Some Disease Burden of Obesity Requires Pharmacotherapy, Not Just Lifestyle Interventions

The National Health and Nutrition Examination Survey reported that 42.5% of adults 20 years and older are obese, with another 31.1% being overweight, from 2007 to 2018. According to the CDC, national spending on semaglutide reached approximately $10.7 billion in 2021 and increased by approximately 300% between quarter 1 of 2020 and quarter 4 of 2022. Further, approximately 53.8% of patients who are taking a glucagon-like peptide-1 (GLP-1) receptor agonist have a history of type 2 diabetes, though some medications have been approved for indications beyond diabetes.¹

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“For the vast majority of people, they've been trying to lose weight with lifestyle intervention 7 times prior to coming to see a clinician for obesity,” Angela Fitch, MD, chief medical officer of Knownwell, said in a session at the Academy of Managed Care Pharmacy Nexus 2024. “We have patients that who have tried to be successful with lifestyle interventions, and unfortunately, they have lost 5 pounds or so but have gained back.”

Fitch added that, for some patients, the disease burden is so great that they need an intervention for 10% to 15% weight loss, which would call for some pharmacotherapy treatment for patients. For lifestyle intervention alone, patients average approximately 3% to 5% weight loss.

Recently, the FDA removed tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the federal drug shortage list, leading to a lawsuit filed by the Outsourcing Facilities Association. The lawsuit alleges that the action was taken without the required notice and disputes the agency’s warning of a localized supply disruption. As of October 2, tirzepatide was marked as resolved on the FDA website. However, in response, the FDA will reevaluate the shortage of tirzepatide and will allow compounding pharmacies to compound tirzepatide during the reevaluation and until 2 weeks after the agency makes its decision. The agency states that it does not intend to take action against the plaintiffs for conditions including compounding tirzepatide or compounding the drug in bulk under section 503A(b)(1)(D), sections 503B(a)(2)(A), and (a)(5) under the Federal Food, Drug, and Cosmetic Act.²

“Drug shortages are not a new concept,” Mckenzie McVeigh, PharmD, MS, clinical pharmacy manager of Massachusetts Medicaid at the UMass Chan Medical School, said in the session. “The GLP-1s are somewhat unique. Shortage issue have been brought into the public eye.”

Currently, liraglutide (Saxenda, Victoza; Novo Nordisk) and semaglutide (Ozempic, Wegovy; Novo Nordisk) are still in shortage as of October 22, 2024. In the session, McVeigh notes that social media and celebrity endorsements contributed to shortages, which impacted many patients with diabetes. She added that these individuals could see an impact in their glycemic control if treatment is interrupted for 2 to 3 weeks. As a potential solution, some therapy has been reinitiated at lower dosages and alternative dosing strategies.¹

Additionally, Fitch added that a major hurdle for patients who do not have diabetes, but have obesity, is that obesity is not seen as a disease from a payer perspective. She stated that the medical community needs to start treating it as any other disease and have coverage for treatment that shouldn’t be optional or elective.

McVeigh stated that, even with the wealth of data regarding GLP-1 medication, many commercial and state plans have either walked back or stopped coverage. She also highlighted off-label considerations, including prescribing diabetic GLP-1 medication for weight loss in patients without diabetes and oral phentermine in long-term durations.

Currently in the pipeline, investigators are studying semaglutide for nonalcoholic fatty liver disease, tirzepatide for sleep apnea, and cagrilintide (Novo Nordisk), an amylin receptor agonist, in combination with semaglutide for obesity.

“Because of stigma of the disease obesity, there's still an overwhelming belief in society that we can be cured, that you take a medication, and your weight is down and now you’re done. and that is not the case overall,” Fitch said. “This is a chronic disease that we have to manage long term with chronic therapy.”

Eliza Anderson, PharmD, clinical pharmacy program consultant at MassHealth for UMass Chan Medical School, was also a presenter.

REFERENCES

1. Fitch A, Anderson E, McVeigh M. “Pound for Pound” Assessment of Anti-Obesity Medications, Coverage Policies, and Financial Considerations. Academy of Managed Care Pharmacy; Las Vegas, Nevada. October 14 to October 17, 2024.

2. Gallagher A. Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List. Pharmacy Times. October 14, 2024. Accessed October 22, 2024. https://www.pharmacytimes.com/view/outsourcing-facilities-association-sues-fda-over-sudden-removal-of-tirzepatide-from-drug-shortage-list