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Coping With the Ozempic-Wegovy-Mounjaro Tsunami

News
Article
MHE PublicationMHE June 2023
Volume 33
Issue 6

Insurers are using prior authorization and other managed care strategies to control costs associated with the growing number of prescriptions, on- and off-label, for the weight-loss medications.

Net prices for the new drugs can be more than 20 times higher than the net prices for the older ones and that lifetime use might be necessary to prevent weight regain. © Wild Awake - stock.adobe.com

Net prices for the new drugs can be more than 20 times higher than the net prices for the older ones and that lifetime use might be necessary to prevent weight regain. © Wild Awake - stock.adobe.com

As obesity levels rise to all-time highs in the United States and around the world, a new crop of blockbuster drugs are poised to become game changers for millions of adults who may develop myriad health problems associated with an overabundance of pounds. The drugs present a problem for managed care executives: Should we roll out the welcome mat for these medications, potentially saving on medical costs over the long haul? Or should we clamp down to control what could be a huge short-term expense?

Obesity affects nearly 42% of U.S. adults, the Centers for Disease Control and Prevention (CDC) reports. It has been linked to heart disease, stroke, type 2 diabetes and certain types of cancer, which are among the leading causes of preventable and premature death. In 2019, the estimated annual medical cost of obesity was nearly $173 billion. For obese adults, annual medical costs were $1,861 higher that year than for their healthy counterparts.

“There is a significant unmet need for an effective pharmaceutical option for obesity,” says Andrew Maiorini, Pharm.D., vice president of clinical programs at PerformRx, a pharmacy benefit manager (PBM) in Philadelphia that is part of AmeriHealth Caritas. “As the data continues to demonstrate the effectiveness and safety of these products, we expect the demand will only continue to grow.” The ineffectiveness and side effects of previous generations of medications likely led many states to exclude obesity medications from coverage “as a precautionary measure to safeguard consumers,” Maiorini says, but “now, some state Medicaid plans have started to cover these new products, with prior authorization.”

Off-label use

The FDA has recently approved several new medications for obesity, including Wegovy (semaglutide), while Mounjaro (tirzepatide) and CagriSema (semaglutide–cagrilintide) are under review for this indication (as a weight-loss drug, Mounjaro may be marketed under a different name). In clinical trials, this new wave of drugs has resulted in weight loss ranging from 15% to more than 20% of a person’s prior weight, “representing a clear advance from previous-generation medications (e.g., phentermine–topiramate, bupropion–naltrexone, and liraglutide),” according to Khrysta Baig, M.S.P.H., of the Vanderbilt University School of Medicine, and other co-authors of an opinion piece published recently in The New England Journal of Medicine. But Baig and her co-authors also warned that the net prices for the new drugs can be more than 20 times higher than the net prices for the older ones and that lifetime use might be necessary to prevent weight regain.

Ozempic and Wegovy are the same drug — semaglutide — but Ozempic is the brand name for the semaglutide indicated for diabetes whereas Wegovy is the brand name for semaglutide indicated for obesity. Even so, Ozempic has been used extensively off-label as a weight-loss drug. The FDA approved Mounjaro as a diabetes drug in May 2022, but many people are also taking it off-label to shed excess pounds. “There is an extensive literature showing that off-label use of prescription drugs is associated with an increased risk of adverse drug events,” notes Rosa Rodriguez-Monguio, Ph.D., M.S., professor and director of the Medication Outcomes Center at the University of California, San Francisco. Moreover, the off-label use of these drugs has led to a shortages for patients with type 2 diabetes, she says.

When it comes to weight loss, research has shown that Mounjaro may achieve better results than semaglutide. Some industry experts expect Mounjaro — or whatever it will be called when it is marketed as a weight-loss drug — to become the first drug with more than $100 billion in annual sales. FDA approval of Mounjaro for weight loss is expected later this year.

Gastric emptying

These new self-injectable anti-obesity medications belong to a class called incretin mimetics or GLP-1- based drugs, which simulate the effects of a hormone called glucagon-like peptide 1 that can induce a sense of fullness. (Mounjaro has another mechanism of action.) Due to delays in gastric emptying, “patients tend to eat smaller portions,” says Amanda Pitts, D.N.P., an advanced registered nurse practitioner at a weight management clinic at University of Iowa Health Care In Iowa City. The medications also target neurons in the brain, so they send signals to reduce food intake, says Pitts.

The side effects, which can be tempered by raising the dose slowly, include abdominal bloating, constipation, diarrhea, nausea and a slight increase in heart rate, says Amy Rothberg, M.D., an endocrinologist at the University of Michigan Health in Ann Arbor. The medications are contraindicated in patients with MEN2A, a rare genetic disorder that causes medullary thyroid cancer and benign tumors in the parathyroid and adrenal glands. The drugs also should not be used in pregnant or lactating women or anyone who may be allergic to their components,
Rothberg says.

But Rothberg says the GLP-1 obesity drugs are a clinical advance. “There is now a small trove of highly efficacious medications for the management of obesity. Given the number of people seeking help for excess adiposity, physicians welcome these drugs.”

However, many insurance companies are mandating prior authorization for prescriptions. “This requires time and resources and often hamstrings the providers,” Rothberg says, while emphasizing the need “to be forward thinking.”

“Obesity is a chronic disease that is associated with a multitude of negative health consequences,” says Rothberg.“We need to be treating the root problem. These medications are highly effective. They are one part of the strategy. We also need to change the environment in which we live, including reducing poverty, providing quality nutrition, safe water, safe places to recreate, etc.”

Over the past two years, most payers have been managing anti-obesity medications based on their FDA-labeled indications with utilization management, formulary design or both, says David Lassen, chief clinical officer at Prime Therapeutics, a PBM in Eagan, Minnesota. “The majority of benefit designs across our health plan customers don’t cover GLP-1 medications for weight loss,” says Lassen, while noting that the use of GLP-1s for weight loss has doubled in the past two years, from less than 10% of prescriptions in 2021 to 20% in 2023.

There is, though, a sharp falloff in use, according to Lassen: 70% of members using GLP-1s for weight loss are no longer are taking them one year after starting the drugs.

Lisa Liburd, Pharm.D., MBA, director of clinical pharmacy at Independence Blue Cross in Philadelphia, says the insurer is “focused on helping members address obesity. This includes supporting them as they manage their weight and work to achieve their goals of a healthy body mass index.”

The company offers coverage for weight-loss medications, bariatric surgery and preventive care services, such as obesity screening and behavioral and nutritional counseling. “Member access to that coverage depends on their health plan benefits and if they meet the medical necessity criteria,” Liburd says, adding that “we use utilization management tools like prior authorization to help make sure that the drugs our members are being prescribed are medically necessary and clinically appropriate, and are being prescribed according to FDA-approved, labeled or medically accepted use.”

Susan Kreimer is a freelance writer in New York.

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