17 Jun

First and foremost let me say, I am not a medical professional, nor do I claim to be. The below article is my own research with links to public domains to show where this was located and found. I myself am a Zepbound user (only) and not compounded medications. Please remember, compound medications are not FDA approved drugs or regulated, while the API that make up the compound may be. I am not making any claims to the safety or effectiveness of any drug product(s). Links below may contain affiliate programs or sponsorships where I may earn additional earnings. 

I am a YouTuber and content creator that has been on Zepbound GLP-1 + GIP injections for 18 weeks now. Gastric inhibitory polypeptide (GIP) and glucagon‐like peptide‐1 (GLP‐1) are the two primary incretin hormones secreted from the intestine on ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic β cells. You can read more about them here if interested. 

For me, an autoimmune rheumatologic patient that has done nothing but gain weight on my cosentyx injections for my ankylosing spondylitis and axial spondyloarthritis; Zepbound (also referred to as Tirzepatide and often interchangeable with Mounjaro - it's diabetic counterpart) has been nothing short of a blessing. Over the course of 1 and a half years I gained close to 80 lbs on treatment aimed to help me "move better". Well, how are you moving better with more weight on your body? At some point, you aren't. I reached that point and finally had specialists agree with me that after trial and erroring MULTIPLE other scenarios, causes, and diets, it WAS and IS the cosentyx injections. I know many of you are thinking, why not just change that medication? I tried 3 others and the next 2 on my "approved drug list" cause unexplained cardiovascular events (aka heart attacks out of no where). So, cosentyx does work. I can move without as much pain and throbbing from inflammation BUT how do I get weight off when it keeps packing on with each injection regardless of what I do?

Enter Zepbound. I lose weight week 1 of each month (let's say 1 lb). The 2nd week I take my cosentyx and gain 2 lbs. Week 3 on Zepbound I lose 0.5 lbs (so I am still up 0.5 lbs) going into Week 4 of each month. So I typically get 1 week a month to actually lose part of my last year and half long weight gain. But beggars cannot be choosers! I am only able to obtain the 2.5 mg Zepbound for the past 12 weeks. BUT here is the real SHOCKER that hit me this week. Pharmacy Benefit Managers (sometimes also called prescriber benefit managers) that work alongside insurance companies are CHANGING the requirements to be able to obtain GLP-1 medications. That's right, the FDA and Manufacturer agreed upon requirements, are being changed by PBMs. Here are a few Images I have found from patients posting what they have recently been sent, or Dr office staff sharing what their office has received. Below I will summarize and what this means for US - The Patients! 

Who is currently eligible to take Zepbound? (per FDA guidelines)

The Food and Drug Administration approved Zepbound for use by adults with a body mass index, or BMI, of at least 30 or a BMI of 27 or more if a patient also has another weight-related condition, such as high blood pressure, heart disease or obstructive sleep apnea. The agency said the drug should be used along with a reduced calorie diet and exercise. Find clinical trail data for this approval, here.

What are the main changes in these New PBM guidelines?

Patient Impact :

- BCBS of Michigan is pulling all access come Jan 2025 (Yikes!) If you think this will not spread across all BCBS in each state, you may want to think again. "Best practices" aka how to save money, is typically a cross company benchmark shared. 

- They also are requiring an ALL NEW PA (prior authorization) come Aug 1, 2024 - Dec 2024 of patients who are currently taking the medication. However with their 2nd requirement of having 6 months of documentation to show the patient is, was, and has been working with a fitness/nutritionist/food tracking system/trainer - MOST people are not going to be able to provide this by Aug 1st to continue their medication. Or at minimum will have over a month in medication lapse due to waiting for a response. 

- Breaks in medication can be extremely difficult for patients and can even lead to additional weight gain or obesity related conditions and complications. Interruptions in GLP-1 medications due to these new stringent PA guidelines can lead to lapses in treatment that can inhibit long term health benefits and outcomes. Why are companies deciding what the requirements should be, and not a medical professional or the FDA?

- Many patients utilize a telehealth provider (such as I use Weight watchers clinic also referred to as Sequence clinic) for their prescription. I personally found that the virtual provider was more thorough that my in person doctor AND they had an entire financial team around helping getting the Prior Authorization approved. My local office spent close to 2 months with every submission being denied. And FYI I am well over the BMI 30 marker and my weight was continuing to go up. WW Clinic also gives you access to nutritionists/dieticians and a fitness coach, PLUS the ability to track your food and water intake. (If you would like to try WW clinic here is $25 off with my personal referral link, you also get your first month free if you qualify per their quiz). However these PBMs are now requiring In person providers ONLY. I do have an issue with this despite everyone knowing my issue with compounded GLP-1s and their access via virtual visits not even checking that they are who they say they are. Many patients live in areas with limited doctor access in general and even less with knowledge of the benefits of these drugs. The in person doctor requirement in my opinion is just another attempt to try and limit access to patients so the insurance and PBM can continue to control what patients can and cannot have, not a medical professional, but the BUSINESSES that are profiting from patients being sick with other ailments. Often conditions related to obesity. 

- I did read that employers are asking for the mandate of the fitness or food tracking systems. Therefore the express scripts letter in my opinion is a new requirement being asked of patients, likely from company's having to cover the cost. After a long day, who wants to go and sit down and have to log lessons, classes, peer groups, or speak to a coach? Or remember to weigh so many times a week? This type of mandatory requirement will also be difficult for anyone with limited access to technology or a lesser understanding of technology. If my father were still alive, someone else would have to set this up for him and walk him through exactly what to do. 

- The required BMI keeps going up dependent on which PBM is overseeing it. Even Medicare has risen it to a BMI of 35+. This means, even if you do gain access to the drug, once you hit this NEW required BMI, they will revoke access all over again. And you have to begin again with your required training, fitness and food logging, or 6 months worth of data before they will approve a new PA for you to gain access again. This type of yoyo back and forth for people in their journey in an attempt to become healthy, is not going to be beneficial (for anyone but company's and insurances). 

What I see happening?

Here are a few things in the news I have seen happening beyond this. First, I have encouraged everyone to watch this YouTube from ABC Australia on their investigation into compounded GLP-1s. This investigation led to Australia BANNING the compounding of all GLP-1s by Oct 2024

I also encourage everyone to watch this panel from the UK on what they see happening as well. 

With new, and more stringent requirements and restrictions around the FDA regulated and approved GLP-1 drugs, I see more and more people moving to the compounded versions. 

Let's face it, they are easier to obtain. But let me be clear, they are not FDA regulated. They are not tested for stability. They are not the "same drug" or of the same integrity as the manufactured brands. The quality requirements and clinical testing around an FDA approved drug for human use is no where near the handful of random quality tests that a compounding pharmacy performs (or maybe does not perform) on their batch they are about to ship out to patients. Based on the state they are in, and who they pay off to look the other way as well, many pharmacies have little to no oversight that are shipping out large batches of compounds a day.  The FDA 503a guidelines state that less that 5% of their compounds should be leaving their own state. This is LAUGHABLE when it comes to GLP-1 drugs. I think the government is about to have a big problem on their hands with these new GLP-1 mandates from insurances and businesses going against the FDA recommendations for these drugs. Ultimately, will the US and FDA have to follow Australia and ban the compounding of GLP-1 all together to try and control this? Do they even care?

Will Bernie Sanders keep going after the manufacturers that are producing miracle drugs for patients, or will his team finally switch over and start going after insurances and PBMs making NEW requirements going against the FDA? Will Bernie's team go after compounders that are not being monitored and making HUGE amounts of cash by shipping drugs out with as little as a random online form being submitted? By putting pressure on the FDA and FDAC, legislatures could easily get this done. But do they take away the "easy access" for patients even though their safety may be in peril? And if they do, how do they get all patients access to the branded, regulated drugs when companies are placing new strict requirements on obtaining them?

Only time will tell. How do you think this is all about to unfold? Watch me weekly on YouTube - here. Let's Chat it out !

- The Ketosis Mom - Jen 

Interested in Compounds? Check out this Blog Post I did on compound GLP-1 research

This Emerge Medical referral link gets you $50 off ($25 off your first 2 shipments) of compound tirzepatide:


- This is a personal referral link, even though I only utilize Zepbound via my insurance to date. 

What can You do? 

Let's all write to Bernie! or at least your own legislators. 

Look up Your Representative here

Look up your Senator contact here  

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