics to seek out the drugs in order to slim down. Greater demand led to shortages.

Why this is bad news for employers

Increased prices mean potentially higher healthcare costs for employers. A recent article on Inc.com notes that the impact on employers may be more significant this year due to the already high costs and widespread use of Ozempic and Mounjaro. Associate Editor Brit Morse writes that market demand, coupled with inflationary pressures, is cited as the reason for the price hikes.

Morse quotes Nelly Rose, a pharmacist at NFP, a benefits consulting company, who said that covering said drugs through a workplace benefits program could be beneficial not only to employees but also to the companies who decide to offer them long-term. Employees who struggle with their weight are more likely to be on more expensive medication, or need more frequent hospital visits, Rose told Inc.com.

What Medicare won’t cover and why

If you have Medicare and want to lose weight, Ozempic won’t be covered. But if you need to take it for your type 2 diabetes, you are in luck. In an article for VeryWellHealth.com, Tanya Feke, M.D., a board-certified family physician, patient advocate and best-selling author, discussed the conditions for which Medicare covers Ozempic and when it does not.

In a nutshell, it’s super simple. Dr. Feke writes:

Medicare covers medications that it considers to be medically necessary. This includes most drugs approved by the Food and Drug Administration (FDA) for certain indications, which include a diagnosis, illness, injury, syndrome, or condition.

Ozempic is an injectable medication in the class of drugs known as glucagon-like peptide agonists (GLP-1 medications). It has an FDA-approved indication for type 2 diabetes and for cardiovascular-event reduction in people who have both type 2 diabetes (the body cannot properly regulate and use blood sugar as fuel) and known cardiovascular disease (conditions affecting the heart and blood vessels). Many Medicare Part D plans will cover Ozempic for beneficiaries who have these conditions.

Off-label use for weight loss may not be covered by Medicare due to regulations from the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, restricting coverage for cosmetic or weight loss purposes. Ozempic can be expensive, and if not covered by insurance, patients may need to go through prior authorization or step therapy processes.

Still, Dr. Feke notes, “That could change as professional organizations lobby for coverage of weight-loss medications by Medicare in the future.

Your responses and feedback are welcome!

Source: “What Are the Side Effects of New Weight Loss Medications?,” AARP.com, 1/17/24
Source: “Views on Medications for Weight Management,” HealthyAgingPoll.com, 12/13/23
Source: “The weight loss drug market may soon get more crowded. Here are the companies trying to enter the booming space,” CNBC.com
Source: “Drugmakers hiking prices for more than 700 medications, including Ozempic and Mounjaro,” CBSNews.com, undated
Source: “Prices for Weight-Loss Drugs Like Ozempic Are Skyrocketing. That’s Bad News for Employers,” Inc.com, undated
Source: “Medicare Coverage for Off-Label Ozempic to Lose Weight,” VeryWellHealth.com, 1/16/24
Image Copyright mahmud7.

Childhood Obesity Specialists Struggle to Get GLP-1 Agonists

This week’s Medscape report by journalist Alicia Ault discusses the latest challenges faced by pediatric obesity specialists in accessing glucagon-like peptide 1 (GLP-1) agonists, medications approved by the U.S. Food and Drug Administration (FDA) for weight loss in adolescents aged 12 years or older. She opens with:

While adults, many of whom don’t meet the clinical definition of obesity, scramble to procure glucagon-like peptide 1 (GLP-1) agonists for weight loss, pediatric obesity specialists said their young patients who could benefit more over the long term often are unable to access the potentially life-altering medications.

The FDA approved two GLP-1 agonists so far — both marketed by Novo Nordisk — for use in adolescents aged 12 years or older: Saxenda and Wegovy. Several pediatricians told Medscape that despite the potential benefits of these medications for young patients with obesity, the increasing demand for GLP-1 agonists has led to supply shortages, making it difficult for pediatricians to initiate new treatments or maintain existing ones.

Ault writes:

The crushing demand for semaglutide in the past year, driving a thriving market in compounded versions and online prescriptions, has made it increasingly difficult to find pharmacies that can fill prescriptions.

Two pediatric specialists, Brooke Sweeney, M.D., medical director of weight management services at Children’s Mercy in Kansas City, Missouri, and Sarah Raatz, M.D., a pediatrician at the University of Minnesota’s Center for Pediatric Obesity Medicine, both said because of the supply issues they can’t prescribe the medication for new patients because then the patients already taking it might not have enough, which may lead to weight loss reversal and other negative outcomes.

Potential benefits appeal to some pediatricians

Ault quotes Susma Shanti Vaidya, MPH, M.D., associate medical director of the IDEAL pediatric obesity clinic at Children’s National Hospital in Washington, D.C., who said that “patients taking GLP-1 agonists in her practice have reduced their body mass index and have seen resolution of prediabetes, diabetes, and fatty liver disease.”

Insurance denials are piling up

Insurance coverage for these medications, even for FDA-approved indications, is also becoming more difficult, with insurers setting weight trajectory thresholds that, if not met, could result in coverage withdrawal. Ault explains:

In January 2023, the American Academy of Pediatrics urged aggressive treatment of childhood obesity, including using FDA-approved medications such as GLP-1 agonists combined with lifestyle and dietary modifications.

The U.S Preventive Services Task Force, however, has issued a draft proposal that recommends a variety of lifestyle and behavior modification interventions for children and adolescents but says the evidence does not yet support recommending bariatric surgery or medications.

Concerns about more restrictions this year

Pediatricians express concerns about potential restrictions in 2024, creating uncertainties for patients who have benefited from these medications. Some of the patients, for example, were told that prior authorization would be required for new prescriptions for a GLP-1 agonist.

Some parents want GLP-1 agonists for their kids, too

Some parents, when they feel they have exhausted all other options for their children, are requesting GLP-1 agonists for their children, emphasizing the life-changing effects reported in some cases. The pediatric obesity specialists quoted in the article cited one such effect as stopping the “food noise” and thus curbing cravings.

In a recent poll by Morning Consult, 65% of parents of children with weight-related issues said they would be interested in GLP-1 agonists for their kids. And a third of parents said “they would be interested in having their children use the drugs if they were available.”

However, there is a need for more data on the long-term effectiveness and safety of these medications in pediatric patients, and clinicians are counseling families that obesity is a chronic disease, requiring lifelong treatment with GLP-1 agonists in some cases.

Your responses and feedback are welcome!

Source: “Pediatric Obesity Specialists Struggle to Get GLP-1 Agonists,” Medscape, 1/8/24
Source: “Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity,” American Academy of Pediatrics, 1/9/23
Source: “High Body Mass Index in Children and Adolescents: Interventions,” U.S. Preventive Services Task Force, 12/12/23
Source: “A Third of Parents Are Interested in Weight Loss Drugs Like Ozempic for Their Children,” Pro.MorningConsult.com, 12/4/23
Image by Elena Leya on Unsplash

The Effects of Taking Weight-Loss Drugs

December started with breaking news in the realm of weight-loss drugs, making the case yet again that GLP-1 drugs can potentially cause significant adverse side effects and should be approached with caution and under medical supervision.

On December 1, 2023, pharma giant Pfizer announced that it decided to halt the development of the twice-daily version of its experimental weight loss pill due to serious side effects observed in a mid-stage clinical study. Obese patients experienced notable weight loss but struggled with tolerating the drug, primarily facing mild gastrointestinal issues.

Despite the setback, Pfizer still plans to release data on a once-a-day version of the drug in the first half of 2024, which will influence its decision on whether to proceed with a phase three study. The company had hoped to capture a share of the lucrative weight loss drug market, but this development puts it behind competitors such as Eli Lilly and Novo Nordisk, who are working on pill versions of their successful weight loss and diabetes injections.

Pfizer’s stock closed 5% lower after the announcement, impacting its aspirations to rebound from declining demand for its COVID products. CNBC Digital Reporter Annika Kim Constantino wrote that:

The new data is a blow to Pfizer and its hopes to win a $10 billion slice of the booming weight loss drug market, which CEO Albert Bourla previously said could eventually grow to $90 billion.

The side effects spread to stopping taking the drugs, too

As we’ve mentioned in our previous post, not just taking but stopping the meds can have serious negative consequences, too. This has been backed up by both research and observing the patients who have experienced them. The list is rather long and includes weight gain, blood sugar increase, an increase in blood pressure, mood changes, a negative change in cholesterol levels, and so on.

Health.com writer Michelle Pugle wrote about Ozempic in particular:

Experts emphasize that Ozempic is intended for long-term use and should always be used under the supervision of a healthcare professional. Experts recommend people who are going off the drug should enroll in a nutrition program before going off the medication, so they’re better equipped to make healthy choices that support their health needs post-Ozempic.

And yet, the weight-loss drug market is thriving

An investigative report by Chad Terhule and Robin Respaut that was published on the same day of Pfizer’s announcement by Reuters said that the Danish drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.

One such doctor is Dr. Lee Kaplan, the chief of obesity medicine at Dartmouth College’s medical school, and a leading U.S. obesity specialist. Terhule and Respaut quoted him in their piece:

Obesity, he said, should be treated as aggressively as other chronic diseases such as high blood pressure or diabetes — with lifelong prescriptions. “We are going to have to use these medications,” he said at the June gathering, “for as long as the body wants to have obesity.”

Novo’s most lucrative market is, you guessed it, the USA. The authors explain why:

[…] because more than two-thirds of adults are overweight or have obesity and drugs frequently command the highest prices worldwide. Novo charges U.S. customers $1,300 a month for the weekly injection.

The Reuters report also quotes Dr. Arthur Kellermann, a health administrator and former dean of the Uniformed Services University of Health Sciences, the U.S. military’s medical school, who reviewed Reuters’ findings on Novo’s spending.

The company’s large-scale payments to doctors, he said, illustrate a longstanding problem in the drug industry “The pharmaceutical industry still sees value in paying medical thought leaders to promote their products, and too many of them are happy to sign up for a six- or seven-figure check,” he said, calling such lavish payments “morally and ethically way over the line.”

Your responses and feedback are welcome!

Source: “Pfizer to discontinue twice-daily weight loss pill due to high rates of adverse side effects,” CNBC.com, 12/1/23
Source: “Maker of Wegovy, Ozempic showers money on U.S. obesity doctors,” Reuters.com, 12/1/23
Source: “What Happens to Your Body When You Stop Taking Ozempic?,” Health.com, 11/30/23
Image by Diana Polekhina on Unsplash

Can You Stop Taking Anti-Obesity Drugs?

There has been an ongoing debate about whether people taking anti-obesity drugs can stop taking them after their desired effect is achieved, and what happens if they do.

In her recent article, Axios writer Tina Reed discusses an emerging debate around a class of anti-obesity drugs known as GLP-1 agonists, particularly whether patients should expect to take them indefinitely. These drugs, initially used for treating Type 2 diabetes, have gained approval for weight loss. The debate centers on whether treating obesity as a chronic disease means patients should remain on these drugs long-term or if they can eventually stop.

The tension arises from insurers’ concerns about the costly implications of prolonged drug use and clinicians’ uncertainties about whether patients should commit to a lifetime of treatments. Some argue that, like other chronic diseases, it makes sense for patients to stay on the drugs continuously. Others suggest that more data is needed to understand how these drugs affect the brain, proposing the possibility of using them as a bridge to less intense therapies and lifestyle changes.

Studies indicate that many patients stop taking these drugs within a year due to challenging side effects and coverage limits. Some experts suggest the need for clinical studies to explore options like lower doses, switching to less expensive medications, or intermittent drug use to maintain weight loss.

Insurers’ reluctance to cover these drugs for obesity adds to the complexity of the issue. While weaning may be plausible for some patients, there isn’t enough clinical data yet to support taking all patients off the drugs. Regardless of the stance, there is agreement on the importance of strong patient support services to enhance the success of these drugs.

What happens when you stop taking Ozempic?

An uncredited but medically reviewed article on Drugs.com provides information on the potential consequences of stopping the use of Ozempic, an injection used for type 2 diabetes and weight loss. Apparently, if patients discontinue Ozempic, they may experience weight regain within a few months to a year, an increase in blood sugar levels, and potential loss of positive heart health benefits.

The mechanisms of Ozempic involve controlling blood sugar levels, insulin secretion, and digestion, contributing to weight loss by reducing appetite and slowing gastric emptying. Upon stopping Ozempic, these mechanisms cease, leading to an increase in appetite, weight regain, and potential worsening of type 2 diabetes and heart health.

The article discusses a study on the effects of stopping semaglutide, the active ingredient in Ozempic, which showed that individuals who received semaglutide regained some weight after discontinuation, but still had an overall weight loss compared to a placebo group. Additionally, improvements in heart health observed during treatment were reversed after stopping.

Reasons for discontinuing Ozempic include common side effects like nausea, vomiting, and stomach issues. Ways to prevent weight gain after stopping Ozempic include maintaining a healthy lifestyle, consulting with a healthcare professional, prioritizing sleep, meeting with a dietitian, and staying hydrated.

Your responses and feedback are welcome!

Source: “The big question about obesity drugs: Can people ever stop taking them?,” Axios.com, 11/27/2023
Source: “What happens when you stop taking Ozempic?,” Drugs.com, 9/18/2023
Image by Myriam Zilles on Unsplash