Monday, March 07, 2022

Generic Glucagon for $200, Where's the Savings? Get it for $5...WITH a coupon

In December 2020, the U.S. FDA approved several long-delayed generic versions of traditional mix-and-inject form of glucagon emergency kits. Among them were from Amphastar Pharmaceuticals, Inc. of Rancho Cucamonga, CA which was the very first, followed by another from Fresenius Kabi USA based in Lake Zurich, IL (in suburban Chicago, the parent company is based outside of Frankfurt Germany)









Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, noted the approval was a major step forward for people with diabetes. 

"Glucagon for injection has been approved for use in the U.S. for more than 20 years [blogger note: it's actually been on the market nearly 50 years; the same old-school kits were the ones my parents had when I was a child, although they weren't biosynthetic versions back then], but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar," she said in a statement.

The FDA statement suggests that FDA approvals for other generics would be a straightforward matter, but without a visit to the FDA orange book, I'm not sure there are any others right now.

The FDA decisions on generic glucagon were a very long-overdue move to lower prices, rather than innovating on glucagon, which has traditionally been a very cumbersome and inconvenient treatment. Given a choice, most patients or caregivers would prefer the newer glucagon autoinjector hypopens from Xeris or Zealand Pharma which are far more convenient for caregivers to use because neither requires reconstitution which the old-school kits require (and let's face it, by the time patients need glucagon, they usually can't give it to themselves).

FDA's own research proves that greater competition among generic drug makers is associated with lower overall generic drug prices. For products with a single generic producer, the generic Average Manufacturer Prices (AMP) reported to the Centers for Medicare and Medicaid Services (CMS) comes in 39% lower than the brand AMP before generic competition, compared to a 31% reduction using invoice prices. With two competitors, generic prices are 54% lower. With four competitors, generic prices are 79% less. With six or more competitors, generic prices using show price reductions of more than 95% compared to brand prices. 





Accordingly, old-school glucagon emergency kits should be priced about 54% less than Lilly's or Novo Nordisk's glucagon emergency kits. That doesn't appear to be true on glucagon emergency kits, which is victimized by the PBM rebate scheme which also impacts insulin. So far, prices on the newer generic glucagon kits are only marginally lower (IF they are even lower; sometimes they are not) than the brand-name old-school products from Lilly and Novo Nordisk. 

For example, the prices for the Fresenius Kabi glucagon kits sell for about $200.00 a kit (or even more) compared to the average prices for the branded products from Lilly and Novo Nordisk, which are now priced about $209.25 assuming one uses a GoodRx coupon to get the lower price from a local pharmacy. McKesson's ScriptHero (which is powered internally by CoverMyMeds, SingleCare and the PBM MedImpact's own ScriptSave WellRx) won the lowest price, coming in at $127.37 at Walgreens. Currently, manufacturer coupons on Zegalogue pens brings the cost of that down to about $25.00 for a 2-pack. Based on my review of the coupon fine-print, I also believe that Zealand Pharma's Zegalogue coupon also works for non-insured cash-paying customers; many coupon offers exclude cash-payers, so this one is different.

Still, one must ask why FDA had done absolutely nothing until December 2020? Something was badly broken about that.

Patients with commercial healthcare insurance CAN now get the Fresenius Kabi glucagon kit for a mere $5.00 with a coupon so the cost is very reasonable with that. I'm not certain why there's a Medicare/Medicaid/VA exclusion, but most coupons seem to try excluding those (that said, the coupon does appear to work for cash-payers up to a maximum dollar amount), but one part I don't understand is why it even requires a coupon to get that price? 

It's a GENERIC! 

Aren't generics SUPPOSED to be much cheaper in the first place?

We know that ongoing FDA inaction on generics, combined with FDA prioritization of newer, branded products, is a reason prices still remain sky-high on old-school glucagon rescue kits. Especially now that multiple generic versions are available. Let's face it: there's no reason for an old-school generic glucagon product first developed in the 1930's should cost patients nearly $200.00, and yet that's the case in the badly-broken U.S. prescription drug market. Why?!

In the end, its yet another example of how completely dysfunctional the U.S. prescription drug market really is.

Author P.S., March 18, 2022: Since this post, I reached out to a several people who might be in a position to influence Civica Rx to also include old-school, mix-and-inject glucagon rescue kits along with insulin when it anticipates a launch in early 2024. I heard back from virtually all of them, specifically people at Civica Rx and JDRF's CEO Aaron Kowalski. The consensus was the same for all of them: "Good idea. Glucagon rescue kits are not new, nor are they innovative like new  Xeris Gvoke or Zealand Pharma's Zegalogue products (and maybe Lilly's Baqsimi) are, yet they are all victimized by the same rebate-driven market dysfunction, and in spite of several generics, prices on these are all stubbornly high, therefore it makes sense to also consider mix-and-inject glucagon rescue kits." Watch this space! 

Author P.S., July 2, 2022: diaTribe reports that Eli Lilly & Company has just announced that it will discontinue manufacturing its old-school, mix & inject Glucagon Emergency Kits. Lilly already sells a much more "modern" glucagon rescue treatment called Baqsimi, and with two rival generic products from Amphastar and Fresnius Kabi USA already on the market, sales of the Lilly kits have declined.

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