The Inflation Reduction Act of 2022 (the “IRA”) established a new manufacturer discount program, Part B and Part D inflation rebates, and a Drug Price Negotiation Program under which the prices for Medicare units of certain high Medicare spend drugs without generic or biosimilar competition are capped by reference to, among other things, a specified non-federal average manufacturer price, with negotiated prices set to take effect starting in 2026. Whether our product is selected for negotiation for a given year will depend on whether it is at least 7 years post-approval/licensure; whether it meets any of the exclusions from eligibility for selection for negotiation; its expenditures under Medicare Part B or Part D during a statutorily specified period; and whether a generic of the product has been determined to have come to market. Our understanding of whether and when our product is likely to be subject to selection for negotiation could evolve as the Drug Price Negotiation Program is implemented.
