The supply of GLP-1 drugs for weight loss and diabetes treatment is expected to be strengthened this week due to a federal deadline to halt the sale and production of unbranded products that many patients in the US have relied on.
From 2022, increased demand has led to a shortage of semaglutide injections sold by Novonordisk under the brand names Ozempic and Wegovy, as well as Zepbound of tilzepatide injections and tilzepatide injections from competitor Elilyli. The combined pharmacy was allowed to intervene to fill the supply gap while name branded products were shortages and sold copycat products that used the same active ingredients but were not approved by the U.S. Food and Drug Administration.
However, the FDA declared several months ago that the shortage of semaglutide and tilzepatide injections had ended and effectively ended the flexibility of the combined product. The bounty period, when manufacturers stop producing and selling composite tilzepatide, ends in March, with Thursday being the final cutoff date for composite semaglutide.
Thousands, and possibly millions of patients, have used these combined GLP-1 receptor agonist drugs. This is usually sold at a lower price than branded products, making it more accessible to many people.
Michelle Pierce, who receives a Semaglutide injection from Olympia Pharmaceuticals to help with weight management and hyperglycemia, said her insurance had rejected requests for GLP-1 drugs multiple times before exploring combined product options. The effect was “life and change,” says the 25-year-old from Texas, and she is scared to cancel the progress that will help her avoid back surgery and get her lowest blood sugar levels in A1C levels.
“Now, I’m planning on getting my medicine down because it’s lacking. I really have no other options. I definitely can’t afford to pay completely out of my pocket,” she said.
Olympia Pharmaceuticals offers vials of combined GLP-1 drugs to more than 70,000 people each week, said Josh Fritzler, the company’s chief financial officer. The GLP-1 accounts for about 40% of the company’s production, and plans a suspension date after the shortage is announced.
“We sat down and said, “Here’s the goal. Here’s how we handle it. Here’s what we can do to advocate access to patients. Here’s what we can do to make sure we have a product here. “We had to be transparent. … “OK, we’ll prioritize the need for the shortage for the next three months, so that we can meet as many patients as possible before this transition is over.”
Dr. Jody Duchey, an endocrinologist at Beth Israel Deecones Medical Center and an assistant professor of medicine at Harvard Medical School, not only does not support the use of combined GLP-1 drugs, but he also said he is worried that the restrictions could add a new strain to the overall supply.
“There is no security that (combined version) is FDA-regulated. I don’t know what this compound has. I don’t know about purity. I don’t know about safety. I don’t know about dosage. I don’t know about drug interactions,” says Dushay. “I really don’t want to take responsibility for that.”
But the new restrictions could make her look for new prescriptions from providers like her, she said, for some people who rely on compound products.
Those who use GLP-1 injections usually start with a low dose of medication and scale up gradually. Combined versions of drugs do not necessarily follow the same effectiveness and strength standards as branded products, Dushay said, making one-to-one swap difficult, and assessing each patient’s new prescribing needs regardless of the combined drug dose they were using.
“I’ll try them again. I’ll start them with the starting dose,” Dushay said. “So the question is: Will pressure increase at the starting dose of tilzepatide and semaglutide?”
The limitations on composite GLP-1 products are due to concerns over existing shortages budding.
The FDA declared that the shortage of tilzepatide and semaglutide has ended, saying that the drugmaker’s “product availability and manufacturing capacity can meet current and projected national demand.”
“Patients and prescribers may see intermittent localized supply disruptions as products pass supply chains from manufacturers and distributors to local pharmacies,” the agency said when it was declared that the shortages for each were over.
In an email to CNN, Novo Nordisk said it was in Wegovy and Ozempic’s “continued dialogue with the FDA on manufacturing and supply,” and said the company is “confident” in supply since the shortage ended. Recent investments in building and expanding manufacturing capacity have helped grow supply, Novo said.
A spokesman for Lily said in a statement that Zepbound and Mounjaro are “fully available” to patients and “should not be exposed to untested, unapproved, imitation products.”
“People who continue to sell bulk compound Tilze Patide, including what they call “personalized,” “customized,” or similar, are breaking the law and putting their patients at risk,” Lily’s statement said.
Both Novo Nordisk and Eli Lilly are taking steps to reduce costs and make access easier, such as creating online platforms and providing single-dose vials instead of injector pens.
“We had a direct conversation on behalf of the Outsourcing Facilities Association and provided information to both the FDA and the HHS, which we believe that these products (both GLP-1) are still lacking. “My fear when the deadline comes at the end of this week is that patients and providers don’t have access to the medications they need and will be financially impacted as they move forward for this.”
The Outsourcing Facility Association filed a lawsuit against the FDA over the “sudden removal” of tilzepatide and semaglutide from the drug shortage list, but in both cases the judge ruled that the FDA plan would allow the combined product to continue.
Healthcare providers say they have noticed an improvement in the availability of GLP-1 drugs since the shortage ended, but unstable insurance on drug coverage is hindering accessibility.
“The shortage is much better. Insurance coverage is much worse,” says Dr. Disha Narang, endocrinologist and director of obesity medicine at Endeavor Health. “From a practical standpoint, patients are unable to obtain medication employer benefits, which is currently possible that almost 50% or more in our country will qualify. So it’s a very strange time to try and justify insurance companies that obesity is a chronic disease.”
Pierce, which uses the combined product, said it has stocked supply for six months. However, on the online community forum she is part of it, and some members have just started on combined medicines without knowing that they can lose access right away.
“I’m definitely afraid and I’ll do whatever I need to do to avoid fallout,” she said. “But unfortunately, I don’t have much control over the situation.”