Legal
Court Rules AbbVie's Botox Exempt From Medicare Price Negotiation
A federal judge in the U.S. District Court for the District of Columbia ruled Oct. 29 that AbbVie's Botox must be excluded from Medicare's Drug Price Negotiation Program. AbbVie had sued HHS in February, arguing Botox qualifies as a "plasma-derived product" exempt under the Inflation Reduction Act because one of its three ingredients, human serum albumin, is derived from human blood plasma. The court agreed, finding HHS's decision to include Botox violated the law, and barred the agency from publishing a negotiated "maximum fair price" for the drug. The ruling marks a win for AbbVie and narrows the scope of drugs subject to Medicare price negotiation.
Why it mattersThe ruling signals that drugmakers can successfully challenge CMS's selection methodology under the Inflation Reduction Act, potentially shrinking the negotiated-price drug list that also shapes Medicaid pricing benchmarks tied to Medicare's negotiated rates.