FILE - Packaging for AbbVie's drug, Humira. Patients who take the autoimmune disease treatment can ... [+]
As of March, the blockbuster autoimmune drug Humira (adalimumab) still held 96% of the market share of all adalimumab-based products in the U.S., according to Endpoints News, despite there being ten Humira-referenced biosimilars on the market, nine of which launched in 2023. Until now the biosimilars have gained minimal traction. But that is changing. The number of new prescriptions written for biosimilar versions of Humira soared to 36% from just 5% during the first week of April, after CVS Caremark altered its formulary. But this may not be what policymakers had in mind when they first articulated the phrase biosimilar competition ten years ago.
In a move that was first announced in January, CVS Caremark—the pharmacy benefit manager of CVS Health—removed the blockbuster branded drug Humira from its national commercial “template” lists of reimbursable drugs starting April 1. In its place, the PBM included the Humira-referenced biosimilars Hyrimoz, Hadlima and adalimumab-fkjp (a Biocon-produced unbranded product).
Humira is used to treat several immune conditions, including among others rheumatoid arthritis, psoriasis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease.
The big leap in biosimilar prescriptions was attributed to one particular product called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. Hyrimoz is jointly marketed with Cordavis, a new wholly owned subsidiary that CVS created last August, and has a wholesale acquisition cost that is roughly 80% lower than Humira.
To further complicate matters, Formulary Watch says that CVS Caremark has entered into an agreement with AbbVie, the manufacturer of the original branded Humira, to supply Cordavis with a “committed volume” of Humira to develop a “co-branded” product.
So, while removal of the originator Humira from the formulary may be the headline, the story is more complex than meets the eye. This is because Humira is being replaced with a preferred Humira-referenced biosimilar manufactured by CVS-owned Cordavis which at the same time is producing a co-branded product with AbbVie.
It appears that the PBM Express Scripts is following a similar path to the one taken by CVS Caremark. Starting in June, Evernorth, a division of Cigna which owns Express Scripts, is launching its private label Humira-referenced biosimilar, adalimumab-adbm, with a list price that is about 85% lower than the originator product. The product will be manufactured by Boehringer-Ingelheim for Quallent Pharmaceuticals, which is a wholly owned Express Scripts subsidiary. Moreover, the product will be available to patients at Accredo, which is the PBM’s specialty pharmacy.
What CVS Caremark is doing—and later this year, Express Scripts—is (mostly) steering patients to their preferred products, which aren’t necessarily the most inexpensive.*
In such a scenario it’s unlikely other biosimilars will make inroads in terms of uptake, despite the fact that the wholesale acquisition cost of Hyrimoz is higher than, for example, the biosimilar Yusimry which Mark Cuban’s Cost Plus Drug Company sells.
One might question whether other biosimilars get a fair chance.
Effectively the strategies employed by CVS Caremark and Express Scripts preserve elements of the oft-criticized rebate system, though not with rebates per se but rather with co-branded licensing fees and acquisition cost discounts.
It’s doubtful that this is what policymakers envisioned biosimilar competition would look like, namely a web of vertically integrated stakeholders, including health insurers, pharmacies, PBMs and manufacturers, all operating under corporate umbrellas.
*For patients, out-of-pocket cost—usually in the form of a co-insurance percentage of the list price—is not the only factor determining their preferred choice of Humira-reference biosimilar. Hyrimoz’s citrate-free, high concentration formulation can also be a consideration, though Hyrimoz isn’t the only biosimilar that is formulated as such.
