Pylarify (F-18 Piflufolastat) Attachment 2: Request for Limited Sources Justification Format >SAT VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-25-AP-2686 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C250-25-AP-2686 (1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 5500 Armstrong Road, Battle Creek, MI 49037, in support of VISN 10 LTC Charles S. Kettles VA Medical Center at 2215 Fuller Road, Ann Arbor, MI 48105. 2237: 506-26-1-020-0001 (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). New requirement for Pylarify radiopharmaceutical. Order against: FSS Contract Number: 36F79725D0093 (Expires March 31, 2030) Name of Proposed Contractor: Progenics Pharmaceuticals, Inc. Street Address: 331 Treble Cove Road City, State, Zip: N. Billerica, MA 01862 Phone: 414-336-9169 (3) Description of Supplies or Services: Nuclear Radioactive Drug Pylarify (F-18 Piflufolastat) A prostate cancer treatment drug. Nuclear Medicine is requesting procurement of an estimated 300 doses per year of the radioactive drug Pylarify (F-18 Piflufolastat), used for therapy treatment of metastatic castrate resistant prostate cancer, from FDA-approved sole source vendor Progenics Pharmaceuticals, Inc. This radioactive therapy drug is to be ordered and received by trained Nuclear Medicine staff only. An FSS BPA with a base and four 1-year options is being requested. Estimated period of performance: 10/01/2025 09/30/2030 inclusive of all options. The estimated value of the proposed action is $1,082,616.00/Year; $5,413,080.00 inclusive of all options. (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; All Nuclear Medicine imaging agents are unique and highly specialized, specific to each individual patient. This is currently the only F-18 Piflufolastat product that is FDA approved. There is a similar product that came to market in 2024 called Posluma (F-18 Flotufolastat). It also targets PSMA receptors. F-18 Posluma currently appears to only be available in the open market. Due to performing over 1,500 patients with F-18 Pylarify and having repeated exams for comparisons, it is critical that the same radioactive pharmaceutical be used for accuracy of image and avid disease response. Even though both products target PSMA receptors, they bind to their target in different manners which could compromise accuracy when comparing to previous exams in which F-18 Pylarify was used. The effectiveness for prostate cancer detection has changed patient care standard practices for Oncology. Oncology-recommended guidance is that patients with diagnosed prostate cancer are to receive a Nuclear F-18 Piflufolastat (Pylarify) PET/CT scan. This is part of cancer treatment workup. The delay of this scan can delay therapy treatment planning for current and future patients, which could potentially lead to a life/death outcome. The radioactive drug Pylarify (F-18 Piflufolastat) is manufactured and distributed in the USA by one company Progenics Pharmaceuticals, Inc. 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: This is the only vendor that is FDA-approved for manufacturing F-18 Piflufolastat Pylarify prostate imaging radioactive drug. There is no generic form or other manufacturer. Product is on a VA NAC contract and therefore the pricing has already been determined fair and reasonable by the VA NAC Contracting Officer. In accordance with FAR 8.405-4, additional price reductions will be sought. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: VetCert was queried using NAICS Code 325412, which provided 132 potential SDVOSB/VOSB vendors. DSBS was also queried using the same NAICS code, along with keyword Pylarify ; this search provided no potential vendors. In addition to the above searches, eCMS, GSA, SAM.gov, and the NAC Pharmaceutical Catalog were all reviewed for any updated information on this FDA approved radioactive drug. This product was found on the NAC Pharmaceutical Catalog, showing as a single source vendor that could provide this product. Progenics Pharmaceuticals, Inc., has also provided documentation stating they are the sole manufacturer and authorized supplier of Pylarify. (7) Any Other Facts Supporting the Justification: None (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: If a requirement for this drug or similar product becomes available in the future, the market will be re-surveyed to see if the circumstances requiring limiting competition have changed. Every effort will be made to promote competition to the fullest extent possible. (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.
