Glucagon-Like Peptide-1 agonist medications, more commonly known as ‘GLP-1s’, are a class of drugs that are typically used to manage type 2 diabetes mellitus (T2DM), but have recently become a method for obesity management. Although these drugs offer significant benefits for blood sugar control and weight management, appropriate patient selection is crucial and necessary to ensure they are used safely. Both appropriate and potentially inappropriate uses of these products have risen steadily over the past few years – at a wholesale cost of nearly $1,200 per prescription or ~$15,000 annually, costs can rise very quickly for both the utilizer and their health plan. Read on to learn more about GLP-1 medications and how they should be utilized most effectively.
What are GLP-1 medications?
Since the first FDA approval of a GLP-1 in 2005, several variations of these products have been released, including weekly-dosed versions, injectables, orals, etc.. These medications mimic the action of the natural hormone GLP-1, which is involved in regulating blood sugar levels and appetite. Common examples include semaglutide, liraglutide, and dulaglutide. These drugs can be administered through an oral tablet, or more commonly, a subcutaneous injection. Most recently, an oral formulation was approved for weight loss. These drugs have become increasingly popular over the past several years due to their high efficacy in managing sugar levels and A1c in patients with T2DM, as well as their ability to help overweight individuals lose weight.[1]
How do GLP-1 medications work?
GLP-1 medications work by stimulating the release of insulin in response to high blood sugar, suppressing glucagon release, and slowing gastric emptying. When insulin is released, sugar is absorbed from the bloodstream to be used as energy. Glucagon does the opposite, pulling sugar out of cells and into the blood when necessary. Gastric emptying is another way of saying ‘stomach emptying’- slowing this process helps people feel full faster, for longer, reducing total food intake. For patients who are utilizing the medication for T2DM, these processes help lead to better A1c results and blood sugar control over time. For patients who are utilizing the medication for weight loss, the primary benefit is the slowing of gastric emptying. This process helps reduce the number of calories consumed, and in turn, the body uses fat and muscle tissue as its fuel instead.
Further, while studies are still ongoing, GLP-1 products are also thought to have benefits for sleep apnea, cardiovascular events (like heart attack and stroke), Type 1 Diabetes, and more.1
Who should utilize GLP-1 medications?
GLP-1 medications are recommended for adults with T2DM who have not achieved their target blood sugar control with oral medications, like metformin, especially those who are overweight, obese, or have other chronic health conditions. They may also be considered for individuals seeking weight loss solutions under medical supervision.
When used for weight loss, they should be used in conjunction with a diet and exercise program, along with behavioral modification programs. While these medications have been advertised as a ‘magic bullet’ for weight loss, the individual utilizing them still needs to put in a great amount of effort in order to successfully lose weight.1
Are GLP-1 medications safe, and what are the risks?
Safety is of utmost importance when prescribing GLP-1 medications. While these drugs have very good efficacy when utilized appropriately, there are still side effects and risks associated with them.
Prior to prescribing, the healthcare provider should do a thorough patient assessment to determine if a GLP-1 medication is appropriate for each individual patient. Per the approved FDA labeling information, individuals must be diagnosed with type 2 diabetes mellitus or be considered ‘obese’, with a body mass index (BMI) above certain thresholds.
Common adverse effects include gastrointestinal symptoms, like nausea, vomiting, and diarrhea, but rare risks such as pancreatitis or thyroid tumors have been reported. For oral formulations, the gastrointestinal side effects are more pronounced. This commonly results in the person utilizing the medication to either switch to an injectable variation or discontinue the product completely. Extended-use side effects are still being determined, but muscle wasting (or muscle loss), mental health concerns, and vision issues have been marked as key long-term side effects. It is also important to note that non-commercially available GLP-1 products have not been proven to be safe and efficacious for their marketed uses.3,4
What controls should be in place for GLP-1 medications?
There are a few things that should be considered prior to the prescription of these medications. First off, GLP-1 products for diabetes are generally covered by all plans in the market, as they are an essential treatment for the condition. With that said, several states consider GLP-1 products for obesity ‘cosmetic’ products, not maintenance, nor ‘essential health benefit’ products. If this is the case, the plan will likely exclude the patient from coverage unless the plan sponsor (the school or university, in this case) requests an exception. This will generally raise the premium paid by all students who join the plan.
Beyond inclusion of coverage by the plan, all GLP-1 products will likely have some sort of prior authorization, quantity limit, or step therapy (or a mixture of the three) attached to them. Wellfleet requires prior authorization for both diabetic GLP-1s and weight loss GLP-1s. The prior authorization requires documentation of the diagnosis, which may include an A1c level, fasting glucose, BMI, etc.
Since instituting these documentation requirements, we have observed an improvement in preventing inappropriate approvals for these medications, ensuring that students are using the products safely, appropriately, and as recommended by the FDA. Further, the prescription requirements for appropriate use have resulted in significant student plan cost decrease, allowing schools and students to save more on Wellfleet health plans.
What does all this mean?
GLP-1 products are highly effective medications for both type 2 diabetes and obesity. While they work very well, caution needs to be taken to ensure that they are utilized appropriately.
As stated above, they are not a ‘magic bullet’– lifestyle changes, including diet and exercise, need to be included in the overall regimen for each patient to ensure the outcomes are optimized.
Further, appropriate controls should be in place through each health plan to ensure that the individuals that need these medications have access to them, and more appropriate options are considered for others.
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Resources
1 Cleveland Clinic. (2023, July 3).GLP-1 Agonists: What They Are, How They Work & Side Effects. Retrieved from, https://my.clevelandclinic.org/health/treatments/13901-glp-1-agonists.
2 Healthline. (n.d.) A Guide for Deciding If GLP-1s Are Right for You. Retrieved from, https://www.healthline.com/health/type-2-diabetes/considering-glp1s.
3 Rowley, K. (2024, November 22).FDA Side Effects Update: GLP-1 Drugs and Breathing Risks – MedShadow Foundation. Retrieved from, https://medshadow.org/drug-updates-recalls/fda-side-effect-updates/fda-side-effects-update-glp-1-drugs-and-breathing-risks/.
4 FDA. (n.d.)FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Retrieved from, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss.
