36C244-26-AP-1574_JA Xofigo_Redacted.pdf

This is a Justification and Approval (J&A) document for other than full and open competition submitted by the Department of Veterans Affairs.

The acquisition seeks a five-year fixed-price, indefinite-delivery, indefinite-quantity (IDIQ) contract for Xofigo (Radium 223 Dichloride injection, 6ml/vial, NDC 50419-0208-01), a radiopharmaceutical treatment for castration-resistant prostate cancer with bone metastases. Three VA facilities require this product: Lebanon VA Medical Center (LVAMC), VA Pittsburgh Health System (VAPHCS), and Corporal Michael J. Crescenz VA Medical Center (CMJCVAMC). The contract will be awarded directly to Cardinal Health, LLC (7000 Cardinal Place, Dublin, Ohio 43017, Phone: 616-481-4156), the sole authorized distributor of Xofigo. Bayer HealthCare Pharmaceuticals, Inc. is the manufacturer. The period of performance is April 1, 2026, through March 31, 2031. The yearly estimated usage across three facilities is 4,400 units with an undisclosed total estimated contract value. Cardinal Health must maintain inventory within the greater Pittsburgh, Philadelphia, and Lebanon areas to support the 68-minute half-life requirement, hold Nuclear Regulatory Commission licensure, and provide continuous inventory management services during normal business hours.

The J&A justifies sole-source procurement under 41 USC §3304(a)(1) based on the contractor's unique qualifications. Xofigo is the only known treatment for prostate cancer resistant to prior medical or surgical treatments with symptomatic bone metastases, with no comparable alternatives available. Cardinal Health is the exclusive distributor, and Bayer is the sole manufacturer. A Special Notice (Intent to Sole Source 36C24426Q0363) was posted from March 4, 2026, to March 9, 2026, with no competing offers received. Market research confirmed that no other sources can provide the required radiopharmaceutical treatment under the specified conditions, and the VA will continue monitoring the marketplace for future competitive opportunities.