Lutathera and Pluvicto JA__Redacted.pdf

Control Number: 23-RHCO-C-362

CUI//CP-PROCURE

Controlled by: USAHCA Controlled by: MRCO-W

CUI Category: PROCURE

LDC: FED ONLY

POC:

Justification Review Document for Other than Full and Open Competition - FAR Part 6

Program/Equipment: Lutetium Lu-177 Dotatate and Lutetium Lu-177 Vipivotide Tetraxetan for Brooke Army Medical Center (BAMC), JBSA Fort Sam Houston, TX.

Authority: 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.

Amount:

Prepared by:

Typed Name: DSN:

Title: Contracting Officer Date: 30 May 2023

E-mail:

Contracting Officer:

Typed Name: DSN: 2

Date Reviewed: 31 May 2023 E-Mail: c

Technical Representative:

Typed Name: DSN:

Title: Nuclear Medicine Supervisor Date: 01 June 2023

Requirements Representative:

Title: Nuclear Medicine Department Chief Date: 01 June 2023

Control Number:23-RHCO-C-362

Reviews

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

Legal Counsel

Signature: _________________________________ Date: _______________________

Command Advocate for Competition

Typed Name:

Signature: _ ____ Date: ______________________

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

1. Contracting Activity: U.S. Army Health Contracting Activity (USAHCA), Joint Base San Antonio Health Contracting Branch (JBSA HCB), Medical Readiness Contracting Office, West (MRCO-W), 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The Brooke Army Medical Center Department of Nuclear Medicine requests a sole source Indefinite-Delivery Indefinite-Quantity contract with firm-fixed-price Contract Line Item Numbers. The contractor is Advance Accelerator USA, (include address). The Government projects award by September 2023, with a start date of 1 October 2023, contingent upon the availability of FY24 Defense Health Program funds. 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 Brooke Army Medical Center (BAMC) requires two 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 and quantities, and estimated prices:

Lutetium Lu-177 Dotatate Quantity (Qty) per year: 15 Lutetium Lu-177 Vipivotide Tetraxetan Qty per year: 200

Dotatate Qty Cost/Dose Total Cost Vipivotide Qty Cost/Dose Total Cost Base 15 200

Delivery Dates: 1 October 2023 to 30 September 2024

Estimated total amount:

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.

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.” Advanced Accelerator Applications USA (AAA), Inc is the only contractor that manufactures these pharmaceuticals. AAA manufactures the only FDA approved Dotatate product indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors and for treatment of prostatic-specific membrane antigen-positive metastatic castration-resistant prostate cancer.

Lutetium Lu-177 Vipivotide Tetraxetan received FDA approval on 23 March 2022 for the treatment of adult patients with acertain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic). It is the first and only FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeuticradioisotope (a radioactive particle).

Lutetium Lu 177 dotatate received FDA approval on 26 January 2018 for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP- NETs. It is indicated for adult patients with somatostatin receptor-positive GEP-NETs. It is indicated for a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing (Only 1 in 27,000 are diagnosed with GEP-NETs per year).

Market Research reveals there is no other company that provides FDA approved Dotatate products for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Historically, once received, FDA approval last 10 years, however for rare cancer drugs, the approval process for new treatments, can take up to 12 years given the three phases of clinical trials required and the limited number of participants available for the clinical trials.

These are the only medication for use in the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors and for treatment of prostatic-specific membrane antigen-positive metastatic castration-resistant prostate cancer and no generic alternatives exist. Failure to acquire these products limits the treatment possibilities of stricken patients reducing probable positive outcomes significantly.

6. Efforts to Obtain Competition: A sources sought notice was posted to the government point of entry, sam.gov, on 19 May 2023 with responses due 26 May 2023.

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 Advanced Accelerator Applications USA, 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 2023 and vendor profile assessment and contact, there is no reasonable indication that this requirement can be competed. The Defense Logistics Agency Pharmacy Prime Vendor Program does not provide these radiation drugs. 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 one capable vendor, Advanced Accelerator Applications USA.

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

10. Other Facts:

a. Procurement history.

W81K0022P0229

Description of requirement: Lutathera and Pluvicto Advanced Accelerator Applications USA POP 01-OCT-2023 to 30-SEP-2023 Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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

W81K0022P0068

Description of requirement: Lutathera and Pluvicto Advanced Accelerator Applications USA POP 03-MAR-2022 to 30-SEP-2022 Total awarded amount:

Sole Source, FAR 13.501(a)(1)(ii) Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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

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)

Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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) Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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

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) Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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) Previous Paragraph 7: The customer has continued to monitor the marketplace for new entrants, however as explained in this J&A, there are no new manufacturers of these pharmaceuticals.

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

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: _______________________

Title: Nuclear Medicine Supervisor Typed Name:

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: _

Approval

Based on the foregoing justification, I hereby approve the procurement of Lutetium Lu- 177 Dotatate and Lutetium Lu-177 Vipivotide Tetraxetan with Advanced Accelerator Application for the estimated 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 responsible source and no other supplies or services will satisfy agency requirements. The approval is subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for this acquisition.

Signature: _ __ _ Date: __________________________

Typed Name: Title: Command Advocate for Competition

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