HCA Signed NCO 2 FOR HCA SIGNATURE - P03 - Limiting Sources over SAT MDW.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

GSAR 538.7104-3(b) Page 1 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C242-26-AP-1778

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3(b)

Acquisition Plan Action ID: 36C242-26-AP-1778

(1) Contracting Activity: Department of Veterans Affairs, VISN 02 Contracting Office, located at 113 Holland Avenue, Albany, NY 12208, in support of VISN 02 VA Health Care System.

526-26-2-059-0233 528-26-2-4314-0260 528-26-2-7314-0566 561-26-2-045-0031 620-26-2-024-0254 632-26-2-034-0394

(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).

Lenalidomide is an oral immunomodulatory medication that treats several types of blood cancers. The purpose of this contract is to establish a reliable and continuous supply of Lenalidomide used primarily to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS) in adults, and certain types of lymphoma. Lenalidomide works by enhancing the immune system’s ability to fight cancer cells.

Generic lenalidomide (by Exelan) is on FSS contract. Generic lenalidomide (by Exelan) is more cost-effective compared to Revlimid brand. This specialty medication is on VA National Formulary and is only dispensed by Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies.

Contractor shall provide all materials, labor, and equipment necessary to supply Lenalidomide in accordance with all applicable federal regulations, Good Manufacturing Practices (cGMP) and the Food and Drug Administration (FDA) requirements. This is an emergent need to ensure continuous supply, to meet regulatory obligations (Risk Evaluation and Mitigation Strategy – REMS) program, and to support patient access.

Order against: FSS Contract Number: 36F79720D0227

Name of Proposed Contractor: Exelan Pharmaceuticals

Street Address: 370 Camino Gardens Blvd

City, State, Zip: Boca Raton, FL 33432

GSAR 538.7104-3(b) Page 2 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C242-26-AP-1778

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 26,272,218.00

The New York/New Jersey Health Care Network is requesting the purchase of Lenalidomide 2.5MG, 5MG, 10MG, 15MG, 20MG, and 25MG medication for patient care. The quantities below depict annual quantities needed.

NDC Part Number / Description

76282-0696-48 Lenalidomide 2.5MG CAP, Oral, per pill

76282-0697-48 Lenalidomide 5MG CAP, Oral, per pill

76282-0698-48 Lenalidomide 10MG CAP, Oral, per pill

76282-0699-47 Lenalidomide 15MG CAP, Oral, per pill

76282-0700-47 Lenalidomide 20MG CAP, Oral, per pill

76282-0701-47 Lenalidomide 25MG CAP, Oral, per pill

(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.

GSAR 538.7104-4 : Items peculiar to one manufacturer:

Lenalidomide is an oral immunomodulatory medication that treats several types of blood cancers. The purpose of this contract is to establish a reliable and continuous supply of Lenalidomide used primarily to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS) in adults, and certain types of lymphoma. Lenalidomide works by enhancing the immune system’s ability to fight cancer cells.

Generic lenalidomide (by Exelan) is on FSS contract. Generic lenalidomide (by Exelan) is more cost-effective compared to Revlimid brand. This specialty medication is on VA National Formulary and is only dispensed by Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies.

GSAR 538.7104-3(b) Page 3 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C242-26-AP-1778

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7102-2(b)(4) aid the contracting officer in making this best value determination:

Anticipated Cost is fair and reasonable as we are purchasing off of an FSS contract and by definition, fair and reasonableness has already been determined.

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

GSA was searched for Lenalidomide and Lenalidomide there was not an exact match

FPDS/SAM was searched for Lenalidomide and there were multiple results including an Task Order 36C24626N0406 awarded pm 1/14/2026 showing that item is currently on FSS contract.

SBA VETCERT was searched for NAICS code 325412 and yielded 0 results.

SBA was searched for 325412 and yielded 0 results.

The NAC was searched for 76282-0697-48 and Lenalidomide and yielded no results.

Contracting officer verified via a phone call with manufacturer Exelan Pharmaceuticals that Biologics Mckesson is their distributor and that the item is on GSA contract.

(7) Any Other Facts Supporting the Justification: N/A

(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:

NAC was searched and there is an FSS contract #36F79720D0227 related to this medication.

Pharmacy Benefits Management (PBM) website under how to purchase specialty medications for the VA refers to Biologics by McKesson to procure the medication. This specialty medication is on VA National Formulary and is only dispensed by Risk Evaluation and Mitigation Strategy (REMS)- certified pharmacies.

(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

GSAR 538.7104-3(b) Page 4 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C242-26-AP-1778

Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

NAME: Marina E. Distant Williams TITLE: Acting VISN Pharmacy Executive

(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/DESIGNEE’S SIGNATURE DATE

NAME: Anthony Murray TITLE: Contracting Officer

HIGHER LEVEL APPROVAL (Required for orders over $900,000):

b. VHA RPO HCA Review and Approval (over $900,000 to $90 million): 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.

NAME: Gerald Jacobs DATE Executive Director, Regional Procurement Office East VHA Head of Contracting Activity (HCA)