Evernorth Reveals Stelara Biosimilar Strategy, but Will Others Get Same Discount?

Reprinted with AIS Health permission from the September 2024 issue of Radar on Specialty Pharmacy 

Ahead of the much-anticipated launch of the next wave of biosimilars for a high-cost specialty drug, The Cigna Group’s Evernorth Health Services has said that it will roll out a program to manage the drugs that is similar to one it first began offering this summer. But several aspects of the upcoming launch remain unclear, including whether the discount provided for the new drug will be available to all payers.

Evernorth revealed on Sept. 5 that it will offer an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.) 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 new agent’s price will be more than 80% less than Stelara’s list price. “For many employers, unions, municipalities and other health plan sponsors that choose to work with Accredo as part of their specialty pharmacy network offering, this represents an opportunity for significant savings,” said Evernorth in a press release.

The company says that more than 30,000 of Accredo’s patients use Stelara and that it expects that the program will save individuals around $4,000 on average annually.

The program mirrors one that Evernorth rolled out in June for biosimilars of AbbVie Inc.’s Humira (adalimumab). At a $0 out-of-pocket cost to eligible Accredo patients, the company currently offers two interchangeable Humira biosimilars via Quallent: Alvotech and Teva Pharmaceutical Industries Ltd. affiliate Teva Pharmaceuticals’ adalimumab-ryvk (also available as Simlandi) and Boehringer Ingelheim Pharmaceuticals, Inc.’s adalimumab-adbm (also available as Cyltezo).

When introducing the Stelara biosimilar offering, Matt Perlberg, president of Evernorth Health Services’ pharmacy and care delivery businesses, said that the company is “already seeing strong interest” in Quallent’s biosimilar Humira offering. Evernorth says that more than 25% of eligible patients are using that biosimilar.

Multiple Stelara Biosimilars Are Poised to Launch

The FDA has approved human interleukin-12 and -23 antagonist Stelara for four indications: for 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 FDA has approved three Stelara biosimilars as of early September.

Amgen Inc.’s Wezlana (ustekinumab-auub) is approved for all of Stelara’s indications and for both intravenous and subcutaneous administration, and it has interchangeable status. It can launch as soon as Jan. 1, 2025.

Samsung Bioepis Co., Ltd. and Sandoz’s Pyzchiva (ustekinumab-ttwe) also is approved for all of Stelara’s indications and in both subcutaneous and intravenous formulations. It has provisional interchangeability due to an “unexpired period of exclusivity for the first interchangeable biosimilar.” It can launch Feb. 22, 2025.

Alvotech and Teva’s Selarsdi (ustekinumab-aekn) is approved in a subcutaneous formulation only, so it does not have approval for two of Stelara’s indications — the treatment of adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis — that initiate dosing with the intravenous formulation. It does not have interchangeability. It can launch Feb. 21, 2025.

Not having approval for both subcutaneous and intravenous formulations “could limit use of all Stelara biosimilars in patients with Crohn’s or ulcerative colitis, making those available in all formulations more favorable for a preferred therapy,” says Tara Higgins, Pharm.D., a senior clinical consultant for Pharmaceutical Strategies Group (PSG), an EPIC company.

Having approval for both formulations, observes Andy Szczotka, Pharm.D., chief pharmacy officer at AscellaHealth, “may provide an enhanced opportunity for uptake by physicians and payers for these biosimilars across the current multiple indications that are approved for Stelara.”

Several Stelara Biosimilars Are Awaiting FDA Decision

According to the Sept. 1, 2024, edition of the U.S. Biosimilars Report from Cencora (formerly known as AmerisourceBergen), there are five ustekinumab biosimilars whose applications are pending at the FDA:

• BAT2206 from Hikma Pharmaceuticals PLC and Bio-Thera Solutions, Ltd. is pending as an interchangeable biosimilar;
• Bmab 1200 from Biocon Ltd subsidiary Biocon Biologics Ltd, which is cleared to launch in February 2025;
• CT-P43 from Celltrion USA. Inc., which is cleared to launch on March 7, 2025;
• FYB202 from Fresenius Kabi and Formycon is cleared to launch on April 15, 2025; and
• DMB-3115 from Accord Biopharma Inc., the U.S. specialty division of Intas Pharmaceuticals Ltd, is cleared to launch on May 15, 2025. Dong-A Socio Holdings and Meiji Seika Pharma developed the agent.

In its Biosimilars Landscape report, published May 8, 2024, Cardinal Health also lists two additional agents in clinical trials: NeuLara from NeuClone Pharmaceuticals Ltd and BFI-751 from BioFactura, Inc., the latter of which will be commercialized by CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, the companies said in July 2023.

In addition, Celltrion and Rani Therapeutics are developing an oral formulation of ustekinumab known as RT-111 that utilizes the latter’s robotic RaniPill capsule. The technology allows the capsule to break down in the small intestine, delivering the drug to that organ by injecting it into the intestinal wall. In February, Rani unveiled positive topline results of a Phase I study.

How Does Strategy Compare With Prior One?

Because it has an early 2025 launch date (Jan 1.) and interchangeability status, the most likely Stelara biosimilar that Evernorth initially will offer is Amgen’s Wezlana.

Evernorth did not respond to several AIS Health questions about the offering.

Amgen’s Amjevita also was the first of several branded and unbranded Humira biosimilars to come onto the U.S. market, launching Jan. 31, 2023, almost six months ahead of several more biosimilars that launched in early July 2023.

When Amjevita came onto the market, it offered both a high-wholesale acquisition cost version at 5% off Humira’s WAC — or $6,576 — and a low WAC version at a 55% discount — or $3,115. So if the new Quallent biosimilar is indeed Wezlana, that 80% discount is a much different launch strategy for Amgen.

Noting that there has been no confirmation of Quallent’s manufacturing partner, Szczotka says that “it is likely that the product partner would be either Amgen or Janssen.”

Amgen has not disclosed Wezlana’s price, “but with the potential of limited product partners for Evernorth for an interchangeable version, an 80% discount to Stelara is larger than what would have been expected for an initial product launch,” he tells AIS Health, a division of MMIT. With the other two approved biosimilars cleared to launch in February, “Amgen will not have the same six-month exclusivity period they had with adalimumab, so this likely will have an impact on their pricing.”

Amjevita “continues to have a very low percentage of utilization even though they were the first to launch,” points out Higgins. “Amgen is changing its strategy based on the slow uptake of Amjevita and coming out at a much deeper discount. Having interchangeability makes it easier in that it will not require a new prescription, which helps give Amgen a better strategy for successful conversions with the Stelara biosimilar.”

Szczotka agrees. “It is likely that Amgen applied the learnings from the slow adoption of Amjevita and is hoping to improve on Wezlana’s acceptance in the ustekinumab market in the initial market launch phase, as compared to Amjevita, which will lead to capturing and maintaining long-term utilization.” Its interchangeability designation “will assist with market adoption and acceptance by managed care payers.”

Will 80% Discount Be Available for All Payers?

It is unclear at this point whether that 80% discount is strictly for Quallent or will be offered to everyone. “Payers would hope that this discount would be available across the market to aid in biosimilar adoption,” observes Szczotka. “Similar to the adalimumab biosimilar market, each biosimilar product did not have universal pricing across all payers, so it would be anticipated that a similar model would likely follow for the ustekinumab biosimilars.”

Higgins says that the pricing strategy is likely to be for Quallent only. “As additional Stelara biosimilars enter the market by mid-2025, we will have to watch and see how this drives the pricing of the additional options,” she tells AIS Health. “It could be a different scenario than Humira as the pressure is building for quicker savings for payers and patients.”

The two Quallent-produced Humira biosimilars are offered at 46% off Humira’s WAC, or $3,750. However, those agents’ manufacturers also offer unbranded versions of them at 85% and 81% off Humira’s WAC, as well as a branded version of one at 5% off the WAC. That variation, says Szczotka, “indicates that they are attempting to be flexible and offer multiple options for payers to consider that would best fit their individual and specific client needs, as well as various options for different plan benefit designs.”

According to Higgins, “Formulary placement matters for the success of a biosimilar, and white-labeled products like Quallent gain access on one of the big three PBM formularies, but the net price is less clear, leaving impact of any other discounts including rebates or copay assistance unknown. This is the difference in the pricing strategies that we continue to see; deep-discounted biosimilars vs. higher priced biosimilars with rebates or preferred positioning with a large PBM under a white-labeled agreement can make it challenging for payers to realize optimal savings from Humira biosimilars.”

Stelara is one of the drugs in the first round of IRA-mandated Medicare negotiations, and CMS recently revealed that it negotiated a price that is a 66% discount from the 2023 list price. That negotiated price will be effective Jan. 1, 2026. Is that likely to impact biosimilar ustekinumab uptake?

Stelara’s list price, states Szczotka, “will likely be higher in 2026, and the discount may be not as attractive relative to the available biosimilars. The 66% discount does, however, provide a reference price that will used as a potential benchmark for this molecule going forward in 2025 and current ongoing manufacturer discussions.”

Ultimately, payers have been preparing for the launch of Stelara biosimilars and have been aided by some lessons learned from the Humira biosimilars. “Payers have been planning for the additional ustekinumab products for their 2025 formularies and having discussions with each of the manufacturers on product options, pricing and initiating educational efforts with physicians and clients on this potential cost savings opportunity,” Szczotka maintains.

“The arrival of the Humira biosimilars uptake has played out differently than expected in that it has been slow,” says Higgins. “Payers have been frustrated and are pressuring the PBMs to maximize biosimilar utilization and plan savings, which is leading to differences in approaches, as seen with the much deeper discount on the Quallent Stelara biosimilar. It is unclear if branded Stelara will remain on Evernorth’s formulary, co-preferred with the biosimilar, or if the brand will be removed from the formulary. When the brand continues to be preferred, utilization of the biosimilar is significantly reduced.”

By Angela Maas