Managing the mad rush on GLP-1s: how to prioritize patients who have on-label prescriptions for diabetes therapy

Shortages in the manufacturing chain have led to label hopping and an increase in off-label use

April 13, 2023

A rush for effective weight loss management has led to shortages in drugs with weight loss indications. Patients are turning to other drugs in that class. This has led to shortages in drugs used for type 2 diabetes.

Additionally, two GLP-1s have label indications for chronic weight loss: Wegovy® (semaglutide) and Saxenda® (liraglutide).

Patients are using the GLP-1s indicated for diabetes for the off-label purpose of weight loss.

Can a health plan effectively identify this on-label and off-label use utilizing only pharmacy claims? A study from Magellan Rx, a Prime Therapeutics company, shows us the answer is yes.

A run on drugs in the GLP-1 class

What caused the shortages in weight loss medications? High demand, social media trends, and manufacturing issues led to a Wegovy shortage.3  Some patients — who would have been taking Wegovy for weight loss — started getting Ozempic solely for off-label use.

This trend has led to shortages of Ozempic. This potential off-label misuse of Ozempic solely for weight loss has impacted patients with diabetes, who now may have to seek alternative therapies.3

As quoted in an article in the New York Times: “These drugs were not designed for normal-weight people who want to get down to be super thin,” said Dr. Janice Jin Hwang, chief of the division of endocrinology and metabolism at the University of North Carolina School of Medicine.4

“Supplies ran short after Ozempic was touted by celebrities and others on social media as an effective off-label substitute for the company’s obesity treatment, Wegovy,”5 she added.

What we know about obesity and type 2 diabetes

Obesity and type 2 diabetes are disease states that can diminish people’s quality of life, increase health care costs, and may require lifelong management and treatment.1

The prevalence of obesity continues to increase nationwide. It is estimated by 2030, obesity and severe obesity in adults may increase to 50% and 25%, respectively.2​ That means half of the U.S. adult population will be classified as obese in less than 10 years.

The prevalence of diabetes is also startling. The number of people in the U.S. with diabetes is 15% (this includes diagnosed and undiagnosed.)6 The prevalence of pre-diabetes adds to the issue. Nearly 40% of the U.S. population has pre-diabetes.7 Common contributors are being overweight and obese.8

In Vanity Fair, Kim Shapira, a registered dietitian, commented on the more problematic, trendy use of Ozempic, “The problem is not Ozempic. It’s people looking for a quick fix, or people who don’t really need the drug, or the absence of other professional help to address the roots of their issues.”9

The marketplace demand for GLP-1 drugs is high. How can a health plan manage the appropriate use of these popular medications?

Prime’s study sought to identify off-label use

Magellan Rx, a Prime Therapeutics company, looked at administrative pharmacy claims to find patients who were prescribed Ozempic or Victoza for off-label use.

The retrospective study was presented at the Academy of Managed Care Pharmacy’s annual gathering in San Antonio, TX in March 2023.

The study used medical and pharmacy claims to identify 27 million continuously enrolled, commercially insured adults. Patients were flagged if they had two or more claims for Ozempic® or Victoza® on two or more different dates of service every year from 2018 to 2021. Patients with diagnoses for type 1 diabetes, pregnancy, pancreatitis, or end stage renal disease were excluded from the study.

Patients who met the criteria were divided into two groups. The on-label group had more one or more one type-2 diabetes diagnosis codes assigned each year. The off-label group did not have a type-2 diabetes diagnosis code.

This study identified 6,528 patients with on-label prescriptions, and 3,099 with off-label prescriptions.

The on-label group was more likely to have a pharmacy claim for anti-clotting or antiplatelet therapy, which may relate to macrovascular complications associated with type 2 diabetes. They were also more likely to have a pharmacy claim for metformin or dyslipidemia (statin) therapy. This falls within guidance with appropriate prescribing for type 2 diabetes.

The study showed that from pharmacy claims data alone, payers can classify commercially insured adult patients into on-label or off-label users of Ozempic or Victoza.

Health plans can use these findings to help them achieve cost savings and encourage the use of on-label use of GLP-1 drugs. This may prevent future shortages for patients with diabetes.


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References

  1. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html
  2. Ward ZJ, Bleich SN, Cradock AL, et al. Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity. N Engl J Med. 2019;381(25):2440-2450.
  3. ASHP Current Drug Shortages. https://www.ashp.org/drug-shortages
  1. What Is Ozempic and Why Is It Getting So Much Attention? By Dani Blum, November 22, 2022. © New York Times. Accessed at: https://www.nytimes.com/2022/11/22/well/ozempic-diabetes-weight-loss.html?action=click&pgtype=Article&state=default&module=styln-weight-loss-drugs&variant=show&region=MAIN_CONTENT_1&block=storyline_top_links_recirc
  2. Weight-loss drugs are a milestone for the obese but expose health inequity, by Laurie McGinley and Lenny Bernstein. December 19, 2022. © Washington Post. Accessed at: https://www.washingtonpost.com/health/2022/12/19/ozempic-mounjaro-wegovy-weight-loss-drugs/
  3. Prevalence of Both Diagnosed and Undiagnosed Diabetes. Centers for Disease Control and Prevention. Accessed at: Prevalence of Both Diagnosed and Undiagnosed Diabetes | Diabetes | CDC, Centers for Disease Control and Prevention. Accessed at:  https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-undiagnosed-diabetes.html
  4. Prevalence of Prediabetes Among Adults. Centers for Disease Control and Prevention. Accessed at: https://www.cdc.gov/diabetes/data/statistics-report/prevalence-of-prediabetes.html
  5. Prediabetes: Definition, Symptoms, Causes, Diagnosis, and Treatment (webmd.com). https://www.webmd.com/diabetes/what-is-prediabetes
  6. Hollywood’s Latest Diet Craze? Ozempic, the Insulin Drug With Vanishing—Literally—Side Effects, by Emily Jane Fox. December 1, 2022. Accessed at: https://www.vanityfair.com/hollywood/2022/11/ozempic-hollywood-diet-drug
  7. FDA Drug Shortages. Accessed at: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

Drug names are the property of their respective owners.

Classification of Ozempic® and Victoza® utilizers into on-label and off-label cohorts

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