What Employers and Brokers Need to Know about GLP-1s

Glucagon-like peptides-1 receptor agonists (GLP-1s) and Glucose-dependent Insulinotropic Polypeptide receptor agonists (GIP) are medications that mimic hormones naturally produced by the body. When referring to ‘GLP-1s', this includes GLP-1s and dual GLP-1s/GIPs. The Food and Drug Administration (FDA) has approved several GLP-1s to treat type 2 diabetes, obesity, and reduce the risk of cardiovascular disease.

GLP-1 therapies, first approved in 2005, have been part of the pharmacy landscape for nearly two decades. Recently, their demand has surged due to their effectiveness and benefits, such as treating obesity and reducing cardiovascular risks. GLP-1s are also being studied for treating various chronic diseases like heart failure, obstructive sleep apnea, and liver disease. Their future growth is expected to continue, driven by their efficacy and safety, the rising prevalence of diabetes and obesity, and new FDA- approved indications, likely making them a significant driver of employer plan sponsors’ pharmacy benefits spending.

Pharmaceutical Strategies Group (PSG) reported¹ that nearly 80% of health plans and employers respondents were moderately or very concerned about the affordability of GLP-1s. According to the same PSG report, 91% of health plans and employers currently cover GLP-1s for type 2 diabetes, while 33% cover them for obesity.

According to a study by PSG², the top cost containment strategies are prior authorization, Body Mass Index (BMI) requirement, quantity limits, comorbid condition requirement, step therapy, and lifestyle modification program participation requirement.

As of July 2024, due to increased demand, there is a FDA nationwide shortage of GLP-1 medications (specifically, Semaglutide injections and Tirzepatide injections). To ensure continued access to medications on the FDA’s Drug Shortages list, compounded versions using the same active ingredients may be made during such shortages under certain conditions and state and/or federal requirements.

GLP-1s may be prescribed by providers for diabetes and obesity. With the rising demand, there are also direct-to-consumer options for weight loss. 

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Alarmingly, 38% of respondents of a 9amHealth study³ have tried knock-off GLP-1s/semaglutide or black market weight loss products, greatly increasing the risk of complications or adverse reactions as these drugs could contain contain too little, too much or no active ingredient at all, or contain the wrong of other harmful ingredients.  The FDA recommends that individuals should only get compounded semaglutide from state-licensed pharmacies or outsourcing facilities registered with FDA.⁴

Compounded GLP-1s are typically supplied in multi-dose vials and measured using a syringe. Brand products are supplied as prefilled pens devices. 

Compounding pharmacies that meet the requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act and use the base formulation–not the salt form– use the same active ingredients as semaglutide commercial products. 

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Compounded medications can be used, in situations when a specific medication must be made for one person (e.g., due to an allergy to an inactive ingredient contained in the brand or generic version of a drug), or when drugs are on the FDA’s Drug Shortages list to ensure you have access and  can continue taking your medication for treatment. 

The most common side effects of compounded GLP-1s are similar to the commercial GLP-1s, and include nausea, abdominal pain, constipation, and vomiting. These side effects are typically mild and usually go away over time as the body adjusts to the medication. It is important that patients consult with their provider regarding the use of compounded GLP-1s. 

In addition to controlling blood sugar and promoting weight loss, some GLP-1 medications have kidney and heart benefits, such as reducing the risk of heart attack and stroke. There is ongoing research into new indications and beneficial uses of GLP-1s. 

Semaglutide is used to treat type 2 diabetes and chronic weight management. It is a glucagon-like peptide-1 (GLP-1) receptor agonist, which means it mimics the effects of the natural hormone GLP-1.  Semagltuide has been shown to be effective in lowering blood sugar levels and aiding in weight loss. 

Tirzepatide is the first GLP-1 with an additional mechanism of glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and is used for the treatment of type 2 diabetes and chronic weight management. The dual GLP-1/GIP mechanism of action is thought to be an enhanced GLP-1, with greater effects on blood sugar control and weight management.