P03 Sole Source Justification 36C245-27-AP-0068 Pylarify 2_Redacted.pdf

Request for Sole Source Format >SAT GSAM/R 538.7104-3(b) Sole Source Justifications - Federal Supply Schedule Ordering

Procedures – Acquisition ID: 36C245-27-AP-0068

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C245-27-AP-0068

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting

Office 05, located at 811 Vermont Ave NW, Washington DC 20420, in support of VISN 05 VA Health Care System at Baltimore VA Medical Center, 10 N. Greene Street, Baltimore MD 21201, Nuclear Medicine Department.

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 Department of Veterans Affairs Medical Center Baltimore MD (Baltimore VAMHCS) seeks a company to deliver a radiopharmaceutical that diagnoses prostate cancer metastatic disease to the Nuclear Medicine Section Monday through Friday as needed. The VA clinician prescribed product, Pylarify is on contract with the National Acquisition Center (NAC) with small business vendor Progenics Pharmaceuticals, Inc. (36F79725D0093) under SIN 42-2A- Single source innovator, multiple source innovator, biological & insulin pharmaceutical products. This will be awarded as a new firm fixed price delivery order.

Order against: FSS Contract Number: 36F79725D0093

Name of Proposed Contractor: PROGENICS PHARMACEUTICALS, INC.

Street Address: 331 TREBLE COVE ROAD

City, State, Zip: N. BILLERICA, MA 01862

Phone: 978-436-7624

3. Description of Supplies or Services:

The estimated value of the proposed action is $599,047.52

Delivery/Task Order: $599,047.52 Estimated Quantity: 166

Baltimore VAMC, Nuclear Medicine is requesting a delivery/task order of a radiopharmaceutical that is used to diagnose prostate cancer metastatic disease. The FDA approved sole source vendor, Progenics Pharmaceuticals, Inc., provides radioactive pharmaceutical Piflufolastat F-18 (Pylarify) Injection, National Drug Code (NDC): 71258- 0022-01. The DC VAMC requires an estimated quantity of 166 units per year of supply to care for veteran patients.

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.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 538.7104-3(b)(1)(ii): 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 a 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. The NAC has contracted with the only authorized manufacturer of the medication, Progenics Pharmaceuticals, Inc. under FSS contract number 36F79725D0093. 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.

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. Through market research two PSMA imaging radiopharmaceuticals were found: Ga-68 gozetotide (Illuccix) 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. The GA-68 Illuccix radiopharmaceutical has a significantly shorter half-life compared to F-18 PSMA (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 increases delay in Veteran care.

Clinicians at the Baltimore VA Medical Center have prescribed Pylarify F-18 PSMA due to its longer half-life and improved clinical utility. All veterans currently imaged within the DC VAMC PET/CT Department have been receiving F-18 PSMA doses. Transitioning to GA-68 Illuccix would create difficulties in comparing current and prior studies, potentially compromising image quality, diagnostic consistency, and ultimately patient 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, Inc. will fully satisfy this requirement.

Progenics Pharmaceuticals Inc. is the sole manufacturer and authorized supplier of Pylarify.

The product is currently on a contract with the National Acquisition Center (NAC) with small business vendor Progenics Pharmaceuticals, Inc. (36F79725D0093) under SIN 42-2A - Single source innovator, multiple source innovator, biological & insulin pharmaceutical products. This is a brand-name drug with patent protection.

GSAM/R 538.7104-3(b)(1)(iii): 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.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

5. Describe Why You Believe the Order Represents the Best Value consistent with

GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination:

The VA is unable to satisfy this requirement for supplies from the mandatory sources. The use of a non-mandatory source, Federal Supply Schedules, 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 GSAM 538.7102(c)(2). 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

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

On 12/08/2025, a sources sought notice (36C24526Q0163) was published on SAM.gov.

One small business responded with a capability statement:

SOFIE Co. – distributor of 18F-FDG Fluorodeoxyglucose. DetectNet®, and PYLARIFY®. SOFIE Co. does not manufacture Pylarify. SOFIE Co. has in the past distributed Pylarify, but is no longer authorized to distribute Pylarify due to a FDA approved letter from the manufacture stating that Progenics Pharmaceuticals, Inc. is the only company that manufactures and distributes Pylarify.

One large business responded with a capability statement:

PETNET Solutions – distributor of Fludeoxyglucose F 18 Injection (F-18 FDG) PETNET Solutions has an alternative to Pylarify but does not meet the specifications in the statement of work.

On 12/08/2025 a search was conducted on the NAC, and one small business was capable of fulfilling this requirement.

Progenics Pharmaceuticals, Inc. / Lantheus – manufacturer and distributor of Pylarify (piflufolastat F18) Injection. Received a letter stating that Progenics Pharmaceuticals, Inc., is the only company that manufactures and distributes Pylarify and is FDA approved.

On 12/17/2025 a search of the Small Business Administration (SBA) Veterans Small Business Certification was queried using NAICS 325412. The search resulted in 7 SDVOSB/VOSB contractors.

Market research was conducted in FPDS, GSA and NAC through procurement history. Based