The latter circumstance is what allowed for the rise of GLP-1 compounding. The designation of sure GLP-1s as weight-loss brokers—beginning with Wegovy in June 2021 and adopted by Zepbound in November 2023—made these medicine out there to a brand new, big swath of individuals. Now anybody who’s overweight as outlined by physique mass index (BMI) or who’s obese per BMI and has no less than one weight-related well being situation is eligible for a GLP-1 prescription. Beforehand, meds on this class have been simply FDA-approved for kind 2 diabetes. With guarantees of weight reduction on the desk, the demand surged so excessive that the pharma firms couldn’t sustain with it, and the medicine went into scarcity and bam: Compounders stepped in to fill the hole.
Minimize to now, when each Wegovy and Zepbound have been faraway from the scarcity checklist. Once more, that might usually be a very good factor, suggesting that folk taking compounded variations might swap to the brand-name choices, which carry the added security of getting gone via the FDA approval course of (extra on this under). However the large variety of individuals taking compounded GLP-1s has raised questions on whether or not there truly is sufficient provide of the brand-name medicine to fulfill demand.
Looming even greater is the fee challenge. There may be sufficient brand-name medicine out there now, however that definitely doesn’t imply they’ll be accessible. These meds have traditionally run upward of $1,000 with out insurance coverage (and protection continues to be restricted)—although each Eli Lilly (Zepbound) and Novo Nordisk (Wegovy) have not too long ago lower that worth in half, to $499 a month, for people with out protection who decide in to direct-pay packages with the drugmakers. Against this, compounded choices usually price round $200 a month.
The associated fee hole is what makes GLP-1 compounding such a novel scenario. Normally medicine that go into scarcity are low-cost generics, not costly brand-name ones which might be nonetheless below patent, Tenille Davis, PharmD, chief advocacy officer on the Alliance for Pharmacy Compounding, tells SELF. So, whereas GLP-1 compounders have technically been working to fill an availability void, they’ve additionally been de facto fixing for the worth challenge. Therefore why latest strikes to chop them out of the image might majorly slash entry.
What’s the distinction between a compounded GLP-1 drug and a brand-name one?
As talked about, pharmacy compounding is supposed to serve a number of particular functions, particularly the creation of a customized type of a drug on a per-patient foundation (e.g., when somebody wants a formulation or dose that isn’t commercially made) or boosting provide throughout a drug scarcity. Given the comparatively decrease danger of those sorts of small-batch and non permanent operations, it isn’t legally essential for compounders to leap via all of the regulatory hoops which might be required of business drug producers to market a product, nor would it not be possible, Michael Ganio, PharmD, senior director of pharmacy follow and high quality at American Society of Well being-System Pharmacists, tells SELF. Because of this, there are a number of key variations to notice in how brand-name and compounded GLP-1s come to be.
Course of and security checks
Business drugmakers must obtain the FDA’s stamp of approval on a brand new drug utility for each merchandise they carry to market. That requires doing analysis and scientific trials to show efficacy; fine-tune the dose and route of administration; and make sure the closing product abides by Present Good Manufacturing Processes (CGMP), which ensures the medicine is sterile if relevant (as within the case of injectables like GLP-1s) and can stay steady for normally a pair years. Against this, compounders don’t undergo the FDA approval course of for his or her medicine and are usually not topic to those requirements. This distinction additionally separates a compounded drug from a generic one: Whereas the latter has an abbreviated FDA-approval course of (because the current brand-name drug has already been proven secure and efficacious), the maker nonetheless has to show to the FDA that their model is equal to the OG on each fronts. A compounded drug doesn’t have that oversight. (The brand-name GLP-1s aren’t out there as generics as a result of the patents haven’t expired—Novo Nordisk has its US patent on semaglutide till 2032, and Eli Lilly on tirzepatide, till 2036.)
