OBESITY- Is The Treatment an Epidemic

A white paper about the on & off-label use of the GLP-1 Agonists

What is happening with the treatment of obesity?

In this white paper, we will dive into the GLP-1 receptor agonists (“GLP-1”) for the treatment of obesity. Although GLP-1s have been used primarily for diabetes, we are focused on the recent surge in utilization for use in weight management, and the rising cost has caused great concern for payers. New medications that were previously only used and indicated for diabetes are now being sought after and used off-label for weight loss, and even those with a weight loss indication when covered by payers are seeing exorbitant use.

A quote from the New York Times speaks about a medical provider desperate for extra money going to work for a weight loss clinic run by a chiropractor being paid to prescribe weight loss medications. The article describes the tale as “the willingness of some doctors, who see a quick flow of ready cash free from the constraints of managed care, to lure desperate patients, who will do almost anything to lose weight.”1 The article is from 1997 when the use of the popular weight loss medications known as “Phenfen” declined overnight only a few short years after the boom in 1992. Is history repeating itself? Thirty years after the nearly overnight explosion in the use of “Phen-fen” as medication for weight loss, we are again seeing an explosion in the use of GLP-1s for weight loss with widespread prescribing from an array of providers.

Phen-Fen Rise and Fall

Phenteramine combined with fenfluamine became known by the common term “Phen-fen” as a “miracle medication” to lose weight. In an age without social media or the technology of cell phone use, word still quickly spread, and it has been estimated that 18 million prescriptions were written for the popular weight loss medication between 1992-1997.

In 1997, we saw the fall of usage in Phen-Fen when the Food and Drug Administration (FDA) ordered the removal of the drugs fenfluramine and dexfenfluramine from the market after a study demonstrated that they caused damage to heart valves.

The World Health Organization (WHO) defines obesity as a Body Mass Index (BMI) greater than or equal to 30. Someone is deemed overweight with a BMI greater than or equal to 25. Body Mass Index is a calculation of a person's weight in kilograms divided by their height in meters squared. It is estimated that more than 70 million Americans are considered obese and over 100 million would be considered overweight.

What causes a person to be overweight or obese? The fact is that the fundamental biological cause for obesity and being overweight is an energy imbalance; calories consumed, and calories expended. Some would want us to think the only way to treat is through medications; with the GLP-1s, it can be quite costly. The underlying societal cause remains that the world in which we live has created the treatment epidemic. There has been an increase in the production and use of energy-dense foods that are high in fat and sugar content with a decrease in physical activity such as sedentary forms of work, changes in the modes of transportation used and increase in lifestyles in which people are in urban environments. The issues brought by these changes have been compounded in their impact with a lack of supportive policies in sectors including health, agriculture, transport, urban planning, food processing and more.2

“Harvey the Gila Monster”

Many parents of young children in the United States, especially those in the Sonoran Desert of Arizona and New Mexico, know of the musician “Persephone” and her character Harvey which was brought to life in a song. Why does this children’s character come to mind in the fight against diabetes? Well, Harvey is a Gila Monster, also known as an American Aztec Lizard.

Gila Monsters are the only native lizard in the United States that has a venomous bite. One bite causes extreme pain and a reaction of severe nausea and vomiting. The study of the saliva components from venomous bites resulted in the discovery of a hormone, exendin-4, which could be used in the treatment of Type 2 diabetes due to its similarity to the GLP-1 protein of humans. All of this research, led by Dr. Drucker, created the first GLP-1 medication, Byetta, in a class of medications now being used to treat both diabetes and obesity.3

Harvey the Gila Monster's lyrics include that he has a poisonous bite, but wants to be your friend. In this case, the lyrics of a children’s song have come to reality with the poisonous bite being the original basis for a treatment for diabetes and is now being used around the world. But could the discovery now be reaching a tipping point where the inappropriate focus is on the use of treatments instead of the prevention of disease?

Coverage of GLP-1 Class for Treatment of Obesity

Deciding to have coverage for this class of medications can be a major decision for clients. Costs associated with the management of the comorbidities of the obese population may drive people to desire coverage, however, others argue that the cost versus benefit is far from desireable with the expectation that there is a need for continued maintenance treatment as evidence has shown; a large number of patients return to their starting weight within one year of discontinuation of therapy.

There are some clients designing a different approach while still choosing to cover these medications for their obese population. This consists of a management program that is a hybrid between traditional prior authorization or step-therapy coupled with a lifestyle management program and limited provider network.

Two Diagnosis – Same Medications

A major issue with the decisioning on coverage of these medications are due to their original indication of medication class – diabetes. While most payers have coverage of GLP-1 medications for diabetes, the manner in which they confirm the diabetes diagnosis varies and allows ‘wiggle room’ for prescribers and patients to circumvent the intention of the claims edits in order to gain coverage for the medication.

Some payers use a claim look-back to ascertain the diagnosis of diabetes. The 90 to 180 days lookbacks are simply looking for less novel agents used in the treatment of diabetes (e.g., glyburide, glucophage). When the claims adjudication finds the reference claim for one of these medications, it acts as a confirmation of the diagnosis and therefore allows the GLP-1 claim to be covered.

Impact of Rebate Contract Stipulations

Another concern becomes the language in PBM agreements with the manufacturers that can create a barrier to more effective utilization management programs as it may disqualify the claims from rebates. Most of the negotiated rebate agreements between PBMs and manufacturers create barriers to effective utilization management by limiting the use of alternatives and limiting the use of more extensive prior authorization criteria.

With the medication costs being so largely tied to rebate value, the analysis becomes a spreadsheet exercise to evaluate the cost to the payer for removing medication with more clinically appropriate utilization management and prior authorization criteria with the loss of the rebate value. PBMs are incentivized to drive utilization, not reduce it, as they receive revenue off the claim transactions, rebates, and dispensing revenue when using their specialty pharmacies. They have little to no incentive to drive rebate agreements to allow for more aggressive management by the payers.

Will the rise of the GLP-1s be short-lived or live-on?

The quick rise of the GLP-1 class has been fueled by the movement from use for those with a diabetes diagnosis to those who are overweight or obese. The rise has been largely the result of direct-to-consumer (DTC) advertising and media impact. There is also concern or excitement (depending on which side of the equation you sit – as the payers or the pharmaceutical manufacturers respectfully) that the utilization will continue with additional use for even more disease states.

Media Impact

Unlike the Phen-Fen craze, the GLP-1 class has the power of manufacturer advertising budgets and the wide-scale adoption of social media boosting the utilization of these medications. Nicknamed “The Hollywood Drug”; many high-profile influencers in social media have created even more buzz about medication use. Producers of hit Hollywood shows, Elon Musk, and others are all putting out social media posts and fueling the fire of these medications.4

With the use of social media platforms, such as Twitter, Facebook, and TikTok, it’s a ‘me too’ phenomenon as many document their use of these products in real-time on these online platforms. These online platforms have also created a fully established marketplace for providers, both prescribers and pharmacies, to directly engage with prospective patients by offering a quick fix and easy engagement with their services to get patients started on these medications. They will openly ‘advertise’ their services, which brings patients into their folds with ease and leaves room for providers to use the medications off-label, circumvent payer plan designs, and even prescribe outside their scope of practice (e.g., chiropractors).

It’s not only a social media impact. The mainstream media is also infatuated with coverage of these products as they become the talk of the town. From digital and print media to television/radio coverage, you will find frequent media content dedicated to the GLP-1 class.

DTC Advertising

The United States remains one of the few nations which allows Direct-to-Consumer (DTC) advertising for pharmaceuticals. The world of DTC is big business accounting for the majority of the costs incurred by pharmaceutical manufacturers. The DTC influence allows for direct influence on the population, creating a wave of patients seeking care not based on their health but based on the promise of drug outcomes from advertisements.

DTC has also begun to shift as they engage with social media influencers by paying those who have a large number of followers and for mentions of their products. We are in an age of a tech-enabled population where the practice of medicine is being replaced with influencers and advertising budgets.

Utilization Increase

As we stated, the increase of the GLP-1 class is extensive as utilization went from the treatment of diabetes to the treatment of the overweight or obese. Is there value in the distinction of the ‘approved use’ being only diabetes or only weight loss? Is this the extent of the indications we expect?

The medication Ozempic, which is the brand name of semiglutide, was manufactured by NovoNordisk and is used for the treatment of diabetes. NovoNordisk simply came out with a new higher-priced version, Wegovy®, for the treatment of obesity. In the recent SURMOUNT-2 trial by Lilly, the medication tirzepatide (brand name Mounjaro™) was evaluated for patients who were overweight or obese and diabetic and included weight loss in the outcome endpoints, which lead to a beginning of a gray line between diabetes and obesity and the start of bringing forward the notion that we can treat both without distinction.

These manufacturers are also pouring money into the study of these medications for even more disease states. GLP-1 medications have an impact in autoimmune disease, cardiovascular disease, diabetic kidney disease, diabetic foot ulcer, polycystic ovary syndrome, and Alzheimer's disease. There are even reported uses for addiction treatment. Each of these represents potential new patients who could become users of these expensive injectables.

Has the Treatment become the Edipemic?

The cost of these medications is a chart-topper for nearly every payer, whether they are covering for only diabetes or both diabetes and obesity/weight loss. While Obesity has been characterized as an epidemic, one could argue that the epidemic is the creation of the obese population in order to treat those who are obese. The failure to promote healthy lifestyles, through access to adequate nutrition and exercise, creates these health problems which then fuel these high-cost treatments – that failure to promote healthy living may be the epidemic.

Additionally, there is concern that instead of fixing the problem, these medications offer a ‘quick fix’ that turns into a maintenance nightmare. It is estimated that nearly 70% of patients return to their pretreatment weight within one year of discontinuation of the treatment. The studies, like SURMOUNT-2, used a calorically reduced diet and increase in physical activity, which would be clinically important to any patient’s weight loss journey as is likely the only way patients who use these agents could achieve long-term success, however, are seemingly never part of the requirements within the treatment protocols which govern the formulary decisions and rebate contracts.

Unfortunately, it goes back to the source of the problem. The American lifestyle is the precursor for illnesses and without major changes to the lifestyle, the expectation for quick fixes, and the allowance for the control of the health-care dollar to shift to the advertising budgets and media, we can expect to continue to see a sharp increase in the use of the GLP-1 class. The use of these medications for obesity should be seen as a WARNING SHOT across the healthcare system and a call to action to go beyond the management of the use of these products and into the realm of fighting to get our population healthier to prevent the inflammatory and insulin-resistance disease processes that are plaguing the nation.

What can we do to manage the Cost?

Managing these costs is the million-dollar question this year. While some are managing with prior authorization criteria or just eliminating coverage, is this enough, and how will the market shift?

Prior authorizations (PA) are almost exclusively being used to manage these high-cost medications, however, the PA criteria are typically part of the PBM negotiated contract with the manufacturer of which both parties have a vested interest to see a high volume of use. So, when the PA criteria are limited to encourage use, there is inherently a problem.

When clients cover the GLP-1s for overweight and obesity diagnosis, there are some pushing the prior authorization envelope beyond the typical BMI requirements. Some are adding new utilization management criteria that include validation of enrollment in a specific lifestyle management program and continued engagement with that program in order to continue the authorization month over month.

Another tool being deployed is limited networks. With the social media push and use of prescribers interested in driving their own revenue versus those truly engaged in patient outcomes, there has been a resurgence looking to only allow a narrow group of prescribers who are appropriate in the management of obesity long-term and have been selected by the payer.

In the end, these medications are not only high-cost, but truly new-to-market considering the time we have spent creating an obesity epidemic. We cannot allow the medications to drive considerable cost but not produce considerable value. When clients choose to cover the medication, managing the patients to ensure that the medication creates long-term value is key.

Although not yet seen in the industry, it would be great to see a value-based contract around these medications where this high-cost was only paid when the medication could prove long-term weight control success.

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