6505--Notice of Intent - Sole Source for Pluvicto
Closed Special Notice Posted
- Solicitation number
- 36C25225F0191
- Agency
-
Veterans Integrated Service Network 12
Veterans Health Administration, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- PSC
- 6505 Drugs And Biologicals
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12, through its VHA Regional Procurement Office Central, Great Lakes Acquisition Center, has published a Special Notice announcing its intent to award a sole source contract for Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) to Novartis Pharmaceuticals Corporation. This specialized radiopharmaceutical procurement is intended for the Edward J. Hines, Jr. VA Medical Center in Hines, Illinois. Pluvicto is an FDA-approved radiologic therapeutic agent specifically designed to treat adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have previously received androgen receptor pathway inhibition and taxane-based chemotherapy. The contract falls under NAICS code 325412 for Pharmaceutical Preparation Manufacturing and will be structured as a firm-fixed-price delivery order. Novartis is the manufacturer and trademark holder of this highly specialized radiopharmaceutical.
The purpose of this Special Notice is to satisfy the Federal Acquisition Regulation requirement to publicize the proposed sole source contract action, though it explicitly states this is not a request for competitive proposals. Interested parties who believe they can meet the specialized requirements have until 5:00 PM EST on August 26, 2025, to submit written notice to the contracting officer at Parris.Weidenbach@va.gov. Any responses must include supporting evidence furnished in sufficient detail to demonstrate the contractor's ability to meet the subject requirement, provided at no cost or obligation to the Government. The Government retains sole discretion in determining whether to compete the proposed acquisition based on any responses received to this notice. Given the highly specialized nature of this FDA-approved radiopharmaceutical and its specific therapeutic application, the VA appears positioned to proceed with the sole source award to Novartis unless compelling evidence suggests alternative sources exist.
Notice text
The Department of Veterans Affairs, VHA Regional Procurement Office Central, Great Lakes Acquisition Center, Network Contracting Office 12, located at 115 S. 84th Street, Suite 101, Milwaukee, WI 53214-1476 intends to award a sole source, firm-fixed-price delivery order to Novartis Pharmaceuticals Corporation 59 Route 10, East Hanover, NJ 07936, for the purchase of Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan). The associated North America Classification Systems (NAICS) Code is 325412, Pharmaceutical Preparation Manufacturing.
The Edward J. Hines, Jr. VA Medical Center, 5000 South 5th Avenue, Hines, IL, 60141-3030, has a requirement for the purchase of Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan). Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) is a highly specialized radiopharmaceutical. Pluvicto is a radiologic therapeutic agent indicated for the
treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive
metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Per the FDA website https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Pluvicto is an FDA approved drug. Pluvicto manufactured and is a trademark of Novartis Pharmaceuticals Corporation.
This notice satisfies the requirement at FAR 5.201(b)(1), to publicize the proposed contract action. This notice of intent is not a request for competitive proposals. No solicitation documents are available at this time. Interested parties may give written notice to Parris.Weidenbach@va.gov by 5:00pm e.s.t. on 08/26/2025. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to meet the subject requirement. This information shall be provided at no cost or obligation to the Government. Responses will be considered by the Government; however, a determination by the Government not to compete the proposed acquisition based upon responses of this notice is solely within the discretion of the Government.
Inquiries shall be emailed to Parris.Weidenbach@va.gov. No telephone requests will be accepted. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government in future procurements.
Files
| File | Type | Posted |
|---|---|---|
| 36F79720D0180 36C25225F0191_1.docx | DOCX document |
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