Ustekinumab biosimilar (Amgen)

Next up is a vote to determine whether Stelara will be subject to an upper payment limit in Colorado. Colorado’s Prescription Drug Affordability Review Board (PDAB) isn’t waiting for the Inflation Reduction Act (IRA) to lower prices on certain drugs starting in 2026. After the board previously voted to enforce an upper payment limit on Amgen’s Enbrel in the state, Johnson & Johnson’s Stelara could be next in line. During its June 7 meeting, the board’s five members unanimously voted that Stelara’s use under its current labeling is “unaffordable” for Colorado consumers. The vote paves the way for an upcoming decision on whether the group will favor setting an upper payment limit on the medicine. Under Colorado's state laws, the PDAB can put upper payment limits on "all purchases of and payer reimbursements for" selected drugs in the state. Any savings generated by the limits must be used to lower costs for consumers. Prior to the vote, the PDAB detailed its rationale in a draft summary report, which included survey results from patient and caregivers plus models laying out the Stelara price’s effect on access. Stelara’s wholesale acquisition cost has increased 198.55% since its 2009 approval and jumped 26.53% just in the past five years, the board said, determining the average price paid per patient to be $150,176 in 2022. That adds up to a total statewide paid amount of $255 million.  Ahead of the meeting, J&J had a chance to defend itself with an emailed letter from Michael Valenta, the company's vice president of value, access and pricing in its strategic consumer group. In the letter, Valenta not only urged the board to vote in favor of affordability but also to make tweaks to its draft report as “the inclusion of inaccurate, inappropriate and opaque information creates a misleading picture.” J&J pointed to its own evidence, including an analysts of out-of-pocket costs, stating that the drug is affordable. Stelara is one of five drugs that were deemed eligible for a Colorado affordability review in a list that was whittled down from an original total of 604 meds. So far, Enbrel is the only drug on the list that will face the upper payment limits, which are to take effect six months after a 180-day rulemaking process to establish a specific amount. Amgen responded to that development with a lawsuit challenging the constitutionality of the PDAB’s process. On the flip side, the review board has determined that Gilead Sciences' HIV med Genvoya and Vertex Pharmaceuticals' cystic fibrosis therapy Trikafta do not meet the bar for unaffordability and will not be subject to an upper payment limit. Novartis’ psoriasis treatment Cosentyx is next up for review June 14. This year is the last of Stelara’s exclusivity before biosimilars enter the market starting Jan. 1, 2025, with Amgen’s Wezlana. Besides Amgen, biosimilars from several other drugmakers are slated to reach the market early next year. Then, in 2026, J&J and its star autoimmune drug will grapple with the pricing outcomes of the IRA negotiation process.