Colorado’s PDAB Faces Second Legal Challenge Over Drug Pricing
Key Takeaways
Amgen has filed a new lawsuit challenging the Colorado PDAB upper payment limits, specifically contesting the $600 per unit Enbrel upper payment limit set by the board.
The PDAB UPL authority lawsuit centers on claims that state drug pricing boards may be overstepping by interfering with federal patent law and regulating economic activity beyond state borders.
Although the Enbrel upper payment limit is set, it will not take effect until January 2027, giving time for legal proceedings to unfold.
The outcome of this case could impact state prescription drug affordability efforts and influence how other states with PDABs approach upper payment limits.
Amgen Files New Lawsuit Against Colorado PDAB Over Enbrel Price Limits
In October, the manufacturer of Enbrel, Amgen, filed a new lawsuit against the Colorado PDAB, challenging the PDAB’s authority to set upper payment limits (UPLs). On October 3, the PDAB adopted regulations to set the first-ever UPL on Enbrel at $600 per unit, which is based on Medicare maximum fair price (MFP). In the suit, the manufacturer argues that UPLs interfere with federal patent laws, attempt to regulate economic activity outside of the state, and violate due process.
Previous Lawsuit Dismissed Due to Lack of Standing
Amgen filed a separate lawsuit when Enbrel was initially selected for a UPL, but the case was dismissed with the judge determining that Amgen lacked standing since 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 new lawsuit is significant as now the UPL has been set; however, it does not go into effect until January 2027. In addition, the result of the lawsuit and interpretation of UPLs in the courts will influence state drug pricing policies, especially in Maryland, Minnesota, and Washington, which also have PDABs with UPL authority.
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