Cigna Is Latest Payer to Nudge Patients Toward Private-Label Stelara Biosimilar

When deciding how to cover Stelara (ustekinumab) and its recent spate of follow-on products, prominent PBMs and payers are favoring Biocon Biologics Ltd.’s Yesintek and their own private-label biosimilars — including one that has been the target of litigation. 

Cigna Healthcare, a division of The Cigna Group, on May 15 issued a new drug-coverage policy that prefers branded Stelara, Yesintek, Alvotech/Teva’s Selarsdi and ustekinumab-ttwe, a biosimilar manufactured by Cigna subsidiary Quallent Pharmaceuticals. 

As nonpreferred products, Cigna’s new policy lists Formycon/Fresenius’ Otulfi, Celltrion’s Steqeyma and Sandoz/Samsung’s Pyzchiva. Regarding Pyzchiva, the policy notes that patients will instead be “directed to ustekinumab-ttwe,” Quallent’s unbranded version of the drug. 

Janssen Biotech, Inc., which manufactures the original Stelara, sued Samsung in February, accusing the firm of breaching a patent-litigation settlement agreement by trying to sell a Stelara biosimilar via an unidentified PBM’s private-label subsidiary, in addition to Pyzchiva via Sandoz. Subsequent court filings indicated that the unnamed private-label subsidiary was Cigna’s Quallent.  

A New Jersey district court in late April denied Janssen’s motion for a preliminary injunction, which the drugmaker had sought to delay the launch of Quallent’s private-label Stelara biosimilar. In its recently unsealed opinion, the court wrote that while Janssen demonstrated that its claim was likely to succeed on the merits, the firm did not prove it needed an injunction to avoid suffering “irreparable harm” from the launch of Quallent’s biosimilar. 

Janssen then appealed the district court’s decision to the U.S. Court of Appeals for the Third Circuit. The Johnson & Johnson subsidiary is now known as Johnson & Johnson Innovative Medicine. 

In a statement sent to AIS Health, a division of MMIT, Johnson & Johnson maintained that barring Samsung from marketing its unauthorized private label product is the “appropriate and equitable relief for its willful breaches” of the parties’ “license agreement and its duty to act in good faith.” Johnson & Johnson added: “We were compelled to commence this action after numerous good faith efforts to avoid litigation and will continue to pursue our rights to remediate Samsung Bioepis’ misconduct.” 

Lumicera, Nuvaila Get in the Game 

Navitus Health Solutions unveiled in March that starting in July, it would remove Stelara from its commercial and exchange formularies and instead prefer biosimilars, a move expected to save $120 million annually. 

Navitus said its subsidiary Lumicera Health Services inked a purchase agreement for a lower-priced biosimilar version of Stelara that will “deliver upfront, real-time net savings of approximately $10,000 per fill compared to the reference product,” saving plan sponsors between $112,000 and $336,000 per patient per year. 

And for clients that do not use Lumicera for their specialty pharmacy, Navitus added the branded biosimilars Yesintek and Steqeyma to its formularies as of April. 

UnitedHealth’s Nuvaila subsidiary was the first mover when it came to embracing Stelara follow-on products. When Wezlana launched in January as the first available Stelara biosimilar, manufacturer Amgen Inc. said Nuvaila would be the sole distributor of the product. Wezlana is interchangeable for Stelara, meaning pharmacists can substitute the biosimilar for the reference product without needing a prescriber’s approval. 

Three other biosimilars are also now interchangeable for Stelara: Selarsdi for all its formulations, and Pyzchiva and Otulfi for some of their formulations. 

Meanwhile, Biocon said on May 5 that it had secured market access agreements for its Yesintek biosimilar from “numerous plans” representing over 100 million U.S. lives. 

Cigna added Yesintek to its commercial formulary beginning on March 21, and the firm’s Express Scripts division added the product to its National Preferred Formulary, effective on the same date.  

Biocon also said UnitedHealthcare has added Yesintek to several formularies, including commercial, beginning on May 1; managed Medicaid beginning on March 1; and Medicare beginning on June 1. UnitedHealth division Optum Rx added Biocon’s product to its Premium and Select formularies beginning on July 1, and CVS Health added coverage with the same effective date.  

Additionally, Biocon said Yesintek was added to formularies by Costco Health Solutions, MedImpact, Priority Health, UPMC and several other regional health plans. And it was selected as the exclusive ustekinumab by Blue Cross Blue Shield of Michigan, Florida Healthcare Plan and “several closed-door health systems.” 

Humira Biosimilars Walked So Stelara’s Could Run 

Stelara is one of the most expensive prescription drugs on the market, with an estimated wholesale acquisition cost (WAC) of $30,000 per 90 mg dose, Navitus noted, adding that “while Stelara may be dosed every 8 weeks or 12 weeks, many patients require a monthly dose which increases total treatment costs.”  

Like AbbVie’s blockbuster drug Humira (adalimumab), Stelara is indicated for the treatment of autoimmune conditions including Crohn’s disease, psoriasis, psoriatic arthritis and ulcerative colitis. 

Uptake of Humira biosimilars started off slow when major PBMs elected to keep the reference product on their formularies alongside the new follow-on products. But that changed when CVS Health Corp.’s Caremark removed Humira from its main commercial formularies and instead favored a cobranded version sourced from Cordavis, prompting competitors Express Scripts and Optum Rx to eventually make similar moves. 

The three major PBMs’ standard commercial formularies also generally exclude Humira biosimilars that are being marketed by a drug manufacturer rather than their own private labels. Examples include Biocon Biologics’ Hulio, Celltrion’s Yuflyma and both the low- and high-list-price versions of Pfizer’s Abrilada, each of which was excluded from all three major PBMs’ standard commercial formularies as of January 2025.  

The original Humira still controls more than 75% of the adalimumab market, according to a biosimilar market report published by Samsung in April.  

This article was reprinted from AIS Health’s biweekly publication Radar on Drug Benefits.