Notice of Intent to Sole-Source for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) for Buffalo VA Medical Center

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Subpart 5.101 requiring dissemination of information for proposed contract actions.

The Network Contracting Office (NCO) 2, Department of Veterans Affairs intends to award a firm-fixed-price sole source contract with Novartis Pharmaceuticals Corporation, a large business, for the purchase of 9 units of Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) for VA Western New York Healthcare System Buffalo VA Medical Center Nuclear Medicine 3495 Bailey Avenue Buffalo, NY 14215 This sole source determination is in accordance with FAR 8.405-6(a)(1)(B), Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

Advanced Accelerator Applications USA, Inc. is the only known authorized supplier for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan). The North American Industry Classification System (NAICS) code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The Federal Supply Class (FSC) is 6505, Drugs and Biologicals. The Small Business Administration (SBA) size standard for this sector is 1,300 Employees.

Statement of Need: The New York/New Jersey Healthcare System Veterans Integrated Service Network (VISN) 2, in support of VA Buffalo Medical Center has a requirement for 9 units of Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan), a radioactive therapy treatment for Prostate-specific Membrane Antigen-Positive Metastatic Castration-Resistant Prostate Cancer (PSMA-Positive mCRPC).

If your firm provides the radiopharmaceutical therapy on GSA Federal Supply Schedule or any Federal Supply Schedule, please provide applicable contract number and identify which supply/service are applicable to that FSS contract, and the following additional information (1) A tailored capability statement indicating the firm s ability to provide a product and related services; (2) The respondents SAM UEI number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc.,) pursuant to the applicable NAICS code; (3) Information should be provided electronically.

Potential offerors must be a manufacturer or fully licensed, authorized distributor for the radiopharmaceutical items. Potential offerors must be FDA certified. This notice of intent is not a request for competitive quotes. However, interested parties may identify their interest and capability to respond to the requirement and submit capability statement no later than 10:00 am., ET, Monday October 20, 2025, to Myra.Green2@va.gov.

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government. If no written response is received within the closing date of this notice, a single source delivery order award will be made to Novartis Pharmaceuticals Corporation without any further notice.

This notice does not obligate the Government to award an agreement or otherwise pay for the information provided in response to this notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.