Drugs anticipated to be selected for Medicare price negotiation in 2026 for implementation in 2028

The 2028 incorporation of Part B drugs into the Medicare Drug Price Negotiation Program, established by the Inflation Reduction Act (IRA), introduces several unique challenges. The Centers for Medicare & Medicaid Services (CMS) final guidance for Initial Price Applicability Year (IPAY) 2028 indicates that both traditional fee-for-service Medicare and Medicare Advantage encounter data will be used to identify eligible Part B drugs. Furthermore, the newly enacted One Big Beautiful Bill Act of 2025 (OBBBA) also has implications for which drugs are selected because of its expanded "Orphan Drug Exclusion" criteria.

To predict 15 drugs likely to be selected for IPAY 2028.

Using CMS's 2020-2023 Part D and Part B Spending by Drug datasets and 2024 Average Sales Price Pricing Files, we projected 2024 expenditures for Part D and B drugs separately via regression models for utilization and pricing trends. Utilization and pricing were multiplied to estimate 2024 gross expenditures. Exclusion criteria were then applied, consistent with the IRA, OBBBA, and final CMS guidance, to arrive at 50 Part B and 50 Part D negotiation-eligible products. We selected 15 IPAY 2028 products based on their ranked combined Parts B and D 2024 projected gross expenditures.

The 15 selected drugs had projected 2024 expenditures above $800M, with 8 biologics and 7 small molecule drugs, and 7 Part B and D products and 8 exclusively Part D products. OBBBA significantly alters eligibility, delaying eligibility for 5 products and excluding at least 3 products from future negotiations.

Part B drugs will be negotiated for the first time in IPAY 2028. Policy changes, such as the OBBBA, exclude several high-cost products from negotiation. These policy decisions have major implications for how the Drug Price Negotiation Program targets high-spend drugs and achieves meaningful savings for the Medicare program.