PG Part808.405-6 Atch2 Limiting Sources Justification OVER SAT 36C255-26-AP-0008 SAM_Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT PYLARIFY (piflufolastat F 18) Injection for Topeka VA Medical Center

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C255-26-AP-0008

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:36C255-26-AP-0008

1. (1) Contracting Activity: Department of Veterans Affairs, VISN 15, Network Contracting Office 15, 3450 S. 4th Street Trafficway, Leavenworth, KS 66048 in support of the Colmery- O’Neil VA Medical Center located at 2200 Gage Blvd, Topeka, KS 66622-0001

2237: 589-26-1-2618-0001

(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).

The action being reviewed and approved is for PYLARIFY (piflufolastat F 18) It will be awarded as a new, sole-source open-market firm-fixed price blanket purchase agreement to Progenics Pharmaceuticals, Inc., a Lantheus company.

Order against: FSS Contract Number: 36F79725D0093

Name of Proposed Contractor: Progenics Pharmaceuticals, Inc

Street Address: 331 Treble Cove Rd

City, State, Zip: North Billerica, MA 01862-2849

Phone: Chris Thomas 978-436-7344

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 793,918.40

The radiopharmaceutical to be acquired is PYLARIFY (piflufolastat F 18). PYLARIFY (piflufolastat F 18) is an IV injection of the radioactive material Fluorine 18 attached to a small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

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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 (CO) in making this best value determination:

Progenics Pharmaceuticals, Inc. has a five-year Federal Supply Schedule award under contract 36F79725D0093 for PYLARIFY (piflufolastat F 18) priced at and provided a quote at per injection, which was previously determined to be fair and reasonable. Due to the previous contract expiring on March 31, 2025, it is not available for this procurement; however, Progenics Pharmaceuticals, Inc. has confirmed for a multi-year PO they will guarantee their long-term pricing of per injection through the end of the contract term in 2030, which was the exact pricing as on their old contract 36F79719D0170.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

The CO conducted a search of the GSA eLibrary that identified the small business concern Progenics Pharmaceuticals, Inc. PYLARIFY (piflufolastat F 18) is a proprietary medication created by the pharmaceutical company Lantheus, which owns Progenics Pharmaceuticals, Inc.

Progenics has a five-year Federal Supply Schedule award contract 36F79725D0093 for PYLARIFY that ends on March 31, 2030, making it suitable for this procurement.

The overall North American Industry Classification System (NAICS) code was determined to be 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1,300 employees.

A search of Service-Disabled, Veteran-Owned Small Businesses (SDVOSB) and Veteran-Owned, Small Businesses (VOSB) under NAICS Code 325412 was conducted at https://search.certifications.sba.gov/. While 191 SOVOSBs and VOSBs were identified under this NAICS code, no vendors were identified that could provide the required supply when the keyword Pylarify was added. The contracting officer, therefore, does not have a reasonable expectation that two (2) or more small business concerns owned and controlled by veterans will submit offers and that the award can be made at a fair and reasonable price that offers the best value to the United States.

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The Diagnostic Imaging Service at the Topeka VA Medical Center conducted research regarding the technical characteristics of the required supply.

The Buy American Act requires Federal agencies to procure domestic materials and products.

Two conditions must be present for the Buy American Act to apply: (1) the procurement must be intended for public use within the United States; and (2) the items to be procured or the materials from which they are manufactured must be present in the United States in sufficient and reasonably available commercial quantities of a satisfactory quality. The Buy American Act does not apply to this procurement as PYLARIFY (piflufolastat F 18) is manufactured in the United States.

(7) Any Other Facts Supporting the Justification:

The procurement of PYLARIFY (piflufolastat F 18) through Progenics Pharmaceuticals, Inc. is the best option for the Topeka VA Medical Center’s Diagnostic Imaging Service based on the extended half-life of the product versus all available options. In addition, the available alternatives would not provide a diagnostic advantage and would hinder diagnostic reliability, affecting patient care.

A The CO conducted a Google search to determine if other medications like PYLARIFY (piflufolastat F 18) are available in the United States. It has been determined that there is currently no therapeutically equivalent version of Pylarify (piflufolastat F 18) available in the United States. Pylarify (piflufolastat F 18) is subject to the requirements outlined by the Food and Drug Administration (FDA). The delivery of this medication is subject to the terms outlined in the Department of Transportation (DOT) and all local and state requirements.

(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:

In an effort to remove or overcome barriers to competition, the Government intends to routinely survey the marketplace and determine whether competition is available or if exercising subsequent ordering periods is in the best interest of the Government. Should there be a change in the VA facility’s requirement, competition would be sought at that time.

(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. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

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SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

(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.

Stephen Parrott Date Contracting Officer Network Contracting Office 15