March 24, 2023
GLP-1 agonists (GLP-1s) – a class of drugs used to treat type 2 diabetes and obesity – have been the subject of recent headlines for a variety of reasons: their efficacy, surging consumer demand and subsequent drug shortages, celebrity endorsements, concerns about appropriate prescribing and use, and their high price tag. For many employers, these topics are jumping off the page and into conversations with business leaders and vendor partners.
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 antiobesity medications, with data showing positive effects on weight loss and cardiometabolic outcomes. For example, results from a clinical trial published in The New England Journal of Medicine showed that when used with lifestyle changes, semaglutide (Wegovy®), a GLP-1 medication approved by the Food and Drug Administration (FDA) for the treatment of obesity in 2021, led to an average 14.9% reduction in body weight after 68 weeks (more than 1.5 times higher than the next best obesity drug).1 Study participants who took semaglutide also demonstrated greater improvement in BMI, waist circumference, blood pressure and lipid levels. Additional information on the effectiveness of GLP-1s, as well as other FDA-approved antiobesity 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 - Wegovy® and Saxenda®- are indicated for adults with a BMI ≥30 or BMI ≥27 with a weight-related comorbidity. More than 40% of adults in the U.S. have obesity (a BMI ≥30).2 Furthermore, Wegovy® and Saxenda® have also been approved 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 antiobesity medications to adolescents 12 years and older who are diagnosed with obesity as an adjunct to behavior and lifestyle interventions.3,4
- 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 that has weight loss as a side effect) and virtual health companies that prescribe these medications, has led to a rapid rise in their use. According CVS Health, there was 15% growth in utilization from the third quarter in 2020 to the third quarter of 2021 for antiobesity drugs, with Saxenda® and Wegovy® driving this trend.5 This is particularly notable since Wegovy® was approved in June 2021. As a result, Wegovy® has been in short supply, although the manufacturer has said it is ramping up production to meet consumer demand.6 There has also been a meteoric rise in the utilization of Ozempic®, with The Wall Street Journal reporting that prescriptions for Ozempic® in the last full week of January 2023 were up 78% from the year before. In part, this increase may be attributed to off-label, and in some cases, inappropriate, prescribing.7 Shortages of Ozempic® have been widely reported, and many people with type 2 diabetes, for whom the drug is indicated, aren’t able to obtain their medication.7
- 4 | GLP-1s will likely need to be used long term to maintain weight loss: 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. A study published in Diabetes, Obesity and Metabolism examined the health and weight effects on patients who had taken semaglutide for 68 weeks and subsequently stopped taking it. After 1 year “participants regained two‐thirds of their prior weight loss, with similar changes in cardiometabolic variables.”8 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.9 The long-term nature of these medications is raising significant concerns among employers because their costs far exceed that of other drugs used to treat chronic conditions.
- 5 | GLP-1s are creating cost management challenges: According to CVS Health, antiobesity medications were one of the three classes of drugs driving non-specialty spend, primarily due to increases in the cost and utilization of GLP-1s.5 Based on anecdotal reports, costs may have increased even more quickly in recent months. Indeed, The Economist has reported that the market for GLP-1 drugs could reach $150 billion by 2031.10 Such cost increases are alarming for employers, who well understand that more than 40% of adults in the U.S. have obesity. However, other employers point to the potential costs related to obesity and cardiometabolic conditions over time as justification for coverage of GLP-1s.
- 6 | A number of virtual health companies now (or will soon) 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 antiobesity medications and offer intensive behavioral interventions (the foundation for the treatment of overweight and obesity) or coaching. However, according to reporting by The Wall Street Journal, 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.11 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.12,13
- 7 | Opportunities – and potential challenges - presented by GLP-1s will soon extend beyond the U.S: 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 35.14 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.15
- 8 | Additional GLP-1s are in the pipeline: Tirzepatide, a novel medication that acts as a dual GLP-1 and GIP receptor agonist, received ”fast track” designation by the FDA in October 2022, and clinical trial data associated with its submission is expected to be finished in April 2023.16 Tirzepatide; has gained attention prior to FDA approval due to data showing a greater than 20% weight loss in more than 50% of trial participants who received the highest weekly dosing.17 Additionally, an oral GLP-1 for the treatment of diabetes entered phase 2 testing in 2022, which has been described as a ”game changer,” since GLP-1s currently available are all injectable, potentially deterring some patients.16
- 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. 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.18 In addition, because of the checkered history of weight-loss drugs (since the late 1990’s several medications were withdrawn from the market due to serious side effects), the FDA requires that these medications undergo post-marketing trials to assess cardiovascular effects. These studies are ongoing for GLP-1s, but thus far, few adverse cardiovascular events have been reported.
- 10 | GLP-1s are being studied for other uses/benefits: Because of their broader cardiometabolic benefits, GLP-1s are being studied in certain populations for the primary and secondary prevention of cardiovascular disease.19 And 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.20
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 what types of antiobesity medications to cover and determine the type of utilization management strategies 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 antiobesity medications, such as GLP-1s, as these medications are not standard across pharmacy benefit management (PBM) formularies. If you currently cover antiobesity medications or wish to in the future, consider including multiple agents in your formulary; while employees with overweight or obesity may respond favorably to at least one drug, the response may vary from medication to medication. When covering multiple medications, consider implementing step therapy based on efficacy, cost and rebates.
- 3 | Consider ramifications on health equity: Even when antiobesity medications are covered, there may be substantial out- of- pocket costs for employees, making them unaffordable for those who are lower paid. Determine how you will address any inequities to access to these medications.
- 4 | Press PBMs on how utilization management tools can be implemented to ensure appropriate use: Employers report that current utilization management tools are not effective or are not being applied to GLP-1s. 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. Some employers are also considering step therapy for antiobesity medications as a means of providing access while also managing costs.
- 5 | Promote intensive behavioral interventions to employees taking GLP-1s: GLP-1s are intended to be used as an adjunct to a reduced-calorie diet and increased physical activity. 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 antiobesity 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 antiobesity 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.
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- 1 | Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. NEJM. 2021;384(11):989-1002.
- 2 | Centers for Disease Control and Prevention. Adult obesity facts. https://www.cdc.gov/obesity/data/adult.html. Accessed March 1, 2022.
- 3 | Centers for Disease Control and Prevention. Childhood obesity facts. https://www.cdc.gov/obesity/data/childhood.html. Accessed March 20, 2023.
- 4 | American Academy of Pediatrics. American Academy of Pediatrics Issues Its First Comprehensive Guideline on Evaluating, Treating Children and Adolescents With Obesity. https://www.aap.org/en/news-room/news-releases/aap/2022/american-academy-of-pediatrics-issues-its-first-comprehensive-guideline-on-evaluating-treating-children-and-adolescents-with-obesity/#:~:text=Overweight%20is%20defined%20as%20a,the%20same%20age%20and%20sex. January 9, 2023. Accessed March 20, 2023.
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- 7 | Loftus P. Ozempic runs low for diabetes patients as weight-loss use surges. The Wall Street Journal. February 22, 2023 https://www.wsj.com/articles/ozempic-runs-low-for-diabetes-patients-as-weight-loss-use-surges-286bf21a?page=1. Accessed March 20, 2023.
- 8 | Wilding JPH, Batterham RL, Davies M, et al. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. Aug 2022;24(8):1553-1564.
- 9 | Blum D. Ozempic can cause major weight loss. What happens if you stop taking it? The New York Times. February 3, 2023. https://www.nytimes.com/2023/02/03/well/live/ozempic-wegovy-weight-loss.html. Accessed March 20, 2023.
- 10 | The Economist. New drugs could spell an end to the world’s obesity epidemic. https://www.economist.com/leaders/2023/03/02/new-drugs-could-spell-an-end-to-the-worlds-obesity-epidemic. Accessed March 20, 2023.
- 11 | Winkler R. Health startups offer diabetes drugs like Ozempic for weight loss with little oversight. The Wall Street Journal. February 15, 2023. https://www.wsj.com/articles/health-startups-offer-diabetes-drugs-like-ozempic-for-weight-loss-with-little-oversight-f2a69456. Accessed March 20, 2023.
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- 14 | National Institute for Health Care and Excellence. Semaglutide for managing overweight and obesity. https://www.nice.org.uk/guidance/TA875. Accessed March 20, 2023.
- 15 | Rackham A. Weight loss drug semaglutide approved for NHS use. BBC News. March 8, 2023. https://www.bbc.com/news/health-64874243. Accessed March 20, 2023.
- 16 | Adams B. Pfizer CEO talks up experimental oral GLP-1 diabetes/obesity hopeful as $90B Lilly, Novo battle looms. Fierce Pharma. January 10, 2023. https://www.fiercepharma.com/marketing/pfizer-ceo-talks-experimental-oral-glp-1-diabetesobesity-hopeful-90b-lilly-novo-battle. Accessed March 20, 2023.
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