Preparing your plan for the GLP-1 era

Given the ongoing wave of media coverage, a class of drugs known as GLP-1 agonists is becoming increasingly well-known. 

GLP-1 drugs were first indicated as a treatment option for type 2 diabetes. The drugs work by mimicking the action of the glucagon-like peptide hormone involved in insulin sensitivity and the regulation of blood glucose.

The role of GLP-1 agonists on a person’s appetite and caloric intake has become better understood over the years. As a result, so has interest in the use of the drugs as a weight management tool. In clinical trials, GLP-1 drugs given in higher dosages than for diabetes showed the ability to stimulate double-digit-percentage weight loss in patients.

In 2021, the U.S. Food and Drug Administration approved a GLP-1 drug, Wegovy®, for use by adults with obesity or a weight-related condition. An estimated 150 million Americans are considered obese.¹ That means roughly half of U.S. adults are eligible to qualify for Wegovy, according to its FDA label instructions.

With the cost of GLP-1 medicines exceeding $1,000 per month, this combination of high drug costs and a large patient population has profound affordability implications for both plan sponsors and their members. 

The explosion in popularity of GLP-1s will not come as a surprise to those sponsoring pharmacy benefits.

Leaving aside their newly approved use for obesity, accelerated growth in the utilization of GLP-1s for diabetes had already made them a top trend driver over the past few years. Given their glucose-lowering effects, GLP-1s have become standard of care for type 2 diabetes, supplanting other medication classes such as sulfonylureas.² In 2023, GLP-1s represented 63% of diabetes spend, up from 38% in 2020.2

While diabetes GLP-1s will continue to account for a greater portion of spend compared to obesity, costs related to GLP-1s prescribed for obesity are expected to grow at a faster rate over the next 3 years. One consideration unique to covering GLP-1s for anti-obesity is that while plan sponsors will incur new short-term pharmacy costs, expected cost offsets such as lower medical benefit costs may not materialize until years later.

The promising obesity outcomes enabled by drugs such as Wegovy have prompted other drug manufacturers to pursue their own development efforts to help claim their share of this unprecedented market opportunity. 

This chart shows GLP-1 and GIP drug class including route of administration, frequency and indications.

Thus, one growing challenge for managing costs related to GLP-1 medicines is the sheer complexity and rapid activity in the drug pipeline. In fact, the term “GLP-1 drug” itself is becoming somewhat restrictive as researchers create drugs targeting other incretin hormones.

For example, 2 drugs based on the molecule tirzepatide, Mounjaro for diabetes and Zepbound for obesity, work by targeting both GLP-1 receptors and another incretin hormone known as gastric inhibitory polypeptide or GIP. The fact that 2 drugs with the same chemical composition have different names, indications and list prices only underscores the complexities plan sponsors must account for when developing a GLP-1/GIP approach.

In addition to these dual agonists already available, a triple hormone receptor agonist drug is currently in clinical trials. In all, there are currently 45 GLP-1/GIP drugs intended for obesity in the pipeline. Many of these drugs feature novel mechanisms of action or routes of administration and this increased competition may eventually exert downward pressure on pricing.

Perhaps just as important as the wave of new GLP-1/GIP drugs for obesity is the expansion of already approved GLP-1 drugs into other therapeutic areas. Recent clinical trials have examined the use of GLP-1s in resolving many other issues commonly related to obesity, including heart disease, sleep apnea and kidney disease.

Last year, the SELECT trial demonstrated that use of Wegovy significantly reduced the risk for first occurrence of adverse cardiovascular events, including heart attacks and strokes in study participants. As a result, the FDA granted an additional indication for Wegovy to reduce the risk of major cardiovascular events in March 2024.

With indications for other diseases including liver disease and Alzheimer’s disease currently being explored, the utilization of this drug class will only expand in the coming years. Thus, even plan sponsors who have so far elected not to cover GLP-1s for anti-obesity may still need to formulate a strategy to cover them as doctors begin to prescribe a greater variety of GLP-1s for a greater variety of conditions.

As we noted, one inherent complexity to managing GLP-1s is that the same drug will have a different name and price according to indication. Plan sponsors need to adopt formulary and benefit designs that account for this and make sure that GLP-1s are used for the indication prescribed. 

Given the complex and evolving nature of this drug class, plan sponsors need a strategic partner with the capabilities to provide options and management strategies to help balance cost and utilization of GLP-1s. Our pipeline and drug surveillance teams continuously monitor new drug launches, formulations and indications of GLP-1s. After a drug launches, our independent Pharmacy & Therapeutics (P&T) Committee reviews clinical and safety information and provides recommendation for formulary inclusion.

Optum Rx has also introduced a host of changes to ensure GLP-1 drugs are used responsibly, including optional utilization management (UM) and enhanced system edits. Our risk-stratified UM option includes additional clinical rigor such as the submission of chart notes and step therapy prior to reauthorizing weight loss treatment with a GLP-1 drug.

Other improvements include enhanced automated Prior Authorization (PA) processing for GLP-1 agonists used for diabetes. To help manage GLP-1 supply, Optum Rx provides clients with additional utilization management strategies to prevent stockpiling of GLP-1 agonists. For example, a percent use requirement can be added to confirm a patient has utilized most of their existing supply of a GLP-1 prior to issuing an automated PA approval.

Moreover, as new indications are approved, avoiding unintentional duplicate therapy is essential. To address this, Optum created a new duplicate therapy management solution for commercial clients to reduce waste, stockpiling and potential adverse events related to the use of GLP-1 drugs. An addition to the Optum Rx Concurrent Drug Utilization Review (cDUR) program, the new solution uses Duplicate Therapy (DUPTHER) screening to ensure members are using appropriate doses of GLP-1 medications.

In addition to changes at the formulary, benefit design and utilization management levels, successfully managing GLP-1 agonists requires extra support for members. It is important to note that the weight loss benefits observed in clinical trials came in conjunction with diet and exercise regimes. That’s why Optum Rx has created clinical programs designed to provide ongoing monitoring and motivation for members taking GLP-1 drugs. Optum Rx Weight Engage helps members achieve and sustain their weight loss goals through behavior modification support such as diet and exercise planning.

As the GLP market becomes more segmented, a more granular understanding of your unique population needs is required. Optum Rx can provide precision analytics to demonstrate cost impacts spanning multiple scenarios as well as expert clinical consultation and insights to help you make timely decisions.

The benefits of leveraging our comprehensive capabilities are far from theoretical.

A new wave of GLP-1 medications looms over the horizon. We believe plan sponsors should start preparing now for increased demand and develop a program approach that balances providing access with maintaining benefit affordability.

To dig deeper on the history and future implications of this drug class, check out this white paper.