NiceRx and its affiliated healthcare providers are taking measures to assist patients in their weight loss journey. Providers may personalize the treatment plan for patients if deemed clinically appropriate. These adjustments could involve prescribing alternative GLP-1 medications, customized dosing and formulations, and working collaboratively on a personalized treatment plan, in combination with diet, lifestyle, and fitness activities. Compounded semaglutide is a customized preparation created by licensed compounding pharmacies. This process may influence blood sugar regulation, digestion speed, and appetite signals.
But, there’s no training necessarily involved, whereas with the injectables — you do need to make sure that you’re following that correctly. But as you said, pricing remains a question, which will always influence access as well as payer coverage. With drug development costs escalating and competition for trial sites intensifying, manufacturers and payers are under increasing pressure to balance innovation with affordability. “Semaglutide’s manufacturer, Novo Nordisk, has applied for over 300 patents on this one active ingredient in the U.S. alone. They were granted 154 of them,” Kaylor clarified. “The main compound’s patents are now extended from 2026 to 2031. With delivery device and dosage patents, market exclusivity stretches to 2042.”
- Bonello says she’s hearing from more and more patients who are turning to the gray market.
- The program is not for individuals prescribed Ozempic or Rybelsus for weight loss.
- And so that officially ends the temporary permissions that allowed compounding pharmacies and outsourcing facilities to make the different versions of these drugs.
- Your Rex MD-affiliated provider will guide you through the dosing plan that’s right for you.
- These specially designed medications could come with some risks, such as unwanted side effects.
Online pharmacies
“So this sets up a dynamic in which companies on both sides, either compounders or pharmaceutical companies, can threaten to tie them up for a while. And drugmakers are trying other ways to end compounding of the blockbuster drugs. A few days after the suit was filed, the agency said it would re-evaluate its decision, allowing compounders to continue preparing tirzepatide in the meantime. Novo Nordisk and Eli Lilly are moving to end compounding of their medicines for good.
About CenterWell CenterWell is a leading health care services business focused on creating integrated and differentiated experiences that put our patients at the center of everything we do. The result is high quality health care that is accessible, comprehensive, and, most of all, personalized. CenterWell is the largest provider of senior-focused primary care, one of the leading providers of home health care, and a leading integrated home delivery, specialty, hospice, and retail pharmacy. CenterWell Pharmacy’s home delivery pharmacy services are designed to provide safe, convenient, and affordable access to medications, while supporting adherence to treatment plans. Compounding pharmacies serve an important role in the US health care system, offering, for example, ways for patients with allergies to get custom-mixed versions of lifesaving drugs. Advocates of compounding stress that the practice has been around for a long time and that the FDA permits it to preserve vital access to medication.
How to Safely Switch to Ozempic or Wegovy
Here’s everything you need to know about compounded semaglutide availability, including manufacturing deadlines and prices for alternative medications. Novo Nordisk last month filed a petition to add semaglutide, the key ingredient in Ozempic and Wegovy, to an FDA list of drugs deemed too difficult to compound safely. While the FDA looks at a number of factors before deciding whether to take something off the list, including the drugmaker’s ability to fulfill backorders, Lee Rosebush, who chairs the trade group, says the agency didn’t do enough. No one from the agency asked his group order semaglutide tablets or its members how many patients they were compounding the drugs for. Over the summer, Eli Lilly, declared that Zepbound and Mounjaro were “available,” implying that they were not in short supply anymore. On October 2, the FDA formally removed them from its official drug shortage list.
If you’ve been successfully using compounded semaglutide for medical weight loss or blood sugar management, this change could present a serious challenge. If you rely on compounded semaglutide for weight loss or diabetes management, now is the time to secure your supply before the deadline. Legitimate providers will ask about your medical history, current medications, previous attempts at weight loss, and any chronic conditions you’re managing. Your prescription may be based on your insurance coverage, BMI, lab results, and overall medical history. If approved, the prescription is sent to a partner pharmacy or your preferred pharmacy, and Calibrate works behind the scenes to handle insurance prior authorizations, which are often required for these meds. Compounded semaglutide contains semaglutide, a type of GLP-1 agonist medication, and there are alternative medications that contain semaglutide or other GLP-1 agonists like tirzepatide and liraglutide.
While Novo Nordisk and Eli Lilly have started offering certain doses of their products for $500, that’s still higher than those offered by compounders. The dose Futter is on, 12.5 mg, isn’t available under Lilly’s self-pay program, and he worries that a lower dose will be less effective. In February 2022, the 46-year-old from New Jersey had prediabetes and high blood pressure when his doctor asked if he had considered trying a GLP-1 medication. She prescribed him Wegovy, the blockbuster anti-obesity drug made by Novo Nordisk. Health insurance companies may cover Ozempic and Rybelsus if you have type 2 diabetes.
For the past few years, compounded semaglutide has been a key option for medspas looking to meet patient demand during the Wegovy® and Ozempic® shortages. But now, the FDA has declared the shortage over, and with that comes new regulations that will phase out compounded versions. At OVYVO, we take a holistic, patient-centered approach to weight loss, recognizing that lasting success requires more than just a prescription.
Speak with a licensed medical provider for a personalised plan
FDA continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply. There aren’t, you know, those FDA-registered facilities making those anymore because they’re not allowed to. You know, there could be a lack of communication between prescribers and pharmacies with patients. So yeah, the shortage isn’t necessarily being caused by a lack of active ingredients, but just a lack of injector pens. And I don’t know if you wanted to kind of talk a little bit more about that.
Can You Get Semaglutide Without Insurance?
The list price for the brand names is about $1,000 a month or more, while compounded versions can cost hundreds of dollars less. A Novo Nordisk spokesperson points to a study the company funded describing quality issues it identified with compounded versions. The company has also nominated semaglutide to be included on FDA’s lists of drugs that show “demonstrable difficulties for compounding.” Additionally, there are many well-established weight loss medications that have been on the market for decades and remain viable solutions when carefully matched to a patient’s current health status and needs. These time-tested therapies can still play a key role in a personalized, comprehensive weight loss plan. If you’ve tried certain medications before without success, it may be worth revisiting them with your provider to explore whether they could now be a better fit.
For Physicians: Assess & Document Medical Need for Compounded Drugs
Compounded versions of these medications helped fill the gap created during the shortage and have helped some people afford the medications who might not otherwise, but it was a “highly imperfect solution,” says Dr. Wood. Starting in 2022, high demand led to shortages of semaglutide injections sold by Novo Nordisk under the brand names Ozempic and Wegovy, as well as tirzepatide injections Zepbound and Mounjaro from Eli Lilly. It’ll start with a text message, and then you’ll confirm your name and address as it appears on your government-issued ID. Once you’ve confirmed your identity, you’ll review your cart (the Semaglutide option you selected), enter your shipping and payment info, and check out.
