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Summary of Challenges to the Sustainability of the U.S. Public Cord Blood System

Core Content

The U.S. public cord blood banking system (CBB) faces significant economic sustainability challenges. Hematopoietic stem cells (HSCs), which can be sourced from bone marrow, peripheral blood, or umbilical cord blood, are used to treat various diseases, including cancers like leukemia, blood disorders, and certain inherited conditions. Cord blood is particularly valuable for patients who cannot find a matched donor, especially in minority populations, due to its more flexible human leukocyte antigen (HLA) matching requirements. However, the use of cord blood in transplants has declined over time, while the use of alternative HSC sources, such as haploidentical donors, has increased.

The report outlines the current U.S. public CBB system, which includes 19 public banks, and evaluates factors that influence its long-term viability. It highlights that while the national cord blood inventory has grown, the increase has been concentrated in lower-quality (i.e., smaller total nucleated cell (TNC) count) units. This trend has financial implications, as banks lose money on units with TNC counts below 1.5 billion cells.

The report also explores the economic model of the cord blood banking industry, emphasizing the costs of collection, testing, processing, and storage, and the revenues from transplants. It concludes that the social value of the cord blood system far exceeds its social costs, suggesting that government intervention could be justified to ensure continued supply and diversity of the inventory.

Key Findings

• Declining Demand for Cord Blood Units (CBUs): The use of cord blood in transplants has decreased over time, from 12% in FY 2010 to 8% in FY 2015.
• Alternative HSC Sources: The rise in haploidentical and related donor transplants has contributed to the decline in cord blood use.
• TNC Count and Quality: Higher TNC count units are more likely to be used in transplants and are more cost-effective for banks.
• Financial Strain on Public CBBs: Many public banks are struggling financially, particularly due to the low profitability of low-TNC units.
• Racial/Ethnic Diversity: The federal government has prioritized increasing the diversity of the cord blood inventory, as minority patients are more likely to benefit from cord blood due to less stringent HLA matching requirements.
• Social Value Outweighs Costs: The societal benefit of the cord blood system is estimated at around $1.7 billion annually, compared to a cost of about $60–70 million.

Main Recommendations

NCBI Program Recommendations

1. Increase Diversity: HRSA should focus on encouraging the collection of more minority CBUs by providing funding or increasing subsidies for minority units.
2. Raise TNC Threshold: Consider increasing the minimum TNC count threshold, especially for nonminority units, to improve the financial viability of CBBs.
3. Standardize Funding: HRSA should standardize and consistently fund NCBI contracts to reduce market instability and ensure long-term investment in diversity.
4. Specialization: Explore the possibility of CBBs specializing in different types of CBUs (e.g., minority vs. Caucasian) to better align with program goals.

Broader Recommendations for Public Cord Blood Banking

1. Payment Structures: Adjust payment structures to reflect the full cost of cord blood transplants, similar to how organs are reimbursed.
2. Research Funding: Continue federal support for cord blood stem cell research, despite shifting focus toward alternative HSC sources.
3. Knowledge Sharing: Promote knowledge sharing within the industry to preserve clinical and technical expertise, especially if the industry shrinks.

Key Information

• Cord Blood Advantages: Less invasive collection, no risk to mother or baby, and more flexible HLA matching.
• Cord Blood Disadvantages: Longer engraftment time, lower TNC count, and financial challenges for banks.
• TNC Count Importance: A higher TNC count correlates with better clinical outcomes and higher usage rates.
• Government Role: The federal government supports the NCBI program and has a responsibility to ensure the sustainability and diversity of the public cord blood system.
• Market Trends: The U.S. market for cord blood is facing competition from international banks and alternative HSC sources.

Economic Overview

• Costs and Revenues: Banks incur significant variable costs for collection, testing, processing, and storage. Revenues are derived from transplants, with higher TNC units being more profitable.
• Clinical Benefits: Cord blood transplants offer comparable clinical outcomes to matched bone marrow grafts when TNC counts are sufficient.
• Public Goods Justification: The report suggests that the cord blood system has characteristics of a public good, warranting government intervention to ensure adequate supply and diversity.

Conclusion

The report emphasizes the need for policy changes and financial adjustments to support the sustainability of the U.S. public cord blood system. It advocates for a more targeted and efficient approach to funding and collection, ensuring that the system can continue to serve a diverse patient population while maintaining economic viability.