In December 2014, Saxenda (liraglutide) was FDA-approved as a treatment for obesity and chronic weight management. Like Ozempic and Wegovy, Saxenda comes from the pharmaceutical company Novo Nordisk. Unfortunately, sometimes health insurers deny claims for Saxenda due to its high cost and because the Affordable Care Act doesn’t require insurers to cover weight loss medications. This page addresses Saxenda health insurance claims. It also covers how insurance companies determine medical necessity. And it discusses what to do after receiving a Saxenda health insurance denial. If you receive a Saxenda health insurance denial, contact the Law Offices of Scott Glovsky.
What is Saxenda?
Saxenda® is an injectable prescription drug prescribed for weight loss and weight maintenance. It is for adults with obesity (BMI ≥ 30) and for adults with excess weight (BMI ≥ 27) who also have weight-related medical problems. These problems can include hypertension, type 2 diabetes, and dyslipidemia. In December 2020, Saxenda was also approved for children aged 12 to 17 with obesity and a body weight above 132 pounds. It is prescribed together with a reduced-calorie diet and increased physical activity.
What is Obesity?
Obesity is a condition with an excessive accumulation of body fat that leads to an unhealthy weight. It’s associated with an increased risk of many health problems such as heart disease, certain cancers, sleep apnea, and type 2 diabetes. Body Mass Index (BMI) is the measure used to determine obesity. BMI is calculated by dividing an individual’s weight in kilograms by the square of their height in meters. A BMI equal to or greater than 30 is considered obese, while a BMI between 25 and 30 is considered overweight.
A large percentage of people in the United States struggle with overweight or obesity. According to the National Institutes of Health and the NHANES Study, 30.7% of American adults are overweight, and 42.4% are obese. Looking at kids, nearly 20% of children between the ages of 2 and 19 are obese. A study published in March 2023 assessed young adults between 20 and 44 years old from 2009 to 2020 and discovered that the prevalence of diabetes rose from 3% to 4.1%, and the occurrence of obesity increased from 32.7% to 40.9%.
What are the Differences Among Saxenda, Wegovy, Ozempic and Mounjaro?
Saxenda, Wegovy, Ozempic, and Mounjaro are all GLP-1 receptor agonists that assist type 2 diabetics and aid in weight loss. Patients are told to take these medications in conjunction with a reduced calorie diet and an increase in physical activity. Although they all contain GLP-1 receptor agonists, there are differences in terms of their formulations, doses, costs, and what they are FDA approved for. Novo Nordisk manufactures Saxenda, Wegovy and Ozempic, with semaglutide as their active ingredient. All medications are subcutaneous injections. Eli Lilly manufactures Mounjaro.
- Administration Frequency: All but Saxenda are weekly injections. Saxenda is a daily injection.
- Dosage: Wegovy has a main dose of 2.4 mg weekly, Ozempic has a primary dose of 2 mg weekly, Mounjaro’s starting dose is 2.5 mg weekly and goes as high as 15 mg weekly. Saxenda’s recommended dose is 3 mg daily.
- FDA-Approval: Wegovy is FDA-approved for obesity and chronic overweight with at least one weight-related health issue. Ozempic is FDA-approved for type 2 diabetes and cardiovascular issues. Saxenda is FDA-approved for obesity and overweight. While Mounjaro was initially FDA-approved in May 2022 to improve glycemic control in adults with type 2 diabetes, it then received a fast-track FDA review for the treatment of obesity in October 2022. Mounjaro’s Phase 3 clinical trial went well and is over, so Mounjaro may be FDA-approved for obesity and weight loss sometime in 2023.
- Cost: Wegovy’s list price is $1,349/package and Ozempic’s list price is $892 for a 2 mg pen. Saxenda’s list price is $1,349/month, and the list price for Mounjaro is $1,023 per pen.
- Formula: All except Monjaro are GLP-1 receptor agonsists. Ozempic and Wegovy contain semaglutide. Sexanda contains liraglutide. And Mounjaro is a dual GIP and GLP-1 receptor agonist with tirzepatide as its active ingredient.
- Weight Loss Efficacy: Mounjaro appears to be the most effective for weight loss. Its clinical trial participants who took the highest dose lost up to 22.5% of their body weight, which is more than the 15% weight loss observed in Wegovy clinical trial participants. Ozempic study participants lost 15%-18% of their body weight. And Saxenda study participants lost either 5% or 10% of their body weight depending on the specific clinical trial.
Even though it is off label, Ozempic is sometimes prescribed for weight loss due to its lower cost than Wegovy, wider availability, and more frequent approval by insurers since it is FDA-approved for diabetes. Of course insurance policies under the Affordable Care Act aren’t mandated to cover obesity drugs or surgeries.
How Do Health Insurance Companies Assess New Treatments and Prescription Medications?
Every health insurance provider has distinct guidelines referred to as a “medical” or “pharmacy” policy. These policies contain internal clinical rules outlining the criteria and circumstances under which specific drugs and treatments are considered “medically necessary.” (Approved medications are found in the company’s formulary.) Health insurance companies monitor new drugs that have been approved by the FDA. Their in-house pharmacists conduct research on the medical literature surrounding these medications. Based on their findings, the pharmacists provide a recommendation on whether the drugs are deemed medically necessary or experimental/investigational.
Health insurance providers often present their internal recommended policies to external physicians for evaluation of their appropriateness. However, since the doctors who assess the policies are frequently compensated by the insurance companies, there is a potential for bias towards approving excessively restrictive policies. Moreover, some of these physicians may want to work for the insurance company in question, providing another incentive to agree with proposed policies. In addition, insurers may be motivated to exclude costly treatments and medications, as they can impact the company’s bottom line.
Frequently, health insurer policies are excessively rigid and may not align with the safety and effectiveness standards set by 3rd party medical specialist organizations for treating medical health conditions. “Generally accepted standards of medical practice” refers to the protocols and guidelines typically followed by physicians in a particular specialty. These standards are established based on reliable scientific evidence published in peer-reviewed medical journals and are generally recognized and accepted by relevant medical groups and other healthcare professionals in the community. It is not uncommon for an insurance company’s policy to differ from what a patient’s doctor deems “medically necessary.”
What is the Difference Between Medically Beneficial and Medically Necessary?
Just because a treatment or prescription drug can treat a particular health condition (i.e., medically beneficial), it may not be considered medically necessary under a specific health insurance policy. For example, some insurers may deem a more expensive and advanced treatment procedure for a symptom unnecessary if a less expensive and less invasive alternative is available.
Health insurance providers regularly utilize “step therapy,” where they deny more expensive medications and approve less costly ones first. In California, patients are required to remain on an approved medication for 60 days before switching to another drug. Although a policyholder can request an exemption in California, there are numerous loopholes in the exemption laws, and enforcement procedures are lacking. Unfortunately, delaying access to the doctor prescribed medication may lead to patient harm. And health insurance companies often use step therapy for complex, debilitating medical conditions such as immune disorders and cancers, since these health conditions necessitate specialty medications that are usually costly.
Medically Necessary vs. Experimental or Investigational
If a medication or treatment is classified as “experimental” or “investigational,” it is not deemed medically necessary by your health insurance company. Even FDA-approved drugs might be classified as experimental by an insurer. And unfortunately, nearly anything may be deemed experimental or investigational for various reasons. An example is that a drug or treatment may be effective for some individuals but not for others. Of course this is true for almost every medication or treatment. Similarly, a medication or treatment may address certain health conditions but not others. As a result, one insurance company may view a drug as medically necessary while another may classify the same medication as experimental or investigational.
Insurance Company Duties When Reviewing Claims
Health insurance companies must abide by state laws when they review claims. First, they must conduct a full and fair investigation and consider all potential reasons to approve the claim. Of course, they must respond to the request quickly and within a set timeframe. Also, insurance companies need to have qualified medical professionals reviewing claims.
Will Insurance Companies Cover Saxenda as a Treatment for Obesity?
Some insurance companies cover Saxenda for obesity. However, coverage varies depending on the specific insurance plan, whether the plan considers Saxenda medically necessary, and a person’s medical condition. Plans that are Affordable Care Act-compliant aren’t required to cover obesity-related medications or surgeries. Traditional Medicare does not cover Saxenda except in an outpatient setting or during an inpatient hospital stay. Medicare Advantage plans may cover Saxenda but it depends on specifics as mentioned above. And Medicaid differs state to state so reaching out to the state is helpful.
Coverage policies differ among major commercial insurance providers such as Health Net, Oscar, Cigna, UnitedHealthcare, Kaiser, Blue Shield, Anthem Blue Cross, and Aetna. Commercial private health insurance plans usually approve Saxenda claims when they consider them medically necessary.
What Can You Do if You Receive a Saxenda Health Insurance Denial?
Of course, an initial step is appealing your denial. It is critical to act quickly. You’ll want to know if your health insurance plan is an ERISA (Employment Retirement Income Security Act of 1974) or non-ERISA. If you are unsure, you can ask your employer’s plan administrator or call your insurance company directly. It is likely that you have an ERISA plan if your health insurance coverage is from your employer. However, there are exceptions to this rule.
Plans from government employers, religious organizations, business plans that only cover the business owner and his/her family, and many individual and family plans purchased through Covered California or directly from commercial insurers such as Blue Shield and Anthem Blue Cross are not covered by ERISA. Also, most plans for Native American tribes or entities are not ERISA plans.
We recommend speaking with a lawyer who focuses on healthcare denials before you submit an appeal – regardless of the type of plan you have. The reason is that this attorney can provide tips on the best path to follow. As we explain here, you have more limited options with an ERISA plan than with a non-ERISA plan. If you have a non-ERISA plan, you have several options, and you should understand why your claim was denied before acting. Find out more about non-ERISA steps here.
Contact the Law Offices of Scott Glovsky if you Receive a Saxenda Health Insurance Denial
Our firm has represented insurance policyholders, injured consumers, and victims of wrongful business practices for over twenty years. We are well known and respected for litigating health insurance bad faith and health insurance denial cases. We also work on catastrophic personal injury, sexual abuse, and other consumer-related cases. Contact us, we get justice for our clients and hold those responsible accountable.