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, it is also FDA “fast tracked” to treat obese and overweight individuals. Initial study results are extremely promising, showing 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 is Mounjaro and How Does it Work?
Mounjaro® (tirzepatide) was FDA-approved to improve glycemic control in adults with type 2 diabetes in May 2022. According to its maker Eli Lilly, it is the first and only FDA-approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. 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. Mounjaro is used as a monotherapy or in combination other diabetes drugs.
Does Mounjaro Help With Obesity And Overweight?
Mounjaro has been shown to 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.
Is Mounjaro 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 is using data from its Phase 3 SURMOUNT-1 trial and the SURMOUNT-2 trial currently in progress. Both include overweight and obese participants. The fast track aspect enables 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 will end in April 2023. Based on clinical trials, Mounjaro could be approved for weight loss as early as Summer 2023.
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. 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 only, specifically for the treatment of type 2 diabetes. There is currently no approval for use of this drug in children or adolescents. And it is not recommended for people with type 1 diabetes or diabetic ketoacidosis.
How is Mounjaro Administered?
Mounjaro is given via a weekly injection, typically in the abdomen, thigh, or upper arm. It comes 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. However, when prescribed for weight loss, the dose will be higher. A medical director from the Institute for Clinical and Economic Review projected a “fair” cost will be $13,000 a year.
Is There a Difference Between Mounjaro, Wegovy and Ozempic?
All three of these medications include GLP-1 receptor agonist and help with type 2 diabetes. However, there are differences in their formulations, dosages, how they work, and what they are approved to treat.
Wegovy and Ozempic
Novo Nordisc makes Ozempic and Wegovy. Both are glucagon-like peptide-1 (GLP-1) receptor agonist injections with the active ingredient semaglutide. The differences between the two are the dosage, cost, and health conditions they were approved to treat. The main Ozempic dosage is 2 mg weekly, while the primary Wegovy dosage is 2.4 mg weekly. As of the end of 2022, Ozempic was about $890-$950 per month with a coupon and Wegovy was about $1,340-$1,435 per month with a coupon. 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.
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 (Tirzepatide), on the other hand, is the only dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It contains tirzepatide instead of semaglutide found in Ozempic and Wegovy. It was approved by the FDA to improve glycemic control in adults with type 2 diabetes in May 2022. Then, in October 2022, Mounjaro received an FDA fast track review to be designated as a treatment for obesity. This means it might be approved for obesity and weight loss in 2023.
Comparing the three drugs for weight loss, Mounjaro appears to show the greatest weight loss. Participants in a Wegovy clinical trial lost, on average, 15% of their body weight. But Mounjaro study participants lost up to 22.5% of their body weight when they consumed the highest dosage.
Is Mounjaro 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.
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. Meanwhile, Medicaid programs vary from state to state, and fewer than 20 state Medicaid programs provide coverage for obesity medications.
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 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 is deemed medically necessary by the insurer, then it usually provides coverage for the medication.
What are Alternative Drugs to Mounjaro 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)
What Should I Do If I Get a Mounjaro 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
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.