HRSA's latest 340B program data, released in Q1 2025, shows total 340B purchases reached $53.7 billion in 2024, up 22% from the prior year. Contract pharmacy claims accounted for 71% of total 340B volume, continuing a decade-long shift away from in-house dispensing at covered entities.
The growth is concentrated in specialty drugs. Oncology and immunology products represent 44% of total 340B spending but only 8% of prescriptions, reflecting the high per-unit cost of specialty medicines purchased at 340B ceiling prices. For a $10,000-per-month oncology drug, the 340B ceiling price discount is approximately $2,300, creating substantial margin opportunity for covered entities and their contract pharmacy partners.
Six manufacturers currently restrict 340B contract pharmacy distribution: Eli Lilly, AstraZeneca, Sanofi, Novartis, Novo Nordisk, and United Therapeutics. HRSA has sent violation letters to all six but lacks clear enforcement authority following the Sanofi and Novartis federal court victories. The legal landscape remains unsettled, with circuit courts split on HRSA's authority to mandate unlimited contract pharmacy access.
For payers and PBMs, 340B overlap creates a different concern: duplicate discounts. When a 340B-purchased drug also generates a Medicaid rebate, manufacturers pay twice. CMS estimated $2.1 billion in potential duplicate discounts in 2024. The 340B ceiling price calculator and Medicaid rebate systems remain poorly integrated, allowing duplicate exposures to persist.
