HT941026N0009 Control Number FY26-0473 JA v4_Redacted.pdf

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Control Number: FY26-0473

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division - West CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Cha-on P. Gordon, cha-on.p.gordon2.civ@health.mil

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: Naval Medical Center San Diego

(NMCSD), Healthcare Contracting Division – West (HCD-W), Defense Health Agency Contracting Activity (DHACA).

2. Nature and/or Description of Action being Approved: This is a request for firm fixed price five (5) year Blanket Purchase Agreement (BPA) to procure the radiopharmaceuticals-- Pluvicto (NDC Number 69488-010-61), Lutathera (NDC Number 69488-003-01), Locametz (NDC Number 69488-017-61) and Netspot (NDC Number 69488-001-40)—for the treatment of prostate cancer.

3. Description of Supplies/Services: Naval Medical Center San Diego (NMCSD) and Medical

Treatment Facilities (MTFs) within the HCD-W Area of Responsibility (AOR) request a five

(5) year Blanket Purchase Agreement (BPA) for Pluvicto (NDC Number 69488-010-61), Lutathera (NDC Number 69488-003-01), Locametz (NDC Number 69488-017-61) and Netspot (NDC Number 69488-001-40) injections, which are radiopharmaceuticals used for the treatment of prostate cancer. Currently there are no other radiopharmaceuticals on the market that specifically treat this type of cancer, and there are no generic alternatives available. These products are exclusively distributed by Novartis Pharmaceuticals Corporation UEI: G61ZA8TADW3 CAGE: 04520.

Period of Performance: 2 February 2026 to 1 February 2031

Type of Funding: Operations and Maintenance (O&M)

Product Description NDC Number

PLUVICTO injection for intravenous use 69488-010-61

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LOCAMETZ injection for intravenous use

69488-017-61

LUTATHERA injection for intravenous use

69488-003-01

NETSPOT injection for intravenous use 69488-001-40

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items as implemented in FAR 6.302-1(c).

5. Rationale Justifying Use of Authority Cited: This sole source justification is prepared using the format specified in FAR 6.303-2, modified to adhere to the procedures outlined in FAR Subpart 13.5, in accordance with 41 U.S.C. 1901. As of February 1, 2025, all distribution activities related to the radioligand therapy and radioligand imaging products listed below have been transferred from Advanced Accelerator Applications USA, Inc.

(ADACAP), the manufacturer, to its affiliate, Novartis Pharmaceuticals Corporation (Novartis). Novartis will serve as the distributor of these products under the Novartis FSS Contract 36F79720D0180.

Novartis Pharmaceuticals Corporation is the exclusive FSS distributor for the radiopharmaceuticals Pluvicto (NDC Number 69488-010-61), Lutathera (NDC Number 69488-003-01), Locametz (NDC Number 69488-017-61), and Netspot (NDC Number 69488-001-40), all indicated for the treatment of prostate cancer. As a unique and highly specialized vendor, Novartis Pharmaceuticals Corporation is the only source able to meet the Government's needs, with no known alternative distributors for the required supplies. The relevant U.S. Department of Veterans Affairs Federal Supply Schedule (FSS) contract number covers the radiopharmaceuticals Pluvicto (NDC Number 69488-010-61), Lutathera (NDC Number 69488-003-01), Locametz (NDC Number 69488-017-61), and Netspot (NDC Number 69488-001-40).

In accordance with FAR 13.106-1(b), Novartis Pharmaceuticals Corporation is the only responsible source capable of fulfilling the needs of the Naval Medical Center San Diego (NMCSD) and the Medical Treatment Facilities (MTFs) within the HCD-W Area of Responsibility (AOR).

6. Efforts to Obtain Competition: The Notice of Intent to Sole Source HT941026N0009 was posted on the System for Award Management website (SAM.gov) from November 19, 2025, to December 9, 2025, in accordance with FAR Subpart 5.2. There were no responses to the Notice of Intent. Novartis Pharmaceuticals Corporation is the exclusive disturber of these

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products option due to the unique nature of radiopharmaceuticals available for treating prostate cancer.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

NMCSD and DHACA HCD-W will continue to survey and engage the market for any additional potential vendors.

8. Market Research: Market research was conducted by technical experts in December 2025.

This research included reviews of similar past procurements, the use of search engines to identify open market contractors, and an examination of mandatory sources. The search engines utilized encompassed SAM.gov, FPDS-NG, Federal Prison Industries (FPI), AbilityOne, ECAT-DLA, GSA Advantage, and the VA, to identify potential sources capable of fulfilling the Government’s requirements.

The research indicated that the necessary radiopharmaceuticals—Pluvicto, Lutathera, Locametz, and Netspot—are commercially available and used by private, public, and government medical institutions for the treatment of prostate cancer. Currently, there are no other radiopharmaceuticals on the market that specifically treat this type of cancer, nor are there generic versions available. These products are exclusively distributed by Novartis Pharmaceuticals Corporation, which acquired distribution rights from its affiliate, Advanced Accelerator Applications (ADACAP), as stated under FSS Contract: 36F79720D0180.

ADACAP confirmed that the distribution rights for Pluvicto, Lutathera, Locametz, and Netspot were transferred to Novartis on February 1, 2025.

The Notice of Intent to Sole Source HT941026N0009 was posted on the System for Award Management website (SAM.gov) from November 19, 2025, to December 9, 2025, in accordance with FAR Subpart 5.2. There were no responses to the Notice of Intent. Based on market research, it has been determined that this requirement will be sole sourced to an Other than Small Business: Novartis Pharmaceuticals Corporation (UEI: NG61ZA8TADW3, CAGE: 04520).

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

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(ADACAP), to its affiliate, Novartis Pharmaceuticals Corporation (Novartis) under NPC FSS Contract: 36F79720D0180.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not applicable

b. Additional Information: None

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division - West CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Cha-on P. Gordon, cha-on.p.gordon2.civ@health.mil

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Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501 Signature Page for Control Number: FY26-0473

10. Interested Sources: To date, no other sources have written to express interest. The Notice of Intent (NOI) HT941026N0009 was posted to contract opportunities 19 November 2025, and it closed 9 December 2025, allowing potential vendors to provide capability statements meeting the Government's minimum requirements, required by FAR 5.201.

11. Technical and Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Administrative Services Specialist, Business Manager, Radiology Department Naval Medical Center San Diego (NMCSD)

12. Prepared by:

Contract Specialist, Alpha Branch Healthcare Contracting Division - West Defense Health Agency Contracting Activity

13. Fair and Reasonable Cost Determination and Contracting Officer Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5., and the required supplies are commercially available and have been previously procured, which established current and historical information that will be used as a

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basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3).

I certify this justification is accurate and complete to the best of my knowledge and belief.

Healthcare Contracting Division - West Defense Health Agency Contracting Activity

14. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

15. Contracting Officer Certification:

I certify this justification is accurate and complete to the best of my knowledge and belief.

Review

I have reviewed this justification and find it adequate to support the sole source acquisition.

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Approval Based on the foregoing justification, I hereby approve the procurement radiopharmaceutical injection is indicated for the treatment of Prostate Cancer on a limited basis pursuant to the authority of FAR 8.405-6(b), subject to availability of funds, and provided that the equipment herein described has otherwise been authorized for acquisition.