Attachement P03 LSJ Pluvicto signed.pdf

VHAPG Part 808.405 6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C249 24 AP 2708

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FARPART 8.405 6

Acquisition Plan Action ID: 36C249 24 AP 2708

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 09, located at 1639 Medical Center Parkway, Suite 200, Murfreesboro, TN 37129 in support of Veterans Integrated Service Network (VISN) 09.

Identify purchase request (i.e. 2237): 603 25 1 1070 0006 Additional purchase requests will be submitted by other facilities after the Blanket Purchase Agreement(BPA) is established.

(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). This procurement is for Veterans Integrated Service Network (VISN) 09, Firm Fixed Price (FFP) BPA with base and four option years agreement for PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). VISN 9 facilities require radiopharmaceutical treatment for metastatic castration resistant prostate cancer. Advanced Accelerator Applications (AAA) USA, Inc. is a large business.

Order against: FSS Contract Number: 36F79719D0169

Name of Proposed Contractor: Advanced Accelerator Applications USA, Inc.

Street Address: 57 East Willow Street

City, State, Zip: Millburn, NY 07041

Phone: 646 634 6614

(3) Description of Supplies or Services: The estimated value of the proposed action is $49,200,107.74.

PLUVICTO delivers targeted radiation doses to prostate cancer while minimizing exposure to healthy tissue with mild to moderate side effects. PLUVICTO is solely manufactured and distributed by AAA USA, Inc., a subsidiary of Novartis Pharma SAS. The Independent Government Cost Estimate (IGCE) for the Federal Supply Schedule (FSS) BPA with base and four option periods agreement is estimated at $49,200,107.74.

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan), with National Drug Code (NDC): 69488 0010 61, is a radiopharmaceutical targeted therapy that was approved by the Food and Drug Administration (FDA) on March 23, 2022, for the treatment of adult veterans with prostate

Acquisition ID#: 36C249 24 AP 2708 specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer(mCRPC). Each veteran requires 6 cycles of treatment that is provided every 6 weeks to complete the treatment.

Doses will be ordered/scheduled with at least 72 hours advance notice to the vendor.

Radiopharmaceutical should arrive at least 60 minutes before the requested calibration date and time. Deliveries must be made directly to the Nuclear Medicine service, with Nuclear Medicine staff present on site.

The contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. The contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, Occupational Safety and Health Administration (OSHA), and all other applicable agency rules and regulations, both State and Federal. The contractor is also responsible for delivering the material following the shipping protocols required by the Nuclear Regulatory Commission. The contractor will adhere to USP797 regulations.

Pluvicto (Lu177 vipivotide tetraxetan) is a beta particle emitting radiopharmaceutical, which is used for treating patients with PSMA positive mCRPC who have been treated with androgen receptor (AR) pathway inhibition and taxane based chemotherapy.

Services or Performance required Base year 12/01/2024 11/30/2025 Option Year 1 12/01/2025 11/30/2026 Option Year 2 12/01/2026 11/30/2027 Option Year 3 12/01/2027 11/30 2028 Option Year 4 12/01/2028 11/30/2029

(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. The AAA USA, Inc. is the sole FDA approved source of this highly specialized therapeutic radiopharmaceutical, PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). There is no other radiopharmaceutical that can treat the same cancer.

Acquisition ID#: 36C249 24 AP 2708

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 projected estimated cost breakdown for the proposed acquisition based upon the IGCE is $49,200,107.74 for base plus four option years. There is a National Acquisition Center (NAC) contract in place with AAA USA, Inc. for Pluvicto (36F79719D0169) with a price of $33,109.09 per dose. The price was also compared with prior award under 36F79719D0169 and has already been determined to be fair and reasonable to the Government.

(6) 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 VetCert using NAICS 325412 returned 133 results. A search of VIP Search using NAICS 325412 using keyword “PLUVICTO ” returned 0 result. Intent to sole source was posted in www.SAM.gov from 06/12/2024 06/27/2024 under 36C24924Q0314 with no response. A search on the Supply Chain Master Catalog (SCMC) found a BPA 36C25023A0020 awarded off VA NAC 36F79719D0169.

This decentralized BPA was awarded to AAA USA, Inc. on a sole source basis. Only the local Radiation Safety Officers are authorized to place calls off the BPA. A search of DSBS using NAICS 325412 and keyword “PLUVICTO ” returned zero result. Lu 177 vipivotide tetraxetan (Pluvicto) is a therapeutic radiopharmaceutical utilized in the Nuclear Medicine Setting to treat PSMA positive mCRPC. Advanced Accelerator Applications is the only vendor able to supply this radiopharmaceutical due to FDA approval.

(7) Any Other Facts Supporting the Justification: The contractor must be compliant with FDA policies and principles as well as the handling of radioactive materials. Utilizing FSS for Pluvicto ensures compliance with these regulations. The delivery will incorporate sufficient lead or other high density metal shielding to comply with all applicable federal and/or state standards and regulations relating to the shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include the Department of

Acquisition ID#: 36C249 24 AP 2708

Transportation (DOT), Department of Energy (DOE), and Nuclear Regulatory Commission (NRC), and/or agreement state licensure.

Pluvicto is Trade Agreement Act (TAA) compliant since the requirement is being procured using the General Services Administration (GSA) contract. The TAA, which provides a waiver to the Buy American Act, stated that only U.S. made or designated country end products may be offered or sold under a Scheduled contract. Pluvicto is compounded at Advanced Accelerator Applications at the United States manufacturer plant AAA USA, Inc. 57 East Willow Street Millburn, NJ 07041, and the original contract from AAA USA, Inc. has been uploaded in the eCMS briefcase as P02 Trade agreement compliant.

(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: In the future, if another vendor supplies a suitable alternative, their qualifications will be evaluated. The market will be continually assessed to determine if other vendors can provide the required supplies.

(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.

William P. Williams DATE

VISN AUS

VISNMidsouth Healthcare

Acquisition ID#: 36C249 24 AP 2708

JOHN MCCOMAS Digitally signed by JOHN MCCOMAS Date: 2024.11.04 11:19:13 -06'00'

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

John McComas DATE Acting Division Chief/Contracting Officer Network Contracting Office 9

b. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

Digitally signed by ROBERT

KELLNER

Date: 2024.11.05 16:07:24 -06'00'

Robert M. Keller DATE Deputy Director Network Contracting Office 9

c. Director of Contracting Concurrence: I concur/non concur that the justification meets requirements for exception to fair opportunity.

Susan F. Nagel Director of Contracting Network Contracting Office 9

DATE

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 for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Daryl A. Berg DATE Executive Director, RPO Central Head of Contracting Activity

ROBERT KELLNER

11/25/2024DARYL BERG

Digitally signed by DARYL

BERG

Date: 2024.11.25 15:23:45 -06'00'