AbbVie hit as CVS says it will cut Humira from formularies

CVS Health has said it will remove AbbVie’s big-selling immunology drug Humira from most of its national formulary lists of reimbursable products, and offer biosimilar versions of the drug instead.

Shares in AbbVie weakened after the announcement, as investors considered the prospect of a faster-than-expected decline in Humira (adalimumab) sales in the US.

Global sales of the drug for rheumatoid arthritis and other autoimmune diseases hit a high of $21 billion in 2022 after more than a decade of $10 billion-plus growth, but have been predicted to fall by as much as a third this year now that biosimilars are available in the US market. The US accounted for $18.6 billion of the product’s total revenues in 2022.

The move comes shortly after CVS Health made its own play in the biosimilars category with the launch of Cordavis, a business working with other drugmakers to bring private-label biosimilar therapies to the US market.

The first product to be announced by the new venture was a biosimilar of Humira developed by Sandoz and recently approved as Hyrimoz by the FDA, and the de-listing announcement fires a shot across the bows of other biologic drug developers whose products are facing biosimilar competition.

The Cordavis Humira product is due to launch in the second quarter at an 80% discount to the original brand’s list price.

In a statement, CVS Health said that Humira will continue to be an option for its customers with some of its commercial formularies used by employers, unions, and health plans for prescription drug coverage.

In addition, AbbVie has agreed to provide Cordavis with a “committed volume” of co-branded Humira. That is likely to be a similar arrangement to the Sandoz deal, in which CVS Health is purchasing the finished biosimilar. Cordavis eventually plans to provide a range of biosimilars, some of which it will produce using contract manufacturers.

“We are committed to accelerating the adoption of biosimilars and providing customer choice alongside a seamless member experience,” remarked David Joyner, executive vice president of CVS Health and president of CVS Caremark, the group’s pharmacy benefit manager (PBM) division.

“Our customers want to have choices,” he added. “By preferring biosimilars that have a significantly lower list price than their reference product, CVS Caremark is putting our customers in the driver’s seat to best meet the health care needs of their members and lower drug costs.”

There are now nine biosimilar versions of Humira on the US market, but just one is currently interchangeable - a coveted status that allows it to be switched for the brand without prescriber intervention – and AbbVie has been working hard to minimise their impact through formulary deals with insurers.

Nevertheless, sales of the drug fell by almost a third in the first nine months of 2023 to $11.1 billion, of which $9.4 billion was generated in the US.