GLP-1 Shortages Raise Questions About Prioritizing Access for Diabetics

As consumer demand has skyrocketed for GLP-1 medications to reduce weight this has created substantial supply issues. Sometimes type 2 diabetic patients can’t obtain medically necessary GLP-1 drugs. This raises questions about ways to possibly prioritize access to these treatments for diabetics and whether government agencies and payers could do more to address this problem.

Glucagon-like peptide 1 receptor agonists are blockbuster drugs in terms of sales. This owes to their ability to help type 2 diabetes patients manage their disease by inducing the pancreas to make more insulin. And it’s due to GLP-1s’ capacity to reduce patients’ weight by curbing hunger and slowing the movement of food from the stomach into the small intestine.

The popularity of the new wave of diabetes and obesity drugs has been driven by their effectiveness. At the same time, social media—influencers and advertisements—has fueled demand from not only people who have diabetes or are overweight or obese, but also those who may want to take these drugs for cosmetic reasons, such as to shed a few pounds.

With so many individuals now being prescribed GLP-1s for weight loss, shortages of the drugs have become chronic. To illustrate, some type 2 diabetics have been unable to get the GLP-1s Ozempic (semaglutide) and Mounjaro (tirzepatide), both of which have marketing authorizations as diabetes medications.

Ozempic is often used off-label for weight loss. Such use accounts for at least 32% of the product’s sales nationwide, according to CNN. And one analysis conducted by Anthem Blue Cross Blue Shield suggests that the percentage could be much higher. Of the patients for whom doctors prescribed Ozempic, Anthem’s review found that more than 60% lacked “sufficient evidence” of diabetes.

The image below triggered an outcry on the fashion brand Namilia’s Instagram, with readers remarking that Ozempic is in short supply for people with a medical need for it.

The GLP-1 Mounjaro’s active ingredient tirzepatide is the same substance contained in Zepbound, which now accounts for more than 21% of tirzepatide-based sales, Associated Press reports. Tirzepatide products combine GLP-1 with another incretin hormone called a gastric inhibitory polypeptide.

Another semaglutide-based GLP-1 product named Wegovy was approved by the Food and Drug Administration as an obesity drug in 2021. It too is in short supply.

More than 90% of semaglutide-based drugs were prescribed for type 2 diabetics in 2018. That percentage dropped to 58% in 2023 as many people are now taking medications such as Ozempic and Rybelsus off-label for obesity, as well as Wegovy on-label.

NPRreveals that pharmacists are even running out of the GLP-1 Trulicity (dulaglutide) which is approved strictly for diabetes but can be used off-label for weight loss.

If diabetics miss GLP-1 doses this can lead to uncontrolled blood sugar, which is a serious health risk.

While drug manufacturers have invested in factories and are ramping up production of GLP-1s, it’s unclear how soon the shortages will be resolved. A British Medical Journalpublication says it’s unlikely to happen in 2024.

As insufficient supply problems persist, the European Medicines Agency considers this a “major public health concern.” It has advised medical professionals to only prescribe these medicines for their licensed uses and that it is necessary to strictly adhere to national clinical practice guidelines.

Furthermore, some governments in Europe have explicitly asked clinicians not to prescribe GLP-1s for obesity and instead reserve them for people with type 2 diabetes.

This has led to closer scrutiny of off-label use prescribing in countries such as Sweden, the United Kingdom and France.

French public health officials, for example, have openly criticized the deployment of social media to promote Ozempic. They worry that because the online videos are promoting Ozempic for a different purpose than treating diabetes this could lead to insufficient inventory of a medically necessary item.

In March of last year, in an alert posted by the French National Agency for the Safety of Medicines and the public insurer the Assurance Maladie the two entities stated that Ozempic would be subject to “enhanced surveillance.” According to Le Monde, Isabelle Yoldjian, director of drugs in oncology, cardiology and endocrinology at FNASM, said that “given the shortage situation, any use of Ozempic by people who do not need it risks depriving patients of their treatment.”

Despite widespread scarcity, U.S. government agencies have not asked clinicians to reserve GLP-1s for patients with type 2 diabetes. The FDA does list GLP-1s as medications experiencing shortages and cites problems related to counterfeit and compounded products. But it does not make specific recommendations to limit prescribing of such medicines to licensed indications.

Some payers in the U.S. are clamping down on prescriptions of Ozempic for weight loss. This means that not only are these insurers not reimbursing off-label uses, they’re also trying to influence doctors’ prescribing behavior with respect to cash-paying patients. An article in the Washington Post last year indicated that 14 Anthem BCBS plans cautioned healthcare providers in several states about Ozempic prescriptions for non-diabetic patients. It’s unknown, however, the extent to which other payers are following suit with similar warnings.

Without a directive emanating from, say, the FDA, it’s doubtful that access will be prioritized for diabetes patients. And such an edict is very unlikely to come from an agency that generally takes a hands-off approach regarding off-label use prescribing.