P03 - Limiting Sources Justification - Pluvicto.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 2 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0480

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C242-26-AP-0480

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

2237# 528-26-1-4322-0002

2. Description of Action: The Nuclear Medicine Service at VA Western New York Healthcare System is requesting a 1 year indefinite Delivery Contract ( IDC) with a period of performance fo 11/01/2025 – 10/31/2026 for the purchase of 9 units of Lutetium Lu 177 Vipivitide Tetrazetan ( Pluvicto ) for the therapeutic treatment of patients with metastatic prostate cancer.

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)778-2100

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 299,062.26

The Nuclear Medicine Service at VA Western New York Healthcare System is requesting a contract to purchase Pluvicto (Lutetium Lu 177 Vipivotide Tetraxetan) for the treatment of patients with prostate specific membrane antigen (PSMA) positive metastatic resistant prostate cancer Pluvicto (Trade name) or Generic Name of Lutetium LU 177 Vipivotide Tetraxetan 27mCi/ML, with 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 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. This is a requirement for 9 doses, and the Period of Performance is November 01, 2025 – October 31, 2026.

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 2 of 2 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C242-26-AP-0480

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

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

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)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority:

Novartis Pharmaceuticals Corporation is the sole Food & Drug Administration (FDA) approved source of this highly specialized therapeutic radiopharmaceutical, PLUVICTO (Lutetium Lu 177 Vipivotide Tetraxetan). There is no other radiopharmaceutical that can treat the same cancer.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Myra Florisa N. Green Contracting Officer

NCO 2

Date: October 08, 2025 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-6#FAR_6_303