Mounjaro (Zepbound) Health Insurance Denial

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 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. And as of the end of 2023, Mounjaro accounted for 27% of all U.S. prescriptions for injectable incretins (medicines that modulate the hormones that control the production of insulin).

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.” By the end of December 2023, doctors wrote a total of 25,000 new Zepbound prescriptions every week.

What Are Other Health Benefits of Moujaro and Zepbound?

On April 17, 2024, Eli Lilly announced that the active ingredient in both products, tirzepatide, in both 10 and 15 mg dosages, reduced sleep apnea severity by 63% (approximately 30 less events in which a participant’s breathing revealed a restricted or 100 percent blockage of airflow per hour of sleep) in obese adults with obstructive sleep apnea (OSA). Findings were based on initial results from the SURMOUNT-OSA phase 3 clinical trial.

Tirzepatide is also being studied to determine if it can treat nonalcoholic fatty liver disease and other chronic illnesses. In fact, on June 8, 2024, Eli Lilly publicized detailed positive results from the SYNERGY-NASH Phase 2 clinical study published in the New England Journal of Medicine. The study included 190 patients with or without diabetes who had MASH and stage 2 or 3 fibrosis. It found that at 52 weeks, 51.8% (taking 5 mg), 62.8% (taking 10 mg) and 73.3% (taking 15 mg) achieved the absence of MASH without a worsening of fibrosis on liver histology compared to 13.2% of those taking placebo. The study met its primary endpoint. (Note that NASH and MASH refer to the same health condition.)

On August 20, 2024, Eli Lilly shared three year topline results from the SURMOUNT-1 Phase 3 clinical study with pre-diabetic overweight or obese individuals. Study participants had a 94% reduced risk of developing type 2 diabetes after 176 weeks on and 17 weeks off terzepatide, the active ingredient in these medications. In addition, those who took 15 mg weekly lost 22.9% on average of their body weight.

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. National Institutes of Health (NIH) named obesity a disease in 1998, the American Obesity Society called obesity a disease in 2008, and then in June 2013, and the American Medical Association (AMA) voted to acknowledge obesity as a disease requiring treatment and prevention. 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. Note below that as of August 27, 2024, Zepbound is also available in single-dose vials in 2.5 mg and 5 mg doses to certain patients.

How Much Does Mounjaro Cost?

Mounjaro is an expensive medication. When prescribed for type 2 diabetes, as of 2024, a 28-day supply lists for $1,069.08. 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 launched at the end of 2023 with an auto-injector list price of $1,059.87 per month in the United States. This list price was about 20% lower than the list price of Wegovy. Eli Lilly set this price after communications with employers. Similar to Mounjaro, Eli Lilly offers a savings card for certain commercially insured individuals. 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.

A four week supply of Zepbound single-dose 2.5 mg vial lists for $399 and a four-week supply of Zepbound single-dose 5 mg vial lists for $549. These prices are in line with the savings card prices of the auto-injector pens. The vials must be purchased directly from LillyDirect. Selling direct and removing third parties like Pharmacy Benefit Managers facilitates lower price points. And paying out of pocket means that people who aren’t eligible for the savings card (i.e., those on Medicare) can more easily access the medication.

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. In February 2024, the FDA sent warning letters to two online firms US Chem Labs and Synthetix, Inc. (doing business as Helix Chemical Supply) for selling unapproved and misbranded semaglutide and tirzepatide products with claims including “reducing the risk of heart attack, stroke, weight loss and treatment of Alzheimer’s disease.” The FDA letters give the firms 15 days to respond.

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.

On June 20, 2024, Eli Lilly issued a new warning about counterfeit and compounded tirzepatide and announced six lawsuits against firms selling products that claim to contain tirzepatide. The lawsuits were filed in Ohio, Texas, Hawaii and Washington D.C.

Can My Doctor Prescribe Zepbound Now?

As of December 5, 2023, Zepbound was available at pharmacies. In fact, in the week of March 8, 2024, there were more new Zepbound prescriptions filled (77,590) in the United States than Wegovy prescriptions (which were about 6,000 less).

Can I Order Zepbound and M0unjaro Directly From Eli Lilly?

On January 4, 2024, Eli Lilly launched the direct-to-consumer service “LillyDirect” in which patients can find providers and order diabetes, migraine and obesity medications like Zepbound directly from Eli Lilly. This website connects patients with both in-person and telehealth providers and offers pharmacy services through a variety of pharmacies. The website also ensures that coupons that bring the cost of Zepbound down to $550 per month are applied. You can visit the LillyDirect to lean more about this service. On March 14, 2024, Amazon Pharmacy announced it’s a third party dispensing option for LilyDirect Pharmacy Solutions. Patients can order not only Zepbound, but also other prescription medications including insulin brands like Humalog and basaglar as well as medication for migraines like emgality. Amazon Pharmacy already fulfills Mounjaro prescriptions.

Zepbound Now Available In Single-Dose Vials

On August 27, 2024, Eli Lilly announced that 2.5 mg and 5 mg doses of Zepbound are also available in single-dose vials to patients who pay for the medication out-of-pocket. The Zepbound vials are sold at a significantly less expensive price point (see above). The vials are sold through LillyDirect to patients with on-label prescriptions.

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 April 2024, the list price for Ozempic was $968.52 per month and the list price for Wegovy was $1,349 per month. Also in April 2024, 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 was $1,069 as of April 2024 and the list price of Zepbound as of April 2024 was $1,059.87.

Efficacy

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.

As of December 5, 2023, Zepbound was on the United States list of preferred medicines for reimbursement at Cigna owned pharmacy benefit manager Express Scripts and is now on Cigna’s commercial formularies. The large pharmacy benefit manager Caremark, owned by CVS Health, is reviewing Zepbound to determine if it will be included in its formularies.

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 that Medicare might cover GLP-1 medications in the future is possible savings. Obesity drives up general medical costs because it leads to additional health concerns. The USC Schaeffer Center for Health Policy & Economics 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. This same whitepaper projected almost $1 trillion, or $100 billion annually, in social benefits over the next decade. In February 2024, Goldman Sachs estimated that these medications could increase United States GDP by 1% (assuming 60 million users) in future years. The reason is that reduced obesity-related employee issues will probably increase employee efficiency. GlobalData estimated in a February 2024 report that overweight and obesity likely led to $425.5 billion of economic costs to employees and employers in 2023. 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. As of July 2023, sixteen Medicaid programs pay for at least one weight loss or anti-obesity medication. These states include California (where Medicaid is called, “Medi-Cal“), Hawaii, Kansas, Texas, Louisiana, Mississippi, Minnesota, Wisconsin, Michigan, Pennsylvania, Delaware, Maine, New Hampshire, Rhode Island, South Carolina and Virginia.

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 2023 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.

In terms of pricing, in March 2024 Cigna announced that for employers and health insurers who participate in its PBM Express Script’s weight management program EncirleRx, future price increases of GLP-1 medications like Zepbound would not exceed 15%.

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) – In a class of drugs called, “lipase inhibitors,” it helps prevent some fat from being absorbed into the body.
• Phentermine (brand name: Adipex-P, Lomaira) – Taken for up to 12 weeks to help patients feel less hungry.
• Phentermine-topiramate  (brand name: Qsymia) – Taken orally, this medication helps to decrease appetite and supports feeling full for longer.
• Liraglutide (brand name: Saxenda) – A daily injectable from Novo Nordisk, maker of Ozempic and Wegovy.
• Naltrexone-bupropion (brand name: Contrave) – An oral medication to help control cravings and reduce hunger.
• Setmelanotide (brand name: Imcivree) – This injectable drug aids individuals with inherited health conditions to burn more calories and reduce appetite.

Will Other Weight Loss Medications Enter the Market?

Many pharmaceutical companies are clinically studying obesity and weight loss drugs today. In fact, GLP-1 drugs like Wegovy and Mounjaro are estimated to be a $100 billion market with as many as 30 million overweight or obese users in the United States by the year 2030. Interestingly, in 2024, GLP-1 drugs are predicted to exceed cancer immunotherapies as the best-selling prescription drugs in the world. And Mounjaro, with estimated annual sales of $33.4 billion in 2029, is projected to be the best-selling GLP-1 drug in this year. As of 2023, 124 medications were in clinical trials for obesity. Some medications in development include the following:

• Amgen’s maridebart cafraglutide, AKA MariTide, is not expected to be available in the market until 2026. Early-stage results from a Phase 1 clinical study found this monthly injection to be highly effective, both during and after taking the medication. In this study, trial participants lost up to 14.5% of their body weight while on the drug. And participants kept lost weight off for up to 150 days after ceasing the medication. Phase 2 data is expected in late 2024.
• Pemvidutide from Altimmune, Inc. is a glucan/peptide-based GLP-1 dual receptor agonist in clinical studies for NASH (noncirrhotic non-alcoholic steatohepatitis) and obesity. The Phase 2 clinical revealed a mean weight loss of 6% at 48 weeks on the highest dose of 2.4 mg. Because of promising results, in October 2023 the FDA gave Pemvidutide a fast track designation for NASH. (It’s interesting to note that the one FDA-approved drug for NASH is Rezdiffra. This drug received accelerated approval on March 14, 2024 for adults with NASH and moderate to advanced liver scarring, to be used in conjunction with exercise and diet.)
• The Lancet published Phase 2 clinical results of Novo Nordisk’s weekly injection CagriSema. This drug is a combination of the medications semaglutide and cagrilintide. Semaglutide is a GLP-1 receptor agonist and cagrilintide enhances feeling full after eating. Phase 2 trial participants lost an average of 15% of their body weight after taking the drug for 32 weeks. Phase 3 is expected to end in October 2026 with data readings in late 2024 or early 2025.
• Viking Therapeutics’ weekly injection VK2735 is a dual agonist like Zepbound that targets both GLP-1 and GIP. Less than 200 study participants in a Phase 2 clinical trial lost an average of 14.7% (13.1 percent when placebo adjusted) of their body weight after 13 weeks. Although it had higher weight loss after 72 weeks, Zepbound had similar results (seven to eight percent of body weight) to VK2735 at 13 weeks. And Eli Lilly’s Retatrutide had similar results at 13 weeks. Unlike some other GLP-1’s with side effects, VK2735 was tolerable and the placebo group had higher dropout rates than the active group. Viking is working on an oral form of this medication and is planning a Phase 3 trial.
• Survoductide, a glucagon/GLP-1 receptor dual agonist from Boehringer Ingelheim and Zealand Pharma, showed positive results in its Phase 2 clinical trial and is now in five Phase 3 clinical trials. In Phase 2, as much as 83.0% of adults achieved a statistically significant improvement in MASH (metabolic dysfunction-associated steatohepatitis). Phase 2 results showed as much as 19% weight loss after 46 weeks in overweight or obese individuals. Phase 3 readings expected in late 2025.
• Participants in Novo Nordisk’s once-a-day pill amycretin Phase 1 trial lost 13.1 % of their body weight in twelve weeks. This drug stimulates GLP-1 and amylin and impacts both blood sugar and appetite. Amycretin’s Phase 2 clinical trial is set to start in the second part of 2024 and to conclude in the first part of 2026.
• Through its purchase of Carmot, Roche is expected to join the weight loss category. Carmot is in the middle of three clinical trials in 2024 (CT-388 is a weekly injectable GLP-1, CT-996 is an oral GLP-1, and CT-868 is a GLP-1/GIP agonist). Early CT-388 Phase 1 results showed an 18.8 percent weight reduction over twenty four weeks.

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.

Another biotechnology startup, BioAge Labs, raised funds in February 2024 for a Phase 2 study to test incretin medications like Zepbound and Wegovy with its experimental pill azelaprag, an apelin receptor agonist that helps maintain muscle mass. The Phase 2 clinical, set to begin mid-2024, aims to show that azelaprag in combination with an incretin like Zepbound will both increase weight loss and improve body composition by promoting muscle metabolism, increasing energy expenditure, and preventing muscle atrophy. In fact, at the preclinical stage, BioAge revealed that its pill doubled weight loss of incretin drugs with enhanced body composition and muscle function.

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.

If You Receive a Mounjaro Denial or a Zepbound Denial, Make Sure You Understand Your Health Insurance Policy’s Formulary and Criteria for Coverage

If you are denied coverage of Mounjaro or Zepbound, your health insurance company is required to put the the reason for it’s denial in writing. Sometimes this reason includes information about its formulary and what is called it’s “criteria for coverage.” Unfortunately, sometimes your insurance company doesn’t share its criteria.

• Formulary: The formulary is a list of medications that your health insurance company covers for your specific plan. Formularies usually have different tiers that represent your percentage of the cost to get the drug. And formularies change often – sometimes every month. If the medication is not in your health insurance policy’s formulary, you oftentimes can request the drug anyhow. For example, in California, your doctor can complete a “Prescription Drug Prior Authorization Or Step Therapy Exception Request Form” asking your insurance company to cover this medication.
• Criteria for Coverage: The criteria for coverage is your insurance company’s requirement for a policyholder to receive this medication. For weight management medications, sometimes insurance companies require a policyholder to have tried alternate methods to lose weight. In California, for example, one insurance company requires that a policyholder has been on a doctor-supervised weight loss program including exercise and nutrition for at least 6 months. Other insurers have criteria including an individual’s BMI must be greater than a number such as 35 or 40, and a person must try a different drug first (AKA step therapy) such as Metformin prior to Mounjaro. You need to understand this criteria to know if you are eligible to receive this medication.

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.