Did You Receive an Ozempic Health Insurance Denial? Perhaps We Can Help.
Although Ozempic was FDA-approved in 2017 to treat adults with type 2 diabetes, some physicians prescribe it to obese or overweight individuals for weight loss. But health insurance companies often deny Ozempic, in part because it is expensive. This page provides an overview of the drug and how health insurers evaluate its medical necessity. We also include information on what steps to take if you receive an Ozempic health insurance denial. In the event of an Ozempic health insurance denial, it can be beneficial to seek the assistance of qualified health insurance attorneys like those at the Law Offices of Scott Glovsky. With over twenty years of experience helping policyholders overturn denied claims, we know how insurers operate and can help you get the coverage you deserve.
What is Ozempic?
Ozempic is a medication classified as a glucagon-like peptide-1 (GLP-1) receptor agonist. It helps regulate blood sugar levels and promotes weight loss in individuals with type 2 diabetes. GLP-1 receptor agonists work by mimicking the effects of a natural hormone called GLP-1 that is produced in the intestines. GLP-1 stimulates insulin secretion from the pancreas, suppresses the production of glucagon (a hormone that raises blood sugar levels), and slows down the rate at which food is emptied from the stomach. This slowdown can help promote feelings of fullness and reduce food intake. In turn, these effects can improve blood sugar control and support weight loss. Physicians usually prescribe Ozempic in combination with diet and exercise to improve glycemic control. The U.S. Food and Drug Administration (FDA) approved Ozempic for the treatment of type 2 diabetes in 2017. In terms of volume, from its approval in 2017 through the end of 2022, Ozempic accounted for 65.4% of all GLP-1 prescriptions.
What Health Conditions Does Ozempic Help?
Practitioners use Ozempic to treat type 2 diabetes and to help improve blood sugar control while reducing the risk of cardiovascular complications. Ozempic works by increasing insulin sensitivity, reducing glucose production by the liver, and slowing down the digestion of carbohydrates in the gut. So Ozempic reduces appetite and increases the feelings of fullness. For this reason, some physicians prescribe Ozempic off-label to help treat obesity or overweight. Oftentimes doctors prescribe Ozempic in combination with a reduced calorie diet and increased physical exercise.
On October 11, 2023, Novo Nordisk stopped its kidney outcomes trial (AKA FLOW trial) because a third party interim analysis found Ozempic met its efficacy criteria. The study’s primary endpoint was delaying renal function decline at greater than or equal to 50 percent and reducing the risk of cardiovascular and chronic kidney disease-associated mortality. The dosage in this study was 1.0 mg of the active ingredient semaglutide.
Does Ozempic Help with Obesity and Overweight?
Even though Ozempic helps regulate blood sugar levels and promotes weight loss, the FDA has not specifically approved Ozempic for the treatment of obesity. Healthcare providers may prescribe Ozempic off-label to help with weight loss in individuals who do not have diabetes but struggle with obesity. In addition, in clinical studies, Ozempic has been shown effective for weight loss. Across the majority of phase 3 clinical trials, most overweight or obese participants lost between 15% and 18% of their body weight.
What Are Obesity and Overweight?
Obesity is an unhealthy amount of body fat that leads to excessive weight that remains over time. This health condition increases the likelihood of developing various health issues including heart disease, type 2 diabetes, sleep apnea, and some types of cancer. Body Mass Index (BMI) is often used to determine obesity. BMI is calculated by dividing an individual’s weight in kilograms by the square of their height in meters. A person with a BMI equal to or exceeding 30 is obese, while a BMI 25 – 30 is overweight.
Statistics indicate that just under 31% of American adults are overweight, and 42% are obese. In addition, almost 20% of children aged between 2 and 19 years are obese. The New England Journal of Medicine published an article predicting that 48.9 percent of American adults will be obese by the year 2030.
Who Can Take Ozempic?
Doctors prescribe Ozempic as a medication for adults with type 2 diabetes. Ozempic is not recommended for people with type 1 diabetes or pancreatitis.
How is Ozempic Administered?
Ozempic is an injectable medication administered once a week under the skin (subcutaneously). The typical dosage is 2 mg.
Is There a Generic Version of Ozempic?
There are no generic versions of Ozempic’s active ingredient semaglutide. Generic drug manufacturers have challenged Novo Nordisk’s patents. On October 1, 2023, a federal judge rejected Mylan’s challenge to two of the brand manufacturer’s patents. And Novo Nordisk has filed multiple patent lawsuits against other companies trying to launch generic versions of Ozempic.
The FDA sent letters in October 2023 to a few online companies to stop selling unapproved semaglutide, the active ingredient in Ozempic. The letters explained that unapproved drugs don’t carry the same assurances of efficacy and safety as FDA-approved drugs. In addition, the letters stated that these companies violated the law by selling their products without prescriptions from licensed providers. In February 2024, the FDA sent warning letters to the online companies US Chem Labs and Synthetix (with the website Helix Chemical Supply) for selling misbranded and unapproved semaglutide and tirzepatide products with claims including “reducing the risk of stroke, heart attack, treatment of Alzheimer’s disease, weight loss,” and more.
Not only are there no generic forms of Ozempic and similar GLP-1 medications, but another recent issue is counterfeit medications. An October 2023 article pointed out that unlike most fake drugs that are marketed in poor countries, GLP-1 fake drugs are typically sold in wealthy countries because they are expensive. These wealthy nations include the United States, Europe and the Middle East. Another article in October 2023 found that many people in Austria were hospitalized after they took fake Ozempic. And in January 2024, suspected fake Ozempic was connected to three cases of hypoglycemia in the United States. (In 2023, several individuals developed hypoglycemia after consuming fake Ozempic in Austria and Lebanon.)
The maker of Ozempic and Wegovy, Novo Nordisk, sued twelve compounding pharmacies, medical spas and clinics that claim to sell the active ingredient semaglutide in their products. On February 9, 2024, Novo Nordisk settled with both Med Spa and Nuvida Rx Weight Loss and Cosmetic Laser Professionals. These two companies are permanently banned from misleading advertising, from using any Novo Nordisk trademarks or logos in products, and from claiming that their products are FDA approved.
Is the Ozempic Tablet Available Now?
Although it was clinically studied, an Ozempic tablet is not yet available. On May 22, 2023, Novo Nordisk announced results from its phase 3a clinical trial “OASIS 1” with a daily 50 mg oral tablet of semaglutide, the active ingredient in Ozempic. 667 obese or overweight adults with at least one comorbidity participated in this 15.6-month trial that compared the active semaglutide to a placebo. These study participants did not have type 2 diabetes. Similar to weekly Ozempic injections on the market today, participants also modified their diets and increased their exercise. Study participants given semaglutide lost 15.1% of their weight compared to participants given placebo who lost 2.4% of their weight. And 84.9% of people on the active ingredient lost 5% or more of their weight as opposed to only 24.5% of people who lost weight on the placebo. The study was published in The Lancet in June 2023.
A second study, also published in The Lancet in June 2023, focused on tablet doses with type 2 diabetics. This study tested 14 mg, 25 mg and 50 mg oral daily doses. As expected, participants who took 25 mg and 50 mg doses had better results in terms of weight loss and HbA1C reduction than those who took 14 mg doses.
Given that it tested individuals with and without type 2 diabetes, it will be interesting to see what specific FDA approvals Novo Nordisk seeks.
Novo Nordisk expects to apply for FDA approval by the end of 2023. The company also plans to apply for regulatory approval in the EU in 2023.
Although it is not FDA-approved for weight loss, there is a different semaglutide tablet on the market now. FDA-approved to improve glycemic control in type 2 diabetics, Rybelsus, also from Novo Nordisk, comes in 7 mg and 14 mg doses.
How much does Ozempic Cost?
Ozempic is an expensive medication. As of the 3.5% price increase in 2024, it costs nearly $970 per month in the United States. Interestingly, Ozempic costs much less in some other countries. A study from August 2023 showed that Ozempic’s monthly cost was $83 in France, $87 in Australia, $93 in the UK, $96 in Sweden, $103 in Germany and the Netherlands, $144 in Switzerland, $147 in Canada, and $169 in Japan. In August 2023 Ozempic’s monthly list price in the United States was $936.
Is There a Difference Between Ozempic and Wegovy?
Both drugs are made by Novo Nordisc and contain the active ingredient semaglutide. Both are given via weekly injections. The main differences are health conditions the two were approved to treat, the dosage, and the cost. Ozempic was FDA-approved for type 2 diabetes and to help prevent cardiovascular issues in 2017. Wegovy was FDA-approved for obesity and chronic overweight in 2021. The primary Ozempic dosage is 2 mg weekly, while the main Wegovy dosage is 2.4 mg weekly. As of November 2023, Ozempic costs about $970 per month and Wegovy costs $1,349 per month. Ozempic is often prescribed instead of Wegovy for weight loss because it is cheaper, more widely available, and more often approved by insurance since it is approved for diabetes. The Affordable Care Act doesn’t require health insurers to cover obesity medications or surgeries.
Can Wegovy Be Substituted for Ozempic and Vice Versa?
While they share the same active ingredient semaglutide, Ozempic may be prescribed instead of Wegovy for weight loss because it is sometimes more available, less expensive, and more frequently approved by health insurance companies since it’s FDA-approved for diabetes. Affordable Care Act-compliant health plans don’t need to pay for obesity surgeries or medications. In addition, the two drugs are FDA-approved for different health conditions and have different doses.
How Do Ozempic and Wegovy Compare to Saxenda, Mounjaro and Zepbound (Tirzepatide)?
Mounjaro and Zepbound share a formula that is different than Ozempic, Wegovy and Saxenda. They are the only dual glucagon-like peptide-1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide (GIP). Instead of the active semaglutide found in Ozempic and Wegovy, Mounjaro and Zepbound contain tirzepatide. Saxenda contains liraglutide. Like Ozempic, Mounjaro was FDA-approved for type 2 diabetes. In November 2023, the FDA approved Zepbound for obesity and weight loss if a person has at least one other weight-related health issue. And Zepbound is available to patients as of December 5, 2023.
Comparing the medications specifically for weight loss, Mounjaro and Zepbound’s clinical trials show the greatest weight loss. Individuals who participated in a Wegovy clinical trial lost, on average, 15% of their body weight. But Mounjaro/Zepbound clinical trial participants lost up to 22.5% of their body weight when they took the highest dose of the drug. As mentioned above, Ozempic clinical participants lost 15-18% of their body weight. And Saxenda study participants lost either 5% or 10% depending on the particular clinical trial.
How Does Retatrutide Compare To Wegovy, Saxenda, Mounjaro and Zepbound for Weight Loss?
In a Phase 2 Clinical trial published in June 2023, Eli Lilly’s Retatrutide was more effective than Ozempic, Wegovy, Mounjaro, Zepbound and Saxenda both in terms of weight loss and in speed of weight loss. Like Mounjaro, Retatrutide mimics GLP-1 and GIP. One difference is that Retatrutide has another hormone glucagon. While it likely won’t be available until 2025 or 2026, learn about the recent clinical trial here.
Will More GLP-1 Drugs Enter the Market?
Because the GLP-1 market is projected to reach $100 billion with thirty million obese or overweight American users by the year 2030, 70+ GLP-1 medications are currently in Research & Development. Pharmaceutical drugs in R&D include the following:
- A Phase 2 clinical trial is in process on MariTide, a GIPR (Gastric Inhibitory Polypeptide Receptor) and GLP-1 receptor agonist. Preclinical and early-stage clinical trial results of Amgen’s MariTide found meaningful weight loss in which participants lost as much as 14.5% of their body weight. In addition, some individuals maintained their weight loss for as many as 150 days after stopping the medication. Phase 2 clinical results are expected in late 2024.
- Roche will join the weight loss category through its acquisition of the biotech company Carmot. This company has three obesity drug clinical trials including CT-388, an injectable GLP-1, and CT-996, an oral GLP-1.
- Pfizer reported Phase 2b clinical trial results on an obesity medication called, “danuglipron.” The company has backed off a bit due to gastrointestinal side effects and the fact that over half of participants stopped taking the medication. Pfizer has abandoned its twice daily dose and will continue studying a once-daily dose.
Is Ozempic Covered By Health Insurance Companies?
Most Medicare prescription drug plans cover Ozempic for type 2 diabetes. That said, when Ozempic is prescribed off-label for weight loss, it is often not covered by insurance. Why? Because the Affordable Care Act doesn’t mandate that health insurers cover obesity or overweight medications or surgeries. And according to AHIP, a national association of providers of health care and other health services, there isn’t enough evidence to show anti-obesity drugs are effective over the long-term. In fact, it claims that weight loss isn’t maintained when a person stops taking the medication. It isn’t surprising that some health insurers don’t want to cover an expensive medication that might be taken for a patient’s entire life.
As for other types of weight loss coverage, Medicare pays for bariatric surgery for severely obese patients. And in many cases, Medicare covers nutrition counseling and behavioral therapy for weight loss. Medicaid programs are state specific. As of July 2023, sixteen state Medicaid programs paid for at least one anti-obesity or weight-loss medication. These states include California, Delaware, Hawaii, Kansas, Louisiana, Maine, Michigan, Minnesota, Mississippi, New Hampshire, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, and Wisconsin.
Less than 20 Medicaid programs pay for obesity medications.These state Medicaid programs (as of July 2023) include California, Michigan, Pennsylvania, New Hampshire, Rhode Island, Delaware, Minnesota, Kansas, Virginia and Wisconsin. Other states including Tennessee, New Mexico, New Jersey, South Carolina, Georgia, and Louisiana provide limited coverage of obesity/weight management prescription drugs.
As more people take GLP-1 medications like Ozempic and achieve positive results, it is not out of the question that Medicare could cover Ozempic for obesity in the future. Why? We know that obesity leads to other health issues and thus drives up medical costs. In fact, one organization estimated that Medicare could save $176 billion over a decade because of fewer surgeries, hospitalizations, doctor visits and other procedures. And Goldman Sachs estimated on February 22, 2024 that these drugs could increase U.S. GDP by 1% (assuming 60 million patients) in future years. The reason is that reduced obesity-related employee problems (i.e., working less and working less efficiently) will probably increase employee efficiency. Plus, in some states like California, external appeals have resulted in several overturned health insurer Ozempic denials. Another reason is the fact that as of October 2023, there are over 70 new weight management drugs in development. As more are clinically tested and FDA-approved, prices for all GLP-1 drugs are likely to decrease.
Commercial health insurance plans determine whether to cover Ozempic based on their internal policies. This means that providers including Health Net, Kaiser, Blue Shield, Anthem Blue Cross, Cigna, Oscar, Aetna, UnitedHealthcare and others all have unique policies. Their policies depend on various considerations such as individual patient circumstances, the specific health plan (PPO, HMO, etc.), the physician recommendation of medical necessity, and others. Certain health insurance companies cover Ozempic for treating specific health conditions, while others do not. If insurance companies deem Ozempic medically necessary, then they typically cover the medication.
Is Ozempic Expensive for Insurance Companies?
While patients pay prescription list prices without insurance or a portion of list prices with insurance, health insurance companies pay a different amount. The reason involves gross-to-net (GTN) drug prices and Pharmacy Benefit Managers (PBM). GTN is the percentage of a drug’s list price that a PBM actually pays. The amount paid, or the net price, integrates discounts, rebates and returns.
PBMs are middlemen. They manage prescription benefits for health insurance companies, Medicare Part D health plans, and some employers and pharmacies. PBMs set formularies and medication costs for health insurers (and policyholders) as well as amounts pharmacies get paid for medications. The top three PBMs are owned by companies that also own health insurers. Caremark (Aetna), OptumRx (UnitedHealthcare) and Express Scripts (Cigna) oversee prescription benefits for 260 million Americans.
A September 2023 study from the American Enterprise Institute evaluated four quarters ending with the first quarter of 2023. AEI estimated that Ozempic’s average discount from its list price to the actual net payment was 69%. So while patients paid an amount based on Ozempic’s 2023 monthly list price of $936 (net of any manufacturer coupons), Ozempic’s pharmaceutical company Novo Nordisk received an estimated $290 and PBMs paid an amount in between $936 and $290, or give or take $646. (Note that Novo Nordisk gave $150 coupons to patients who didn’t receive any Ozempic coverage from their insurance companies.)
Based on the tremendous differential between Ozempic’s list and net prices, while health insurance companies may pay a significant amount, oftentimes their sister PBMs make a nice profit. This is speculated to be one of the reasons why, as of October 2023, owners of the largest PBMs did not appear to take hits to their bottom lines.
Do Employers Cover Ozempic?
Big companies often have self-funded plans. Here, employers, as opposed to health insurance companies, pay for employee health care. Many use a third party administrator (TPA) like a health insurance company to implement their plans. So the TPAs take care of the medical provider network, formulary, claims, prior authorizations, and so on. A potential employee benefit of self-funded plans is that employers can weigh in on coverage decisions.
An August and September 2023 Accolade survey of over 500 companies revealed that 43% of companies may cover GLP-1 drugs like Ozempic in 2024. Today, only 25% of companies cover these drugs.
What are Alternative Drugs to Ozempic for Weight Loss?
There are several other medications to manage obesity if Ozempic is unsuitable or not covered by insurance. These drugs include Orlistat (brand name Xenical), which blocks the absorption of fat in the gut. Orlistat is approved for use in adults and is available over the counter (OTC) in a lower dose form called Alli. Phentermine (brand names Adipex-P and Lomaira) is a stimulant that reduces appetite. Adults typically take it only for a short period of time. Liraglutide (brand name Saxenda) is a GLP-1 receptor agonist similar to Ozempic but approved at a lower dose for weight loss.
Other drugs include Naltrexone/bupropion (brand name Contrave), a combination of two drugs that reduce appetite and promote weight loss. It’s approved for adults with obesity or overweight with at least one comorbidity. Phentermine/topiramate (brand name Qsymia) is a combination of two drugs that reduce appetite and promote weight loss. It is approved for obese or overweight adults with at least one weight-related comorbidity.
One additional medication from Pfizer, Danuglipron, is not yet on the market but showed promise in a phase 1 clinical trial published in May 2023. Tested on 411 type 2 diabetics, weight loss from this glucagon-like peptide 1 receptor agonist at the 120-miligram twice daily dose resulted in an average weight loss of about 10 pounds after 16 weeks. That weight loss amount is similar to Ozempic mid-stage clinical trial data.
What Should I Do If I Get an Ozempic Health Insurance Denial?
Your health insurance company outlines a path to follow that typically begins with an appeal. But before you appeal your Ozempic insurance denial, review if you have an ERISA or non-ERISA plan. Why? Because the path you take might very well be different.
ERISA stands for the Employee Retirement Income Security Act. If your health insurance comes from your employer, you likely have an ERISA plan. However, some employer-sponsored plans do not fall under ERISA. These include the following:
- your employer is the government
- you work for a religious group like a church, synagogue or mosque
- the health plan is a business plan that only covers owners and their families
- you purchased a family and individual plan from healthcare.gov or Covered California
- your family and individual plans was bought directly from a private insurance company such as Anthem Blue Cross or Blue Shield of California
- several plans for Native Americans
Your options are more limited if you have an ERISA plan. In this case, file an appeal. Discussing your situation with a qualified health insurance attorney can be helpful before you do. Read more about the ERISA appeals process.
If you have a non-ERISA plan, you have more options. Typically you would start with a non-ERISA appeal.
Remember there are several reasons that you may have received an Ozempic health insurance denial, and some of them are easily rectified. For example, if the denial is a mistake. But if after reviewing the reason for the denial, you feel it is unjustified, we recommend you speak with a health insurance attorney.
Contact a Qualified Health Insurance Attorney if You Receive An Ozempic Health Insurance Denial
Scott Glovsky has been helping overturn insurance denials for policyholders for nearly 25 years. The Law Offices of Scott Glovsky spends a significant amount of time on health insurance denials and health insurance bad faith. We not only get justice for our clients, we also get insurance companies to change their policies so others don’t suffer the same fate. Contact us now.