Sole Source Justification Summary

This is a Sole Source Justification document for a Federal Supply Schedule (FSS) order under GSAM/R 538.7104-3(b). The Department of Veterans Affairs, Network Contracting Office (NCO) 8 in San Juan, Puerto Rico is procuring 138 doses of Pluvicto on behalf of the VA Caribbean Healthcare System (VACHS). The proposed contractor is Novartis Pharmaceuticals Corporation (59 Route 10, East Hanover, New Jersey 07036), and the FSS contract number is 36F79720D0180. The estimated award date is February 6, 2026, with a base contract term of six months.

The justification is based on the authority that only one source is capable of providing the supplies at the required quality level because the supplies are unique and highly specialized. Pluvicto is a radioligand therapy (RLT) manufactured by Advanced Accelerator Applications and distributed exclusively by Novartis Pharmaceuticals Corporation for treating metastatic castration-resistant prostate cancer. The product is FDA-approved, and Novartis is the sole authorized distributor; no substitutions are permitted due to patents and proprietary data limiting competition. Market research across the National Acquisition Center (NAC), SCMC, GSA, FPDS, SBS, and SAM.gov databases confirmed no alternative sources. The contracting officer certified that the FSS pricing is fair and reasonable, and the order represents the best value for the government due to the product's innovative potential and life-extending benefits for advanced prostate cancer patients.