LSJ Over SAT_Emergency Breyanzi Infusion_Redacted.pdf

VHAPG Part 808.405‐6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C248‐25‐AP‐3789

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405‐6

Acquisition Plan Action ID: 36C248‐25‐AP‐3789

(1) Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration, Regional Procurement Office East, Network Contracting Office 08 (NCO 08) on behalf of C.W.

Bill Young Department of Veterans Affairs Medical Center at 10000 Bay Pines Blvd, Bay Pines, FL 33744.

2237: 516‐25‐3‐121‐0908

(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 Bay Pines VA Health Care System’s (BPVAHCS) Pharmacy Service has an urgent requirement for Breyanzi (CAR‐T therapy) Infusions. A new delivery order will be placed off the following contract:

Order against: FSS Contract Number: 36F79724D0101

Name of Proposed Contractor: Bristol‐Myers Squibb Company

Street Address: 3401 Princeton Pike

City, State, Zip: Lawrenceville, NJ 08648‐1205

Phone: (609) 302‐4897

Generic Name: LISOCABTAGENE MARALEUCEL 50000000T CELLS/VIAL

Trade Name: BREYANZI 50000000T CELLS/VIAL

National Drug Code (NDC): 73153‐0900‐01

(3) Description of Supplies or Services:

The estimated value of the proposed action is

Breyanzi (Lisocabtagene Maraleucel) is a type of CAR T‐cell therapy used for the treatment of certain types of lymphoma. Specifically, Breyanzi is used to treat adult patients with relapsed or refractory large B‐cell lymphoma after two or more lines of systemic therapy, including diffuse large B‐cell lymphoma (DLBCL), high‐grade B‐cell lymphoma, and primary mediastinal large B‐ cell lymphoma. The therapy involves modifying a patient's own T‐cells (a type of white blood

VHAPG Part 808.405‐6 Limiting Sources Page 2 of 4

Acquisition ID#: 36C248‐25‐AP‐3789 cell) to express a chimeric antigen receptor (CAR) that can specifically target and destroy cancer cells. The modified T‐cells are then reintroduced into the patient's body.

(4) Identify the Authority and Supporting Rationale

FAR 8.405‐6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

BPVAHCS has an urgent need for Breyanzi infusions for a patient receiving VA Community Care treatment through Moffitt Cancer Center. The patient is scheduled for apheresis on 23 MAY 2025 and per manufacturer, an order must be placed prior to the date of appointment to ensure timely delivery. If this order is not placed as soon as possible, the patient must be rescheduled; however, given the patient’s condition and limited apheresis slots available per month at Moffitt, the option to reschedule is not feasible. This treatment is considered highly specialized for the treatment of relapse/refractory multiple myeloma. Not procuring this specialized medication would result in unacceptable delays in patient care that would lead to delays in life‐saving therapies.

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 Federal Supply Schedule (FSS) includes specialized commercial pricing available for the Big Four government agencies: Department of Veterans Affairs (VA), the Department of Defense

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Acquisition ID#: 36C248‐25‐AP‐3789

(DoD), the Public Health Service (including the Indian Health Service), and the Coast Guard which represents the best value.

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

Market research was conducted by reviewing historical contract information as well as queries on Federal Procurement Data System (FPDS), VA National Acquisition Center (NAC), General Services Administration (GSA), and System for Award Management (SAM).

A Veteran Small Business Certification (VetCert) search utilizing NAICS code 325412 yielded 132 Service‐Disabled Veteran Owned Small Business (SDVOSB)/ Veteran Owned Small Business (VOSB) vendors that can possibly fulfill this requirement. The U.S. Small Business Administration (SBA) Dynamic Small Business Search (DSBS) database was queried the same NAICS code, specifically for active Service‐Disabled Veteran Owned Small Business (SDVOSB)/Veteran Owned Small Business (VOSB) and resulted in 29 SDVOSB/VOSB vendors that can possibly fulfill this requirement.

The VA National Acquisition Center (NAC) database was queried and resulted in only one contractor available on schedule: Bristol‐Myers Squibb Company. Bristol‐Myers Squibb Company is the sole U.S. Food and Drug Administration (FDA) approved manufacturer of Breyanzi.

FPDS was queried utilizing key word “Breyanzi.” Historical contract, 36F79718D0405 36C24824F0098, was awarded on 26 January 2024 in the total amount of $310,935.67 for Bay Pines VA Health Care System. Additionally, there have been multiple delivery orders placed off the existing contract, 36F79724D0101 for the same item.

(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: None