LSJ PLUVICTO_Redacted.pdf

This is a Limited Sources Justification document for a Department of Veterans Affairs (VA) sole-source delivery order for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radiopharmaceutical targeted therapy approved by the FDA on March 23, 2022, for treating adult Veterans with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

The acquisition is conducted under the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501) through the VA's Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of Veterans Integrated Service Network (VISN) 21 and VA Northern California Health Care System (VANCHCS) in Mather, California. The contractor is Novartis Pharmaceuticals Corporation, a large business, under FSS Contract Number 36F79720D0180, located at 59 Route 10, East Hanover, NJ 07936. The base order covers 54 treatments (six cycles of six weeks each per Veteran) with an option to increase by 36 additional treatments in accordance with FAR Overhaul 52.217-6. The period of performance runs from October 1, 2026, through September 30, 2027. The justification cites sole-source authority under RFO 538.7104-3(b)(ii), establishing that only Novartis offers the required pharmaceutical via the mandatory VA National Acquisition Center (NAC) contract, making it the only capable source at the required quality level. Market research confirmed no small businesses distribute this pharmaceutical through the VA NAC. The document certifies the requirement as a bona fide need and approves restriction of Federal Supply Schedule contractor consideration to fewer than required by FAR 538.7104-3.