The Skinny About Weight Loss Medications

It's difficult to scroll through social media or watch the news without hearing about one of the latest weight loss drugs on the market. From their suspected use in Hollywood or the many vlog updates from users that discuss their progress and experiences, weight loss medication options have made their way back to the top of the trend list.

But, they are not new. Way before supersized fries, Big Gulps and Jazzercise, in 1959, one of the first FDA-approved weight loss medications hit the market with the drug phentermine, brand name Adipex. Phentermine is an appetite suppressant meant for short-term use and it is still on the market today. Over the last 65 years, many new drugs have been released specifically to help fight the growing concern of obesity. The weight loss medications continue to evolve along with their impact on treatment and plans.

A Common, Chronic and Costly Disease

Overweight and obesity are defined by the Centers for Disease Control and Prevention (CDC) as "weight that is higher than what is considered healthy for a given height".^[1] About 3 out of 4 adults over 20 years old in the United States are either overweight or obese.^[2] In the United States, obesity affects 100.1 million (41.9%) adults and 14.7 million (19.7%) children and accounts for approximately $147 billion in annual health care costs.^[3] Even with all the attention and visibility, the prevalence of obesity continues to increase, jumping from 30.5% of the U.S. population in 2000 to 41.9% in 2020.^[4]

Standards of Care for Weight Loss Management

The Endocrine Society and The American Gastroenterological Association (AGA) have both published guidelines on the pharmacological management of obesity, and both recommended a patient-tailored approach to determine what medication is best for each patient.

FDA-Approved Drugs for Weight Management ^[11]

There are currently six FDA-approved medications for chronic weight management. These medications work in a variety of ways and come in a variety of forms and dosing schedules. Some medications suppress appetite, reduce cravings and control hunger while others decrease dietary fat absorption. Of the medications approved for chronic weight loss, the glucagon-like peptide-1 (GLP-1) receptor agonists (RA) have increased in popularity due to their increased weight loss as compared to other agents, dual type 2 diabetes mellitus (T2DM) indication, less frequent administration and potential cardiovascular benefit.

The Good the Bad and the Popularity of GLP-1s

Glucagon-like peptide-1 Receptor Agonists (GLP-1 RAs ) bind to and activate the GLP-1 receptor, which causes regulation of appetite and caloric intake, slows gastric emptying, increases glucose-dependent insulin secretion and decreases inappropriate glucagon secretion.^[12]

GLP-1 RAs are:

• Approved for chronic weight management under the brand names, Saxenda, Wegovy and as GLP-1 RA and GIP agonist, Zepbound
• Approved for T2DM with the brand names, Byetta, Mounjaro™, Ozempic®, Trulicity®, Rybelsus® and Victoza®.
• Available in both oral and subcutaneous formulations with dosing frequencies ranging from daily to weekly.

While GLP-1 RA medications are considered safe, many contain a warning regarding thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), and are contraindicated in those with a personal or family history of MTC cancer or multiple endocrine neoplasia syndrome type 2a or 2b. There are also common adverse effects that patients and prescribers should be aware of prior to initiating therapy.^[13] These include nausea, vomiting, diarrhea and abdominal pain, possible concerns of stomach paralysis.

One of the biggest notes about GLP-1 RAs is their increased off-label use for weight loss for those with normal or near-normal BMIs without T2DM. The surge in demand has caused many of the GLP-1 RAs to be out of stock over the last months leaving some patients who meet the indication requirements of obesity and/orT2DM struggling to obtain the medication. ^[14]

While the demand is hot, the medication pipeline includes many derivations of GLP-1 RA. Some with additional mechanisms of action or attempts to lessen side effects while hopefully increasing weight loss potential. These products do have potential side effects and it is likely that if a patient stops taking them, the weight will return.

The Acceptance of Care: Lifestyle or Disease?

The Center for Disease Control (CDC) considers obesity a complex disease. The American Medical Association officially recognized obesity as a disease in 2013. However, for commercial clients, weight loss coverage is often driven by benefit design and can be included or excluded if the indication is felt to be lifestyle in nature.

But the tides may be turning. In a recent survey of employer, union and health plan respondents 43% of plans currently cover FDA-approved medications for weight loss and another 28% were considering doing so in the next 1 to 2 years.^[22]

The Centers for Medicare and Medicaid Services (CMS) also currently excludes weight loss and weight gain therapies from Medicare Part D. Current legislation, a bill titled "Treat and Reduce Obesity Act of 2023"^[23], is being proposed by some members of the U.S. Senate. This bill would expand Medicare weight loss management coverage to those who are overweight and have one or more comorbidity. As additional results become available from trials such as SELECT and new indications potentially may be granted to reduce cardiovascular mortality, the coverage landscape may significantly change.

Impact to Pharmacy Care Experience

The influx of pharmaceutical options for weight loss has had an impact on patients, providers and benefit plans. From increased requests and managing medication shortages, to controlling high costs, these drugs are tipping the scale in many directions.

GLP-1 RAs are helping patients experience positive weight loss, but their side effects may be limiting some from long-term use. And, while the use of these drugs may empower some providers and patients to make significant weight loss management changes in relatively short periods of time, the providers are also dealing with possible off-label use of the medications for weight loss for those patients who may not necessarily clinically qualify as overweight/obese.

As more drugs (possibly more effective drugs) are FDA approved, the interest in weight loss products and the challenges for plans and payers will continue.

Payer Action Plan

Payers should closely monitor the use of weight loss medications and GLP-1 RA for weight loss and diabetes. Utilization management tools such as a prior authorization process to prevent off label use of GLP-1 RAs is suggested. As more GLP-1 RAs gain FDA approval for weight loss, a preferred products list may also offer a valuable advantage.

Elixir's clinical team closely watches the pipeline and its National Pharmacy and Therapeutics (P&T) Committee reviews newly approved products for appropriate drug placement and utilization management. Decisions regarding lifestyle vs. non-lifestyle status of weight loss management medication for Commercial payers currently lie in their benefit design choice. Member satisfaction, payer and patient cost, and clinical endpoints such as improvement in cardiovascular health may be points to consider in choosing to cover weight loss medication. Utilization management will continue to be key as lifestyle modifications are considered essential to maintain a healthy weight. Medicare coverage of weight loss medications will continue to be dictated by Centers for Medicare and Medicaid Services guidance and Elixir will review legislation or updates as they occur to help provide guidance.