December 12, 2023

Below are 10 things about GLP-1s you need to know as you engage in these discussions. This list is followed by 10 recommendations on how to assess - and address- the use of these medications in your population.

10 Things to Know

• 1 | GLP-1s are highly effective: These medications are categorically different from other anti-obesity medications, with data showing positive effects on weight loss and cardiometabolic outcomes. According to a physician quoted in The New York Times, Zepbound®, which was approved by the FDA in November 2023, “is now likely the most effective treatment to combat obesity besides bariatric surgery,” with clinical trial results demonstrating 18% average weight loss.¹ The largest clinical trial of Wegovy®, another GLP-1 approved for weight loss, showed that when used in conjunction with lifestyle changes, it led to an average 14.9% reduction in body weight.² Moreover, according to clinical trial results published in November 2023, the use of semaglutide (Wegovy®) significantly decreased major adverse cardiovascular events, including non-fatal heart attack and stroke, by 20% among patients with overweight or obesity and cardiovascular disease without diabetes.³ Additional information on the effectiveness of GLP-1s, as well as other FDA-approved anti-obesity medications, can be found in An Employer’s Practical Playbook for Treating Obesity.
• 2 | Eligibility for these medications is vast: GLP-1s approved for weight loss in the U.S. – Wegovy®, Saxenda® and Zepbound® (a medication that acts as a dual GLP-1 and GIP receptor agonist)  – are indicated for adults with a BMI ≥30 or BMI ≥27 with a weight-related comorbidity. Almost 42% of adults in the U.S. have obesity (a BMI ≥30); globally, obesity impacts more than 1 billion people.⁴ Furthermore, Wegovy® and Saxenda® have also been approved by the FDA for use in kids older than 12 with obesity. In the United States, more than 22% of 12- to 19-year-olds have obesity.³ Guidelines from the American Academy of Pediatrics released in January 2023 recommend that physicians offer anti-obesity medications to adolescents 12 years and older who are diagnosed with obesity, as an adjunct to behavior and lifestyle interventions.^5,6 
• 3 | Demand for GLP-1s is outpacing supply: The efficacy of GLP-1s, combined with celebrity and influencer endorsements of Ozempic® for weight loss (Ozempic® is a GLP-1 approved for the treatment of type 2 diabetes) and the proliferation of virtual health companies that prescribe these medications, have contributed to a rapid rise in their use and subsequent drug shortages. Due to these shortages, Wegovy’s manufacturer has limited the number of patients who are able to start treatment, and this practice may persist into 2024.⁷ The continued demand for GLP-1s, coupled with their short supply, has led some patients to seek compounded versions of these medications, which the FDA has advised against due to safety concerns.^8,9 Some are projecting  that the approval of Zepbound® in 2023 may ease shortages in the U.S.  
• 4 | GLP-1s may need to be used long term to maintain weight loss results: As with medications used to treat high blood pressure, cholesterol or diabetes, the benefits of GLP-1s may only be realized while patients remain on the drug regimen. One study found that patients who took semaglutide (Wegovy®) for 68 weeks and subsequently stopped taking it “regained two‐thirds of their prior weight loss, with similar changes in cardiometabolic variables.”¹⁰ Discontinuing use may lead to weight regain because of the mechanism by which GLP-1s work: They delay stomach emptying and decrease appetite, but once people stop taking these medications, feelings of hunger return.¹¹ The chronic nature of these medications is raising significant concerns among employers for two main reasons: 1) their costs far exceed that of other drugs used to treat chronic conditions, and 2) low patient adherence (a study showed that most patients who start taking GLP-1s (68%) stopped after a year), which diminishes the longer-term value of this treatment.¹² 
• 5 | GLP-1s are creating cost management challenges: According to an Aon analysis of prescription claims from 500 employers, the utilization of Saxenda®, Wegovy® and Rybelsus®, along with off-label usage of Ozempic® for weight loss, increased employer health care costs by more than $300 per worker in 2023.¹³ Indeed, Mercer indicated that GLP-1s will accelerate the rise in employer medical costs in 2024, with one actuary noting that they “could contribute between 50 and 100 basis points to the trend.”¹⁴ Such cost increases are alarming for employers, who well understand the rising prevalence of obesity around the world. When asked, over half (53%) of employer respondents revealed they are very concerned about the appropriate use and/or long-term cost implications of GLP-1s, while the remaining are concerned (32%) or somewhat concerned (16%).¹⁵
• 6 | A number of virtual health companies prescribe GLP-1s: Some of these companies are exclusively focused on weight management, while others are more broadly focused on an array of health conditions. Many are direct-to-consumer, and some also partner with employers. Among these companies, those deploying evidence-based treatment protocols will require biometrics to determine patient eligibility for anti-obesity medications and offer intensive behavioral interventions (the foundation for the treatment of overweight and obesity) or coaching. However, not all virtual health companies engage in appropriate marketing or prescribing of GLP-1s, which can lead to inappropriate use and exacerbate the cost impact and drug shortages noted above.¹⁶ Eating disorder experts and advocates have also raised concerns that direct-to-consumer marketing of GLP-1s may be harmful, especially to those in recovery for eating disorders, as it may reinforce a cultural ideal of thinness and promote disordered eating.^17,18 
• 7 | Opportunities – and potential challenges – presented by GLP-1s extend beyond the U.S: Shortages of GLP-1s are occurring in several countries in Europe. In March 2023, England’s National Institute for Health and Care Excellence (NICE) issued guidance on semaglutide, recommending its use in tandem with a reduced-calorie diet and lifestyle changes for people with at least one weight-related comorbidity and a BMI of at least 35.¹⁹ According to the guidelines, people who qualify for these medications may be able to use them for up to 2 years and will receive weight management support while on these drugs.²⁰ However, demand for semaglutide outpaced supply and led to guidance limiting the prescribing of this GLP-1 to only patients with diabetes (this practice was also implemented in Belgium). As of late 2023, a limited supply of Wegovy® is now available in the U.K. for patients with obesity.²¹ As another strategy to combat shortages, it’s been reported that Germany is considering banning exports of Ozempic® to preserve supply.²² 
• 8 | Additional GLP-1s are in the pipeline: Numerous GLP-1s are in various phases of development including those in pill form, which if approved has been described as a ”game changer,” since currently available GLP-1s are all injectable, potentially deterring some patients.²³
• 9 | Short-term side effects are well-known and long-term side effects of GLP-1s are still being studied: Short-term side effects include nausea, vomiting and diarrhea. Serious digestive problems such as stomach paralysis, pancreatitis and bowl obstructions have also been noted, though more research is needed to determine the risk for such adverse side effects.²⁴ Patients who take GLP-1s and lose weight may also lose muscle mass; this has been highlighted as an important consideration because people taking these medications may need to alter their diet and physical activity to account for this loss.²⁵ Additionally, the European Medicines Agency, which has been described as the “EU’s drug watchdog”, has asked the manufacturer of Ozempic® and Wegovy® for more data in order to investigate reports of suicidal thoughts among patients taking these medications.²⁶ Due to their side effects, whether used for diabetes or weight loss, GLP-1s require shared decision making between patients and providers, proactive support of patients during treatment, and vigilant monitoring of outcomes and side effects by providers trained in obesity treatment.   
• 10 | GLP-1s are being studied for other uses/benefits: Because of the broader cardiometabolic benefits described above, GLP-1s are being studied in certain populations for the primary and secondary prevention of cardiovascular disease.²⁷ While more research is needed, scientists may also explore the usefulness of GLP-1s for “reward system-related disorders,” including drug, alcohol and nicotine use; there is some evidence showing that GLP-1s affect reward pathways and may have utility beyond diabetes and weight management.^28,29 

10 Tips for Employers

• 1 | Assess the current and potential GLP-1 utilization in your population: Work with your partners to determine current utilization and costs associated with GLP-1s, including off-label use. Additionally, ask partners to estimate the number of employees and family members who may be eligible for GLP-1s, along with the health care costs currently associated with that population, to assess both the potential incremental costs of covering these drugs as well as potential long-term savings. Getting the full picture of current and potential utilization can help organizations make decisions about which anti-obesity medications to cover and determine the type of utilization management strategies and patient support programs that should be put in place to promote appropriate use. 
• 2 | Define coverage for GLP-1s: Check your summary plan description(s) to confirm whether your plan(s) include coverage of anti-obesity medications, including GLP-1s for weight loss, as these medications are not standard across pharmacy benefit management (PBM) formularies. If you currently cover anti-obesity medications or wish to in the future, consider including multiple agents on your formulary. For example, in its Federal Employees Health Benefits (FEHB) Program carrier letter, the U.S. Office of Personnel Management (OPM), the chief human resource agency for the federal government, indicated that “carriers must cover at least one anti-obesity drug from the GLP-1 class for weight loss and cover at least 2 additional oral anti-obesity drug options.”³⁰ Covering multiple agents is important because while employees with overweight or obesity may respond favorably to at least one drug, the response may vary from medication to medication. Furthermore, while GLP-1s can be highly efficacious, other types of anti-obesity medications can also help patients achieve clinically significant weight loss. To illustrate, participants in a clinical trial who took phentermine-topiramate (Qysimia®) lost 10.5% of their baseline weight.³¹ Including multiple anti-obesity medications on the formulary also enables employers to consider implementing step therapy, which may help manage utilization. 
• 3 | Press PBMs on how utilization management tools can be implemented to ensure appropriate use: Prior authorization and reauthorization for GLP-1s should ensure that only individuals for whom the drugs are indicated gain access and that GLP-1s for weight loss are being used in conjunction with lifestyle management. Reauthorization should seek to determine if individuals are responding to treatment.  
• 4 | Consider ramifications on health equity:  Even when GLP-1s are covered, there may be substantial out-of-pocket costs for employees, making them unaffordable for those who are lower-income. Determine how you will address any inequities to access to these medications. 
• 5 | Promote intensive behavioral interventions to employees taking GLP-1s: GLP-1s are intended to be used as an adjunct to lifestyle changes. Physical activity, including resistance training, is particularly important because weight loss (regardless of how its accomplished) can also lead to loss of muscle mass.³² Talk with your partners, including health plans; PBMs; and weight management, navigation and advocacy partners, to identify ways of promoting and sustaining participation in weight management programs when employees are prescribed anti-obesity medications. Employers may want to do the same for employees taking GLP-1s for diabetes. 
• 6 | Communicate about programs or benefits that may assist employees with weight management: Promote the variety of offerings you have in place to assist employees on their weight loss and maintenance journey, from diabetes or weight management programs to benefits or services, which promote good nutrition or physical activity. As you communicate these programs and benefits, ensure these vendor partners are prepared to support employees taking GLP-1s.  
• 7 | Assess the quality of current or prospective virtual health partners that may prescribe GLP-1s: Employers and their PBMs should verify that providers are adhering to FDA guidelines when prescribing anti-obesity medications. Prior authorization requirements may include biometric testing to determine if patients are appropriate candidates for these drugs. Employers should also assess the degree and frequency of patient monitoring and support for the duration of treatment and require appropriate reporting of outcomes to ensure effectiveness 
• 8 | Discuss GLP-1s with bariatric surgery centers of excellence (COEs): Determine if and how these medications impact the program criteria, including any guidelines that may be in place for their use in the pre-authorization process for bariatric surgery. 
• 9 | Focus on stigma-free communications related to weight and GLP-1s: As a trusted source of information, employers should ensure that any messaging about weight or GLP-1s is free from language or imagery that may be stigmatizing. The same goes for communication from partners. Examine current and future communication materials for this type of content, such as headless images of people with obesity, language or images that suggest a person’s body weight is a reflection of their character or intelligence, use of pejorative language or inappropriate humor.  
• 10 | Re-evaluate the comprehensiveness of your weight management strategy: As obesity rates rise across the globe and new ways of treating this condition emerge, the time is now for employers to develop a comprehensive weight management strategy that approaches obesity as a complex, chronic disease. Employers can do this by offering a spectrum of evidence-based interventions, providing support for patients in choosing and adhering to the interventions that are most appropriate for them and establishing a workplace culture and environment that supports healthy habits. In doing so, employers will enable employees with obesity to access care that can make a difference in their health and quality of life. For more information on developing a comprehensive weight management strategy, see An Employer's Practical Playbook for Treating Obesity. For information on global challenges, as well as ways multinational employers can support their workforce, see the Global Guide to Obesity.

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