6505--LSJ | Pylarify | VA Greater Los Angeles

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources

Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-7206

Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-25-AP-5771

Contracting Activity Department of Veterans Affairs (VA), Network/Program Contracting Office 22, located at 4811 Airport Plaza Drive Long Beach, CA 90815, in support of VISN 22 VA Greater Los Angeles Health Care System at 11301 Wilshire Blvd Los Angeles, CA 90073.

PR# 691-26-1-044-0004

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).

This requirement for Pylarify will be awarded as a new requirement as a base plus two option year delivery order against National Acquisition Center (NAC) Federal Supply Schedule (FSS) contract 36F79725D0093.

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: 414-336-9169

Description of Supplies or Services:

The estimated value of the proposed action is $4,715,248.80

Pylarify (piflufolastat F 18) Injection National Drug Code (NDC): 71258-0022-01 is an advanced diagnostic imaging agent used with Positron Emission Tomography (PET)/Computed 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. Veterans Affairs (VA) Greater Los Angeles Healthcare System s Nuclear Medicine Department is requesting a base plus two option year delivery order due to the current and foreseen requirement for this radiopharmaceutical to support with streamlining future orders. The period of performance required, including base plus two option years is:

Period of Performance

Description

Unit Price

Quantity

Unit of Measure

Obligated Funding

Base

11/1/2025

10/31/2026

Pylarify & Canceled Dose Fee

Pylarify:

$3,608.72

1

YR

$1,571,749.60

Missed Dose Fee:

$400.00

Option Year 1

11/1/2026

10/31/2027

Pylarify & Canceled Dose Fee

Pylarify:

$3,608.72

Missed Dose Fee:

$400.00

1

YR

$1,571,749.60

Option Year 2

11/1/2027

10/31/2028

Pylarify & Canceled Dose Fee

Pylarify:

$3,608.72

Missed Dose Fee:

$400.00

1

YR

$1,571,749.60

TOTAL

$4,715,248.80

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:

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 binds to prostate-specific membrane antigen (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 National Acquisition Center (NAC) has contracted with the only authorized manufacturer of the medication, Progenics pharmaceuticals, Inc. under Federal Supply Schedule (FSS) contract number 36F79725D0093. The vendor has provided a letter stating that they are the sole manufacturer and

authorized supplier . 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.

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.

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.

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:

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 $3,774.94 per injection. Network Contracting Office (NCO) 22 did seek further discounts to this order in which the vendor, Progenics, agreed to keep pricing at the prior listed contract pricing at

$3,608.72 for the base plus option year period of performance.

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

A search of the NAC Pharmaceutical website was conducted, which returned the required pharmaceutical, Pylarify, listed under contract 36F79725D0093 awarded to Progenics Pharmaceuticals, Inc. Federal Procurement Data System (FPDS) was also searched to identify prior acquisitions for the medication, as well as a search of the world wide web to determine if other medications like Pylarify are available in the United States. The results from FPDS returned multiple delivery orders against NAC FSS contract 36F79725D0093 awarded by multiple NCOs. The search of the worldwide web returned no equal to products.

Due to the specialized nature of this drug, it is not available from any other vendor. There is currently no therapeutically equivalent version of Pylarify available in the United States. The medication, Pylarify, is a radiopharmaceutical and 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.

Pylarify is on FSS NAC contract 36F79725D0093 awarded to Progenics Pharmaceuticals, Inc. priced at

$3,712.78 per injection. The contract 36F79725D0093 for Pylarify was effective 4/1/2025 and expires 3/31/2030.

The market research was conducted from 3/15/2025 8/21/2025

Any Other Facts Supporting the Justification:

Lantheus owns Progenics Pharmaceuticals, Inc.

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:

The Department of Veteran Affairs will continue to survey the marketplace for equal to or better

therapies that will offer veterans the most up to date care.

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.

JOSEPHINE RIBE

Digitally signed by JOSEPHINE RIBE Date: 2025.10.15 10:38:30 -07'00'

Josephine Ribe DATE

Administrative Officer

VA Greater Los Angeles Healthcare System

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

ADRIENNE BROWN

Digitally signed by ADRIENNE BROWN

Date: 2025.10.08 09:44:00

-07'00'

Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Adrienne Brown, Contracting Officer DATE Supply 4

NCO 22

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.

CECIL NICHOLS

Digitally signed by CECIL NICHOLS Date: 2025.10.15 14:28:06 -07'00'

Cecil Nichols DATE

Supply 2, Branch Chief NCO 22

JAMES MORAN

Digitally signed by JAMES MORAN Date: 2025.10.17 08:43:59 -07'00'

James Moran DATE

Division 4 Chief

FRANCISCO CELIS

NCO 22

Digitally signed by FRANCISCO CELIS Date: 2025.10.22 08:45:43 -07'00'

Sabrina Smith DATE

Director of Contracting NCO 22

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

CURTIS JORDAN

Digitally signed by CURTIS JORDAN

Date: 2025.11.01 09:05:44

-06'00'

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.

Curtis M. Jordan DATE

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) Awarded contract 36F79725D0093 to PROGENICS PHARMACEUTICALS INC for 1571749.60000000 on 2025-11-04.