JA Radiopharm HCA Approved.pdf

This is a Department of Veterans Affairs Justification and Approval (J&A) for Other Than Full and Open Competition requesting authorization for a sole source contract award.

The contracting activity is the Department of Veterans Affairs, Network Contracting Office 4, located in Wilkes-Barre, Pennsylvania, supporting the VA Health Care System at Lebanon VA Medical Center (LVAMC) and VA Pittsburgh Health System (VAPHCS). The acquisition involves a five-year Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) contract for radiopharmaceuticals—specifically Illuccix (Gallium 68 PSMA-11) manufactured by Telix Pharmaceuticals and NETSPOT (Gallium 68 Dotatate) manufactured by Novartis. Cardinal Health 414, LLC is the sole authorized distributor within the required delivery area and will be the direct award recipient. The contract period runs from October 1, 2026, through September 30, 2031, with a total estimated procurement value of $4,558,383.00. Annual estimated quantities include 108 units of Illuccix for Lebanon and 150 units of Illuccix plus 60 units of NETSPOT for Pittsburgh.

The justification for sole source procurement under 41 USC §3304(a)(1) cites the unique nature of these radiopharmaceuticals, which have a 68-minute half-life and require delivery within 24 hours of manufacture or they become waste. Only Cardinal Health operates within the required geographic radius to maintain inventory and meet the 68-minute delivery requirement. Market research confirmed that AAA is the sole manufacturer of Ga-68 Netspot and Telix is the sole manufacturer of Ga-68 Illuccix, with no other authorized distributors capable of serving the Pittsburgh and Lebanon areas. A Special Notice Intent to Sole Source was posted to SAM.gov from August 11-14, 2026, with no responses received. The VA will continue monitoring the commercial marketplace to determine if other sources become available for future competitive procurements.