Limiting_Sources_Justification_OVER_SAT Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C252-26-AP-1200

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

Acquisition Plan Action ID: 36C252-26-AP-1200

(1) Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 12, located at 115 South 84th Street, Suite 101, Milwaukee, WI 53214. This action supports the William S.

Middleton Memorial VA Medical Center Specialty Pharmacy, located at 2500 Overlook Terrace, Madison, WI 53705. .

(2) Description of Action: The Department of Veterans Affairs, Network Contracting Office 12, is requesting approval to purchase specialty medications for the William S. Middleton Memorial VA Medical Center Specialty Pharmacy in Madison, WI. This is a new requirement.

Order against: FSS Contract Number: 36F79724D010

Name of Proposed Contractor: Bristol-Myers Squibb Company Street Address: 3401 Princeton Pike City, State, Zip: Lawrenceville, NJ 08648 Phone: (609) 302-4897

(3) Description of Supplies or Services:

The estimated value of the proposed action is

The William S. Middleton Memorial VA Medical Center Specialty Pharmacy needs to purchase specific medications for patients currently under treatment. These medications include Pomalyst (pomalidomide), Camzyos (mavacamten), and Revlimid (lenalidomide).

Medication Details and Uses:

Revlimid (lenalidomide): Used to treat multiple myeloma, myelodysplastic syndromes, and certain types of lymphoma.

Pomalyst (pomalidomide): Used for patients with multiple myeloma who have received prior therapies and require ongoing treatment.

Camzyos (mavacamten): Used to treat obstructive hypertrophic cardiomyopathy (HCM), a serious heart condition that can lead to heart failure or sudden cardiac death if untreated.

These drugs are subject to strict Risk Evaluation and Mitigation Strategy (REMS) programs, including PS-Pomalidomide REMS, Camzyos REMS, and Revlimid REMS. Under these programs:

Medications can only be dispensed by REMS-certified pharmacies.

Bristol Myers Squibb administers these REMS programs and restricts dispensing to a closed network of specialty pharmacies, which does not include VA pharmacies.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4

Acquisition ID#: 36C252-26-AP-1200

To comply with these requirements, the medications will be dispensed by CoverMyMeds (McKesson Specialty Pharmacy), and a purchase order must be issued to McKesson Corporation.

Currently, there are 14 patients with active prescriptions for these medications. Of these, 4 patients require pomalidomide or mavacamten, with an average monthly cost of approximately for Pomalyst, for Camzyos, and for Revlimid per prescription.

Additionally, while the VA typically uses generic lenalidomide, the preferred generic is intermittently unavailable from the approved vendor. As a result, some prescriptions must be filled with the brand name Revlimid until the generic becomes available again (estimated March 2026).

Urgency and Patient Impact:

These medications are critical for ongoing treatment of serious conditions such as cancer and heart disease. Any delay or lapse in therapy could result in disease progression, hospitalization, or life-threatening complications for these patients. Timely procurement is essential to maintain continuity of care and prevent negative health outcomes.

Pricing and Quantities:

Description Qty per Package Qty Needed Unit Price Extended Price

REVLIMID 5MG ORAL CAP (59572-0405-00) 100 6

REVLIMID 5MG ORAL CAP (59572-0405-28) 28 3

POMALYST 1MG ORAL CAP (59572-0501-21) 21 9

POMALYST 2MG ORAL CAP (59572-0502-21) 21 18

CAMZYOS 15MG ORAL CAP (73625-0114-11) 30 9

Total Estimated Cost: $848,444.00

(4) Identify the Authority and Supporting Rationale for utilizing other than full and open competition:

FAR Overhaul 12.102(b) requires written justification and approval as described in 6.104 when restricting competition for acquisitions valued over SAT. Additionally, 12.102(b) requires citing the applicable statutory authority as found in Table 12-1. Table 12-1 indicates if Simplified procedures found at 12.201- 1 are being used with an acquisition value greater than SAT but less than or equal to $9 million then statutory authority 41 U.S.C. 1901 will be cited. FAR Overhaul 12.200(a) states if commercial product is available on an existing Governmentwide contract to include Federal Supply Schedules to procure the commercial product from that source.

Additionally, this justification is prepared in accordance with Executive Order 14271, Ensuring Commercial, Cost-Effective Solutions in Federal Contracts, and FAR Overhaul 8.104(a)(2), which require agencies to consider existing government-wide contracts or blanket purchase agreements when no suitable “required use” contract exists to meet agency needs.

For this requirement, the specialty medications are being purchased under an existing VA National Acquisition Center (NAC) Federal Supply Schedule (FSS) contract, 36F79724D0101, awarded to Bristol- Myers Squibb Company. This contract is a required-use vehicle for VA facilities and ensures compliance with federal procurement policy.

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Acquisition ID#: 36C252-26-AP-1200

Furthermore, FAR Overhaul 8.401(a) states that agencies must use the Federal Supply Schedule in accordance with 8.104. By using the VA NAC FSS contract, the agency is meeting this requirement and leveraging an established, cost-effective solution for these specialty medications. GSAM/R 538-7104-3 states orders placed against FSS contracts are exempt from requirements in FAR part 6. But, an ordering activity must justify its action when awarding on a sole source basis.

(5) Describe Why You Believe the Order Represents the Best Value to aid the contracting officer in making this best value determination:

By using the existing VA NAC Federal Supply Schedule contract (36F79724D0101), the agency is complying with Executive Order 14271 and FAR Overhaul 8.104(a)(2), which require leveraging government-wide contracts when available. This approach avoids unnecessary administrative costs, ensures regulatory compliance, and provides the most cost-effective solution given the restricted distribution requirements.

(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 to determine if alternative sources exist for the required medications:

Revlimid (lenalidomide), Pomalyst (pomalidomide), and Camzyos (mavacamten).

These medications are subject to strict Risk Evaluation and Mitigation Strategy (REMS) programs administered by Bristol Myers Squibb. Under these programs:

Only REMS-certified pharmacies are authorized to dispense these drugs.

Bristol Myers Squibb limits dispensing to a closed network of specialty pharmacies, which does not include VA pharmacies.

As a result, the VA cannot purchase these medications through its normal supply chain or from other vendors. The only authorized source for these drugs is CoverMyMeds (McKesson Specialty Pharmacy), which operates within Bristol Myers Squibb’s REMS-certified network.

No other manufacturers produce these medications, and no generic alternatives exist for Pomalyst or Camzyos. While a generic version of lenalidomide (Revlimid) is approved, it is intermittently unavailable from the VA’s contracted vendor. Until supply stabilizes (estimated March 2026), the brand name Revlimid must be purchased to ensure continuity of care.

Based on this research, competition is not possible. The requirement is sole source because Bristol Myers Squibb controls distribution through its REMS program and limits access to a closed pharmacy network.

(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:

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Acquisition ID#: 36C252-26-AP-1200

The primary barrier to competition is the REMS program restrictions that limit dispensing of these medications to a closed network of specialty pharmacies managed by Bristol-Myers Squibb. The VA does not currently participate in this network.

To overcome this barrier for future acquisitions, the agency will:

Engage with Bristol-Myers Squibb to explore options for VA pharmacies to become REMS-certified where feasible.

Monitor availability of generic alternatives, such as lenalidomide, and update procurement strategies when supply stabilizes (estimated March 2026).

Review other government-wide contracts and agreements to identify any new sources or distribution models that may become available.

These actions will help reduce reliance on sole source procurement and increase opportunities for competition in future requirements.

(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.

Stephanie R. Stead Pharmacy Technician (Procurement/Inventory) William S. Middleton Memorial VAMC

(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.

Stacy Massey Contracting Officer Network Contracting Office 12

b. One Level Above the Contracting Officer (SAT - $900,000): I certify the justification meets requirements for other than full and open competition.

Parris S. Weidenbach Branch Chief, Supply Team Network Contracting Office 12

STEPHANIE

STEAD

Digitally signed by STEPHANIE

STEAD

Date: 2026.01.06 09:54:28 -06'00'

STACY MASSEY Digitally signed by STACY MASSEY Date: 2026.01.06 10:11:52 -06'00'

PARRIS

WEIDENBACH

Digitally signed by PARRIS

WEIDENBACH

Date: 2026.01.06 12:09:49 -06'00'