Justification _ redacted.pdf

This is a Sole Source Justification document from the Department of Veterans Affairs for the procurement of Pylarify (F-18 Pylarify) radiopharmaceutical from Progenics Pharmaceuticals, Inc. The contract is a firm-fixed-price indefinite-delivery/indefinite-quantity contract for the Charlotte VA Health Care Center in Charlotte, NC.

The justification outlines the requirement for Pylarify, a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The contract period includes a 12-month base period from 02/01/2025 to 01/31/2026 and four 12-month options, with 280 annual doses. Progenics Pharmaceuticals is identified as the sole manufacturer and supplier, as other PSMA imaging agents (Ga-68 tracers and F-18 Posluma) do not meet the specific requirements due to half-life limitations and performance differences. Market research was conducted through SBA VetCert, NAC, SAC, and FPDS, with a notice of intent to sole source posted on Contract Opportunities from December 11-19, 2024. No alternative sources expressed interest in the acquisition.