LSJ_OVER_SAT Pylarify_Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C252-25-AP-3281

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C252-25-AP-3281

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 12, located at 115 South 84th Street, Suite 101, Milwaukee, WI 53214-1476, in support of VISN 12, Edward J. Hines, Jr. VA Hospital, Nuclear Medicine Clinic located at 5000 S. 5th Avenue, Hines, IL 60141-3030.

2237: 578-25-4-735-1007

(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 an FSS Delivery Order for the radiopharmaceutical imaging agent PYLARIFY (PIFLUFOLASTAT F18), NDC: 71258-0022-01. This will be awarded as a new firm fixed price delivery order.

Order against: FSS Contract Number: 36F79725D0093 (Expires: 03/31/2030) Name of Proposed Contractor: Progenics Pharmaceuticals, Inc.

Street Address: 331 Treble Cove Road City, State, Zip: N. Billerica, MA 01862 Phone: 800-964-0446 Op #4

(3) Description of Supplies or Services:

The estimated value of the proposed action is

The Edward J. Hines, Jr. VA Hospital, Nuclear Medicine Clinic is requesting a base plus one option year delivery order for the current and foreseen requirement for this radiopharmaceutical to support streamlining future orders. The FDA approved sole source vendor, Progenics Pharmaceuticals, Inc., provides radioactive pharmaceutical Piflufolastat F-18 (PYLARIFY) Injection, National Drug Code (NDC): 71258-0022-01, as an advanced diagnostic imaging agent used with positron emission tomography (PET)/computer tomography (CT) scans to find tumors in the prostate which identify the prostate-specific membrane antigen (PSMA), as well as in lymph nodes, bones, and other organs.

This requirement will support a base period of performance of 09/01/2025 through 08/31/2026 and one 12-month option period. The estimated value of the proposed action is

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.)

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

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5

Acquisition ID#: 36C252-25-AP-3281

FAR 8.405-6(a)(1)(B): 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;

PYLARIFY (Piflufolastate F18) is a highly specialized radiopharmaceutical. PYLARIFY is the only FDA approved prostate-specific membrane antigen (PSMA) positive emission tomography (PET) imaging drug available in the commercial marketplace. PYLARIFY binds to PSMA, which is an important pharmacologic target for prostate cancer imaging because prostate cancer cells usually contain elevated levels of the antigen. As a radioactive drug that emits positrons, PYLARIFY can be imaged by PET to indicate the presence of the PSMA-positive prostate cancer lesions in the tissues of the body. Currently, there are no other equivalent treatments available in the United States. The NAC has contracted with the only authorized manufacturer of the medication, Progenics Pharmaceuticals, Inc. under FSS contract number 36F79719D0170. There is only one vendor listed on the NAC Pharmaceutical website that can provide this medication due to the proprietary and highly specialized nature of this medication. The radioactive drug PYLARIFY is manufactured and distributed in the USA. All Nuclear Medicine imaging agents are unique and highly specialized, specific to each individual patient.

Due to radioactive material being manufactured via a cyclotron or nuclear reactor it is often difficult for many vendors to invest in research and production of radioactive pharmaceuticals. The average patent on a radioactive pharmaceutical is 10 years before another vendor can manufacture a generic version for competition. Progenics Pharmaceuticals Inc. received FDA approval for Piflufolastat F-18 on 26 May 2021. A radiopharmaceutical PSMA imaging agent for PET/CT exams is a standard of care criteria in the workflow guidelines of the National Veterans Health Administration Oncology and National Comprehensive Cancer Network. While there are currently three (3) PSMA imaging radiopharmaceuticals on the commercial market, gallium (Ga) 68 gozetotide (Illuccix), Ga-68 gozetotide (Locametz), and Piflufolastat F-18 (PYLARIFY). Piflufolastat F-18 (PYLARIFY) is the only PSMA agent tagged with Fluorine (F-18). F-18 PYLARIFY has increased spatial resolution for image clarity of lesion detection due to lower positron range. This results in a lower error percentage for physician misdiagnosed exams. Also, PSMA agent tagged with F-18 has a reduced radiation exposure.

Additionally, all facilities should expose staff and patients to the lowest amount of radiation possible according to ALARA standards (as low as reasonably achievable). The radiation dose to the kidneys is significantly lower using F- 18 PYLARIFY, which is important due to the radioactive injection is primarily excreted via the urinary system (F-18 PYLARIFY Absorbed dose 4.3 mSv / Kidney 45.5 mGy

vs. Ga68 PSMA Absorbed Dose 4.4 mSv / Kidney 96.2 mGy). Furthermore, there is a substantial difference in decay half-life between Ga-68 gozetotide (68 minutes) and Piflufolastat F-18 (110 minutes).

The importance of decay half-life comes into play in situations such as if a Veteran is more than 15 minutes late to an appointment or has a difficult intravenous placement, a 68-minute dose may become unusable due to decaying and regulatory injectable standards. This could lead to the rescheduling of appointments, which can negatively affect therapy treatments and care for the Veterans. The decay half-life of Piflufolastat F-18 is about 38 percent longer than Ga-68 at 110 minutes, which provides more flexibility to account for unforeseen delays affecting patient care. A shorter radiopharmaceutical half would have a detrimental impact to departmental efficiency and significantly increase delay in Veteran care. Due to the unique purpose and function, FDA approval, and the longest known decay half-life of any PSMA on the market, only the Piflufolastat F-18 (PYLARIFY) manufactured and distributed by Progenics Pharmaceuticals will fully satisfy this requirement.

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

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Acquisition ID#: 36C252-25-AP-3281

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 in making this best value determination:

The VA is unable to satisfy the Edward J. Hines, Jr. VA Hospital, Nuclear Medicine Clinic requirements for supplies from the mandatory sources listed in FAR 8.002 and FAR 8.003. The use of a non-mandatory source, Federal Supply Schedules, per FAR 8.0004(a)(1) has been determined to represent the best value and will result in the lowest overall cost alternative, considering price and administrative costs, to meet the VA’s needs. Supplies offered on the schedule are listed at fixed prices. The General Services Administration (GSA) has already determined the prices of supplies under schedule contracts to be fair and reasonable. The VA will seek additional price reductions in accordance with FAR 8.405-4. This order represents best value to the government since the National Acquisition Center (NAC) has already negotiated the best price for the government. The radiopharmaceutical market fluctuates constantly, and it is in the best interest of the government to contract with the manufacturer, Progenics Pharmaceuticals, Inc. with the agreed upon cost of the proprietary and highly specialized medication, PYLARIFY at $3,789.16 per injection.

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

On 07/15/2025 a search of the Small Business Administration (SBA) Veteran Small Business Certification (VetCert) database was queried, as required, using NAICS 325412. The search resulted in 132 SDVOSB/VOSB contractors.

On 07/15/2025 a search of the SBA Dynamic Small Business Search (DSBS) database limited to NAICS 325412, resulted in 1,709 small businesses. A more targeted search adding keyword "Pylarify" resulted in zero small businesses.

On 07/15/2025 a search for the Federal Procurement Data System (FPDS) was completed. The search was limited to awards made in calendar years 2024 – 2025, the Department of Veterans Affairs, and keyword “Pylarify”. The search resulted in 43 sole source awards to Progenics Pharmaceuticals, Inc.

Pylarify (piflufolastat F-18) injection is available on FSS NAC contract 36F79719D0170, for per dose from the manufacturer Progenics Pharmaceuticals, Inc. Pylarify is manufactured in Billerica, MA. NAC contract expires 03/31/2030. Progenics Pharmaceuticals, Inc is a small business.

(7) Any Other Facts Supporting the Justification: None

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5

Acquisition ID#: 36C252-25-AP-3281

(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:

Alternative radiopharmaceuticals will continue to be reviewed prior to future purchases of Pylarify.

(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.)

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.

Stacy Massey Contracting Officer Network Contracting Office 12

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Parris Weidenbach Branch Chief, Supply Team Network Contracting Office 12 ame:

8/11/2025

STACY MASSEY

Digitally signed by STACY

MASSEY

Date: 2025.08.11 13:03:53 -05'00'

PARRIS

WEIDENBACH

Digitally signed by PARRIS

WEIDENBACH

Date: 2025.08.11 14:52:43 -05'00'

VHAPG Part 808.405-6 Limiting Sources Page 5 of 5

Acquisition ID#: 36C252-25-AP-3281

Scott Ivy Division Manager Network Contracting Office 12

Paul Lauro Director of Contracting Network Contracting Office

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

FOR:

SCOTT IVY

Digitally signed by

SCOTT IVY

Date: 2025.08.13 06:57:07 -05'00'

SCOTT IVY

Digitally signed by SCOTT

IVY

Date: 2025.08.13 06:58:37 -05'00'

DARYL

BERG

Digitally signed by

DARYL BERG

Date: 2025.08.18 12:36:00 -05'00'