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Approvals, Shortages and More: The Latest in GLP-1s

December 18, 2023 by Ernesto Munoz, PharmD

Semaglutide is part of a class of drugs referred to as glucagon-like peptide-1 (GLP-1) receptor agonists. Currently, there are three Federal Drug Administration-approved semaglutide products, including two injectable products, Ozempic and Wegovy, and one oral product, Rybelsus. The latter are FDA-approved in combination with diet and exercise to control blood sugar in adults with Type 2 diabetes. Ozempic has an additional FDA-approved indication of reducing the risk of cardiovascular events in patients with Type 2 diabetes. Wegovy, however, carries a unique indication for chronic weight management when used in combination with a reduced-calorie diet and increased physical activity for chronic weight management. While all three products contain the same active ingredient, the FDA has granted approval for each under different indications.

As of May 2023, Ozempic and Wegovy were listed on the FDA’s drug shortages list (Drug Shortages | FDA). When medications are placed on this list, the FDA permits designated pharmacies to compound these medications with the intention of alleviating the supply burden caused by drug shortages. Drug compounding is the process of mixing or altering two or more ingredients to create a medication tailored to the patient’s needs. The FDA does not verify the safety, efficacy or accuracy of compounded medications, making these products not approved by the FDA. The shortage of these popular medications has resulted in compounding pharmacies producing semaglutide in different salt forms not considered safe by the FDA. This can lead to the exposure of a potentially non-efficacious and dangerous medication without the knowledge of the patient. It is important for patients to know they should only obtain drugs with semaglutide from a licensed health care provider and from state-licensed pharmacies or outsourcing facilities registered with the FDA.

When medications are placed on the FDA’s shortage list, it is the only time branded drugs may be produced by a different entity with fewer restrictions. With GLP-1s, this has led to the rise of med spas, clinics and certain compounding pharmacies to prescribe and compound non-FDA-approved forms of semaglutide. Novo Nordisk, the manufacturer of Ozempic, Wegovy and Rybelsus utilizes the only FDA-approved ingredient which is the base form of semaglutide. Other clinics claiming to compound semaglutide may use salt forms of active ingredients such as semaglutide sodium and semaglutide acetate, leading to the rise of alternative dosage forms for semaglutide, such as lozenges.

Plan sponsors must ensure their plan design accounts for potential prescriptions members may be filling at a compounding pharmacy. This includes implementing levers like a prior authorization on compounded prescriptions over a certain cost amount to ensure no non-FDA approved versions of semaglutide are being dispensed to plan sponsor’s members. Plan sponsors should educate their population on the dangers of acquiring medications that are not FDA-approved, as this could potentially lead to dangerous side effects that would cause more harm than benefit from utilizing the medication.

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