P03-36C262-24-AP-7224-FY24-655 JOFOC NCO22 Pluvicto GLA - redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-24-AP-7224

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are 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 VA National Acquisition Center (NAC) has already negotiated and determined the cost of the radiopharmaceutical is fair and reasonable. Also, it is the best interest of the government to establish a delivery order with the manufacturer, Advanced Accelerator Applications USA, Inc.

directly with the agreed upon cost of the proprietary and highly specialized radiopharmaceutical, Pluvicto, at per 27mCi/ML, and Lutathera at per dose. CO has verified this cost is accurate based on VA NAC Pharmaceutical Catalog and directly with the manufacturer; these are uploaded to eCMS briefcase under S10.

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

The VA National Acquisition Center (NAC) Pharmaceutical Catalog, SAM.gov and FPDS were used to research acquisition histories and methods during August 2024. A sources sought notice was posted August 7-13, 2024 to SAM.gov with no responses. A special notice, an intent to sole source, was also posted on SAM.gov September 18-25, 2024 to see if any other potential vendors have the capability of manufacturing or distributing radiopharmaceutical equivalent to Pluvicto and Lutathera. No responses were received.

Due to the specialized nature of these radiopharmaceuticals, Pluvicto and Lutathera are not available from any other vendor. There is currently no therapeutically equivalent version of these radiopharmaceuticals available in the United States that are also FDA approved. Per VA NAC, Pluvicto and Lutathera appear to be available from only one FSS contract holder with Advanced Accelerator Applications USA, Inc. under NAC FSS contract# 36F79719D0169. The pricing of Pluvicto at /EA for 27mCi/ML and Lutathera at per dose is accurate per VA NAC Pharmaceutical Catalog.