P03__Limiting_Sources_Justification_Pylarify_Redacted.pdf

VHAPM Part 808.405-6 Limiting Sources Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C246-22-AP-1084

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO 6), VISN 6, Durham VA Medical Center, Purchase Request # 558-22-1-241-0006

(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).

Order against: FSS Contract Number: 36F79719D0170

Name of Proposed Contractor: Progenics Pharmaceuticals, Inc.

Street Address: 1 World Trade Center Floor 47 Ste J

City, State, Zip: New York, NY 100007-0089

Phone: 646-975-2537

(3) Description of Supplies or Services:

The estimated value of the proposed action is

The Durham VAMC requires F-18 Pylarify Nuclear Medicine Radiotracer, a prostate specific injectable form of the isotope Flourine-18 which allows for positron emission tomography (PET) imaging utilized in the diagnosis and monitoring of prostate cancer. Currently the only nationwide FDA approved prostate specific membrane antigen (PSMA) is F-18 Pylarify.

(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:

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;

VHAPM Part 808.405-6 Limiting Sources Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

On May 26, 2021, Progenics Pharmaceuticals, Inc., a Lantheus company received FDA Approval of Pylarify. Pylarify (piflufolastat F 18) injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate specific membrane antigen positive lesions in men with prostate cancer. PYLARIFY® can only be purchased through Progenics Pharmaceuticals, Inc., the manufacturer. There are no other like items or products available on the market that serve the same purpose or function.

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.

(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 items being purchased are on NAC contract 36F79719D0170 awarded to Progenics Pharmaceuticals, Inc. by the VA’s National Acquisition Center (NAC). In addition, pricing on VA NAC contracts have been negotiated by the VA and presumptively represents fair and reasonable pricing to the VA. The CO will request possibility of additional discount from vendor.

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

Market research demonstrated the required items are available only from Progenics Pharmaceuticals and are on Progenics Pharmaceuticals NAC contract 36F79719D0170.

(7) Any Other Facts Supporting the Justification: None