REDACTED FAR 13.5 Sole Source Justification - SAT-7.5M F18 Pylarify.pdf

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-25-AP-0141

1. Contracting Activity: Department of Veterans Affairs, VISN 6, Durham VA Medical Center and

Network Contracting Office 6 (NCO 6). This action is funded by VA2237 558-25-2-241-0004.

2. Nature and/or Description of the Action Being Processed: This action is a new requirement to procure F-18 Pylarify (piflufolastat or 18F-DCFPyl) radiopharmaceutical for deliveries to be made to the Durham VA Medical Center located at 508 Fulton Street, Durham, North Carolina 27705. An open market Indefinite Delivery Indefinite Quantity contract (IDIQ) will be awarded with a one-year base period and three (3) one-year option periods. The period of performance will be from January 1, 2025 through December 31, 2025 for the base period of the contract. The total estimated value of this action, including the base period and all option periods, is $[REDACTED]. The NAICS code for this action is 325412, Pharmaceutical Preparation Manufacturing with a size standard of 1300 employees.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Veterans Integrated

Service Network 6 (VISN 6) intends to negotiate a sole source IDIQ contract with Progenics Pharmaceuticals Inc. (doing business as Lantheus Medical Imaging, Inc.) for the supply and delivery of F-18 Pylarify (piflufolastat or 18F-DCFPyl). PYLARIFY is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: 1) with suspected metastasis who are candidates for initial definitive therapy, 2) with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The National Drug Code for F-18 Pylarify is 71258-0022-01.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Pylarify injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate specific membrane

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antigen positive lesions in men with prostate cancer. PYLARIFY® can only be purchased through Progenics, the manufacturer. Three other PSMA imaging agents exist. Two of them are Ga-68 tracers (Illucix and Locametz), and the other is F-18 Posluma. F-18 Posluma does not perform exactly in the same manner as Pylarify. As such, Posluma will suffer small differences in repeat exams and treatment planning with Lu-177 Pluvicto.

Ga-68 is not suitable for this requirement due to a shorter half-life of the isotope. Half-life governs the amount of time the PSMA agent is useful for, with a 68-minute half-life, the dose becomes unusable a very short time after the calibration time. F-18 has an additional 40 minutes of half-life which allows more flexibility for patients that arrive late, cannot find parking, or are difficult to gain intravenous access. The opportunity to waste a PSMA dose due to the shorter half life of Ga-68 must be avoided.

The manufacturer, PROGENICS PHARMACEUTICALS INC (UEI: YLYKVRPCTCR3), is the only source for F-18 Pylarify. PROGENICS PHARMACEUTICALS INC (UEI: YLYKVRPCTCR3) is a small business under NAICS 325412 with less than 1300 employees. PROGENICS PHARMACEUTICALS INC also does business under the name Lantheus Medical Imaging, Inc. F-18 Pylarify is unique with no substitutes that are acceptable to the facility.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: PROGENICS PHARMACEUTICALS INC (UEI: YLYKVRPCTCR3) is the only source for Pylarify F-18. The FPDS-NG website was utilized to confirm that federal contracts for F-18 Pylarify have been awarded to PROGENICS PHARMACEUTICALS INC (UEI: YLYKVRPCTCR3). Progenics does utilize distributors due to the half-life of the radiopharmaceutical, but retains all selling rights with regard to F-18 Pylarify. The contract needs to be awarded directly to the manufacturer, Progenics Pharmaceuticals Inc.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: A non-mandatory NAC contract exists for Pylarify F-18, however pricing is only available through August 2025. The pricing of the NAC contract and other awards identified in FPDS will be used to make a price reasonableness determination once a quote is solicited and available for evaluation.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: The SBA VetCert search engine was utilized though the manufacturer retains all selling rights to Pylarify F-18. FPDS-NG was reviewed for acquisition history. A notice of intent to issue a sole source contract was posted to SAM.gov Contract Opportunities on December 6, 2024 and closed on December 10, 2024. No responses were received from alternative sources.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: PROGENICS

PHARMACEUTICALS INC (UEI: YLYKVRPCTCR3)

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: The facility will continue to monitor other potential radiopharmaceuticals that may be suitable.

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12. 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 and belief.

_[REDACTED]___________________ ________________________

Kevin Lee Date Chief Nuclear Technologist Durham VA Medical Center

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13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Daniel Spaulding Date Contracting Officer Network Contracting Office 6 (NCO 6

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

Stephanie Thompson Date Branch Chief, Supply/Services 4

Network Contracting Office 6 (NCO 6)

c. Director of Contracting (DoC):

Irma Ferro Date Director of Contracting

Network Contracting Office 6 (NCO 6)

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Gerald F. Jacobs Date Executive Director, Regional Procurement Office East https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx