P03 - RFO 8 Single Source Justification over SAT.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering Procedures

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for Part 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.)

14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C242-27-AP-0435

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 02, located at 20 Madison Ave Ext, Albany NY 12203, in support of the Veterans Integrated Service Network (VISN) 2 VA Western New York Healthcare System at 3495 Bailey Ave , Buffalo, NY 14215.

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). The Nuclear Medicine Service at VA Western New York Healthcare System is requesting for the purchase of 18 units of Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) and 4 units of Lutathera (Lutetium Lu 177 Dotatate).

Order against: FSS Contract Number: 36F79720D0180

Name of Proposed Contractor: Novartis Pharmaceuticals Corporation

Street Address: 59 Route 10

City, State, Zip: East Hanover, NJ 07936-1080

Phone: (862)390-9927

3. Description of Supplies or Services:

The Nuclear Medicine Service at VA Western New York Healthcare System has an ongoing clinical requirement for radioligand therapies used in the treatment of advanced cancers:

• Pluvicto: FDA approved targeted radiopharmaceutical therapy for Prostate-Specific Membrane Antigen–Positive Metastatic Castration Resistant Prostate Cancer (PSMA positive mCRPC).

• Lutathera: FDA approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumors (GEP NETs), requiring controlled nuclear pharmacy handling.

4. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

GSAM/R 538.7104-3(b)(1)(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;

Pluvicto and Lutathera are FDA‑approved radioligand therapies manufactured exclusively by Novartis Pharmaceuticals Corporation. Both products are proprietary, and no other manufacturer or distributor is legally authorized to produce or supply these radiopharmaceuticals.

GSAM/R 538.7104-3(b)(1)(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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

Pluvicto and Lutathera are brand‑name, proprietary radiopharmaceuticals produced solely by Novartis Pharmaceuticals Corporation. Their unique FDA‑approved composition, radiologic properties, and required compatibility with VA oncology and nuclear medicine protocols make substitutes neither clinically acceptable nor legally permissible.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-

2(4) to aid the contracting officer in making this best value determination:

Pricing for both drugs is established under the Federal Supply Schedule, where firm‑fixed pricing is negotiated and validated by the VA National Acquisition Center to ensure fair and reasonable pricing consistent with statutory and regulatory requirements. Procuring Pluvicto and Lutathera directly from the manufacturer ensures receipt of authentic, FDA‑approved radiopharmaceuticals, eliminates risks associated with gray‑market or counterfeit radioactive products, and guarantees compliance with all USNRC, DOT, and FDA handling and transport regulations. Direct acquisition also ensures reliable, time‑critical delivery needed to maintain radioactive dose integrity and protect patient safety.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research included review of:

• SBA VetCert, DSBS, NAC, GSA Advantage, GSA eLibrary, SAM.gov – All searches showed no vendors other than Novartis Pharmaceuticals Corporation capable of supplying Pluvicto or Lutathera.

• Manufacturer confirmation letters verifying exclusive distribution.

Result: No evidence of competitive sources or the Rule of Two.

7. Any Other Facts Supporting the Justification:

Both drugs are highly specialized, radioactive medical products requiring licensed delivery systems and strict regulatory compliance from U.S. Nuclear Regulatory Commission (NRC), U.S. Department of Transportation (DOT), and U.S. Food and Drug Administration (FDA).

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:

At this time, no actions can meaningfully expand competition because Pluvicto and Lutathera are the only FDA-approved radioligand therapies of their type, and Novartis Pharmaceuticals Corporation is the sole authorized manufacturer and distributor. Competitive conditions can only change if additional FDA-approved radioligand products enter the market or other manufacturers receive authorization to produce equivalent Lu-177 therapies. VA will continue periodic market research to identify any future competing sources.

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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by RFO 8.4.

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.

Myra Florisa N. Green Contracting Officer https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx