GLP-1s, short for glucagon-like peptide-1 drugs, were initially created to treat diabetes. These drugs are making headlines for reducing blood glucose as well as helping the diabetic population lose weight. Use of GLP-1s in overweight and obese individuals without diabetes has also gained increasing attention. These drugs can result in significant weight loss in conjunction with lifestyle changes that include a reduced calorie diet and increase in exercise. Studies to determine the long-term impact of weight loss with GLP-1s on overall health for individuals without diabetes are ongoing.
Role of GLP-1s in managing diabetes and obesity
The drug semaglutide has ushered in a new era for diabetes, and now obesity, treatment in recent years. Semaglutide is a GLP-1 receptor agonist that mimics a gastrointestinal hormone in the body. It assists in reducing blood sugar levels and curbing appetite, making it effective for managing type 2 diabetes and aiding in weight loss.
Currently (at the time of publication), there are three FDA-approved semaglutide products:
- Ozempic Injection. Approved for the purpose of lowering blood sugar levels in adults with type 2 diabetes mellitus, in conjunction with diet and exercise. It is also approved for reducing the risk of heart attacks, stroke, or death in adults with type 2 diabetes mellitus who have known heart disease.
- Rybelsus Tablets. This medication is the tablet form of Ozempic. Similarly, it is indicated for lowering blood glucose levels in adults diagnosed with type 2 diabetes, and should be used in combination with diet and exercise.
- Wegovy Injection. Wegovy, a higher dose of semaglutide, is approved as a treatment to help adults and children aged 12 years and older who are diagnosed with obesity (body mass index (BMI) of 30 kg/m2 or greater for adults and a BMI at the 95th percentile or greater for age and sex in children), or overweight adults (BMI 27 kg/m2 or greater) who also have weight-related medical problems such as high blood pressure or high cholesterol. Wegovy, in combination with diet and exercise, has shown to help facilitate weight loss.
What plan sponsors should be aware of
It has been estimated, more than 49% of U.S. adults have tried to lose weight in the past year, and 45% of American adults are interested in taking a prescription weight loss medication. Notably, of those trying to lose weight, 59% are interested in a safe and effective weight loss drug, including 51% who are only trying to lose less than 10 pounds. Considering these trends, it’s understandable that employers seek to provide a responsible benefit for their employees while balancing concerns about associated risks versus benefits of GLP-1s, overall health outcomes, and costs.
Coverage of weight loss drugs is likely to vary based on the needs of each member population and plan sponsor. In general, decision-makers should be aware that along with the immense popularity of this class of drugs, challenges and potential drawbacks remain, including:
- Increased utilization has led to product shortages for all GLP-1s, which is estimated to continue at least through 2024.
- When used for chronic weight management in people without diabetes, the clinical benefits (e.g., cardiovascular event reduction) were only studied in people who had a history of heart disease (i.e., heart attack, stroke, peripheral arterial disease), are small relative to the cost of therapy, and were not reached for approximately 3 years. Approximately 67 people would need to be treated for almost 3 years to avoid one individual experiencing a cardiovascular event (i.e., death from a cardiovascular cause, nonfatal heart attack or nonfatal stroke).
- Patients have experienced weight regain following the discontinuation of GLP-1 drugs. More long-term studies are needed to understand the optimal length of therapy needed.
- It is important that individuals have support for diet and exercise for long-term weight management.
- Safety risks can be significant with off-label use of GLP-1s, and evidence of long-term safety is currently limited or unknown.
- At this time, studies do not measure potential adverse events of reduction in lean muscle mass or bone density that may occur with long term use.
- Costs to members prescribed GLP-1 medications, as well as costs to plan sponsors, are a concern.
Monitoring and managing the use of GLP-1s
Employers may wonder, "How can we address the issue of these drugs being intended for diagnosed medical conditions other than obesity, and yet we see GLP-1s may also be useful for weight loss?"
At CarelonRx, we rely on evidence-based programs and policies (e.g., prior authorization criteria) to guide the use of these drugs in individuals with conditions where there is clear evidence of clinical benefit. Our primary goal is to optimize health outcomes.
At the same time, we are focused on reducing waste and managing costs. We do this by discouraging use/coverage where there is no evidence of clinical benefit, and encouraging clinically effective treatments that help ensure access to the right medications for the right conditions at the right time.
That’s why we are closely monitoring clinical trials of GLP-1s. We look for evidence of efficacy and improvements in clinical outcomes prior to FDA approval of these drugs. That includes use for other conditions, such as progressive liver disease (i.e., metabolic-dysfunction associated steatohepatitis/MASH) and heart failure.
This helps us ensure our formulary decisions around GLP-1s are based on the quality of evidence available at the time of review and FDA approval. Similar to other drugs gaining new indications, our Pharmacy & Therapeutics (P&T) Committee will evaluate the evidence to assure clinically appropriate therapy.
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