Radar on Specialty Pharmacy

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 beginning of the new year is seeing the start of the next wave of highly anticipated biosimilars: those of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.), kicked off by Amgen Inc.’s Wezlana (ustekinumab-auub) on Jan. 1. As seen in the launches of multiple biosimilars of AbbVie Inc.’s Humira (adalimumab), multiple factors may impact the agents’ uptake, say industry experts.

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.

More than two-and-a-half years after it first brought a lawsuit against SaveOnSP, Johnson & Johnson has added two additional divisions of The Cigna Group to the case challenging its copay maximizer program. In a recently unsealed motion, J&J added Express Scripts and Accredo as defendants “to stop a scheme to pilfer tens of millions of dollars from the financial support that JJHCS [Johnson & Johnson Health Care Systems Inc.] provides for patients.”

Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. But copay maximizer programs will distribute 100% of available manufacturer copay offset funds over 12 months, as opposed to copay accumulators, which apply the maximum manufacturer assistance up front and deplete that contribution before the end of the year. Payments in both approaches do not count toward members’ deductibles and out-of-pocket maximums.

As more and more innovative therapies launch in the U.S., payers will continue to explore a variety of tactics in their coverage of those drugs, including carveouts, outcomes-based arrangements and medical benefit management. And while the Inflation Reduction Act (IRA) is focused specifically on Medicare beneficiaries, the legislation — in particular its drug price negotiation provision — likely will impact commercial plans. These are only some of the specialty pharmacy issues to keep an eye on in 2025, according to industry experts who spoke with AIS Health, a division of MMIT, for our annual series of outlook stories on the year ahead. (Editor’s note: These comments have been edited for length and clarity.) 

Various specialty drug-treated conditions are expected to gain new competitors this year, including hereditary angioedema and metabolic dysfunction-associated steatohepatitis. New formulations and expanded indications of already approved agents are also set to impact a variety of diseases, bringing valuable treatments to patients and stressing payers’ financial situation even further. Industry experts spoke with AIS Health, a division of MMIT, about what drugs and/or therapeutic categories should be on payers’ radar in 2025.