Did You Receive a Mounjaro Health Insurance Denial? We Can Help.
Although Mounjaro was initially FDA-approved in May 2022 to treat adults with type 2 diabetes, its formula was FDA approved to treat obese and overweight individuals in November 2023. The approved obesity product is called Zepbound™. Initial study results showed as much as 22.5% body weight loss. But health insurance companies sometimes deny Mounjaro – partially because it is expensive. This page includes an overview of Mounjaro and how health insurance companies assess its medical necessity. We also include information on what steps to take if you receive a Mounjaro health insurance denial. In the event of a Mounjaro health insurance denial, it is helpful to seek the assistance of qualified health insurance attorneys like those at the Law Offices of Scott Glovsky. With nearly twenty-five years’ experience helping policyholders overturn denied claims, we understand how insurance companies operate and can help you get the medical coverage you deserve.
What Are Mounjaro and Zepbound and How Do They Work?
Mounjaro® (tirzepatide) was FDA-approved to improve glycemic control in adults with type 2 diabetes in May 2022. Zepbound was FDA-approved for obesity and weight loss in November 2023.
According to its maker Eli Lilly, these two medications are the first and only FDA-approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonists. Glucagon-like peptide-1 (GLP-1) receptor agonists mimic the action of the natural hormones GLP-1, which are involved in the regulation of blood sugar levels and the control of appetite. By activating these receptors, GLP-1 receptor agonists can help to increase insulin secretion from the pancreas, decrease the production of glucose by the liver, and slow down the emptying of the stomach, which results in better blood sugar control and decreased appetite. GIP helps weight loss because together with lowering appetite, it may enhance how the body breaks down sugar and fat. Mounjaro is used as a monotherapy or in combination other diabetes drugs.
Together with the medications, patients are advised to exercise more and to follow a reduced calorie diet.
Is Zepbound the Same Formula as Mounjaro?
Although they are FDA-approved for different conditions (diabetes and obesity/overweight), Mounjaro and Zepbound share the same formula. Both Mounjaro and Zepbound come in six different doses in single-dose pens – 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg.
Do Mounjaro and Zepbound Help With Obesity And Overweight?
Mounjaro and Zepbound help with weight loss in obese and overweight individuals. Preliminary results from the Phase 3 clinical trial SURMOUNT-1 showed that overweight or obese participants without type 2 diabetes taking Mounjaro (tirzepatide) lost up to 22.5% (52 lbs.) of their body weight. It also showed that 55% (10 mg) and 63% (15 mg) lost at least 20% of their body weight. Reductions in average body weight varied based on the specific Mounjaro dose. Average body weight loss was 15% at 5 mg, 19.5% at 10 mg, and 20.9% at 15 mg.
Are Mounjaro and Zepbound FDA-Approved For Weight Loss?
The FDA granted Mounjaro (tirzepatide ) a fast track review to be specified as a treatment for obesity on October 6, 2022. For this designation, the maker of Mounjaro used data from its Phase 3 SURMOUNT-1 trial and the in progress SURMOUNT-2 trial. Both include overweight and obese participants. The fast track aspect enabled Eli Lilly to give FDA data in real time as opposed to waiting for the trial to end to submit data. The SURMOUNT-2 trial ended in 2023.
Published on October 15, 2023, results from Eli Lilly’s SURMOUNT-3 trial showed that after 72 weeks, individuals who took tirzepatide lost around 60 pounds while those who took the placebo gained weight. In addition to the drug, study participants also ate a low-calorie diet, exercised, and attended weekly counseling sessions prior to starting tirzepatide.
On November 8, 2023, the FDA approved the formula in Mounjaro for obesity and weight loss. Eli Lilly named the product for weight loss “Zepbound.”
What Are Obesity and Overweight?
Excessive body fat that leads to a persistently high weight is considered obesity, which is a harmful health condition that increases the likelihood of developing several health issues, including heart disease, type 2 diabetes, sleep apnea, and some types of cancer. The Body Mass Index (BMI) is a commonly used measurement to determine obesity, which is calculated by dividing an individual’s weight in kilograms by the square of their height in meters. A person is considered obese if their BMI equals or exceeds 30, while a BMI between 25-30 is considered overweight.
Statistics reveal that approximately 31% of American adults are overweight and nearly 42% are obese. (This number is projected to hit nearly 49% by 2023.) Moreover, nearly 20% of children aged between 2 and 19 years are obese.
Who Can Take Mounjaro?
The FDA approved Mounjaro (tirzepatide) for use in adults (18 years or older) only, specifically for the treatment of type 2 diabetes. There is currently no approval for use of this drug in children or adolescents. (However, as of October 2023, Eli Lilly has an early stage clinical trial with 30 kids as young as six years old.) And it is not recommended for people with type 1 diabetes or diabetic ketoacidosis.
Who Can Take Zepbound?
Zepbound (tirzepatide) is approved for obese adults (BMI 30+) and for overweight adults (BMI 27 ≤ 30) with at least one weight related health condition such as type 2 diabetes, high blood pressure, and high cholesterol.
How are Mounjaro and Zepbound Administered?
Mounjaro and Zepbound are both given via a weekly injection, typically in the abdomen, thigh, or upper arm. They come in a prefilled pen, and a patient usually self-injects the drug. The medication must be refrigerated until it is open, at which point it can be stored at room temperature for as many as 4 weeks.
How Much Does Mounjaro Cost?
Mounjaro is an expensive medication. When prescribed for type 2 diabetes, a 28-day supply lists for $1,023. Of course, Eli Lilly has a savings card program that some commercially insured patients can use to lower their price of Mounjaro. It’s notable that Mounjaro is less expensive in certain countries. A 28-day supply in the Netherlands is $444 and in Japan costs $319.
How Much Does Zepbound Cost?
Zepbound is projected by its manufacturer to list at $1,059.87 in the United States. This list price is about 20% lower than the list price of Wegovy. Eli Lilly set this price after communications with employers. Similar to Mounjaro, Eli Lilly will offer a savings card for certain commercially insured individuals may use to lower their monthly costs. If your health insurance company covers Zepbound, then you can get the medication for $25 for a one or three month prescription. If your policy doesn’t cover Zepbound, then you could pay $550 for a month with the savings card.
Is There a Generic Version of Mounjaro?
There is not a generic version of Mounjaro. In fact, in September 2023, Mounjaro’s manufacturer Eli Lilly filed lawsuits in several states against wellness centers, compounding pharmacies and medical spas for selling products that claim to contain the Mounjaro active ingredient tirzepatide.
On October 2, 2023, the Food and Drug Administration sent letters to Semaspace and Gorilla Healing, two online vendors selling unapproved versions of tirzepatide. The letters stated that tirzepatide is only FDA-approved for diabetes and that unapproved medications don’t have assurances of safety and efficacy like FDA-approved medications have. Finally, the letters explained that these firms were breaking the law by selling these weight loss products without doctor prescriptions.
Another issue is counterfeit Mounjaro and other GLP-1 drugs. An article in Oct. 2023 revealed that unlike most fake medications that are sold in poor countries, GLP-1 fake drugs are expensive and thus are typically sold in affluent countries. These affluent nations include Europe, the United States, and the Middle East.
Can My Doctor Prescribe Zepbound Now?
Zepbound will be available for patients after Thanksgiving 2023.
Can I Take Zepbound Together With Wegovy or Ozempic?
All of these medications contain GLP-1 agonists. Patients should not take multiple GLP-1 agonists. As such, patients should not take Zepbound or Mounjaro together with Wegovy or Ozempic.
Is There a Difference Among Mounjaro/Zepbound, Saxenda, Wegovy and Ozempic?
All of these medications include GLP-1 receptor agonists and help with type 2 diabetes. However, there are differences in their formulations, dosages, how they work, what they are approved to treat, and more.
Wegovy, Ozempic and Saxenda
Novo Nordisk makes Ozempic, Wegovy, and Saxenda. Ozempic and Wegovy are glucagon-like peptide-1 (GLP-1) receptor agonist weekly injections with the active ingredient semaglutide. Saxenda is a daily injection with the active ingredient liraglutide. The main Ozempic dosage is 2 mg weekly, while the primary Wegovy dosage is 2.4 mg weekly. The recommended Saxenda dosage is 3 mg daily. As of November 2023, the list price for Ozempic is $936 per month and for Wegovy is $1,349 per month. Saxenda’s list price was $1,349/month. Ozempic was FDA-approved in 2017 for type 2 diabetes and to help with cardiovascular issues. Wegovy was FDA-approved in 2021 for obesity and chronic overweight with a minimum of one weight-related health issue like type 2 diabetes or high blood pressure. And Saxenda was FDA-approved in 2014 (adults) and then in 2020 (kids 12-17) for obesity and overweight.
While they are nearly identical, Ozempic is often prescribed instead of Wegovy for weight loss because it is less expensive, more available, and more frequently approved by insurers since it is FDA-approved for diabetes. Health plans under the Affordable Care Act don’t need to cover obesity drugs or surgeries.
Mounjaro and Zepbound
Mounjaro and Zepbound (Tirzepatide), on the other hand, are the only dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. They contain tirzepatide instead of semaglutide found in Ozempic and Wegovy. Mounjaro was approved by the FDA to improve glycemic control in adults with type 2 diabetes in May 2022. Zepbound was approved for obesity and weight loss in November 2023. These two share the same formula. The list price of Mounjaro is $1,023 and the list price of Zepbound is $1,060.
Comparing the drugs for weight loss, Mounjaro and Zepbound appear to show the greatest weight loss. Participants in a Wegovy clinical trial lost, on average, 15% of their body weight. But Mounjaro/Zepbound study participants lost up to 22.5% of their body weight when they consumed the highest dosage. (Even at lower doses, participants lost weight. At the 10 mg dose, they lost an average of 21.4% of their body weight. At 5 mg, they dropped an average of 16%.) Ozempic study participants lost 15%-18% of their body weight and Saxenda participants lost either 5% or 10% of their body weight based on the specific trial.
Is Retatrutide More Effective For Weight Loss than Mounjaro and Zepbound?
In a clinical trial published mid-2023, Retatrutide was found to be more effective than all other obesity and diabetes GLP-1 drugs on the market. A difference among Retatrutide and Mounjaro/Zepbound is that Retatrutide has a third active – a Glucagon Receptor Triagonist. Likely to get FDA-approval in 2025 or 2026 after clinical trials end, you can learn more about this medication here.
Are Mounjaro and Zepbound Covered By Health Insurance Companies?
Most Medicare prescription drug plans provide coverage for Mounjaro for type 2 diabetes treatment. However, when Mounjaro is prescribed off-label for weight loss, insurance coverage is often not available. This is because the Affordable Care Act does not require health insurance companies to cover medications or surgeries for obesity or overweight conditions. The national association of health care providers known as AHIP claims that there is not enough evidence to prove the long-term effectiveness of anti-obesity drugs, and that weight loss is not sustained after discontinuing the medication. Therefore, it is not surprising that some insurance companies don’t want to cover the cost of an expensive medication that may be needed for a patient’s entire lifetime. That said, there are many prescription medications for diseases (some incurable) that must be taken long-term including those for multiple sclerosis, cardiovascular diseases, diabetes, rheumatoid arthritis, and others.
Medicare provides coverage for bariatric surgery for patients with severe obesity, and also covers weight loss counseling and behavioral therapy in many cases. But Medicare does not cover weight loss medications. That said, as additional individuals take GLP-1 medications like Mounjaro and Zepbound and get incredible results, in the future Medicare might cover these drugs. In 2021, the House of Representatives in Congress introduced The Treat and Reduce Obesity Act that would have added weight loss medication coverage to Medicare Part D. The term ended prior to a full house vote. Another reason is possible savings. Obesity drives up general medical costs because it leads to additional health concerns. One organization estimated covering drugs like these may lead to a savings of $176 billion over a decade because of fewer doctor exams, hospitalizations, surgeries, and other procedures. Also, some states like California are already overturning health insurer denials in external appeals. In addition, as of October 2023, there are more than 70 new weight management drugs in Research & Development. When more hit the market, GLP-1 price points should be reduced due to increased competition.
Meanwhile, Medicaid programs vary from state to state, and fewer than 20 state Medicaid programs provide coverage for obesity medications. As of May, 2023, states that cover obesity medications in Medicaid programs include California, Delaware, Kansas, Minnesota, Michigan, New Hampshire, Pennsylvania, Rhode Island, Virginia and Wisconsin. Other states including Georgia, Louisiana, New Jersey, New Mexico, South Carolina and Tennessee offer limited coverage of weight management and obesity medications.
Zepbound should be available to doctors and their patients in the United States by the end of 2023.
Health insurance companies such a Cigna, Oscar, Health Net, Aetna, Kaiser, Blue Shield, Anthem Blue Cross, and UnitedHealthcare determine whether to provide coverage for Mounjaro and Zepbound based on their internal policies. Their policies vary depending on various factors including the patient’s individual circumstances, the type of health plan (such as PPO or HMO), and doctor recommendations for medical necessity. Each insurance company has unique policies, and some cover Mounjaro for treating certain health conditions while others do not. If Mounjaro and/or Zepbound are deemed medically necessary by the insurer, then it usually provides coverage for the medication. On November 9, 2023, Eli Lilly’s CEO David Ricks claimed that about half of commercial health insurers include obesity care in their formularies.
Is Mounjaro High-Priced for Insurance Companies?
Patients pay full drug list prices when they don’t have insurance or a fraction of list prices with health insurance. And sometimes, like in the case of Mounjaro, a pharmaceutical manufacturer provides coupons to patients with and without insurance to help lower the out-of-pocket monthly spend on their medication. Insurance companies and their Pharmacy Benefit Managers, on the other hand, pay net prices. Net prices are list prices minus various discounts, rebates and returns.
What are Pharmacy Benefit Managers (PBM)? These are organizations that control drug benefits for several entities including health insurance companies, Medicare Part D (prescription) plans, and some businesses and pharmacies. PBMs dictate formularies and drug prices for health insurance companies (and members) as well as the dollar amount that pharmacies receive for pharmaceutical drugs. The largest three PBMs are owned by parent corporations that also own health insurers. Together, Express Scripts (Cigna), OptumRx (UnitedHealthcare) and Caremark (Aetna) run prescription benefits for 260 million people in the United States.
A September 2023 study from the American Enterprise Institute looked at the first quarter of 2023 and predicted that Mounjaro’s average monthly net price was 79% of its list price of $1,023. So while plan members paid their cost-sharing amount based off of $1,023 and their coupons, Mounjaro’s manufacturer Eli Lilly received approximately $215 and the PBM received somewhere between $215 and $1,023, or +/- $808. Plan members who received health insurance coverage for Mounjaro received $150 coupons, while insured members who didn’t have Mounjaro coverage received $575 coupons.
The main takeaway is that health insurers and their PBMs pay significantly less than Mounjaro’s list price. Also, as of October 2023, it was speculated that health insurer and PBM parent corporations had healthy profits because what the insurers paid for their weight loss and obesity medications was offset by the profits that their PBMs received on these medications.
What are Alternative Drugs to Mounjaro and Zepbound for Weight Loss?
There are several alternative drugs to Mounjaro that are approved by the FDA for weight loss, including:
- Orlistat (brand name: Xenical or Alli)
- Phentermine (brand name: Adipex-P, Lomaira)
- Liraglutide (brand name: Saxenda)
- Naltrexone-bupropion (brand name: Contrave)
- Phentermine-topiramate (brand name: Qsymia)
Do Any Weight Loss Drugs Preserve Muscle Mass?
All of the GLP-1 medications including Mounjaro, Zepbound, Wegovy, Ozempic and Saxenda help individuals lose body weight, but none of them preserve muscle. Eli Lilly, maker of Mounjaro and Zepbound, purchased the biotech company Versanis in July 2023 in part for its research on an experimental obesity treatment. This treatment binds to proteins called activin type II A and B receptors and is believed to help reduce fat while simultaneously preserving muscle mass. Eli Lilly plans to combine Versanis’ treatment with its own obesity medications like Zepbound to create a new medication that can reduce body weight and preserve muscle.
What Should I Do If I Get a Mounjaro or Zepbound Health Insurance Denial?
To handle a Mounjaro health insurance denial, you should start with the appeal process recommended by your insurance company. But before doing so, you need to determine whether your insurance plan is an ERISA or non-ERISA plan. If your health insurance is sponsored by your employer, it is likely an ERISA plan. However, some employer-sponsored plans may not be categorized under ERISA. These include:
- Government employment plans
- Plans when you work for a religious organization
- Health plans that only cover owners and their families
- Family and individual plans purchased from healthcare.gov or Covered California or directly from private insurance companies like Anthem Blue Cross or Blue Shield of California
- Some Native American plans
If you have an ERISA plan, your options are limited, and the appeal process is more straightforward. However, it is still advisable to discuss your situation with a qualified health insurance attorney before you begin the appeal process. Go here to learn more about the ERISA appeals process.
If you have a non-ERISA plan, follow your health insurance company appeals process. Again, we recommend speaking with a qualified health insurance attorney who can help advise you on the process. Learn more about non-ERISA appeals here.
Contact a Qualified Health Insurance Attorney if You Receive A Mounjaro Health Insurance Denial Or A Zepbound Health Insurance Denial
For almost 25 years, Scott Glovsky has been assisting policyholders to overturn insurance denials. At the Law Offices of Scott Glovsky, we devote a considerable amount of time to handling health insurance denials and health insurance bad faith cases. Our goal is not only to obtain justice for our clients, but, whenever possible, to prompt insurance companies to modify their policies so that others do not encounter the same difficulties.