Court Dismisses Challenge to Colorado Prescription Drug Affordability Board
On March 28, a U.S. District Court issued a ruling to dismiss a motion for summary judgment in a case against the Colorado Prescription Drug Affordability Board (PDAB). Last year, the PDAB selected Enbrel for affordability review. In the review, the PDAB determined Enbrel to be unaffordable for Colorado consumers and decided to establish an upper payment limit (UPL) for the drug. Following the decision, Amgen filed suit in March 2024 challenging the constitutionality of the PDAB’s authorizing statute. Amgen claimed the law conflicted with federal law and violated due process.
In dismissing the case, the district court judge determined that Amgen lacked standing. The court found that manufacturers are not subject to direct regulation under the law and that as an unregulated party the injuries alleged by Amgen were too speculative. The court stated that under the law UPLs do not apply to the manufacturer's point of sale, and only apply to downstream transactions for the actual sale and reimbursements of the drug dispensed to Colorado consumers.
The ruling is significant as it maintains the viability of PDABs and UPLs as a policy solution for states to address prescription drug costs. PDABs in Colorado, Maryland, Minnesota, and Washington have UPL authority, and as they move through the process of implementing UPLs, other states will be monitoring the impact and whether it is an effective approach to lower prices for consumers. Colorado is planning for UPL rulemaking for Enbrel in May, though they have delayed rulemaking several times since the beginning of the year.
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