AstraZeneca says CMS guidance around IRA exemptions is ‘unlawful’ in latest court brief

As­traZeneca ar­gued in court on Fri­day that the gov­ern­ment’s rules around which drugs may be ex­empt from Medicare price ne­go­ti­a­tions un­der the In­fla­tion Re­duc­tion Act are un­law­ful and put it at risk of “im­mi­nent harm.”

Un­der the cur­rent guide­lines, 10 drugs will be sub­ject to gov­ern­ment price ne­go­ti­a­tion start­ing in 2026 if they have no gener­ic or biosim­i­lar com­pe­ti­tion. But un­der the gov­ern­ment’s cur­rent in­ter­pre­ta­tion, it isn’t enough to have a com­peti­tor on the mar­ket. CMS must de­ter­mine that “bona fide” mar­ket­ing ex­ists for the gener­ic based on a num­ber of fac­tors, in­clud­ing the num­ber of pre­scrip­tions for Medicare ben­e­fi­cia­ries.

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