Hims & Hers' (HIMS) latest move to introduce compounded GLP-1 injections into its weight loss program is stirring up excitement and raising a few eyebrows among plan sponsors. The GLP-1 drugs, with popular names like Wegovy and Ozempic, are glucagon-like peptide agonists that curb your appetite, helping patients in their quest to slim down.
The HIMS news comes as branded GLP-1 medications face supply hiccups. This new option presents patients with a potentially wallet-friendly and accessible option for members looking to slim down.
What is Compounding?
According to the FDA’s website, “Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” This is referring to a 503A or lesser designated compounding pharmacy where compounds are created for patient-specific prescriptions and not for mass production.
However, according to the release on their site this is not what HIMS is doing at all. The company shared, “Through a partnership with a leading US manufacturer of generic and 503B compounded injectable medications, Hims & Hers can help millions of Americans who have obesity and are looking for help safely managing their weight.”
503A vs 503B Compounding Pharmacies
While HIMS’ website showcases images of "compounded semaglutide," it’s misleading and is likely a strategic move by HIMS’ legal team to avoid drawing attention from big pharma’s lawyers. Instead, the company is working with a 503B compounding pharmacy (also known as a 503B manufacturer) producing large batches of these medications.
Unlike 503A compounding pharmacies, which create drugs based on individual prescriptions, 503B facilities manufacturer medications in bulk as the 503B designation is designed to do.
The quality control for 503B facilities is much stricter than for 503A pharmacies. 503B compounding pharmacies must adhere to the Current Good Manufacturing Practice (cGMP) regulations, including 21 CFR Part 210 and 211, which require validation of every process. For clarity among the masses, it can be beneficial to refer to a 503B facility as a “503B manufacturer”.
Whether it’s a 503A or 503B designation, we’re only talking about highly trained personnel and highly regulated facilities. This is not the alley down the street with someone touting themselves as a “MedSpa” selling semaglutide out of their garage. That is, for sure, cause for alarm.
Considerations for Plan Sponsors
Plan sponsors, it's time to huddle with your consultants and consider the perks of adding these compounded GLP-1 meds to your benefit plans as mentioned above.
At $199 a month, they're a bargain compared to branded alternatives like Wegovy, which come with a hefty $800-$1,600 price tag. This price difference could mean big savings for both you and your members – a win-win situation.
Key points to consider:
Why is the supply of semaglutide low? Both Novo Nordisk and the FDA have cited shortages, yet HIMS has partnered with a vendor that has sufficient access to the active ingredient. Our inside sources reveal that the shortage isn't due to a lack of semaglutide API (active pharmacy ingredients) but mainly because of a shortage of the delivery devices. This affects how patients inject the semaglutide. Using HIMS' vial and syringe could lead to dosage mistakes, which are less likely with the prefilled autoinjectors used in branded versions of semaglutide.
How can plan sponsors provide lower-cost semaglutide to members? Given the prescription requirement for semaglutide, partnering with a telehealth vendor might be the most efficient way to offer this option to members. This can help integrate the benefit smoothly into the member’s existing benefit.
What about regulatory scrutiny? HIMS boasts a partnership with a leading US manufacturer of generic and 503B compounded injectable medications, although this partner remains unnamed. Beyond this, Novo Nordisk and Eli Lilly have patents and lots and lots of lawyers, so it will be interesting to see how enduring a program like HIMS will be.
Before popping the champagne, it’s important to understand the long-term options for these patients. Any hiccup in supply can throw a wrench in treatment plans, which is crucial for effective long-term weight management.
By teaming up with consultants, plan sponsors can make informed decisions about including 503B manufactured GLP-1s in their offerings. This way, members can access effective, affordable, and reliably available weight loss treatments without any nasty surprises.
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