Coverage of Weight Loss Drugs & Considerations for Plan Sponsors
By: Ellen Nastase, CPBS – Benecon Director of Pharmacy Benefits
Coverage of Weight Loss Drugs
The latest benefit buzz for employers is whether or not their health insurance plans should include coverage for weight loss drugs. Media coverage by both the drug industry and celebrities has brought significant attention to a class of drugs known as GLP-1s. These drugs were initially developed for the treatment of diabetes; however, a prominent side effect of these drugs is weight loss. The media hype is not only bringing attention to obesity and the quest for being thin, but it’s also causing drug shortages which is concerning for the diabetics who depend on these medications.
Obesity is one of the largest public health concerns in the US, currently impacting approximately 42% of adults, 20% of children, and accounting for approximately $173B in annual healthcare costs (1). Formerly considered a lifestyle issue, obesity was officially recognized by the American Medical Association as a chronic biological disease in 2013, however this shift in mindset has been slow to adopt, with many people still viewing obesity as a lifestyle choice. Some health plans still consider these drugs to be lifestyle drugs and exclude coverage, while others are including coverage for weight loss drugs. Other plans are waiting and watching to see what Medicare does. Although these drugs are currently excluded from coverage in Medicare plans there has been extensive lobbying over the past few years to change this. Novo Nordisk, the manufacturer of Victoza, Saxenda, Ozempic, Wegovy, and Rybelsus, has paid $4.6M last year and $1.3M the first three months this year to lobby the federal government to include weight loss drug coverage under the Medicare benefit (2).
The media frenzy has created a tsunami of interest in these drugs. A report in the American Journal of Health System Pharmacy showed that the drug Semaglutide, marketed as Ozempic, Wegovy, and Rybelsus, was the fourth most prescribed drug in terms of total costs for 2021, coming in at $10.7B, a 90% increase from the previous year. These drugs are classified as Glucagon-Like Peptide-1 Receptor Agonists, (GLP-1), because they work by mimicking the hormone glucagon-like peptide-1, which increases insulin sensitivity, delays gastric emptying, and increases satiety. Patients on these drugs have achieved considerable weight loss; between 15%-20% of their total body weight. In addition to weight loss, these drugs have been shown to lower total cholesterol levels as well as lowering both systolic and diastolic blood pressure. Mounjaro (Tirzepatide) is a newer class of drug to treat diabetes which has GLP-1 activity combined with Glucose-Dependent Insulinotropic Polypeptide (GIP). Although not FDA approved for weight loss, the uptick in prescriptions for Mounjaro seem to indicate that this drug is also being used off-label.
Today these drugs cost approximately $1000-$1500 per month. Due to price and insurance constraints many people can’t afford to stay on these medications long term. Once a patient stops taking the medication, they experience rebound weight gain. Novo Nordisk released a study in March 2023 that found patients who discontinued treatment regained about half of their lost weight within 3 years, and after 5 years they were back to their original weight. Additionally, once the weight was regained the elevated blood pressure and cholesterol levels returned as well. Currently only Wegovy and Saxenda are FDA approved for chronic weight management, and treatment guidelines for chronic weight management for this class of drugs include having a BMI equal or greater than 30 or having a BMI equal or greater than 27 along with at least one “weight related” comorbidity.
The most common side effects of these drugs include hypoglycemia and gastrointestinal side effects such as nausea, vomiting, and diarrhea. Approximately 10% of patients discontinue use of the medicine due to gastrointestinal side effects. Some people who lose weight quickly (both with the use of these drugs and without these drugs) get what is known as “Ozempic face”, a condition where the fat deposits are depleted from their face, causing a gaunt look. Less common but more severe side effects include an increased risk of pancreatitis, gall stones, renal failure, and intestinal blockages. These drugs carry warnings over the increased risks of birth defects and miscarriage and should not be used in women who are planning to get pregnant. More recently there have been reports of suicide and suicide ideation associated with use of these drugs (3). Additionally, these drugs carry a black box warning about dose-dependent and duration-dependent C-cell tumor risks seen in rats during clinical trials.
Considerations for plan sponsors
- Obesity is a chronic complex condition and effective treatment should focus on all aspects such as nutritional counseling, behavioral counseling, exercise, and metabolic health.
- There is an on-going debate regarding the use of BMI to define obesity. Some people with a high BMI are actually metabolically healthy. This makes it difficult to determine which patients are actually best suited to use GLP-1s. Additionally, some comorbidities have a genetic basis and are unrelated to obesity.
- Effective treatment of obesity in appropriate patients will reduce future healthcare costs by eliminating current comorbidities and preventing future comorbidities.
- Drug therapy is not a magic bullet for obesity. To be effective, the GLP-1 drugs will need to be taken indefinitely, and at this time there are no long-term safety data available. Rebound weight gain (and other comorbidities) occurs when these drugs are discontinued.
- Plans that want to provide coverage for these drugs should ensure that proper utilization management programs, such as step therapy, prior authorizations, and reauthorizations are in place.
- Current price per patient for these drugs range from $10,000-$16,000 per year.
- Plans that do not want to cover these drugs need to ensure their PBM is reviewing all claims for these medications to verify that they are only being prescribed for diabetes.
- Current demand for these drugs off-label use is creating shortages for diabetics.
- There are currently more than 70 weight-loss drugs in the pipeline, which, if approved, will create more pressure for plan sponsors to provide coverage.
While some physicians feel that these new drugs are revolutionary and will change the course of obesity, others express concern that these drugs are merely a band-aid that is obscuring a bigger problem. Obesity is a chronic and complex disease that needs to be addressed. The question remains as to how to best address it.