Tirzepatide No Longer in Short Supply: Impact on Compounded Medications for Weight Loss and How Patients Will Be Affected by FDA's New Decision

FDA Removes Tirzepatide (Mounjaro, Zepbound) from Drug Shortage List: What It Means for Patients Using Compounded Versions

Tirzepatide No Longer in Short Supply: Impact on Compounded Medications for Weight Loss

As of October 2024, the FDA officially removed tirzepatide (the active ingredient in Mounjaro and Zepbound) from its drug shortage list. This marks a significant change after months of supply issues driven by the high demand for tirzepatide as both a diabetes and weight-loss treatment. As the popularity of GLP-1 medications for weight loss have rocketed, the demand has increased to a point where many patients are having a difficult time obtaining them. Eli Lilly, the manufacturer of tirzepatide, has expanded its production capacity, allowing the drug to return to full availability in pharmacies​ which has led to problems for some providers and patients who rely on the more affordable and equally effective compounded versions of the medication.

Impact on Compounded Tirzepatide

During the shortage, many patients turned to compounded versions of tirzepatide, which were legally allowed to be produced by compounding pharmacies due to the FDA’s shortage designation. These compounded drugs are typically created by combining drug ingredients to replicate medications that are in short supply or altering the total volume of medication or adding other medications like vitamin B-12 which changes the brand name formulary. Now that the FDA has resolved the shortage, compounding pharmacies are no longer permitted to produce and sell new compounded versions of tirzepatide which looks as if it will have an impact on many patients currently on weight loss programs using these compounded versions of tirzepatide​.

This is going to have an impact on the cost of Tirzepatide for patients which may make it unaffordable for many people who rely on the compounded version for their weight loss needs. The removal from the FDA’s shortage list is likely to affect the cost of Tirzepatide in two ways:

Higher Costs for Brand-Name Versions

Mounjaro and Zepbound, which are the FDA-approved branded versions of tirzepatide, are typically way more expensive than compounded medications. Brand-name drugs are subject to pharmaceutical company pricing, which can be significantly higher due to research, development, and marketing costs and corporate profitability. They are a business and will try to maximize their profits, which means charging a premium price for these highly sought after medications. If compounding pharmacies are unable to manufacture and dispense these medications, they can then charge anything they want as there is no alternative for patients. It’s worth it for them to fight this battle in court as well, due to the billions in potential profits that will certainly be at stake.

For example, the average cost of Mounjaro for patients without insurance can range from $1,000 to $1,200 per month for diabetes treatment, and Zepbound for weight loss is similarly priced. Insurance plans may cover part of the cost, but for uninsured or underinsured patients, these prices can be prohibitive, PLUS most insurance plans do not cover the costs of these medications for weight loss, despite the overwhelming evidence that supports their use for improving general health and wellness, which would lower the payouts for comorbidities associated with obesity.

Lower Costs for Compounded Versions

Compounded versions of tirzepatide, produced during the shortage, were often much cheaper since compounding pharmacies are not bound by the same pricing structures as major pharmaceutical companies. Patients could potentially pay significantly less for compounded alternatives—sometimes hundreds of dollars less per month—especially when purchased through specialty or local pharmacies or anti-aging and weight loss clinics.

Now that compounding pharmacies can no longer produce tirzepatide, patients will need to switch to the more expensive brand-name versions, leading to an increase in out-of-pocket costs for those who had previously been using compounded options which may be financially out of reach for many patients who rely on these more affordable medications.

Future Pricing Trends:

With Eli Lilly supposedly now able to meet demands, there is hope that increased availability might eventually lead to price adjustments, either through competition or insurance coverage improvements. However, for the time being, the cost difference between the compounded versions and the brand-name medications will likely remain significant, with compounded versions no longer being a legal alternative​. As Eli Lilly is a for profit corporation with shareholders, the board will most likely do everything within their power to maximize profits and keep their current pricing model as high as possible.

Patients transitioning to branded medications should check with their healthcare providers and insurance companies to explore rebate programs, discounts, or generic alternatives (if and when available) to reduce costs, however different insurance plans will ultimately payout differently for one patient to the next. Semaglutide is a generic medication that has similar results and can hopefully remain available and affordable.

Some good news is that there is a 60-day window after the shortage resolution during which compounded pharmacies can dispense tirzepatide orders that were placed before the FDA removed the drug from the shortage list. After this grace period, compounded tirzepatide will no longer be available legally unless another shortage arises​. Some promising news is that the FDA is considering reversing its decision based on public outcry. The U.S. FDA agreed on October 11, 2024, to reconsider its decision barring compounding pharmacies from producing their own versions of Eli Lilly's popular weight loss and diabetes drugs, Mounjaro and Zepbound. This reversal comes in response to a lawsuit filed by the Outsourcing Facilities Association, representing the compounding industry. The argument is that these compounded versions are often cheaper alternatives, especially for weight loss, where insurance coverage is limited. The FDA's reconsideration allows compounders to continue selling tirzepatide while the agency reviews its shortage status.

The lawsuit, now paused by U.S. District Judge Mark Pittman, highlights the continued shortage of Lilly's drugs and the growing demand for compounded alternatives, which have filled gaps for patients unable to access or afford the brand-name versions​. As for now there are several pharmacies that can still fill prescriptions for compounded tirzepatide for the foreseeable future and we’ll be watching the FDA and possible lawsuits carefully to discover what the future holds for patients, providers and pharmacies alike.

What This Means for Patients

For patients who were using compounded tirzepatide due to the shortage, this development means they will need to switch to the FDA-approved versions of the drug—Mounjaro (for diabetes) and Zepbound (for weight management). Patients who have been using compounded versions should consult their healthcare providers to ensure a smooth transition and determine whether their insurance covers the branded medications.

While compounded versions can sometimes offer a more affordable alternative, patients are encouraged to use FDA-approved drugs when available, as these undergo strict regulatory scrutiny to ensure their safety and efficacy. With Eli Lilly now able to meet demand, the availability of the branded versions should improve, reducing the need for compounded alternatives​.

Future Outlook for GLP-1 Agonists and FDA Regulations

This resolution signals an improvement in supply chains and manufacturing capacity, allowing tirzepatide to be widely available for both diabetes and weight management treatments. Eli Lilly's continued investment in manufacturing, including new facilities, is expected to ensure that shortages do not recur in the near future. This is good news for patients who rely on these medications to manage their health conditions however the BETTER news is the FDA may reverse their decision and patients, providers and pharmacies will have this option available to help combat obesity, which is one of the single largest threats to our overall health and wellness in this country. If you would like to learn more about GLP-1 medications or schedule an initial consultation to discuss weight loss programs with Dr. Mackey please call us at 561-277-8260 to set us an initial consultation.

 

Foley & Lardner LLP   BioSpace