P03 LSJ - Emergency Pluvicto and Lutathera_Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-27-AP-1564

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-27-AP-1564

(1) Contracting Activity: Department of Veterans Affairs (VA), Network Contracting Office 22, located at 4811 Airport Plaza Drive, Suite 600, Long Beach, CA 90815, in support of VA Greater Los Angeles Health Care System at 11301 Wilshire Blvd, Los Angeles, CA 90073 for purchase request 691-27-1-044-0008.

(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 requirement for Pluvicto and Lutathera will be awarded as a new requirement for a 1-month delivery order against National Acquisition Center (NAC) Federal Supply Schedule (FSS) contract 36F79720D0180.

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 estimated value of the proposed action is $

VA Greater Los Angeles Healthcare System Nuclear Medicine Service has urgent requirements for radiopharmaceuticals called Pluvito and Lutathera, radioligand therapies (RLT) that use radioactive isotopes to target and treat cancers. The requested supplies are required to maintain continuity of patient care and clinical operations during the transition from the expiring delivery order to the FY 2027 long-term delivery order. A minimum of 1-month bridge procurement is needed to ensure continued availability of the required radiopharmaceuticals, Pluvicto and Lutathera, until the long-term delivery order is awarded and implemented. The projected period of performance is 11/1/2026 through 11/30/2026.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-27-AP-1564

(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.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

The current delivery order (DO) is scheduled to expire on October 31, 2026. Although the FY 2027 acquisition package has been submitted, it was submitted later than necessary, and the estimated annual value of the requirement exceeds $ necessitating additional time to obtain the required reviews and approvals before the long-term delivery order can be awarded. To prevent laps in service and ensure continuity of patient care, the VA Greater Los Angeles Nuclear Medicine service has identified an urgent need for a bridge delivery order and/or PO for a minimum of 1-month until the long-term delivery order is awarded and implemented. Without this interim procurement action, the expiration of the current DO could result in an interruption of essential services, potentially adversely affecting patient care and clinical operations. Accordingly, an interim procurement action is necessary to maintain uninterrupted services while the FY 2027 acquisition completes the required approval process, and the long-term contract action is finalized.

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;

FAR 8.405-6(a)(1)(C): 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.

FAR 8.405-6(b): 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.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-27-AP-1564

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

VA National Acquisition Center (NAC) has already negotiated and determined the costs of requested radiopharmaceuticals are fair and reasonable. The radiopharmaceutical market fluctuates constantly, and it is in the best interest of the government to contract with the manufacturer, Novartis Pharmaceuticals Corporation, with the agreed upon cost of the proprietary and highly specialized medication, Pluvicto at per injection, and Lutathera at per injection.

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

SBA’s SBS query was made under NAICS code 325412 – Pharmaceutical Preparational Manufacturing, and it returned 188 SDVOSBs and VOSBs. However, requested radiopharmaceuticals are highly specialized and identified SDVOSBs and VOSBs do not have capabilities to manufacture or distribute requested radiopharmaceuticals.

VA NAC Pharmaceutical Catalog shows requested radiopharmaceuticals are available under FSS 36F79720D0180, Pluvicto at and Lutathera at . VA NAC has contracted with the only authorized manufacturer of these medications, Novartis Pharmaceutical Corporation under FSS. Novartis Pharmaceutical Corporation is the only one contractor listed on the NAC Pharmaceutical Catalog for Pluvicto and Lutathera.

Novartis Pharmaceuticals Corporation holds a Federal Supply Schedule (FSS) 36F79720D0180.

Novartis has resources to immediately provide Pluvicto and Lutathrea to mitigate urgent needs at the VA Greater Los Angeles Healthcare System. Further market research is limited due to the emergent need for radiopharmaceuticals for direct patient care. Any delays caused by competing this requirement or seeking alternative sources would result in unacceptable delays in patient care and pose a direct threat to the patient’s health.

(7) Any Other Facts Supporting the Justification:

Pluvicto and Lutathera are proprietary medications created by Novartis Pharmaceutical Corporation.

(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 Department of Veterans Affairs will continue to survey the marketplace for equivalent or better therapies that will offer Veterans the most up to date care.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-27-AP-1564

(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 sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Nuclear Medicine Service VA Greater Los Angeles Healthcare System

(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.

Contracting Officer Network Contracting Office 22

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.

Branch Chief, Supply 4 Network Contracting Office 22