Same Drug, New Label: What’s all the Buzz about GLP-1s?

A class of drugs currently used to treat type 2 diabetes, called GLP-1 agonists (GLP-1s), has demonstrated promising weight loss results in recent clinical trials and may soon be approved for use in adults with overweight or obesity without diabetes.

In recent months, obesity has drawn attention from health professionals across the world because of its link to severe COVID-19 and the recommendation that it should be included among the conditions for COVID-19 vaccine prioritization.

But underneath these big pandemic headlines, there’s been industry buzz about obesity for an entirely different reason: a class of drugs currently used to treat type 2 diabetes, called GLP-1 agonists (GLP-1s), has demonstrated promising weight loss results in recent clinical trials and may soon be approved for use in adults with overweight or obesity without diabetes. GLP-1s have been heralded by physicians for their potential to help people with obesity achieve clinically significant weight loss; however, they come with important coverage considerations given their high cost and extended utilization requirements.

Here we describe what all the buzz is about, as well as what employers need to think about as they determine if and how to incorporate these medications into their overall weight management strategy.

Why Are GLP-1s Newsworthy?

GLP-1s are gaining attention because their efficacy surpasses that of even the best available weight management medications on the market today. Results from a clinical trial published in The New England Journal of Medicine showed that, when used in conjunction with lifestyle changes, semaglutide (a GLP-1) led to an average 14.9% reduction in body weight after 68 weeks (more than 1.5X higher than the next best obesity drug). Importantly, study participants who took semaglutide also demonstrated greater improvement in cardiometabolic risk factors (i.e., BMI, waist circumference, blood pressure and lipid levels). A separate trial with published results in JAMA show similar impressive outcomes; in adults with overweight or obesity (without diabetes), a once-weekly injection of semaglutide resulted in reductions in body weight of 16.0% compared to 5.7% among those in the placebo group when used in combination with intensive behavioral therapy and an initial low-calorie, meal-replacement program.

These data are encouraging because many people with obesity – a complex, chronic disease with multiple causes – cannot achieve and maintain clinically significant weight loss through lifestyle interventions alone. In conjunction with behavioral changes, evidence shows that FDA-approved medications intended for long-term weight management can be useful in helping people with obesity achieve and maintain weight loss, yet few pharmacological options are currently available. GLP-1s could provide an important contribution to obesity medicine by providing an additional, highly efficacious treatment option.

GLP-1s Sound Too Good to Be True…What Else Do I Need to Know?

As with all medications, GLP-1s have downsides that physicians should discuss with patients as part of an informed decision-making process:

  • Common side effects include nausea, vomiting and diarrhea. Low blood sugar levels (hypoglycemia) are a more serious risk linked to the GLP-1s.
  • Potential long-term effects of high doses of GLP-1s are unknown. (In clinical trials, GLP-1s are given at higher doses for the treatment of overweight and obesity than used for the treatment of diabetes.)
  • All but one GLP-1 must be taken by injection, an important consideration related to patient adherence. They also must be taken long-term, similar to a high cholesterol or high blood pressure drug regimen.
  • Perhaps one of the greatest drawbacks of GLP-1s is their cost, which may serve as a treatment barrier for patients and a coverage concern for employers. As demonstrated by previous experience, the cost of GLP-1s may increase if these medications receive approval for weight management due to higher dosing and rebranding (there was a marked price increase when Victoza, a diabetes medication, was relabeled as Saxenda, a weight management medication that has the same active ingredient but given at a higher dose).

Considerations for Employers

While there is only one GLP-1 currently approved for weight loss in patients without diabetes (Saxenda® [liraglutide]), there are several others in the pipeline. As a result, now is the time to consider the following:

  • Do you include pharmacotherapy in your company’s weight management strategy? Check your summary plan description(s) to confirm whether your plan(s) already include chronic weight management drugs, including liraglutide (verify coverage since the inclusion of weight management medications on preferred formularies is not standard across PBMs). If you currently cover medications for chronic weight management - or wish to in the future as a means of offering a comprehensive approach to obesity treatment - consider including multiple agents in your formulary; while employees with obesity may respond favorably to at least one weight management drug, it may not be the same medication.
  • How will your health plan and PBM adjudicate GLP-1s for weight management? Talk to your partners and set expectations for how you will collaboratively determine future treatment adjudication. Ask for reports with potential cost and utilization impact based on your demographics.
  • What type of utilization management tools should be implemented to ensure appropriate use? Implement continuous coverage review through utilization management and prior authorization criteria for GLP-1s. Prior authorization forms should be designed to: 1) ensure that only individuals for whom the drugs are indicated gain access and 2) track that GLP-1s are being used in conjunction with lifestyle management programs. Reauthorization forms should be designed to determine if individuals are responding to treatment.
  • What type of support do you provide employees to help them maintain or achieve a healthy weight? GLP-1s are intended to be used as an adjunct to a reduced-calorie diet and increased physical activity, so ensure that employees have ready access to behavior-based interventions and that your workplace is designed to support healthy choices.

Given the early evidence, GLP-1s offer promise as a component of an employer’s comprehensive weight management strategy, while also presenting unique considerations for employers as they strive to manage appropriate utilization and cost.

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