Presentation (CTI)

OBJECTIVES: Immunoglobulin (IG) and other life-saving plasma-derived therapies (PDTs) depend on a uniquely labor-intensive and donor-driven supply chain in which plasma collection accounts for ~60% of total COGS. Yet IG pricing in the U.S.—the world’s dominant market—is now restricted by Inflation Reduction Act (IRA) inflation rebates and may soon be influenced by MFN constraints. This study introduces a Plasma Collection Cost Index (PCCI) as an innovative measure of input-cost inflation and examines the growing divergence between rising plasma collection costs and constrained IG reimbursement, with implications for long-term supply stability.
METHODS: We developed the PCCI by calculating growth in alternative wages for plasma donors, labor costs for clinical staff, and broader economic indicators that shape donor availability and motivation (e.g., wage growth among low-income workers, access to financing such as buy-now-pay-later). PCCI growth from 2019-2023 was compared with CPI-U and weighted Medicare ASP for Medicare. Margin effects were simulated using plasma collection’s proportional contribution to COGS, overlaid with IRA inflation-penalty limits on IG price growth.
RESULTS: We estimate that from 2019-2023, the PCCI increased 6.0% annually—exceeding the 4.5% growth in CPI-U and 5.1% increase in weighted average ASP for IG therapies. Rapid growth in fees required to attract sufficient donors as demand expands was a key driver. PCCI inflation translates into automatic margin erosion of nearly one percentage point per year after IRA price limits. This widening gap reduces incentives to invest in new collection centers, exacerbates competition for scarce donors, and increases the likelihood of supply disruptions.
CONCLUSIONS: The PCCI reveals a structural and growing misalignment between plasma collection cost inflation and IRA-constrained IG price growth. Potential MFN restrictions could make these constraints tighter. Without policy adjustments that reflect plasma’s unique cost dynamics, the divergence is likely to weaken the economic foundation of the U.S. plasma supply—raising meaningful risks of future IG shortages.