Ozempic shortages raise questions about priority access for diabetics

Skyrocketing consumer demand for GLP-1 medications to reduce weight has created significant supply problems, and now some patients with type 2 diabetes are unable to obtain these medications, which may be medically necessary for them. This raises questions about ways to potentially prioritize access to these treatments for diabetics and whether government agencies and payers could do more to address this issue.

Glucagon-like peptide 1 receptor agonists are blockbusters in terms of sales. This is due to their ability to help type 2 diabetes patients control their disease by prompting the pancreas to produce more insulin. And this is due to the ability of GLP-1 to reduce the weight of patients by curbing hunger and slowing the movement of food from the stomach to the small intestine.

The popularity of the new wave of diabetes and obesity medications is driven by their effectiveness. At the same time, so have influencers and social media advertising fueled demand not only of people who have diabetes or are overweight or obese, but also of those who want to use these drugs for cosmetic reasons, for example to lose a few pounds.

Now that so many people are prescribed GLP-1s for weight loss, shortages of these drugs have become chronic. To illustrate, some people with type 2 diabetes have failed to take the GLP-1s Ozempic (semaglutide) and Mounjaro (tirzepatide), both of which have marketing authorization as diabetes medications.

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

The image below sparked outrage on fashion brand Namilia’s Instagram, with readers noting that Ozempic is in short supply for those with a medical need for it.

The active ingredient tirzepatide of GLP-1 Mounjaro is the same substance as Zepbound, which is now good for more than 21% of tirzepatide-based sales, Associated press reports. Tirzepatide products combine GLP-1 with another incretin hormone, a gastric inhibitory polypeptide.

Another semaglutide-based GLP-1 product, called Wegovy, was approved by the Food and Drug Administration in 2021 as an anti-obesity drug. There is also a shortage of supply.

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

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

If diabetics miss GLP-1 doses, they can suffer from uncontrolled blood sugar levels, which is a serious health risk.

While drugmakers have invested in factories and ramped up production of GLP-1s, it is unclear how quickly the shortages will be resolved. a British medical journal publication says this is unlikely to happen in 2024.

Because insufficient supply problems persist, the European Medicines Agency has decided considers this is a “major public health problem.” It has advised medical professionals to prescribe these medicines only for what they are approved for and that it is necessary to strictly adhere to national clinical practice guidelines.

In addition, some governments in Europe have explicitly asked doctors not to prescribe GLP-1s for obesity, but instead reserve them for people with type 2 diabetes.

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

French public health officials, for example, have openly criticized the use of social media to promote Ozempic. They fear that online videos promoting Ozempic will cause a other purpose than the treatment of diabetes could lead to insufficient inventory of a medically necessary item.

In March last year, France’s National Agency for the Safety of Medicines and public insurer Assurance Maladie posted a warning saying Ozempic would be subject to “enhanced supervision.” According to Le MondeIsabelle Yoldjian, director of medicines 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 treatment.”

Despite widespread shortages, U.S. government agencies have not asked doctors to reserve GLP-1s for patients with type 2 diabetes. The FDA does list GLP-1s as drugs in shortage and mentions problems associated with counterfeit and compounded products. But no specific recommendations are made to limit the prescribing of such drugs to approved indications.

Some payers in the US restrict prescriptions of Ozempic for weight loss. This means that these insurers not only do not reimburse abnormal use, but also try to influence the prescribing behavior of doctors towards cash-paying patients. An article in the Washingtonpost Last year, it emerged that 14 Anthem BCBS plans warned health care providers in several states about Ozempic prescriptions for non-diabetic patients. However, it is unknown to what extent other payers will follow suit with similar warnings.

Without guidance from the FDA, for example, it is doubtful whether access will be prioritized for diabetes patients. And it is highly unlikely that such an edict will come from an agency that generally takes a hands-off approach to prescribing off-label uses.