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.
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.
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.
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.
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 in 2023. The company also plans to apply for regulatory approval in the EU in 2023 as well.
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. It costs approximately $890-$950 per month in the United States. Interestingly, Ozempic costs much less in some other countries. A study from August 15, 2023 showed that Ozempic’s monthly cost was $83 in France, $93 in the UK, and $147 in Canada.
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 2022, Ozempic costs about $890-$950 per month with a coupon and Wegovy costs about $1,340-$1,435 per month with a coupon. 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 Mounjaro (Tirzepatide) and Saxenda?
Mounjaro has a different formula than Ozempic, Wegovy and Saxenda. It is 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 contains tirzepatide. Saxenda contains liraglutide. Like Ozempic, Mounjaro was originally FDA-approved for type 2 diabetes. But in October 2022, the FDA gave Mounjaro a fast track review to be specified as a treatment for obesity. And Mounjaro could be FDA-approved for obesity and weight loss in 2023 because its Phase 3 clinical trial showed strong results and finished in April 2023.
Comparing the medications specifically for weight loss, Mounjaro’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 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 and Mounjaro for Weight Loss?
In a Phase 2 Clinical trial published on June 26, 2023 in the New England Journal of Medicine, Retatrutide from Eli Lilly outperformed Ozempic, Wegovy, Mounjaro and Saxenda both in terms of weight loss and in speed of weight loss. In this study of non-diabetic adults with a BMI of 30+, or a BMI of 27 to <30+ and at least one weight-related condition, participants were given varying doses of a Retatrutide injection including 1 mg, 2 mg, 4 mg, 8 mg and/or 12 mg. The primary endpoint was the percent body weight change from baseline to 24 weeks. And the secondary endpoints included the percent change in body weight from the baseline to 48 weeks and a weight loss of 5%+, 10%+, or 15%+.
Results showed the higher the dose, the greater the weight loss. And as expected, weight loss at 48 weeks was greater than at 24 weeks. At 48 weeks, study participants who took the highest dose of 12 mg lost on average 24.2% of their body weight, or about 57.8 lbs. In addition, Retatrutide worked quicker than the other weight loss medications. For example, with semaglutide (found in Ozempic and Wegovy), clinical trial participants lost on average 15% of their body weight (34 lbs.) after 68 weeks. And with Mounjaro (tirzepatide), participants lost on average 22.5% (52 lbs.) after 72 weeks.
In terms of the secondary endpoints, at 48 weeks, “a weight reduction of 5% or more, 10% or more, and 15% or more had occurred in 92%, 75%, and 60%, respectively, of the participants who received 4 mg of retatrutide; 100%, 91%, and 75% of those who received 8 mg; 100%, 93%, and 83% of those who received 12 mg; and 27%, 9%, and 2% of those who received placebo.”
Like Mounjaro, Retatrutide mimics GLP-1 and GIP. And Retatrutide has another hormone glucagon.
Retatrutide is in a Phase 3 clinical study that will likely run through 2025.
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. Less than 20 Medicaid programs pay for obesity medications.
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.
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.