P03 - JA Limiting Sources Over SAT 36C257-26-AP-1104 Lenalidomide Generic Med signed_Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C257-26-AP-1104

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C257-26-AP-1104

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 17, 5441 Babcock Rd., Room 302, San Antonio, TX., 78240, in support of 519, West Texas VA Health Care System, 300 W Veterans Blvd., Big Spring, TX 79720.

(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 action being reviewed and approved is a limited source procurement, and the action will be awarded as a new delivery order.

Order against: FSS Contract Number: 36F79720D0227

Name of Proposed

Contractor:

Exelan Pharmaceuticals, Inc

Street Address: 370 W. Camino Gardens, Suite 204

City, State, Zip: Boca Raton, FL 33432

Phone: 908-331-9191

(3) Description of Supplies or Services:

The estimated value of the proposed action is

West Texas VA Healthcare System Pharmacy Service has 50 approximately patients with active prescriptions of immunomodulatory agent, lenalidomide, in various strengths.

Lenalidomide is a medication used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS) in adults. Lenalidomide helps to slow cancer growth, block new blood vessel growth in tumors, and help the immune system fight cancer.

Generic lenalidomide is only available to purchase under one vendor source and on

FSS contract. Listed below are the quantities required from the date of award until

September 30, 2026:

NDC

Part Number / Description Unit Qty

Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C257-26-AP-1104

76282- 0696-48

Lenalidomide 2.5MG CAP, Oral, 28 bottle count BT 1

76282- 0697-48

Lenalidomide 5MG CAP, Oral, per pill EA 42

76282- 0697-48

Lenalidomide 5MG CAP, Oral, 28 bottle count BT 6

76282- 0698-48

Lenalidomide 10MG CAP, Oral, per pill EA 42

76282- 0698-48

Lenalidomide 10MG CAP, Oral, 28 bottle count BT 24

76282- 0699-47

Lenalidomide 15MG CAP, Oral, per pill EA 42

76282- 0699-47

Lenalidomide 15MG CAP, Oral, 21 bottle count BT 23

76282- 0700-47

Lenalidomide 20MG CAP, Oral, per pill EA 28

76282- 0700-47

Lenalidomide 20MG CAP, Oral, 21 bottle count BT 4

76282- 0701-47

Lenalidomide 25MG CAP, Oral, per pill EA 42

76282- 0701-47

Lenalidomide 25MG CAP, Oral, 21 bottle count BT 14

(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; To avoid embryo-fetal exposure, lenalidomide is only available through a restricted distribution program called the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program. The Lenalidomide REMS program requires prescribers and pharmacies to be certified and patients to enroll and comply with all program requirements. Prescribers and pharmacies certified with Lenalidomide REMS can prescribe and dispense the product to patients who are enrolled and meet all the conditions of the Lenalidomide REMS program.

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.

Revision: 01 Effective Date: 09/01/2024

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: The anticipated cost will be considered fair and reasonable utilizing the information on the price schedule. Supplies offered on the schedule are listed at fixed prices. FAR 8.4 has already determined the prices of supplies under schedule contracts to be fair and reasonable.

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

a. SBA VetCert searched NAICS 325412 resulted in SDVOSB 184 and 193VOSB.

Based upon NMR no SDVOSB, VOSB, or SB manufacture this item and none of them are authorized distributors.

b. FPDS searched for keyword Lenalidomide resulted in 28 VA awarded contracts that have been awarded to LB EXELAN PHARMACEUTICALS INC. (FYZXNHSQTMG8).

GSA Advantage searched for keyword 36F79720D0227 resulted in 0 findings.

c. GSA eLibrary searched keyword Lenalidomide resulted in 0 findings and searched keyword 36F79720D0227 that resulted in finding national contract for LB EXELAN

PHARMACEUTICALS INC.

d. Sources sought 36C25726Q0133 was issued on November 11, 2025, and closed on December 5, 2025. The sources sought received 2 responses from vendors that expressed their interest. Additional emails were sent to both vendors to gather information regarding critical areas such as: Risk Evaluation and Mitigation Strategies (REMS) approval and certified pharmacy authorized to dispense Exelan’s Lenalidomide to the VA; 1 vendor did not respond, and the other vendor does NOT have REMS approval nor an account setup with VA. Not having a REMS account will delay the contract and affect patient care by not having immediate access to the Lenalidomide medication. REMS approval time varies on several different factors; which include type of drug, level of approval and submission of all required documentation; current estimates of approval ranges from 3 months (from time of submission) to 18 months.

e. REMS, is a structured drug safety program mandated by the U.S. Food and Drug Administration (FDA) for certain prescription medications. Its primary purpose is to

Revision: 01 Effective Date: 09/01/2024 manage known or potential serious risks associated with a drug, ensuring that its benefits outweigh its inherent risks. REMS programs are developed by the drug manufacturer but must be approved and overseen by the FDA. They typically include components such as a Medication Guide, a Communication Plan, and Elements to Assure Safe Use (ETASU) to ensure safe use behaviors and monitor for adverse events. Not having a REMS program in place will place VA out of compliance with the FDA and jeopardize care for the veteran populus.

f. The most recent award was made to EXELAN PHARMACEUTICALS INC. (Large Business) on 10/02/2025, delivery order 36C26126N0157 against 36F79720D0227, for “lenalidomide” in the total procurement value of . This requirement was completed as a limited source. Another award was made on 10/01/2025 under delivery order 36C26026F0051 against 36F79720D0227 for “Pharm - LENALIDOMIDE” in the total procurement value of to EXELAN PHARMACEUTICALS INC. as well.

g. According to the VA Ordering Summary from PBM Formulary Management SharePoint site, “To avoid embryo-fetal exposure, lenalidomide is only available through a restricted distribution program called the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program. The Lenalidomide REMS program requires prescribers and pharmacies to be certified and patients to enroll and comply with all program requirements.

Prescribers and pharmacies certified with Lenalidomide REMS can prescribe and dispense the product to patients who are enrolled and meet all the conditions of the Lenalidomide REMS program.

h. The Lenalidomide REMS program has a pharmacy network with a limited number of certified pharmacies and is close to new pharmacy applicants. The certified pharmacy authorized to dispense Exelan’s lenalidomide to VA patients is Biologics by McKesson”.

Both the FSS contract holder, Exelan Pharmaceuticals Inc. (UEI: FYZXNHSQTMG8), and the sole distributor, Biologics by McKesson (UEI: GVRYEDLFU6J3), are Large Businesses according to SAM and are active with no exclusions.

The brand name pharmaceutical, Revlimid, was also listed on the SharePoint site.

According to the pharmacy, “Previously, the brand name Revlimid was supplied by CoverMyMeds and invoiced through Mckesson prime vendor. Starting FY26, brand Revlimid will no longer be invoiced through Mckesson. are in the process of registering with SAM.gov”. A query of shows that they are not active in SAM. They are ineligible to receive payment from the U.S. government, as organizations must be registered and active in the System for Award Management

(SAM).

i. There is no reason to believe that the VA Rule of Two or SBA Rule of Two could be met. There is also no reason to believe that any other entity would be able to fulfill this requirement.

Revision: 01 Effective Date: 09/01/2024

NCO 17, BRANCH CHIEF