Judge rules Botox exempt from Medicare price negotiations

U.S. District Judge Carl J. Nichols ruled on Oct. 29, 2026 that AbbVie’s Botox must be excluded from the Medicare drug price negotiation program because it contains human serum albumin, a plasma‑derived protein. The decision bars the Centers for Medicare & Medicaid Services from publishing a negotiated “maximum fair price” for Botox, which would have taken effect in 2028. AbbVie had sued CMS after the agency selected Botox for the 2028 negotiation round.

The ruling prevents a negotiated Medicare price for Botox, preserving AbbVie’s current pricing and revenue stream for the product. The company expects the decision to shield Botox from potential price cuts under the Inflation Reduction Act.

  • 1Judge Carl J. Nichols issued the decision on Oct. 29, 2026.
  • 2The court found Botox contains human serum albumin, a protein derived from human plasma, which qualifies it for the statutory exemption.
  • 3CMS had selected Botox for the 2028 Medicare price‑negotiation round before the ruling.
  • 4The decision bars the government from publishing a negotiated “maximum fair price” for Botox.
  • 5AbbVie filed the lawsuit on Feb. 11, 2026, challenging the CMS selection.

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