Have You Or a Loved one received a Wegovy Health Insurance Denial? We Can Help.
Wegovy is a medication for obese and chronically overweight individuals. Approved by the FDA in June 2021, both adults and children over the age of 12 take the medication. Oftentimes health insurers deny Wegovy. Not only is it expensive, but the Affordable Care Act doesn’t require insurers to cover obesity medications. This page provides an overview of Wegovy and health insurance claims. We cover how health insurers evaluate Wegovy’s medical necessity. And we give you information on what to do if you receive a Wegovy health insurance denial. If you receive a Wegovy health insurance denial, contact the Law Offices of Scott Glovsky. We understand how insurers operate and have been helping policyholders overturn denied claims for over two decades.
What is Wegovy?
Wegovy, containing semaglutide, is a medication for weight management typically given to obese or chronically overweight patients with at least one weight-related condition. These conditions include type 2 diabetes, high blood pressure and high cholesterol. Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist that works by increasing the release of insulin and decreasing the release of glucagon. Doing so helps regulate glucose levels and reduce food intake. In other words, Wegovy reduces hunger and increases feelings of fullness, which leads to decreased food intake and ultimately weight loss. Like other weight management drugs, Wegovy should be combined with a reduced calorie diet and increased physical activity. Sometimes Wegovy is given to people who cannot lose weight through diet and exercise alone.
In a clinical trial, participants taking Wegovy over a 68-week period lost, on average, 15% of their body weight. In addition to Wegovy, these participants also exercised more and ate fewer calories.
By promoting weight loss, Wegovy may improve overall health, increase energy levels, and improve quality of life. It may also help improve obesity-related health conditions like high blood pressure, heart disease, and sleep apnea. In fact, on August 8, 2023, the drug’s manufacturer released results from its double-blind, placebo-controlled SELECT trial with 17, 604 overweight or obese participants 45+ years old without diabetes and with established cardiovascular disease. Results showed that individuals on 2.4 mg of Wegovy (semaglutide) had a 20% reduction in major adverse cardiovascular events (MACE) including heart attack, stroke and death compared to participants on a placebo. Results of this study were published on November 11, 2023 in the New England Journal of Medicine.
Wegovy is manufactured by Novo Nordisk. The same pharmaceutical company makes Ozempic. Ozempic also contains semaglutide, but it is not FDA approved for weight loss. (It is FDA approved for type 2 diabetes.) That said, doctors sometimes prescribe Ozempic off-label for weight loss.
But at $1,349 per month in the United States, Wegovy is expensive. Of course, a person’s cost depends on several factors including potential insurance coverage and dose. And Wegovy costs less in certain countries. An August 2023 study revealed that Wegovy’s monthly cost was $296 in the Netherlands and $328 in Germany.
What is Obesity?
Obesity is a chronic condition characterized by excessive accumulation of body fat, resulting in an unhealthy weight. It increases the risk of certain health problems including heart disease, type 2 diabetes, sleep apnea and certain cancers. Obesity is determined by Body Mass Index (BMI), which is calculated by dividing an individual’s weight in kilograms by the square of their height in meters. A BMI greater than or equal to 30 is considered obese. (A BMI 25 ≤ 30 is overweight.)
Unfortunately, many Americans are overweight or obese. 30.7% of American adults are overweight and 42% are obese. And almost 20% of kids 2 to 19 are obese. And a study published in March 2023 that evaluated young adults aged 20 to 44 from 2009 to 2020 found that the prevalence of diabetes increased from 3% to 4.1% and the incidence of obesity grew from 32.7% to 40.9%. Nearly 1 in 2 American adults are expected to be obese by 2030.
Who Can Take Wegovy?
Wegovy is approved for use in adults with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with at least one weight-related health condition such as high blood pressure or type 2 diabetes. The medication is also approved for children 12 and older with a BMI at or greater than the 95th percentile standardized for age and sex.
How is Wegovy Administered?
Wegovy is an injection administered under the skin once a week. It is usually given in the abdomen, thigh, or upper arm. The FDA approved dose is 2.4 mg, and Wegovy comes in 5 different doses – 0.25 mg, .50 mg, 1 mg, 1.7 mg, and 2.4 mg. A specific dose may vary depending on a patient’s needs and response to treatment. And doctors often start patients on lower doses.
Is There Also a Wegovy Tablet?
In May 2023, Novo Nordisk announced the results of its “OASIS 1” phase 3a clinical trial evaluating a daily 50 mg oral tablet of semaglutide, the active ingredient in Wegovy. Clinical trial participants included 667 obese or overweight (with at least one comorbidity) adults. The study ran for 68 weeks and compared semaglutide to a placebo. Like weekly Wegovy injections sold today, participants also ate a reduced calorie diet and increased their physical activity. Participants given semaglutide dropped 15.1% of their weight compared to those given placebo who lost 2.4% of their weight. 84.9% of those on semaglutide lost 5% or more of their weight.
With positive results, the company expects to apply for both FDA and EU regulatory approval in 2023.
Is There a Generic Version of Wegovy?
There is not a generic version of Wegovy, or its active ingredient semaglutide. In fact, on October 1, 2023, a federal judge rejected the generic drug manufacturer Mylan’s challenge to two of Novo Nordisk’s patents.
In October 2023, the FDA sent letters to two online companies to cease selling unapproved semaglutide, the active ingredient in Wegovy. The letters claimed that “unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.” They also claimed the sellers had violated the law by selling these products without licensed healthcare practitioner prescriptions.
In November 2023, Novo Nordisk filed a lawsuit against Wells Pharmacy and refiled its lawsuit against Brooksville Pharmaceuticals, both compounding pharmacies, alleging their semaglutide products were impure. Novo Nordisk tested and found that products from Wells contained the ingredient BPC-157, an ingredient that the FDA banned because it may cause dangerous immune system issues. As of November 2023, Novo Nordisk has filed at least twelve lawsuits against compounding pharmacies, weight-loss clinics and spas that sell products claiming to contain semaglutide.
Another problem is counterfeit Wegovy and similar GLP-1 prescription drugs. Unlike the majority of fake prescription drugs that are sold in poor nations, expensive GLP-1 counterfeit drugs are usually sold in wealthy nations in the Middle East, the United States, and Europe.
How Does Wegovy Compare With Ozempic, Saxenda, Mounjaro and Zepbound?
All these medications help type 2 diabetics and include GLP-1 receptor agonist. The differences include what they were FDA-approved for, their formulations, their doses, their costs, and more.
Wegovy and Ozempic
Novo Nordisk manufactures both Wegovy and Ozempic. Both medications are glucagon-like peptide-1 (GLP-1) receptor agonist weekly injections with semaglutide as their active ingredient. While Wegovy’s main dose is 2.4 mg weekly, Ozempic’s primary dose is 2 mg weekly. In terms of cost, in 2023, Wegovy’s list price is $1,349/package and Ozempic’s list price is $892 for a 2 mg pen. Wegovy was FDA-approved in 2021 for obesity and chronic overweight with at least one weight-related health issue such as type 2 diabetes or high blood pressure. And in 2017, Ozempic received FDA-approval for type 2 diabetes and to help with cardiovascular issues.
It’s interesting to note that both Wegovy and Ozempic at a low dosage have diabetes and cardiovascular benefits. Manufacturer Novo Nordisk ceased its FLOW clinical trial early on October 11, 2023 because at just 1 mg of semaglutide (the active ingredient in both Wegovy and Ozempic), the study already met its primary endpoint of delaying renal function decline at ≥ fifty percent and decreasing the risk of cardiovascular and CKD-associated mortality.
Can Ozempic Be Substituted for Wegovy and Vice Versa?
Although they share the same active ingredient, Ozempic is sometimes prescribed instead of Wegovy for weight loss because it is cheaper, more widely available, and more often approved by insurers because it is FDA-approved for diabetes. And health insurance policies under the Affordable Care Act aren’t required to cover obesity drugs or surgeries. That said, they have different doses and are FDA-approved for different conditions.
Saxenda
Saxenda is also made by Novo Nordisk and includes liraglutide as its active ingredient. It’s a daily injection with a recommended dose of 3 mg. Saxenda’s list price is $1,349 each month. Saxenda was FDA-approved in 2014 for adults with obesity and overweight and in 2020 for children 12-17 with obesity and overweight.
Mounjaro and Zepbound
Mounjaro and Zepbound (tirzepatide), on the other hand, have a different active ingredient. Unlike Ozempic and Wegovy that include the active semaglutide, Mounjaro and Zepbound contain the active tirzepatide. Mounjaro and Zepbound are the first and only dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. Mounjaro received FDA-approval in May 2022 to improve glycemic control in adults with type 2 diabetes. Zepbound received FDA-approval for obesity and weight loss with a comorbidity in November 2023.
Weight Loss
When it comes to weight loss, Mounjaro and Zepbound have the edge. (These two share a formula.) While Wegovy clinical trial participants lost, on average, 15% of their body weight, individuals in the Mounjaro/Zepbound clinical trial who took the highest dose lost up to 22.5% of their body weight. Ozempic study participants lost 15-18% of their body weight, and Saxenda participants lost 5% or 10% depending on the particular clinical study.
Is Retatrutide More Effective For Weight Loss Than Wegovy, Mounjaro and Zepbound?
In published clinical trials, Retatrutide is more effective than other similar GLP-1 prescription medications for weight loss. Learn about the medication, its differences from other obesity and diabetes medications, and the most recent clinical trial here. Retatrutide likely won’t be available soon because it is currently being studied in a Phase 3 clinical trial that won’t end until 2025 or 2026.
Do Insurance Companies Cover Wegovy?
Health insurance coverage for Wegovy varies across insurers and disease types. The Affordable Care Act does not mandate health insurers to cover obesity-related surgeries or medications. And Wegovy is not approved to treat diabetes. Medicare (federal health insurance for adults 65+) does not cover medications for obesity. That said, certain Medigap and Medicare Advantage plans for retired individuals do cover Wegovy. The VA covers some drugs for obesity. Medicaid coverage is state-specific so you can check your state’s plan. Less than 20 state Medicaid programs cover weight loss and obesity drugs. As of May 2023, these states include Rhode Island, Delaware, California, Michigan, New Hampshire, Minnesota, Pennsylvania, Virginia, Kansas and Wisconsin. And states offering limited coverage of weight management and obesity medications include New Mexico, South Carolina, Louisiana, Tennessee, New Jersey and Georgia.
As more people take Wegovy and achieve positive results, it is possible that Medicare might cover this drug for obesity in the future. Why? Because obesity causes many other health problems and thus increases medical costs. In fact, it’s estimated that Medicare might save $176 billion over ten years due to fewer surgeries, hospitalizations, physician visits and other medical procedures. As mentioned above, Wegovy has been proven to reduce the incidence of major heart issues such as heart attack and death in non-diabetics with heart disease. And in states like California, there have been multiple instances in which independent medical reviews overturned health insurer obesity medication denials. Given that as of Oct. 2023 there are 70+ new weight management/obesity drugs in development, prices should fall due to increased competition from new medications.
Coverage policies differ among major commercial insurance providers such as Cigna, Blue Shield, Kaiser, Anthem Blue Cross, Aetna, UnitedHealthcare, Oscar, and Health Net. Their coverage depends on several factors, including the specific insurance policy, medical necessity determination, and individual health circumstances. Commercial private health insurance companies typically approve Wegovy claims when they deem them medically necessary. That said, as media outlets like 60 Minutes reveal, getting approval can be difficult even when many alternatives failed. In November 2023, the Vice President of North America Sales for Wegovy’s manufacturer Novo Nordisk claimed that most major Pharmacy Benefit Managers and health insurance companies cover Wegovy. Novo Nordisk reports that as of September 2023, about 50 million Americans have access to Wegovy through their health insurance plans. This 50 million is broken out as approximately 38 million individuals with commercial insurance coverage and about 12 million people on Medicaid.
Do Employers Cover Wegovy?
Many large employers offer self-funded plans. In these plans, employers pay for medical care for their employees. Self-funded companies often utilize a commercial health insurance company as their third party administrators. In other words, the TPAs handle the coverage, claims, authorizations, and so on. How does this make a difference for employees? Here, employers may participate in coverage decisions and can override TPA decisions. A survey of 502 employers published in October 2023 found that 43% of employers may cover GLP-1 medications like Wegovy in 2024 versus 25% that cover these drugs now.
Is Wegovy Expensive For Insurance Companies and Pharmacy Benefit Managers?
Patients pay drug list prices without insurance or a percentage of list prices with health insurance. But health insurance companies don’t pay list prices. Why? Because of gross-to-net (GTN) prescription prices and Pharmacy Benefit Managers (PBM). Gross-to-net is the percentage of a medication’s list price that a PBM pays. This net amount combines discounts, returns and rebates.
Pharmacy Benefit Managers are agents that manage drug benefits for health insurers, Medicare Part D drug insurance plans, and some companies and pharmacies. PBMs dictate formularies and drug costs for health insurance companies (and policyholders) as well as the amount that pharmacies get paid for medications. The biggest three Pharmacy Benefit Managers are owned by corporations that also own health insurance companies. Combined, Express Scripts (Cigna), OptumRx (UnitedHealthcare) and Caremark (Aetna) administer drug benefits for 260 million individuals in the United States.
A September 2023 study looked at four quarters (Q2 2022 to Q3 2023) and projected that Wegovy’s average monthly net price was a 48% discount off of its list price of $1,349. This means that while policyholders paid their cost sharing amount based on $1,349, Wegovy’s manufacturer received approximately $701 and PBMs paid somewhere between $1,349 and $700, or +/- $648. Of course, sometimes drug makers offer patient coupons and in the case of Wegovy, monthly coupons ranged from $225 for policyholders with coverage for Wegovy to $500 for both policyholders without coverage for Wegovy and patients who had no coverage and paid in cash.
There are two key points. First, health insurers paid much less than Wegovy’s list price. And second, because many of their related PBMs (owned by the same company as the insurers) earned profits from Wegovy, as of Q3 2023, these parent companies did not experience a negative impact on their profits (in part) by covering Wegovy. In other words, the cost to one part of the parent company was offset by profits in another part.
Is Wegovy Considered Medically Necessary or Medically Beneficial?
A prior authorization is usually required prior to covering Wegovy. This means that the insurer deems the drug medically necessary for the patient’s condition. However, the process of obtaining prior authorization can be challenging, depending on the insurer’s requirements.
If the insurer doesn’t consider Wegovy medically necessary, it will likely deny coverage for the medication. Although the drug may have medical benefits and be medically beneficial, this doesn’t necessarily mean the insurer considers it medically necessary. In fact, oftentimes insurers want policyholders to try less expensive options first.
Insurers frequently require step therapy when alternative drugs are available. This type of prior authorization requires patients to try a less expensive or generic drug before being allowed to access the prescribed drug. In most cases, a 60-day trial is required before the necessity of the preferred drug is re-evaluated. Because Wegovy is an expensive option, insurance companies may require step therapy for claim approval. Unfortunately, this process can be detrimental to patient health, as the trial of alternative drugs can prolong the symptoms being treated. Without prior authorization, patients may be unable to access the drugs prescribed by their doctors.
How Do Insurance Companies Assess Wegovy Coverage Requests?
Health insurers evaluate coverage requests based on internal pharmacy or medical policies. Upon FDA approval of drugs such as Wegovy, health insurance companies conduct research to establish clinical policies that govern medical necessity decisions. These policies are reviewed and evaluated by a group of external physicians, however, their judgment may be influenced by external factors such as financial incentives or the possibility of working for the insurance company. This can result in the approval of excessively strict internal policies.
Health insurance providers assess claims by determining if a drug is deemed medically necessary or considered experimental or investigational. Rigid policies can lead to discrepancies between what healthcare providers view as necessary and what insurance companies deem so. Medical professionals base their treatment decisions on peer-reviewed literature and personal experience, which often highlight safe and effective options for various patient circumstances. These peer-reviewed sources draw from scientific evidence and research to inform their findings.
Is Wegovy Considered Medically Necessary?
Health insurance providers assess the medical necessity of drugs such as Wegovy. If deemed not medically necessary, it’s referred to as experimental or investigational. There can be several reasons for this classification, including internal policy definitions, inconclusive evidence of its effectiveness, lack of FDA approval, the availability of alternate drugs that are safe and effective, or the drug’s inability to enhance health outcomes.
There can be inconsistencies in how health insurance companies categorize drugs, with one considering a medication medically necessary, while another deeming it experimental or investigational. The criteria used to classify drugs can differ among insurers and are subject to interpretation. Variations in patient responses to the same drug also impact the claims approval process. These decisions are dependent on the specific language outlined in the contract, which can be subjective, leading to complexities.
What Duties Does Your Insurance Company Have When It Receives Policyholder Claims?
Your insurance company must review your submitted claims and approve or deny them. In making its decision, it must thoroughly investigate each claim. Part of its investigation includes researching all possible reasons why the medication or treatment could be medically necessary. Of course, it must respond to each claim promptly and have qualified medical authorities review each claim.
What Can You Do If You Receive a Wegovy Health Insurance Denial?
You can appeal the Wegovy health insurance denial. Before you do, however, understand if you have an ERISA or non-ERISA plan. Why? Because the path you follow may be different based on your plan type. What is ERISA? ERISA is the Employment Retirement Income Security Act of 1974. Many people aren’t sure what type of plan they have. You can ask your health insurance plan administrator or you can call your health insurer directly.
A general rule of thumb is that private employers usually have ERISA insurance plans. The following are exceptions to this rule of thumb:
- government employers since they aren’t private
- religious organizations such as mosques, churches and synagogues
- business plans that only insure business owners and their families
- family and individual plans obtained from Covered California
- family and individual plans bought directly from private insurance companies like Anthem Blue Cross or Blue Shield of California
- many plans for Native American entities or tribes
If your plan falls under ERISA, file an appeal since your options are more limited. Speaking with an experienced health insurance lawyer before filing is helpful. Discover more about the appeals process for ERISA policies here. If your plan does not fall under ERISA, you have more options. First, know why your claim was denied. Non-ERISA plan members can learn more here.
Contact Our Offices if You Receive A Wegovy Health Insurance Denial
For over 20 years, the Law Offices of Scott Glovsky has been a champion for individuals who have suffered injuries or been subjected to unjust business practices. With a focus on health insurance bad faith, catastrophic personal injury, sexual abuse, and consumer-related legal issues, our firm gets justice for our clients and holds those responsible accountable for their actions.