LSJ PLUVICTO_Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Revision: 02 Effective Date: 03/02/2026 Acquisition ID#:

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAM Subpart 538.71 – Federal Supply Schedule Ordering Procedures

Acquisition Plan Action ID:

RPOW JOFOC Tracker:

(1) Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of Veterans Integrated Service Network (VISN) 5, Health Service Area (HSA) 52, VA Palo Alto Health Care System (VAPAHCS), 3801 Miranda Avenue, Palo Alto, CA 94304-1207 2237:

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This action will be a new firm fixed price sole source delivery order for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with Novartis Pharmaceuticals Corporation (Novartis), a large business.

FSS Contract Number: 36F79720D0180 Name of Contractor: Novartis Pharmaceuticals Corporation Street Address: 59 Route 10 City, State, Zip: East Hanover, NJ 07936 Phone: (253) 961-5074

(3) Description of Supplies or Services: Pluvicto (lutetium Lu 177 vipivotide tetraxetan), with the National Drug Code (NDC): 69488-0010-61, is a radiopharmaceutical targeted therapy that was approved by the Food and Drug Administration (FDA) on March 23, 2022, for the treatment of adult Veterans with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Each Veteran requires six (6) cycles of treatment, which is provided every six (6) weeks, to complete treatment. This is a requirement for 54 treatments for Veterans with an option to increase the quantity of treatments by 36 treatments in accordance with Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) 52.217-6, Option for Increased Quantity. The Period of Performance is October 01, 2026 - September 30, 2027.

The estimated value of the proposed action is for an estimated quantity of 120 doses.

Revision: 02 Effective Date: 03/02/2026 Acquisition ID#:

(4) Identify the Authority and Supporting Rationale:

RFO 538.7104-3(b)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

RFO 538.7104-3(b)(ii): 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;

RFO 538.7104-3(b)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

RFO 538.7104-4: Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with RFO 538.7102-2(b)(4) to aid the contracting officer in making this best value determination: Pharmaceutical therapies will be purchased from existing contract at negotiated rates which have already been determined fair and reasonable. Purchase from any other distributor would circumvent a National mandatory-use contract for Pharmaceutical Prime Vendors.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: A search was conducted across the VA National Acquisition Center (NAC) pharmaceutical catalog which located a contract (36F79720D0180) offering the necessary National Drug Code required for this procurement. SAM.gov was searched for previous Pluvicto awards which yielded multiple awards via delivery order to the same vendor, large business, Novartis Pharmaceuticals Corporation. While the Small Business Association Small Business search yielded 185 SDVOSBs and VOSBs under North American Industry Classification System (NAICS) 325412 for Pharmaceutical Preparation Manufacturing, none of these small businesses are included on the mandatory source VA NAC as distributors of the necessary pharmaceutical. Market research found this requirement has been procured previously, through Novartis Pharmaceuticals

Revision: 02 Effective Date: 03/02/2026 Acquisition ID#:

Corporation, via delivery order 36F79720D0180 36C26126F0007, for for 120 doses on 10/01/2025.

Given that only large business Novartis Pharmaceuticals Corporation offers the necessary item via VA NAC contract which is mandatory use for Pharmaceutical Prime Vendor ordering, this shall be a sole source procurement via NAC contract to Novartis Pharmaceuticals Corporation. A limited source justification will be executed for this procurement. The rule of two has not been met and the Non-Manufacturer Rule will not apply.

(7) Any Other Facts Supporting the Justification: There are no other facts.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: The government will continue to monitor the market for equal products but the requirement that pharmaceuticals be purchased from the VA NAC will continue to limit acquisition options.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM Subpart 538.71.

Revision: 02 Effective Date: 03/02/2026 Acquisition ID#:

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval (over $900,000 to $90 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by GSAM Subpart 538.71.