Costco Weight-Loss Program: Omission of Critical Data Puts Patients at (Financial) Risk

This week, the world learned that Costco Wholesale would start selling Novo Nordisk's newest, but vastly overpriced GLP-1 inhibitor medicine known generically as semaglutide (sold under the brand names Ozempic and Rybelsus for Type 2 diabetes, and under the brand name of Wegovy for weight-loss for those with obesity without Type 2 diabetes). 

We learned of the Costco GLP-1 initiative from a press release from Costco's strategic partner known as Sesame https://sesamecare.com/ which is the entity which will connect patients with its network of thousands of outpatient healthcare providers nationwide who are more than willing to prescribe GLP-1 inhibitors as weight-loss drugs with barely an online interview or phone call, much less an actual examination (see the press release at https://www.globenewswire.com/news-release/2024/04/02/2856203/0/en/Wholesale-Weight-Loss-Sesame-Unveils-Specialized-Care-for-Weight-Loss-with-Pricing-Exclusively-for-Costco-Members.html for more). The two companies have a dedicated Costco Weight-Loss Program website at https://www.CostcoWeightLoss.com/. But having a doctor willing to prescribe the overpriced drugs online or over the telephone certainly makes it easier for patients to get the overpriced weight-loss drugs.

I keep mentioning that that semaglutide is vastly overpriced because it is. Little new science, but ever-so-slight improvements on the original molecule. But readers need to understand that a whole bunch of cheaper biosimilars of liraglutide are right now currently pending FDA approval decisions, hence you might consider waiting just a little while longer because we know with certainty that they are coming, and quite soon. I would guess that once they hit the market, Costco Pharmacy and rivals like Mark Cuban Cost Plus Drug Company via its Team Cuban Card retail pharmacy network may likely carry one or more of the cheaper biosimilars. Whether your insurance company's PBM covers only the overpriced versions of those drugs remains a big unknown. But cheaper versions are indeed coming in 2024. In theory, the PBMs should want lower costs, but we know they are mainly concerned about collecting legally-exempted rebate kickbacks, which means they're more likely to "prefer" the more expensive versions of many drugs. Hopefully, the price differential on cheaper biosimilars ends up with patients, but just remember: it is often cheaper to bypass your insurance company's pharmacy benefit.

The idea of making Novo Nordisk's overpriced weight-loss drugs available via Costco and other retailers by providing them easy access to doctors who will freely prescribe the drugs to almost anyone who will ask for them is kind of "off label" marketing that Novo Nordisk thinks will supercharge sales of its overpriced drugs. Left unsaid is that the drugs are vastly overpriced and Sesame (and Costco) will provide little (if any) genuine financial assistance on the cost of the overpriced obesity drugs.

Costco's prices are sometimes cheaper than CVS charges for the same drugs, but not always. The reason is because Costco itself owns a 35% share of a PBM known as Navitus Health Solutions. Because Costco co-owns Navitus, its PBM goes thru its PBM contracts with Aetna/CVS Health/Caremark, Cigna Express Scripts, and United Healthcare's OptumRx to ensure its contracts do not contain some of the "traps" PBMs write into its contracts with other retailers and that's a key reason Costco has been able to remain profitably in the retail pharmacy business while bigger rivals like Target Corp. were forced to sell to CVS instead. I covered that in a previous blog post which can be read at https://blog.sstrumello.com/2023/01/costco-pharmacy-what-is-its-pharmacy.html.

Novo Nordisk's first GLP-1 iteration was known generically as liraglutide which still remains efficacious for both Type 2 diabetes and obesity without Type 2 diabetes. Liraglutide was originally sold under the brand name of Saxenda for obesity without Type 2 diabetes, or as Victoza for the indication of Type 2 diabetes (see the company press release for the 2014 "label extension" approval of liraglutide for obesity at https://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-approval-for-saxenda-liraglutide-rdna-origin-injection-for-chronic-weight-management-300013975.html for more). 

Of critical importance is the fact that NONE of these GLP-1 inhibitor medicines has FDA approval for the treatment of autoimmune Type 1 diabetes, including as a supplent for insulin replacement therapy. Doctors are free to prescribe them but must do so "off-label" which FDA prohibits companies from marketing. Novo Nordisk did try to get an approval for liraglutide for Type 1 diabetes as a "supplemental application". Its just that FDA rejected Novo Nordisk's attempt to gain FDA approval for Type 1 diabetes finding that the drug had no therapeutic benefit for patients with absolute insulin deficiency.

For its part, Sesame currently has a Q&A on its obesity website https://sesamecare.com/join/costco-weight-loss with the following question:

"Can I get a cheaper or generic form of a GLP-1 medication?"

However, the answer Sesame provides is technically true as of today, but it is still only partially true. Sesame's answer reads as follows:

"No, there are currently no generic alternatives to GLP-1 agonists such as semaglutide, tirzepatide and liraglutide; GLP-1 medications are available only as brand-name products.

In line with FDA guidance, and due to potential safety and legal risks regarding compounded GLP-1 medications, Sesame advises against ordering compounded GLP-1 medications.

If you need assistance with navigating your options, you can schedule a video consult with a provider through Sesame’s weight loss program to discuss the best medication for your needs."

That said, generic and biosimilar versions of Novo Nordisk's original GLP-1 inhibitor known generically as liraglutide (sold under the brand names as Victoza for Type 2 diabetes and as Saxenda for obesity) are indeed coming. The thing is that all but one of the companies which now have insulin biosimilars currently pending FDA approval decisions in 2024 (including Biocon, Lannett/HEC, Sandoz/Gan & Lee and Amphastar/ANP; only the nonprofit drug company Civica, Inc./CivicaScript does not have one pending FDA approval) all also happen to have biosimilars of liraglutide also pending FDA approval decisions.

On top of that, Biocon's version of liraglutide received UK regulatory approval in April 2024. It would seem that an FDA approval is likely to happen in the next few months (catch the India-based news outlet known as Business Standard's coverage of Biocon's UK approval for liraglutide at https://www.business-standard.com/markets/capital-market-news/biocon-gains-after-receiving-mhra-uk-approval-for-liraglutide-injection-124040100215_1.html for more).

While the public has grown tired of stories about insulin price insanity, they are suddenly being inundated with stories about obesity drugs as if they were brand new creations. GLP-1 inhibitor drugs have been on the market for many years and are proven to be efficacious not only for Type 2 diabetes, but also for obesity without Type 2 diabetes. Anytime I hear of stupid stories like "Ozempic Babies" https://www.healthline.com/health-news/ozempic-babies-unplanned-pregnancies the stupid term drives me insane. The drugs may interfere with the birth control pill which is a hormone-based contraceptive method, but barrier methods of contraception including condoms, diaphragms and the like are in no way impacted by GLP-1 drugs. But if you're a woman who is going to use a GLP-1 drug for Type 2 diabetes or weight-loss, then you really owe it to ask your own doctor about whether you might need to consider alternative forms of birth control. And, that includes asking the doctors from companies such as Costco's partner known as Sesame.