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If there is a diet, Janet McCaskill says that she is done.
“I tried WeightWatchers. I have tried keto. I went to a nutritionist,” says the 58-year-old grandmother, who lives outside Raleigh in Knightdale, North Carolina. She said some meal plans worked — until they didn't.
In the year In late 2022, weighing about 212 pounds and fearing for her health after losing her brother and both parents to heart disease, McCaskill began using Mounjaro, a diabetes brand for weight loss. It belongs to a class of drugs known as GLP-1 receptor agonists, which also includes Ozempic, Wegovy, and Zepbound.
“It really saved my life,” she said.
But it was expensive, and after switching to a lower-cost drug made by a compounding pharmacy last year, McCaskill is worried she'll lose access to her drugs now that the U.S. Food and Drug Administration has found the brand to be in short supply. The drug has expired – this means that the synthesis of the drug must be stopped.
Legislation that allows compounding pharmacies to step in to fill gaps in drug supply has given thousands or millions of people access to expensive GLP-1 drugs at lower prices — something some doctors worry could raise safety issues because compounded drugs are not approved by the FDA. But it was a lifeline for people like McCaskill. And pharmaceutical manufacturers are increasing dramatically. SupplyTheir access is changing rapidly.
“I was devastated to say the least,” she said.
In a little more than a year, McCaskill said, she has lost nearly 100 pounds and has maintained her current weight of 117 pounds. Her blood pressure is low, and her blood sugar measurements A1C and triglycerides are down, she said. She changed her diet dramatically and started exercising more.
She said McCaskill's four grandchildren, ages 6 to 12, were the “number one reason” for starting the drug. “They enjoy it, and I'm as active with them as ever.
McCaskill, the office manager for Auto Restoration and Repair, said her insurance never covered Mounjaro. The drug uses the active ingredient tirzepatide and was approved By FDA in May 2022 for type 2 diabetes; Although McCaskill said her blood sugar was high, she didn't have diabetes, and many plans don't cover drugs for GLP-1. Weight loss.
She paid out-of-pocket instead, using a coupon from manufacturer Eli Lilly that cut the cost in half, but was still about $500 a month, she said.
Lilly Coupon Program By the summer of 2023, McCaskill's health care provider has proposed another option: compounded tirzepatide, a version of the drug that has not been approved by the FDA but is legally available through a local pharmacy. A month's supply was less than $250. McCaskill changed and continued to see benefits, she said; She's been on that version ever since, and her husband started on it too.
But now she was worried that both of them would have to stop.
Last week the FDA updated database Deficiency drugs to eliminate tirzepatide placed in that list – with related semaglutide-specific drugs, Ozempic and Wegovy – from 2022 in an unprecedented manner Desire.
The move means the compounding of tirzepatide, as done by Maxkill's Local Pharmacy, must end. And although it's a sign that tirzepatide-based drugs — Mounjaro, for diabetes, and Zepbond, approved by the end of 2023 for weight loss — are widely available, it has thrown people like McCaskill into a panic.
“I was working until around 10pm last night to answer patients' questions,” he said. Michelle KesslerA physician assistant at the Durham Women's Clinic and Maxkill Services in North Carolina. “I have all these patients who are doing really well and suddenly they stop without warning.”
Compounding drugs that are “primarily copies of commercially available drugs” is approved by the FDA during a shortage, the agency said. He says.But when the deficiency is resolved, it is allowed only if it is not done “routinely or excessively”.
Often times patients need a medication adjustment, perhaps because they are allergic to an ingredient in the original version or need a liquid instead of a pill.
“It's like you walk into a bakery, and you want chocolate cupcakes with white icing, we make those. If you want vanilla cupcakes with blue icing, we can do that,” said pharmacist and pharmacy owner Jennifer Birch. Central mixing center in Durham, where Kessler refers her patients to mixed tirzepatide. “We can do it any way you want.”
Her pharmacy even makes medicine for pets and can adjust the flavor according to the animal's preference: fish, chicken or, in one case, bubble gum.
“It's me, how did you know the cat likes bubble gum?” Burch said.
But lately, she said, her staff has been working around the clock to combine tirzepatide and semaglutide. In the past six weeks, they have filled nearly 900 prescriptions for tirzepatide and 500 prescriptions for compounded semaglutide, using the active ingredient they buy from chemical suppliers to verify the quality of their products with a prescription known as a booster test, she said. Levels.
Burch's Pharmacy charges $200 to $400 per month for compounded tirzepatide, depending on dosage.
Without insurance, Mounjaro expenses $1,069 per month, and A zipper According to Lilly, it's $1,060. The company also offers a savings card for ZepBond 650 dollars per month for certain patients with commercial insurance that does not cover the drug.
Lily in August Introduced Cheaper versions of Zepbond with lower dosages that come in single-dose bottles. Patients should take out the medicine and inject it with a needle. Standard forms of the drug come in autoinjector pens.
Bottles are available for self-pay through the Lilly program LillyDirectThis makes it easier to find doctors and transport medicines to patients. They charge $399 for the minimum amount for a four-week supply or $549 for the next amount — one McCaskill on.
“Many of us can't afford to continue paying that,” McCaskill said.
Evan Seigerman, a BMO Capital Markets analyst who closely follows Lilly and Novo Nordisk, said it's unclear how many people use the combination tirzepatide and semaglutide because prescriptions aren't filled through traditional channels. Medicines Ozempic and Wegovy.
Some estimates put prescriptions for compounded versions at over 20% of all medications.
Scott Brunner, of CEO Pharmacy combinationit is estimated that millions of people may be using integrated versions – and many will not switch.
“The price is not reasonable to distribute a compounded drug, but the reality is that many patients are able to buy the compounded versions of tirzepatide, and they cannot buy the drug approved by the FDA.” Brunner said.
His organization asked the FDA for at least a 60-day buffer before the merger was stopped to “ensure continuity of patient care.” He said he has heard from more than a dozen member pharmacies that even though the shortage has ended, tirzepatide products are still not available in their ordering system.
The FDA has recognized it press release “Patients and pharmacies may still experience occasional localized supply disruptions as products move from the manufacturer and distributor to local pharmacies,” he said of ending the tirzepatide shortage.
Asked about the 60-day buffer, the FDA said it would not comment on the relationship between the agency and the companies.
Although the merger made it possible to reach people who could not find or afford the right drugs, the move could come with risks because brand and generic pharmaceuticals are not regulated by the FDA.
“Doctors ask me all the time… 'How do I know if the compounded version my patients are getting is safe and effective?' And I'm like, 'You don't.'” said Dr. Angela Fitch, Care Provider's chief medical officer. Well known And Past President Obesity Treatment Association. “This is a problem of all time.”
The FDA has it. warned It said it had received reports of dosing errors in semaglutide products, including some that resulted in hospitalization, and that some products sold by compounders used salt forms of semaglutide, which are “different active ingredients than those used in approved drugs.” The agency has issued warnings about counterfeit versions of drugs and drugs sold under the false label “for research purposes” or “not for human consumption” that it says may be harmful.
And Lily And Novo Nordisk Some medical spas, weight loss clinics, pharmacies and others have taken legal action against people selling compounded products, he said, “posing a huge risk to patients”. Novo Nordisk published this week Research As reported in the journal Pharmaceutical Research, impurities and trace amounts of active ingredients were found in some compounded versions of the drug.
But the end of the shortage cannot be said to be the end of the process of fully integrating the drugs. For now, semaglutide remains on the FDA Shortcomings List the minimum dose of Wegovy allowed for weight loss. Novo Nordisk said it continued to invest in increasing its production capacity, but did not say when the shortage would be fully resolved.
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Even when this happens, companies that have built business models around integration, such as telehealth providers Himes & hersthe FDA may find ways to continue to offer compounded versions by offering different dosages beyond what is approved. The company told analysts on its quarterly earnings. Conference call In August, it “overcomes the flexibility of the shortage” in part by “providing personalized GLP-1 dosages to increase the amount commercially available to patients.”
McCaskill said she hopes Lilly will consider further lowering the price of the drugs to make them more accessible to people who depend on the compound.