If there\u2019s a diet, Janet McCaskill says, she\u2019s done it. <\/p>\n
\u201cI\u2019ve tried WeightWatchers. I\u2019ve tried keto. I\u2019ve gone to a nutritionist,\u201d said the 58-year-old grandmother, who lives in Knightdale, North Carolina, outside Raleigh. Some of the eating plans worked, she said \u2013 until they didn\u2019t. <\/p>\n
At the end of 2022, weighing about 212 pounds and fearful about her health after losing her brother and both parents to heart disease, McCaskill started using the diabetes drug Mounjaro off-label for weight loss. It\u2019s part of a class of drugs known as GLP-1 receptor agonists, which also includes Ozempic, Wegovy and Zepbound. <\/p>\n
\u201cIt literally saved my life,\u201d she said. <\/p>\n
But it was expensive, and after switching to a lower-cost version made by a compounding pharmacy last year, McCaskill now is worried she\u2019ll lose access to her medication because the US Food and Drug Administration determined that a shortage of the brand-name drug has ended \u2013 which means compounding of the medicine must stop. <\/p>\n
A law allowing compounding pharmacies to step in to fill gaps when drugs are in short supply enabled thousands, or even millions, of people to access costly GLP-1 medicines at a lower price point \u2013 something some physicians worried could create safety issues because compounded drugs are not FDA-approved. But for people like McCaskill, it\u2019s been a lifeline. And as drug manufacturers dramatically ramp up supply, their access is changing fast. <\/p>\n
\u201cI\u2019m devastated, to say the least,\u201d she said. <\/p>\n
In a little more than a year, McCaskill said, she lost almost 100 pounds and has maintained her current weight of about 117 pounds since. Her blood pressure is lower, and her levels of A1C, a measure of blood sugar, and triglycerides have come down, she said. She\u2019s dramatically changed the way she eats and started exercising more. <\/p>\n
McCaskill\u2019s four granddaughters, ages 6 through nearly 12, were her \u201cnumber one reason\u201d for starting the medicine, she said. \u201cThey do cheer, and I\u2019m as active with them as I\u2019ve ever been.\u201d <\/p>\n
An office manager for an auto restoration and repair business, McCaskill said her insurance never covered Mounjaro. The drug uses the active ingredient tirzepatide and was approved by the FDA in May 2022 for type 2 diabetes; although McCaskill said her blood sugar was elevated, she didn\u2019t have diabetes, and many plans don\u2019t cover GLP-1 drugs for the purpose of <\/strong>weight loss. <\/p>\n She paid out-of-pocket for it instead, using a coupon from manufacturer Eli Lilly that cut the cost in half, but it was still about $500 a month, she said. <\/p>\n When Lilly\u2019s coupon program ended in the summer of 2023, McCaskill\u2019s health-care provider suggested another option: compounded tirzepatide, a version of the drug that\u2019s not FDA-approved but which was made available legally through a local pharmacy. It was less than $250 for a month\u2019s supply. McCaskill switched and continued to see benefits, she said; she\u2019s been on that version since, and her husband started on it, as well. <\/p>\n Now, though, she\u2019s worried they\u2019ll both have to stop. <\/p>\n Last week, the FDA updated its database of drugs in shortage to remove tirzepatide, which had sat on that list \u2013 along with related semaglutide-based drugs, Ozempic and Wegovy \u2013 since 2022 amid unprecedented demand. <\/p>\n The move means the compounding of tirzepatide, like McCaskill\u2019s local pharmacy did, has to end. And although it\u2019s a signal that branded versions of tirzepatide-based drugs \u2013 Mounjaro, for diabetes, and Zepbound, approved at the end of 2023 for weight loss \u2013 are more widely available, it threw people like McCaskill into a panic. <\/p>\n \u201cI was working until almost 10 o\u2019clock last night answering patients\u2019 questions,\u201d said Michele Kessler, a physician assistant at Durham Women\u2019s Clinic in North Carolina and McCaskill\u2019s provider. \u201cI\u2019ve got all these patients who are doing very well, and they are going to be abruptly stopped without any warning.\u201d <\/p>\n Compounding of medicines that are \u201cessentially copies of a commercially available drug\u201d is allowed by the FDA during a shortage, the agency says, but when a shortage is resolved, it\u2019s allowed only if it\u2019s not done \u201cregularly or in inordinate amounts.\u201d <\/p>\n Compounding can often be done if patients need a tweak made to a medicine, perhaps because they have an allergy to one of the original version\u2019s ingredients or need a liquid instead of a pill. <\/p>\n \u201cIt\u2019s 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 make that,\u201d said Jennifer Burch, pharmacist and owner of Central Compounding Center in Durham, where Kessler sends her patients for compounded tirzepatide. \u201cWe can do that any way you want it.\u201d <\/p>\n Her pharmacy even makes medication for pets and can tweak the flavor based on animals\u2019 preferences: fish, chicken or, in one case, bubble gum. <\/p>\n \u201cI\u2019m like, how did you figure out the cat likes bubble gum?\u201d Burch said. <\/p>\n But lately, her employees have been working around the clock compounding tirzepatide and semaglutide, she said. Over the past six weeks, Burch said, they\u2019ve filled about 900 prescriptions for compounded tirzepatide and 500 for compounded semaglutide, using active ingredients they buy from chemical suppliers that she says validate their products through what\u2019s known as compendial testing to confirm they meet quality standards. <\/p>\n For compounded tirzepatide, Burch\u2019s pharmacy charges between $200 and $400 a month, based on the dose. <\/p>\n Without insurance, Mounjaro costs $1,069 per month, and Zepbound is $1,060, according to Lilly. The company also offers a savings card for Zepbound to offer it for about $650 a month for certain patients who have commercial insurance that doesn\u2019t cover the drug. <\/p>\n In August, Lilly also introduced less-expensive versions of its lower doses of Zepbound that come in single-dose vials; patients must draw up the medicine and inject it using a needle and syringe. The regular forms of the drug come in autoinjector pens. <\/p>\n The vials are available for self-pay through a Lilly program called LillyDirect, which facilitates access to doctors and shipping of medicines to patients. They cost $399 for the lowest dose for a four-week supply or $549 for the next dose up \u2013 the one McCaskill is on. <\/p>\n \u201cA lot of us are not going to be able to afford to keep paying that,\u201d McCaskill said. <\/p>\n It\u2019s not clear just how many people are using compounded tirzepatide and semaglutide, because prescriptions aren\u2019t tracked through traditional channels, according to Evan Seigerman, an analyst with financial firm BMO Capital Markets who closely follows Lilly and Novo Nordisk, which makes semaglutide-based drugs Ozempic and Wegovy. <\/p>\n He said some estimates put prescriptions for compounded versions as high as 20% of all prescriptions for the drugs. <\/p>\n Scott Brunner, chief executive officer of the Alliance for Pharmacy Compounding, estimated that millions of people could be using compounded versions \u2013 and many may not be able to switch. <\/p>\n \u201cPrice is not a rationale for dispensing a compounded medication, but the fact is, a lot of patients were able to afford the compounded versions of tirzepatide, and they\u2019re likely not going to be able to afford the FDA-approved drug,\u201d Brunner said. <\/p>\n His organization asked the FDA for a buffer of at least 60 days before compounding must stop to \u201censure continuity of patient care.\u201d He said he heard from more than a dozen member pharmacies that branded tirzepatide products still weren\u2019t available through their ordering systems despite the shortage ending. <\/p>\n The FDA acknowledged in its statement about the end of the tirzepatide shortage that \u201cpatients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributor to local pharmacies.\u201d <\/p>\n In response to an inquiry about the request for a 60-day buffer, the FDA said it doesn\u2019t discuss interactions between the agency and firms. <\/p>\n Although compounding has enabled access for people who may otherwise not have been able to find or afford the real medicines, the practice can come with risks since it\u2019s not regulated by the FDA the way branded and generic pharmaceuticals are. <\/p>\n \u201cDoctors will ask me all the time \u2026 \u2018How do I know the compounded version my patients are getting is safe and effective?\u2019 And I\u2019m like, \u2018You don\u2019t,\u2019\u201d said Dr. Angela Fitch, chief medical officer of care provider Knownwell and past president of the Obesity Medicine Association. \u201cThis is the problem with it all along.\u201d <\/p>\n The FDA has warned that it\u2019s received reports of dosing errors with compounded semaglutide products, including some that resulted in hospitalization, and that some products sold by compounders used salt forms of semaglutide, which are \u201cdifferent active ingredients than are used in the approved drugs.\u201d It\u2019s also warned about counterfeit versions of drugs and medicines sold that are falsely labeled \u201cfor research purposes\u201d or \u201cnot for human consumption,\u201d which the agency said could be harmful. <\/p>\n And Lilly and Novo Nordisk have taken legal action against some med spas, weight loss clinics, pharmacies and others selling compounded products that they say pose \u201csignificant risks to patients.\u201d This week Novo Nordisk published a study it conducted in the journal Pharmaceutical Research that it said found impurities and lower concentrations of active ingredients in some compounded versions of its drugs. <\/p>\n But the end of the shortages seems unlikely to spell the end of compounding the medicines completely. For now, semaglutide remains on the FDA\u2019s shortages list in the lowest dose of Wegovy, the version approved for weight loss. Novo Nordisk says it continues to invest in increasing its manufacturing capacity but didn\u2019t say when the shortage would be resolved completely. <\/p>\n Even when it is, companies that have built business models around compounding, like telehealth provider Hims & Hers, may find ways to keep providing compounded versions by offering different doses than what\u2019s FDA-approved. The company told analysts on its quarterly earnings conference call in August that it saw a path \u201cbeyond the shortage dynamic\u201d in part through offering \u201cpersonalized GLP-1 doses, which augment the commercially available dosages for patients.\u201d <\/p>\n McCaskill said she hoped Lilly might consider lowering the price of its medicines further to make them more accessible to people who\u2019d been depending on compounded tirzepatide. And Fitch railed against the lack of coverage from insurance companies for obesity care. <\/p>\n Data from trials shows that most people who stop taking GLP-1 medicines regain a significant amount of weight they lost, and McCaskill doesn\u2019t want to backtrack on the improvements she said she\u2019s been seeing in her health. <\/p>\n \u201cI\u2019ve heard some people are trying to split their doses, but I\u2019m scared to do that,\u201d she said. \u201cI just don\u2019t want to mess with anything when it\u2019s working 100% for me.\u201d <\/p>\n<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" If there\u2019s a diet, Janet McCaskill says, she\u2019s done it. \u201cI\u2019ve tried WeightWatchers. I\u2019ve tried…<\/p>\n","protected":false},"author":1,"featured_media":2462,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-2461","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/2461","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/comments?post=2461"}],"version-history":[{"count":0,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/2461\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media\/2462"}],"wp:attachment":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media?parent=2461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/categories?post=2461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/tags?post=2461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}} No longer in shortage<\/h2>\n
\u2018Price is not a rationale\u2019<\/h2>\n
The end of compounding GLP-1s?<\/h2>\n
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<\/ul>\n<\/ul>\n<\/div>\n