Optum’s Nuvaila Is Sole Distributor of First Stelara Biosimilar, Wezlana

Amgen Inc. has tapped Optum Health Solution’s new biosimilars-focused private-label subsidiary Nuvaila to be the sole distributor of its Wezlana (ustekinumab-auub), the first available biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.). While such deals may be beneficial to manufacturers that can strike them, they are essentially locking out competitors that can’t from the biosimilar market, asserts an industry expert.

Stelara is approved for the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.

The interleukin-12/IL-23 antagonist is available in both subcutaneous and intravenous formulations. Most of the agent’s use is via subcutaneous injection, with intravenous infusions used only to initiate treatment for Crohn’s and ulcerative colitis before moving to subcutaneous dosing.

The new interchangeable biosimilar, which is known as Wezlana for Nuvaila, launched Jan. 1, ahead of no less than seven additional ustekinumabs. The drug 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.

PBMs Previously Revealed Formulary Plans

UnitedHealth Group’s Optum Rx previously revealed in August that Wezlana for Nuvaila would be added to its commercial formulary on Jan. 1 and would be available in both high-wholesale acquisition cost and low-WAC versions.

Both of those versions and Stelara are on the second tier of Optum Rx’s Premium, Select and Premium Value formularies and require prior authorization (PA). The Nuvaila biosimilars will be offered at $0 copay support, as well as “up to almost 50%” in savings compared with Stelara’s list price for plan sponsors.

In early September, the Cigna Group’s Evernorth Health Services revealed plans to offer an interchangeable biosimilar of Stelara for $0 for “eligible patients” of Accredo starting “early next year.” The agent will be produced by Quallent Pharmaceuticals, Cigna’s private-label subsidiary. The biosimilar’s price, it said, will be more than 80% less than Stelara’s list price.

Evernorth did not provide any additional information on that offering in response to questions from AIS Health, a division of MMIT.

In response to AIS Health questions about Wezlana’s launch, including its WAC and payer outreach, an Amgen spokesperson replied that “Amgen has entered into a collaboration agreement with Nuvaila to manufacture WEZLANA for Nuvaila and it launched on January 1, 2025. Our goal is to use our best-in-class manufacturing engine to help expand access to these biologic treatment options and we believe this agreement will help support that goal.”

In the August 2024 Pharmacy Passages Formulary Update, Optum Rx noted that the Nuvaila Wezlana will be “manufactured by Amgen.”

When asked to clarify that the new drug is available only as Wezlana for Nuvaila, the spokesperson replied, “At this time, WEZLANA is distributed only through Nuvaila in the US.”

She referred AIS Health to Nuvaila for information “on who can purchase or access the product,” as well as on pricing and payer outreach. As of press time, Nuvaila had not responded to a request for comment.

According to Mesfin Tegenu, R.Ph., CEO and chairman of RxParadigm, Inc., Wezlana for Nuvaila’s high-WAC price is a 1% discount off Stelara’s, while the low-WAC price is an 80% discount.

In its 2024 Artemetrx State of Specialty Spend and Trend Report, Pharmaceutical Strategies Group (PSG), an EPIC company, revealed that inflammatory drugs dominated the top 10 specialty drugs  by spend, with Stelara ranked No. 2 behind AbbVie Inc.’s Humira (adalimumab), which faced biosimilar competition for the first time just under two years ago.

Move Follows Trend Among Payers, Manufacturers

With respect to the Nuvaila agreement, asks Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates, “Is UHC or its Optum subsidiary intending to become a direct competitor to existing drug wholesalers and other distributors of biologic medicines? Or might this be a specialty pharmacy sole distributor play?”

Partnering with Nuvaila on Wezlana — as well as on Humira biosimilar Amjevita (adalimumab-atto) — “follows a pattern of private-label agreements between the major PBM distributor subsidiaries and biosimilar manufacturers,” observes Winston Wong, Pharm.D., president of the W-Squared Group. The Cigna Group launched Quallent Pharmaceuticals in 2021, and CVS Health Corp. unveiled Cordavis in the fall of 2023.

However, this is the first time that a new biosimilar has been offered solely through one of those private-label subsidiaries.

“The private-label subsidiaries Cordavis [from] CVS Caremark ([headquartered in] Ireland), Nuvaila [from] Optum Rx (Ireland) and Quallent [from] Evernorth/Cigna (Cayman Islands) are all efforts by the PBMs to increase revenue directly from sales of the biosimilar drugs (and other drugs according to Quallent) that they are co-branding,” says Madelaine Feldman, M.D., FACR, a clinical assistant professor of medicine at Tulane University School of Medicine and provider with The Rheumatology Group in New Orleans. “This certainly gets away from rebates and fees, which is important to the PBMs, now that rebate pass through and transparency legislative efforts have gained steam.”

The dual-pricing approach follows similar biosimilar launches, “thus maintaining the flexibility of being sensitive to those wishing to maintain their rebate revenue strategies vs. those whose coinsurances are based upon the base cost of the prescription,” says Wong.

“Depending upon the stakeholder perspective, arrangements such as this have positives and negatives,” he asserts. “On the positive side, biosimilar utilization, which has long been stifled here in the U.S., has boomed, promoting less costly alternatives. Private labeling has had a definitive impact to increasing biosimilar utilization almost immediately, as would be expected through specialty pharmacy utilization management programs.”

He notes that while “industry disruptors” such as Mark Cuban Cost Plus Drug “have appealed to the cash-paying patients initially, their impact upon biosimilar utilization has been minimal. Thus, with these private-label agreements in place, biosimilar utilization is seen on both the commercial insured, as well as the cash-paying lines of business.”

But, he says, “on the negative side, private-label agreements have been successful for the manufacturers who have been able to negotiate such deals. However, for those who have not, they have been virtually locked out of the biosimilar market. The question of viability for these small manufacturers comes into play, and eventually they will either be acquired by their competitors or close their doors entirely. Thus, what was envisioned as a competitive market is no longer competitive, and in a sense, we are back to where we started: Big Pharma.”

With biosimilars’ low- and high-WAC pricing, there is “no question that the low-WAC-priced biosimilars for cash-paying lines of business are experiencing a cost savings.” But in lines of business dependent on high rebates, the high-WAC options are offering “significant discount rebates…to lower the net price of the biosimilar, much as we are seeing for drugs still under patent. The high WAC may be slightly below the innovator list price, which produces some cost savings, but the same rebate black box is still in place, which leads one to wonder if transparency is still an issue.”

This article was reprinted from AIS Health’s monthly publication Radar on Specialty Pharmacy.