(Bloomberg) -- Americans who turned to telehealth companies and compounding pharmacies for cheap versions of Eli Lilly & Co.’s weight-loss drugs are scrambling to figure out if they’ll still have access after US regulators signaled an end to their unfettered use.
Lilly is now able to produce enough of its blockbuster obesity and diabetes medicines that the nationwide shortage of Mounjaro and Zepbound is officially over. As a result, regulators can begin cracking down on the industry that sprang up overnight to make the copycat versions that quenched surging demand.
The message from Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding, the industry’s major trade group, to his members and stakeholders is to “immediately cease preparing and dispensing compounded copies of Mounjaro, Zepbound.”
Thousands of patients came to rely on knockoff versions of drugs made with tirzepatide after shortages began as early as 2022. The US Food and Drug Administration allows compounding pharmacies to make copies during shortages, without conducting the rigorous studies typically required of pharmaceuticals.
“I am absolutely terrified,” said Diann Smith, a 59-year-old nurse in Honolulu, who lost more than 60 pounds using the drugs for more than a year. “When we lose compounded tirzepatide, I will be instantly priced-out of my medication.”
Smith says she’s healthier than she’s been in 30 years, but her insurance won’t cover the treatment.
Imperiled Industry
Resolution of the shortage is threatening the market that bankers estimate exceeds $1 billion in annual sales, perhaps significantly given how little information is available.
Many businesses are trying to figure out how to handle the change, leaving patients in the crosshairs.
Mary Esther Prado, 60, was trying not to worry after the compounded version of tirzepatide she gets from the telehealth company Join Fridays showed up as no longer available on its website. A company response acknowledged her concerned but provided few answers.
“We are actively working to understand how this impacts compounded versions of the medication and exploring all options to maintain our standard of care,” it said. The company “will provide updates as soon as we have more clarity.”
Brand Name Switch
While telehealth companies can start prescribing brand name versions instead of compounded copies, they would likely generate a lower profit margin even at a higher cost to patients.
These companies sell the compounded versions for as little as $150 cash, while Lilly’s shots typically cost around $1,000 a month. The drugmaker recently started selling vials directly to patients for as little as $399 a month.
The FDA began laying the groundwork for the changes ahead, saying it was clarifying policies for compounding pharmacies as the national supply of the medication begins to stabilize.
If the agency determines a compounder has violated the law, their products could be seized and they may be subject to an injunction or criminal prosecution, a spokesperson said.
The agency’s backing is a win for Lilly, which launched legal battles against the telehealth firms, medical spas and compounding pharmacies that sell copies of its drugs.
But there is wiggle room. Compounding pharmacies are allowed to keep making copies as long as it’s not done regularly or in “inordinate” amounts, the agency said. Outsourcing facilities, another category of pharmacy, can fill prescriptions received during the shortage until two months after it ends, the FDA said.
Ozempic Access
Compounding pharmacies can make copies of Ozempic and Wegovy, similar drugs sold by Novo Nordisk A/S, as they remain on the shortage list. That could soon change, as all strengths are currently listed as available except the lowest dose of Wegovy, which has “limited availability.”
Some telehealth companies, like Pomegranate, are already switching willing patients to compounded versions of Novo’s drugs. Others have given conflicting reports. OrderlyMeds is offering multimonth vials so patients can “stock up.” LifeRx.md, Emerge Weight Loss and Lavender Sky told patients they can keep providing compounded versions of Lilly’s tirzepatide.
“We have been communicating with pharmacy leadership, and as of this morning, orders are still able to be fulfilled,” Lavender Sky told patients in a message seen by Bloomberg.
The company, which operates out of areas devastated by Hurricane Helene, said it’s getting overrun with emails and refill requests. It asked for patience, saying several staff members and providers are still out of power.
Others told patients availability will depend on the compounding pharmacies that provide them.
Thursday was the last day Red Rock Pharmacy would fill prescriptions for compounded tirzepatide, a pharmacist technician at a store in Utah said. It will soon begin offering “personalized” formulations for the drug combined with glycine, an amino acid that is naturally produced in the body, they said, though the transition will take some time.
One of the largest compounding pharmacies, Hallandale Pharmacy, didn’t immediately respond to a request for comment. Tirzepatide injections were still listed on its website as of Friday.
--With assistance from Ike Swetlitz.
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