JA_Lutathera and Pluvicto_Redacted..pdf

Control Number: 24-RHCO-C-213

(Source Selection Information – See FAR 2.101 and 3.104-4)

CUI//CP-PROCURE

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Chief of Contracting Office

Typed Name:

Signature:

Legal Counsel

Command Advocate for Competition

Senior Contracting Official

Justification and Approval for Other than Full and Open Competition – FAR Part 6

1. Contracting Activity: U.S. Army Health Contracting Activity (USAHCA), Regional Contracting Support Branch (RCSB), Medical Readiness Contracting Office, West (MRCO-W), US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The Brooke Army Medical Center (BAMC) Department of Nuclear Medicine requests a new sole source IDIQ contract with firm-fixed-price Contract Line Item Numbers (CLINs). The proposed vendor is Advanced Accelerator Applications USA (AAA). The Government projects award by September 2024, with an ordering start date of 1 October 2024, contingent upon the availability of FY25 Defense Health Program funds to be applied at the delivery order level. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: The Department of Nuclear Medicine Service at BAMC requires two (2) Food and Drug Administration (FDA) approved products that are required for the imaging and treatment of somatostatin receptor-positive gastroeteropancreatic neuroendocrine tumors and for the treatment of adult patients with prostatic-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The following are description of items, quantities, and estimated prices:

Lutetium Lu-177 Dotatate (Lutathera) Lutetium Lu-177 Vipivotide Tetraxetan (Pluvicto)

Delivery Dates: 1 October 2024 to 30 September 2029 NOTE: As a supply contract, FAR 52.217-8 is not available for use.

Total Contract Value: The estimated maximum quantity for this IDIQ contract is in order to account for variations in quantity that cannot be predicted with certainty. Current projected quantities are estimated at .

4. Authority Cited: 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

Ordering Period

LUTATHERA

qty Cost Total

PLUVICTO

qty Cost Total GRAND Total

Ordering Period 1: 1 October 2024 - 30 September 2025 31 108

Ordering Period 2: 1 October 2025 - 30 September 2026 30 108

Ordering Period 3: 1 October 2026 - 30 September 2027 30 120

Ordering Period 4: 1 October 2027 - 30 September 2028 30 120

Ordering Period 5: 1 October 2028 - 30 September 2029 30 140

5. Reason for Authority Cited:

As described at FAR 6.302-1(a)(2), “when the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.” The proposed vendor, AAA, is the only vendor that manufactures these pharmaceuticals. AAA manufactures the only FDA approved Dotatate product used for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors and for treatment of prostatic-specific membrane antigen-positive metastatic castration-resistant prostate cancer.

6. Efforts to Obtain Competition: A sources sought notice was posted to the government point of entry, sam.gov, on 26 April 2024 with responses due 8 May 2024.

The purpose of the notice was to determine if this effort could be successfully competed through full and open competition. The notice resulted in no responses. Market Research reveals the proposed vendor AAA, a large business, is the only provider of the required supplies. A notice of intent will be posted in accordance with FAR 5.203.

The government will request a subcontracting plan or the appropriate rationale as to why subcontracting possibilities do no exists in accordance with FAR 19.702.

7. Actions to Increase Competition: The customer and contracting office will monitor the marketplace during the life of the requirement to determine if there are other vendors who provide the same support in an effort to increase competition. The government will continue to assess the market for new entrants.

8. Market Research: Based on market research conducted in May 2024, vendor profile assessment, and contact, there is no reasonable indication this requirement can be competed. The Defense Logistics Agency Pharmacy Prime Vendor Program does not provide these radiation drugs. The contracting team received a waiver (email) from DLA on August 21, 2023, which stated that Lutathera/Pluvicto continues to not be supported by prime vendor. On January 8, 2024, another email waiver was received, which recommended that Army MEDCOM purchase with internal Army acquisition assets. The Contracting Officer has concluded that there is not a reasonable expectation of receiving competitive offers. Based on the results from the sources sought and the previous acquisitions, the Government only anticipates the one capable vendor, AAA.

9. Interested Sources: To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement history.

W81K0023C0013 Description of requirement: Lutathera and Pluvicto

Advanced Accelerator Applications USA POP 01-OCT-2023 to 30-SEP-2024 Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii)

Accelerator Applications USA, Inc. is the only known manufacturer of the drug/supply. There has not been a significant change found in the pharmaceutical.

W81K0022P0229

Advanced Accelerator Applications USA POP 01-OCT-2022 to 30-SEP-2023 Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Accelerator Applications USA, Inc. is the only known manufacturer of the

W81K0022P0068

Advanced Accelerator Applications USA POP 03-MAR-2022 to 30-SEP-2022 Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Accelerator Applications USA, Inc. is the only known manufacturer of the

W81K0021P0286 Description of requirement: Lutathera Advanced Accelerator Applications USA

POP 01-OCT-2021-31-DEC-2021

Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii)

Accelerator Applications USA, Inc. is the only known manufacturer of the

W81K0020P0345 Description of requirement: Lutathera and Netspot Gallium Advanced Accelerator Applications USA POP 01-OCT-2020 to 30-SEP-2021

Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii)

Accelerator Applications USA, Inc. is the only known manufacturer of the pharmaceutical.

W81K0019P0437 Description of requirement: Lutathera and Netspot Gallium Advanced Accelerator Applications USA POP 01-OCT-2019 to 30-SEP-2020

Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Accelerator Applications USA, Inc. is the only known manufacturer of the

W81K0018P0655 Description of requirement: Lutathera and Netspot Gallium Advanced Accelerator Applications USA POP 01-OCT-2018 to 30-SEP-2019

Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Accelerator Applications USA, Inc. is the only known manufacturer of the

11. Technical Certification:

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

Signature Date: _______________________

Typed Name: Title: Nuclear Medicine Supervisor

12. Requirements Certification:

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

Signature: Date: ______________________

Typed Name: Title: Nuclear Medicine Department Chief

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. This determination will be made using price analysis and comparison to the independent Government estimate. Pursuant to FAR 15.403, commercial items are exempt from the requirement for certified cost or pricing data.

Signature Date: ______________________

Typed Name Title: Contracting Officer

14. Contracting Officer Certification:

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

Signature Date: _______________________

Typed Name: Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of Lutathera and Pluvicto with Advanced Accelerator Application USA for the estimated maximum amount of on an other than full and open competition basis pursuant to the authority of 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1, Only one (1) responsible source and no other supplies or services will satisfy agency requirements subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for this acquisition.

Signature Date:

Typed Name: Title: Deputy to the Commanding General