Just days after The Cigna Group’s Express Scripts sued the Federal Trade Commission over an interim report that criticized PBMs, the FTC revealed that it is suing Express Scripts, UnitedHealth Group’s Optum Rx, and CVS Health Corp.’s Caremark for “artificially inflating” insulin prices.

The FTC said its administrative complaint also names the “Big Three” PBMs’ affiliated group purchasing organizations that serve as prescription drug rebate aggregators: CVS’s Zinc Health Services, Cigna’s Ascent Health Services, and UnitedHealth’s Emisar Pharma Services.

The FTC alleges that the three PBMs, which together processing 80% of all prescription drug claims, “created a perverse drug rebate system that prioritizes high rebates from drug manufacturers, leading to artificially inflated insulin list prices.”

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022. The study categorized the payers’ coverage policies as:

The Food and Drug Administration’s top gene therapy regulator issued what he acknowledged is a “provocative” call to consider setting a “target product profile” for gene therapy that includes not just what is expected from a clinical perspective, but “what we need to expect out of them from an economic perspective and from a clinical benefit perspective versus cost perspective.”

The FDA, by virtue of legal mandates and historical precedent, tends to avoid discussing the costs of novel medical interventions. But when a senior leader like Center for Biologics Evaluation and Research Director Peter Marks discusses cost-effectiveness tradeoffs, eyebrows raise.

After the chairman of a key House committee accused three top PBM executives of giving “fraudulent testimony,” one of those companies is hitting back. The heads of CVS Health Corp.’s Caremark, The Cigna Group’s Express Scripts and UnitedHealth’s Optum Rx testified before the House Committee on Oversight and Accountability on July 23 to defend their companies against skeptical lawmakers. In late August, committee Chairman James Comer (R-Ky.) sent letters to CVS’s David Joyner, Express Scripts’ Adam Kautzner and Optum Rx’s Patrick Conway, M.D., offering them an opportunity to “correct the record” regarding statements they made, such as Joyner’s assertion that Caremark pays CVS-affiliated pharmacies less than other pharmacies in its network. In a Sept. 10 letter, Caremark responded by asserting that Joyner’s testimony was “accurate and supported by comprehensive analyses of CVS Caremark’s data by an outside economist.”

UnitedHealth Group’s Optum Rx, The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and Prime Therapeutics together control about 70% of the national PBM market in 2022, according to an American Medical Association (AMA) report released on Sept. 9.

Although the PBM industry’s trade group immediately criticized the report, pointing out that the nation’s largest physician trade group could be biased against PBMs, data from AIS Health’s parent company, MMIT, tells a similar story. And one leading health policy expert tells AIS Health that what the researchers found is “very reasonable” and consistent with other reports on the concentration and vertical integration in the PBM market.

In recent years, commercial health plans have increasingly opted to place both biosimilars and their reference biologics on preferred tiers in their formularies, according to a recent Health Affairs study.

The researchers analyzed coverage and market share for seven biologics — also known as “originator products” — and 20 corresponding biosimilars from the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the IQVIA Longitudinal Access and Adjudicated Data Set from August 2017 to August 2022.

Optum Rx recently revealed that Optum Health Solution’s new biosimilars-focused, private-label subsidiary will join the other two big PBMs’ similar offerings. On Jan. 1, 2025, two Nuvaila-labeled biosimilars will be added to three of its commercial formularies — and for a $0 copay.

Amgen Inc.’s Wezlana (ustekinumab-auub), an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine, will be added to Optum Rx’s commercial formulary on Jan. 1, 2025, the PBM revealed. The agent will be provided as a private-label product from Nuvaila — known as Wezlana for Nuvaila — and will be available in both high-wholesale acquisition cost and low-WAC versions.

The human interleukin-12 and -23 antagonist has approval for all of Stelara’s indications and is available in both subcutaneous and intravenous formulations. It also is latex-free, while Stelara contains a derivative of latex.

In the race between the largest PBMs to embrace — and monetize — biosimilars, UnitedHealth Group’s Optum Rx has quietly been making moves to counter its competitors’ headline-grabbing announcements. Specifically, Optum Rx next year will make Humira and Stelara biosimilars available through its new private-label drug distributor, Nuvaila, and change how its formularies treat the two drugs — echoing similar moves by CVS Health Corp. and The Cigna Group.

Now that CMS has revealed the prices of the first 10 drugs subject to Medicare price negotiation, all eyes are on how Part D plans will cover those drugs on their formularies in 2026, when the new prices go into effect.

To that end, a recent poll from Zitter Insights offers some clues about how payers and PBMs are thinking about this thorny question.

Starting in 2025, The Cigna Group’s Express Scripts will drop Humira (adalimumab) from its largest commercial formularies and instead cover only select biosimilars for the blockbuster autoimmune condition treatment.

The move will make Express Scripts the second major PBM to prefer biosimilars over Humira after CVS Health Corp. did so in April. And it comes as both Cigna and CVS recently voiced their support for the FDA issuing draft guidance that would make it easier for biosimilars to get an “interchangeable” designation.