P03_FAR6_JA_OVER_SAT_Yescarta_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:_____36C261-21-AP-2629_____

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office 21 on behalf of Northern California VA Health Care System.

2237: 612-21-2-114-1609

2. Nature and/or Description of the Action Being Processed:

YESCARTA - AXICABTAGENE CILOLEUCEL INJ,SUSP - NDC:71287-0119-01.

Yescarta is prescribed for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

The value of the purchase order is

Description of Supplies/Services Required to Meet the Agency’s Needs:

YESCARTA - AXICABTAGENE CILOLEUCEL INJ,SUSP - NDC:71287-0119-01

The value of the purchase order is

3. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1.

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

(X ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

4. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The requested drug will be purchased to the sole authorized distributor and an urgent or compelling need exists and following the open market ordering procedures would result in unacceptable delays.

Delay in the award would cause patient harm by delaying the medical facility’s ability to provide prescribed medications to patients in a manner necessitated by their plan of care.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: None. This was an emergency pharmaceutical procurement.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer has compared the proposed prices against the Federal Supply Schedule (FSS) price list costs to ensure the costs quoted are equal to or less than the FSS. The Contracting officer has determined that the anticipated costs to be fair and reasonable and in the best interest of the government.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Limited market research was conducted due to limited authorized distributor of this medication.

This is a commercial item available from Cardinal Health, LLC. This particular drug is available under FSS V797D-70252 with Gielad Sciences, Inc. Gilead Sciences, Inc. is the manufacturer but does not process the distribution of the drug. The VA Pharmacy orders this drug from the authorized distributor Cardinal Health, LLC. Cardinal Health does not have an FSS contract; however, they will honor the FSS pricing from the manufacturer.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cardinal Health, Inc.

10. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

Cardinal Health, Inc. is the only known firm capable of providing the requested supplies and services. Market research will be conducted prior to any new requirements to determine if there have been any changes in the marketplace.

11. 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 and belief.

Name Date Title Facility

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mandy Thompson Date Branch Chief, Supply I

NCO 21

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Felicia Demita Date Chief, Division II Acting

NCO 21