In May of 2022, the FDA approved Mounjaro, a new drug from Eli Lilly for patients with type two diabetes. The drug primarily helps control blood sugar, but the Surmount-1 Trial also showed that Mounjaro, also known as Tirzepatide, significantly aids in weight loss. While Mounjaro is currently only FDA-approved for type two diabetes, many doctors, including myself, are prescribing this medication off-label for the disease of obesity based on the trial data. Tirzepatide is being fast-tracked to be approved for the disease of obesity; it will have a different name but it will be the same active ingredient, Tirzepatide.

 

GLP-1 agonists, including Mounjaro, work by saturating hunger receptors in the brain, saturating reward centers in the brain, and slowing down our gastrointestinal system. Some of the strongest ones decrease weight on average by 22%, which rivals gastric sleeves. On top of this, they are very safe and have few side effects.

 

Mounjaro Coupon Cards

One of the main barriers to treatment with these medications for type two diabetes or obesity is cost. The average cost is somewhere between $900 and $1200 per month. Most insurance companies do not cover Mounjaro for the FDA-approved use of managing diabetes yet because it is not on their medication formulary. In addition, many insurance companies do not recognize obesity as a disease and may not cover any medications approved for obesity.

 

To lower the cost and promote their new drug, Eli Lilly put out a coupon card. Here’s how the coupon cards work:

1. A doctor sends a Mounjaro prescription to a pharmacy.
2. Patients download a coupon card from the Eli Lilly website & submit it to the pharmacy.
3. Before the pharmacy can apply the coupon card, they must verify if your insurance will cover the medication.
4. The pharmacy sends a prior authorization form to the doctor. Once complete, the form is sent to the insurance company, which may approve the medication in 1-3 weeks.
5. After approval, the pharmacy can then apply the coupon card.
6. The pharmacy pays the full $1200 cost for the medication and Eli Lilly reimburses them.

 

Patients could use the original card to get the medication for $25 per month; however, these coupons will expire on June 31, 2023. Coupon cards printed after October 2022 do not get it down to $25 a month, but instead to about $500 a month. New coupon cards now also ask patients to confirm that they have been diagnosed with type two diabetes.

 

The coupon cards generated a lot of demand for both approved and off-label use of Mounjaro.

The growing demand placed a large burden on the pharmacies, as reimbursement could take up to 90 days. Unfortunately, neither the doctors’ offices nor the pharmacies have any control over the coupon cards, insurance coverage, or the final medicine prices.

 

Keeping the Weight Off

Patients have seen for themselves how effective Mounjaro has been in curbing hunger and shedding weight. No one wants to regain their weight when the coupons expire and the drug becomes too expensive to purchase out-of-pocket.

 

Obesity is a chronic disease that requires long-term management. The American Medical Association recognizes obesity as a chronic disease that returns when treatment stops, similar to how high blood pressure returns when we stop treatment. Without pharmaceutical interventions, most people with obesity will regain their weight within three years.

 

To prevent weight regain, when a patient with obesity reaches their goal weight, we start a comprehensive maintenance plan. By that time, we hope we have instituted good nutritional practices, physical activity interventions, and behavioral interventions in addition to the medicines. At goal, we begin weaning off the medicine, and stop when we find the lowest effective dose to maintain the weight loss. Hunger will increase as medications are reduced so we adjust until we find the sweet spot.

 

We know patients with obesity need to utilize medicines for both initial weight loss and long-term maintenance, so those currently using the coupon card for Mounjaro need a plan!

 

What Do I Do When My Mounjaro Coupon Expires?

Many patients have experienced success losing weight with Mounjaro and the coupon card has made it very affordable. When coupon cards are no longer available, there are multiple strategies we can try.

 

• Other Off-Label GLP-1 Agonists

For my patients, we hope to change their medication from Mounjaro to an FDA approved  GLP-1 agonist for obesity. There are only two: Wegovy and Saxenda. Checking to see if you have coverage for Wegovy is very simple and takes less than 2 minutes. Simply go to http://www.wegovy.com. Click the red “Check Your Cost and Coverage” button. Fill out the appropriate fields. When finished it will tell you immediately whether or not you have coverage for this medication. If you have coverage then let us know and we can prescribe this medication as long as you do not have any contraindications.

 

Unfortunately, most insurance companies do not recognize obesity as a disease, and therefore do not cover anti-obesity medications. Based on my practice, I would estimate 10% of insurance companies cover FDA-approved anti-obesity medications.

 

One way that doctors have gotten around this is by prescribing GLP-1 agonists off-label–– meaning medications are prescribed for something other than their primary use. For example, if an insurance company does not cover the anti-obesity medicine Wegovy, they may approve the type two diabetes medication Ozempic, which is the exact same medication in a different form and dosage increments. They both use the same active ingredient, Semaglutide. However, when prescribing off-label medicines, we may run into the same issues as the coupon card with prior authorizations and a type two diabetes diagnosis. Examples of GLP-1 agonists used off-label are Ozempic, Trulicity, and Victoza.

 

• Medicare or No Medical Insurance

If you have Medicare or no medical insurance at all then we could apply for assistance through the drug manufacturer (Eli Lilly or Novo Nordisk) which means they send you the medication for free as long as your household income is less than $109,000 per year.

 

• Canadian Pharmacies

Another option is that some patients choose to get their GLP-1 agonists filled in Canada and then shipped to them. The cash cost is much cheaper. For a 30-day supply of Ozempic, it can be as low as $350/month.

 

• Other Medicines

If your insurance does not cover a GLP-1 agonist then we can change to a completely different class of medication. These medications could include but are not limited to Phentermine, Diethylpropion, Lomaira, Qsymia, Topiramate, Zonisamide, Contrave, Metformin, and Plenity. We use many of these in combination.

 

Some of the medications above can be very cheap, even if your insurance does not cover them. We are talking less than $20 per month. They are not as potent as Mounjaro or the other GLP-1 agonists but we can get pretty close. Even if we gain back a few pounds when switching, these medications can help to maintain a majority of the weight loss.

 

Avoiding Compounded Ozempic/Semaglutide

When searching for cost-saving alternatives, patients may come across compounded Ozempic/Semaglutide. Compounded medicines are combined by a pharmacist; they are not covered by insurance but are generally much less expensive. I have included the policy statement regarding compounded Ozempic/Semaglutide from the Evidence-Based Obesity Medicine Practices group I am a part of.

 

We are collectively against the use of compounded Semaglutide. Below details why compounded Semaglutide violates evidence-based practice.

 

Questionable Raw Material

Semaglutide is a patented molecule. Authentic Semaglutide is only available via Novo Nordisk. Only they make it, and they have affirmed they do not sell it to anyone. Sure, it’s a peptide, and the formula is known. Therefore, a molecular biologist/chemist could theoretically synthesize the molecule in the lab. So it is possible that it could be sourced through alternate manufacture, but that violates the patent and without potency or purity standardization.

 

Questionable Manufacturing Standards 

Just because you can synthesize a molecule does not mean there is batch-to-batch, lot-to-lot product consistency. FDA-registered manufacturing facilities must adhere to current Good Manufacturing Practices. One such standard is product consistency. Compounding facilities are not required to adhere to this standard. Pharmaceuticals (but not compounded products) must maintain such standards so that the finished product performs as advertised, and is consistent with published evidence. Think about it: as a clinician, you trust that the product dispensed at the pharmacy is the same as what was tested in clinical trials. Since compounding pharmacies are not required to adhere to cGMP standards, product consistency cannot be assured. And as is not available from the source manufacturer, the product cannot meet cGMP standards.

 

Product Adulteration

One of the standards of compounding is that a compounded product cannot be commercially available. Thus, compounding pharmacies add agents to the active ingredient (e.g. cyanocobalamin). This alters Semaglutide or changes it in a manner that is not the same as authentic Semaglutide used in clinical trials or in branded Semaglutide.

 

Deceitful Practices

In the early age of the specialty of obesity medicine, we are focused on setting standards. We have enough questionable practices in the field of Obesity Medicine to contend with. What we do not need are compounding pharmacies publishing deceitful marketing advertisements promoting a product that violates any or all of the above. This serves to erode public trust in the practice of evidence-based medicine.

 

Going Forward

We hope that in the future insurance companies will recognize obesity as a chronic disease and cover anti-obesity medications. Until then, we have strategies and resources we can use to help patients with obesity get the medications that will help them manage their disease.

 

I hope this was helpful. For an abbreviated version, see my video.

 

Seth Jarrell, MD

Diplomat of the American Board of Obesity Medicine

 

Surmount-1 Trial of Tirzepatide/Mounjaro: https://www.nejm.org/doi/full/10.1056/NEJMoa2206038

N Engl J Med 2022; 387:205-216

DOI: 10.1056/NEJMoa2206038