Limited Source Justification_691 Pluvicto Lutathera_Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-7324

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-25-AP-7324

(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 Veterans Integrated Service Network (VISN) 22 Veterans Affairs (VA) Greater Los Angeles Healthcare System located at 11301 Wilshire Blvd, Los Angeles, CA 90073 for PR# 691-26-1-044-0003.

(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-year 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

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 requirements of Pluvicto and Lutathera, radioligand therapies (RLT) that use a radioactive isotope, to target and treat cancer.

Pluvicto, or generic name of Lutetium LU 177 Vipivotide Terta 27mCi/ML (NDC# 69488-0010-61), is an FDA approved radiopharmaceutical used to treat patients with an advanced cancer called Prostate-specific Membrane Antigen-Positive Metastatic Castration-Resistant Prostate Cancer (PSMA-Positive mCRPC) that either has spread to other parts of the body (metastatic), and/or has already been treated with other anticancer treatments.

Lutathera, or generic name of Lutetium LU 177 Dotatate, is a prescription medicine used to treat a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-7324 positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut.

The cost of these radiopharmaceuticals is The requested quantity is estimated based on usage of FY25. The anticipated period of performance is 11/1/2025 – 10/31/2026. The following is the breakdown:

Line Item Description Qty UOM Unit Cost Extended Cost

PLUVICTO LUTETIUM LU 177 VIPIVOTIDE TETRA

27mCi/ML 105 EA

0002 LUTATHERA LUTETIUM LU 177 DOTATATE 10 EA

Total Estimated Cost

(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:

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.

Pluvicto is the first targeted radioligand therapy for the treatment of progressive, prostate-specific membrane antigen-positive (PSMA) positive metastatic castration-resistant prostate cancer. There are currently no other equivalent FDA approved treatments available in the United States.

Lutathera is an FDS approved treatment for advanced neuroendocrine tumors (NETs) that affect the pancreas or gastrointestinal tract, known as GEP-NETs. Lutetium Lu 177 dotatate is the first radioactive drug approved to treat these rare cancers.

VA National Acquisition Center (NAC) has contracted with the only authorized manufacturer of these medications, Novartis Pharmaceuticals Corporation under Federal Supply Schedule (FSS) number 36F79719D0169. The contractor has provided a letter stating that they are the sole manufacturer and authorized supplier. There is only one contractor listed on the NAC Pharmaceutical Catalog portal that can provide these medications due to the proprietary and highly specialized nature of this medication.

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.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024

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.

(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 cost of the radiopharmaceutical is 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.

The VA National Acquisition Center (NAC) pharmaceutical catalog, SAM.gov, and FPDS were used to research acquisition histories and methods during August 2025.

The VA NAC has contracted with the only authorized manufacturer of these medications, Novartis Pharmaceutical Corporation under Federal Supply Schedule (FSS) 36F79719D0169. Novartis Pharmaceutical Corporation is the only one contractor listed on the NAC Pharmaceutical Catalog for Pluvicto and Lutathera.

SAM.gov and FPDS returned the notice ID 36C24424Q0682, a special notice intent to sole source, posted by NCO 4 for Lebanon VA Medical Center to procure Pluvicto and Lutather isotopes. FPDS revealed that the delivery order (DO) 36C24425F0144 against FSS 36F79719D0169 was awarded to Advanced Accelerator Applications USA, Inc. (ADACAP) on 12/19/2024 at the total cost of for the period of performance 1/1/2025 – 12/31/2025 using FAR 8.406-6 procedure.

This finding concludes that there were no other interested contractors who had the capabilities to provide Pluvicto and Lutathera. Effective 2/1/2025, all distribution activities related to the radioligand therapy and radioligand imaging products, including Pluvicto and Lutathera, were transferred from ADACAP to its affiliate, Novartis Pharmaceutical Corporation, and Novartis became the distributor of Pluvicto and Lutathera. ADACAP remains the manufacturer.

A special notice, an intent to sole source, was posted on SAM.gov August 5, 2025, to see if any other potential contractors have capabilities of manufacturing or distributing radiopharmaceutical equivalent to Pluvicto and Lutathera. The response due date was August 15, 2025. No response was received.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 01 Effective Date: 09/01/2024

Due to the specialized nature of these radiopharmaceuticals, Pluvicto and Lutathera, are not available from any other contractors. There is no therapeutically equivalent version of these radiopharmaceuticals available in the United States that are also Food and Drug Administration (FDA) approved. Per VA NAC, Pluvicto and Lutathera appear to be available from only one FSS contract holder with Novartis Pharmaceuticals Corporation under NAC FSS contract# 36F79720D0180. The pricing of Pluvicto at and Lutathera at are accurate per VA NAC pharmaceutical catalog.

(7) Any Other Facts Supporting the Justification:

Pluvicto and Lutathera are proprietary medications created by the pharmaceutical company, Novartis Pharmaceuticals 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 ‘equal to’ or better therapies that will offer veterans the most up to date care.

(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.

Josephine Ribe 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.

Adrienne Browen Contracting Officer Network Contracting Office 22

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

VHAPG Part 808.405-6 Limiting Sources Page 5 of 5 Revision: 01 Effective Date: 09/01/2024

Peter Kim Branch Chief, Supply 4 Network Contracting Office 22

Sabrina Smith Director of Contracting Network Contracting Office 22

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 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 FAR Subpart 8.4.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)