The Pending Issue with GLP-1 Availability

We have been treating our patients for weight loss for more than 2 years with a variety of medications. We have had excellent results – in pounds lost, in health recovery, and in boosting confidence.

As most of you understand, we have been using vetted compounding pharmacies producing trustworthy medications at a reasonable procing option. NovoNodisk produces Ozempic and Wegovy and Eli Lilly produce Mounjaro and Zepbound. The former is their Type 2 Diabetes medicine while the latter is their weight loss formulation. You know these medications as Semaglutide and Tirzepatide.

These companies invested in research and development of these drugs and have patents on them which will expire over several years time.

• Ozempic patents will begin expiring in 2026-2027
• Zepbound patents will not expire until mid-2030s

Compounding pharmacies have been able to supply us with the base drug because of a shortage situation recognized by the FDA. “Shortage” means that demand for the drug is higher than the amount of medication these companies can produce. Both companies claim there is no longer a shortage.

Keep in mind, this has nothing to do with whether your pharmacy stocks either the medication or the dose you require. Many retail pharmacies simply do not order the drugs because their profit margin is small (or even a negative) after insurance pays the claim. They have also ordered only small quantities because of the exorbitant cost. This leaves patients scattering all over town (or different towns) trying to find their dose. Your mail order pharmacy benefit manager (PBM) can decide not to carry these drugs at all, since most insurance does not cover weight loss.

These two drug companies have said they are not in shortage. The Treasure Hunt is on you, though. Should you choose to have a prescription sent to a local pharmacy and they do not have it, you will be left to search for a pharmacy that has it in stock and have the original prescription transferred. We cannot send prescriptions to seven or eight pharmacies over a week’s time, hoping that one of them has it in stock.

What This Update Means for You

Eli Lilly has made a vial option available in addition to the prefilled pens. The insurance and cash-pay price are significantly lower than the pen price. If you are receiving Tirzepatide and pay cash through the pharmacy and the pens are in stock, you will be able to continue on your current dosing treatment locally. The vials are only available through a Lilly Specialty Mall Pharmacy.

My concern with this process is, how long will your prescription take to arrive? If your prescription is delayed, will your treatment be impacted? Would that be a new shortage, just a minor problem (in their eyes), or a major issue in your struggle to lose weight?

I say the latter.

The pricing on the vial option is listed as “introductory”. Will it stay the same?

They also indicated that once the prescription goes through, the Specialty Pharmacy will contact you and ask about your “usage” of the medication. If your BMI (measure of height vs. weight) does not meet their guidelines, they have the right to decline the prescription. If you are taking Tirzepatide for reasons other than weight loss, they have the right to decline the emdication.

Wegovy does not have a vial option. Using Ozempic or Mounjaro instead of Wegovy or Zepbound is not ethically appropriate for weigh loss in my opinion.

If you have documented (by sleep study) Obstructed Sleep Apnea, both Ozempic and Mounjaro are approved for this indication. Insurance may or may not cover it without a prior authorization. If your primary care physician accepts insurance, I would recommend using that route. As a Medspa, we do not deal with insurance or prior authorizations.

Our Immediate Plan

As of now, we have a limited stock of both Tirzepatide and Semaglutide compounded medication. When you come for your weekly visit, we will administer your injection or dispense your dose for the week. Dosing for multiple weeks is not an option until we have an understanding of the limitations of the stock we will be able to receive.

You will receive a questionnaire about your use of GLP-1 medications. This is to determine if a medical reason for a compounded medication exists. Price of medication is not not a recognized FDA reason to order a compounded medication. (This is the law – not us.)

Please answer these questions honestly. Please stay and fill out your form before leaving the office.

These forms then must be reviewed by medical staff. Keep in mind, all of these forms will need to be reviewed, decisions made, and if appropriate, medication ordered – provided the compounding pharmacies are still allowed to go forward.

What You Can Do

I urge you to contact the elected and appointed individuals in our government who make and interpret the law. REGARDLESS OF YOUR POLITICAL VIEWS, these people can make things happen.

If you get prescriptions for branded medication and have ANY delays or problems getting your medication, please report a shortage situation to the FDA. We can have medication compounded in a shortage situation, and I truly believe we will be back in shortage very quickly. But if you do not report, it will not happen.

I would also like to reveal to you that these companies are not just saying that the shortage is over; they feel so sure that they have convinced the FDA that the shortage is over that they are expanding their introduction of these medications into other companies, including India, Brazil, and Mexico next quarter. They did a limited launch of Zepbound into China last year and plan a bigger launch this year. Wegovy launched in China in November. (Reuters)

To contact your elected officials:

The White House: comments@whitehouse.gov (please note that due to the volume of email they receive, you may not receive a reply, but your request will be counted and processed.)

Department of Health and Human Services: https://www.hhs.gov/regulations/complaints-and-appeals/index.html

FDA: drugshortages@fda.hhs.gov

US Senate:
James Lankford – https://www.lankford.senate.gov/contact/
Markwayne Mullin – https://www.mullin.senate.gov/contact/

US House of Representatives: https://www.house.gov/representatives#state-oklahoma (find your Representative and click on their name to be brought to their website. From there, you will find their contact information.)

Oklahoma Senate: https://oksenate.gov/senators (scroll to find your Senator and click on their picture – from there, you will be brought to their page and can email and/or call their office.)

Oklahoma House of Representatives: https://www.okhouse.gov/representatives (scroll to find your Representative and click on their picture – from there, you will be brought to their page and can email and/or call their office.)