Limited Source Justification_Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-26-AP-7345

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-26-AP-7345

(1) Contracting Activity: The Department of Veterans Affairs, Network Contracting Office 22, located at 4811 Airport Plaza Drive, Suite 600, Long Beach, CA 90815 in support of VISN 22 VA Phoenix Health Care System located at 650 E. Indian School Road, Phoenix, AZ 85012 under Purchase Request 644-26-3-035-2265.

(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).

The VA Pheonix Healthcare System Pharmacy Service seeks to sole-source a medication called Breyanzi.

Order against: FSS Contract Number: 36F79724D0101

Name of Proposed Contractor: Bristol-Myers Squibb Company

Street Address: 3401 Princeton Pike

City, State, Zip: Lawrence Township, NJ 08648

Phone: 609-302-4897

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ .

VA Phoenix Healthcare System Pharmacy Service has an urgent procurement request of

Breyanzi. Breyanzi is an FDA-approved, patient-specific, autologous CAR-T-cell therapy used for the treatment of relapsed or refractory B-cell lymphomas. The product consists of the patient’s own T-cell that have been collected, genetically modified to target CD19-expressing malignant B cells, and cryopreserved for single-use intravenous infusion. This order covers the manufactured CAR T-cell drug product required for the patient’s scheduled treatment. This is a one-time purchase of this drug, and the anticipated period of performance is 7/1/2026 –

7/31/2026.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C262-26-AP-7345

(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:

The VA Phoenix Healthcare System Pharmacy Service requires the immediate procurement of Breyanzi, a patient-specific autologous CAR T-cell therapy. The patient has been clinically approved and is already scheduled for treatment, and the manufacturer requires the order to be placed promptly to secure a manufacturing slot and ensure timely production, shipment, and infusion of the therapy. Any delays in procurement would jeopardize the coordinated treatment timeline, risk disease progression, and potentially render the scheduled treatment invalid due to the strict manufacturing and infusion windows associated with CAR T-cell products. Since competitive ordering procedures would extend procurement timeline beyond what is clinically acceptable, this urgent and compelling exception is necessary to prevent interruption of critical patient care.

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;

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 National Acquisition Center (NAC) has already negotiated and determined the cost of the medication is fair and reasonable. The medication market fluctuates constantly, and it is in the best interest of the government to set up a contract with the manufacturer, Bristol-Myers

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Squibb Company, with the agreed upon cost of the proprietary and highly specialized medication, Breyanzi at .

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

Small Business Administration (SBA)’s Small Business Search (SBS) query returned 187 SDVOSBs and VOSBs, and 90 other small business concerns registered under NAICS code 325412. However, the requested drug, Breyanzi, is considered a highly complex, customized CAR-T cell therapy. It is only supplied directly to a very specific network of vetted, REMS-certified hospitals and authorized treatment centers. Identified SDVOSBs, VOSBs, and small businesses do not have capabilities to provide Breyanzi to VA Phoenix Healthcare System.

A search was conducted on VA National Acquisition Center (NAC) Pharmaceutical Catalog to check if the requested drug is available on the existing Federal Supply Schedule (FSS). The VA NAC has contracted with the only authorized manufacturer of Breyanzi, Bristol-Myers Squibb Company under the Federal Supply Schedule (FSS) 36F79724D0101. Bristol-Myers Squibb Company is the only contractor listed on the NAC Pharmaceutical Catalog for Breyanzi. According to VA’s Pharmacy Benefit Management (PBM), Breyanzi is solely available for purchase from McKesson Specialty.

Further market research is limited due to the urgent need for this medication for direct patient care. Any delays caused by competing the requirement or seeking alternative sources would result in unacceptable delays in patient care and pose direct threat to the patient’s health.

(7) Any Other Facts Supporting the Justification:

Breyanzi is a proprietary medication manufactured by Bristol-Myers Squibb Company.

(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 Department of Veterans Affairs will continue to survey the marketplace for ‘equal to’ or better therapies that will offer veterans the most up to date care.

(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.

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Pharmacy Service VA Phoenix Healthcare System

(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.

Contracting Officer Network Contracting office 22

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K):

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

Branch Chief, Supply 4 Network Contracting Office 22