P03_JnA_Revlimid_DOC signed_updated_HCA__Redacted_.pdf
PDF 736 KB Posted
- Attached to
- Revlimid_BPA
- Solicitation number
- 36C77026A0003
- Issued by
-
Department of Veterans Affairs
About this file
This is a Sole Sources Justification document for a limited sources procurement by the Department of Veterans Affairs, Network Contracting Office (NCO 15) in Leavenworth, Kansas. The document supports a single-source award to Bristol-Myers Squibb for a new Blanket Purchase Agreement (BPA) off the company's existing GSA Federal Supply Schedule (FSS) contract number 36F79724D0101. The procurement is for a 12-month ordering period from February 2, 2026 through February 1, 2027 with no option periods and involves the supply of REVLIMID® (lenalidomide) capsules in multiple strengths (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg) for VA-wide utilization across multiple Veterans Integrated Service Networks (VISNs).
The justification cites GSAM/R 538.7104-3 as the sole source authority, establishing that only Bristol-Myers Squibb is capable of providing the supplies at the required quality level. The VA requires REVLIMID® brand-name product due to REMS (Risk Evaluation and Mitigation Strategy) restricted distribution program compliance requirements and the fact that certain patient populations cannot tolerate generic lenalidomide formulations due to intolerance or hypersensitivity to inactive ingredients. Market research conducted January 27-28, 2026 confirmed that no small-business manufacturers or qualified small-business nonmanufacturers capable of meeting REMS requirements and supporting VISN-wide utilization exist. The procurement was deemed an emergency to ensure continuity of medical treatment for cancer patients. The justification received approvals from the Contracting Specialist (Jennifer Knight), Contracting Officer (J. Braden Smith), Director of Contracting (Andrew J. Raiber, CPCM), and VHA Head of Contracting Activity (Daryl A. Berg) with a higher-level approval threshold of $750,000 to $75 million.
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| File | Type | Posted |
|---|---|---|
| 36C77026A0003_1.pdf |
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Text version
Request for Limited Sources Justification Format >SAT
VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C770-26-AP-0307
ORDER >SAT
Acquisition Plan Action ID: 36C770-26-AP-0307
Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO 15), 3450 S. 4th Street Trafficway, Leavenworth, KS 66048, in support of VA Health Care System, VISN-wide.
Description of Action: The action will be a new BPA generated off Bristol Myers FSS contract to be utilized VA/VISN-Wide.
Order against: FSS Contract Number: 36F79724D0101
Name of Proposed Contractor:
Bristol-Myers Squibb
Street Address: 3401 Princeton Pike City, State, Zip: Lawrenceville, NJ 0864 Phone: (609)302-4897
(3) Description of Supplies or Services:
The estimated value of the proposed action is for a 12-month ordering period (February 2, 2026 - February 1, 2027) with no option periods.
The Veterans Health Administration (VHA) requires a reliable, compliant, and timely mechanism to obtain REVLIMID® (lenalidomide) capsules in multiple strengths (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg) for treatment regimens across multiple Veterans Integrated Service Networks (VISNs). REVLIMID® is only available through the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) restricted distribution program and must be dispensed by REMS-certified pharmacies; therefore, any acquisition strategy must align with REMS requirements and the manufacturer’s authorized specialty pharmacy network.
In certain clinical situations, the brand-name REVLIMID® may be required instead of generic lenalidomide due to intolerance or hypersensitivity to inactive ingredients in generic formulations, which can result in adverse effects or poor adherence. If a patient has maintained stable disease control on REVLIMID® but experiences loss of response or unacceptable side effects after a reasonable trial of generics, the prescriber may document this and request
Request for Limited Sources Justification Format >SAT
Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C770-26-AP-0307
Describe Why You Believe the Order Represents the Best Value consistent with to aid the contracting officer in making this best value determination:
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 on 1/27/2026-1/28/2026.
FSS/NAC Schedule Review: Comprehensive search of VA FSS pharmaceutical listings for Revlimid, which identified Bristol-Myers Squibb (brand Revlimid) on the FSS.
The National Institute of Health (NIH) website DailyMeds was reviewed where it confirmed that Bristol Myer Squibb (BMS) was the manufacturer of the brand name product. Revlimid is a product of Switzerland; all FSS contracts are subject to the Trade Agreement Act (TAA).
BMS website was reviewed where it was confirmed that BMS is a large biopharma business.
BMS was searched on SAM.gov and confirmed to be registered and active able to take awards.
An Integrated Product Team meeting was held on January 27, 2026. This procurement is being conducted on an emergency basis to ensure continuity of medical treatment.
Pharmacy outreach conducted on January 27, 2026, brought together a team of 17 pharmacy and contracting professionals to finalize product details and articulate the necessity of this brand-name item.
NMR Review: This requirement is for Revlimid, a manufactured drug product listed on the VA FSS by the large pharmaceutical manufacturer BMS. Market research conducted in VetCert and DSBS did not identify any small-business manufacturers or qualified small-business nonmanufacturers capable of meeting REMS requirements and supporting VISN-wide utilization for all required strengths. In the absence of any qualified small business manufacturer or nonmanufacturer, applying the Nonmanufacturer Rule would unnecessarily restrict competition and fail to meet the Government’s minimum needs for REMS-compliant, VISN-wide Revlimid treatment.
Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C770-26-AP-0307
Request for Limited Sources Justification Format >SAT
HIGHER LEVEL APPROVAL (Required for orders over $750,000):
VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of .
Daryl A. Berg Executive Director, Regional Procurement Office Central VHA Head of Contracting Activity (HCA)
DARYL BERG
Digitally signed by DARYL
BERG
Date: 2026.01.30 15:19:10 -06'00'
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