P03 - Limiting_Sources_Justification_OVER_SAT - Pluvicto - signed 1.1.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C252-26-AP-1352

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C252-26-AP-1352

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 12, located at 115 S 8th St, Milwaukee, WI, in support of VISN 12 Jesse Brown VA Medical Center at 820 S Damen Ave, Chicago, IL.

(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 is a new requirement for radiopharmaceuticals.

Order against: FSS Contract Number: 36F79720D0180

Name of Proposed Contractor: Novartis Pharmaceuticals Corporation Street Address: 59 Route 10 City, State, Zip: East Hanover, New Jersey, 07936 Phone: 862-390-9927

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 685,880. The products required are radiopharmaceuticals, Pluvicto. Quantities are estimated for six months.

(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; Pluvicto is highly specialized radiopharmaceutical. Pluvicto is the first and only broadly available FDA-approved (March 23, 2022) prostate-specific membrane antigen (PSMA) for the treatment of metastic castration-resistant prostate cancer. Therefore, there is only one responsible source, and no other supplies or services will satisfy our agency’s requirements.

This radiopharmaceutical is only available from Novartis Pharmaceuticals Corporation and is on the manufacturer's FSS contract 36F79720D0180.

https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3

Acquisition ID#: 36C252-26-AP-1352

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 VA is unable to satisfy the Edward J. Hines, Jr. VA Hospital requirements for supplies from the mandatory sources listed in FAR 8.002 and FAR 8.003. The use of a non-mandatory source, Federal Supply Schedules, per FAR 8.004(a)(1) has been determined to represent the best value and will result in the lowest overall cost alternative, considering price and administrative costs, to meet the VA’s needs. Supplies offered on the schedule are listed at fixed prices. The General Services Administration (GSA) has already determined the prices of supplies under schedule contracts to be fair and reasonable. The VA will seek additional price reductions in accordance with FAR 8.405-4. This order represents best value to the government since the Page 3 of 5 Acquisition ID#: 36C252-25-AP-3279 National Acquisition Center (NAC) has already negotiated the best price for the government. The radiopharmaceutical market fluctuates constantly, and it is in the best interest of the government to contract with the manufacturer, Novartis Pharmaceuticals Corporation with the agreed upon cost of the proprietary and highly specialized medication.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The requested drug will be purchased against a VA Federal Supply Schedule (FSS) contract and only one source has the requested drug available on the FSS contract evidenced by researching the VA National Acquisition Center Contract Pharmaceutical Catalog Search Tool.

(7) Any Other Facts Supporting the Justification: not applicable.

(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: The medical center will purchase all pharmaceutical drug

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3

Acquisition ID#: 36C252-26-AP-1352 requirements competitively and fully utilize the prime vendor, national, and FSS contracts whenever possible. However, there are times that contracts sources do not have required drugs available and/or competition isn’t available. The Pharmacy Department will remove or overcome barriers to competition by adequately planning known requirements.

(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.

Brahamjit Raghav Director of Radiology and Nuclear Medicine Nuclear Medicine Jesse Brown VA Medical Center

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

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

Brandon Harris NCO 12, Contracting Officer Great Lakes Acquisition Center

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Parris Weidenbach NCO 12, Supervisory Contracting Officer Great Lakes Acquisition Center https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx