By Tristan Manalac

Pictured: Entrance to the Department of Health and Human Services in Washington, DC/iStock

The Department of Health and Human Services in a supplemental court filing posted late last week has suggested that Johnson & Johnson’s blockbuster psoriasis therapy Stelara (ustekinumab) might soon be “deselected” from the Inflation Reduction Act’s Drug Price Negotiation Program.
The development comes after the FDA last week approved Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara. In May 2023, Amgen and J&J settled their patent dispute over the biosimilar challenge to Stelara, allowing the entry of Wezlana “no later than January 1, 2025.”
Under the current negotiation guidelines, the Centers for Medicare and Medicaid Services can reconsider a drug product for price negotiations when it is “subject to meaningful competition.” HHS referred to this provision in a separate October 2023 court filing, supporting its prior motion to dismiss a lawsuit filed by various trade groups including the Pharmaceutical Research and Manufacturers of America (PhRMA).
“A generic or biosimilar competitor could enter the market, which would remove a drug from the list of those eligible for price negotiation,” HHS wrote last month in its court filing, adding that this would also apply specifically to Stelara for which a biosimilar competitor is “expected no later than early 2025.”
“If those predictions are realized, Stelara will be deselected, and negotiated prices will never take effect for the administration of Stelara,” HHS stated in its October document. Given this possibility, Stelara’s selection for the first round of price negotiations poses no certain future harm to J&J, according to the agency.
HHS noted in its court filing last week that “those predictions are now, in fact, beginning to be realized” with Wezlana’s recent approval.
Under the Inflation Reduction Act (IRA), which was signed into law in August 2022, CMS is authorized to renegotiate the prices for Medicare’s most highly prescribed medicines, with the goal of generating $25 billion in drug savings over the next eight years.
CMS released its initial roster of medicines to be impacted by this program in August 2023. In addition to Stelara, the list also includes BMS’s blood thinner Eliquis (apixaban), Lilly’s diabetes drug Jardiance (empagliflozin) and Novartis’ heart failure treatment Entresto (sacubitril/valsartan). Two other J&J products are up for negotiations, including blood cancer therapy Imbruvica (ibrutinib) and anticoagulant Xarelto (rivaroxaban).
Besides trade groups like PhRMA, several big biopharma players have also lodged lawsuits against HHS seeking to block the drug price negotiation program. These include J&J, AstraZeneca and Merck.