P03 LSJ_Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-2478

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-25-AP-2478

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 22, located at 4811 Airport Plaza Drive, San Diego, CA 90815, in support of VISN 22 VA San Diego Health Care System at 3350 La Jolla Village Drive, San Diego, CA 92161 under 2237# 664-25-2- 100-0054.

(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).

Order against: FSS Contract Number: 36F79722D0197

Name of Proposed Contractor: Telix Pharmaceuticals (US) Inc.

Street Address: 11700 Exit 5 Pkwy, Suite 200, City, State, Zip: Fishers, IN 46037

Phone: 317-509-5747

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ .

The Department of Veterans Affairs San Diego Healthcare System Nuclear Medicine Service has a requirement of radiopharmaceutical called GALLIUM GA 68 GOZETOTIDE INJECTION; Trade name: Illuccix (GA-68 PSMA), for direct patient cares. Illuccix is a prescription radioactive diagnostic agent that is prepared and injected at the facility. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. Illuccix is used in men with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) level. Illuccix is approved by Food and Drug Administration (FDA) and VA for use. Telix Pharmaceutical (US) Inc.

holds the patent rights for Illuccix, but Telix Pharmaceutical (US) Inc. has an agreement with Cardinal Health 414, LLC for Illuccix’s distribution.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-2478

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 consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

The VA National Acquisition Center (NAC) has already negotiated and determined the cost of the radiopharmaceutical is fair and reasonable. Also, it is the best interest of the government to establish a delivery order with the manufacturer’s authorized distributor, Cardinal Health 414, LLC as indicated on VA NAC Pharmaceutical Catalog with the agreed upon cost of the proprietary and highly specialized radiopharmaceutical, Illuccix, at $ per 5mCi. CS verified this cost is accurate based on VA NAC Pharmaceutical Catalog and directly with the distributor.

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

The VA NAC Pharmaceutical Catalog was utilized as a part of market research. NAC has contracted with the only authorized manufacturer of this radiopharmaceutical, Telix Pharmaceuticals (US), Inc. under Federal Supply Schedule (FSS) Contract# 36F79722D0197. Telix Pharmaceuticals (US), Inc. is the only vendor listed on the VA NAC Pharmaceutical Catalog portal for Illuccix/PSMA.

Small Business Administration (SBA)’s VetCert query was made under NAICS 325412 – Pharmaceutical Preparational Manufacturing and it returned 132 SD/VOSBs. However, it was determined that there are no authorized SD/VOSBs who can distribute Illuccix upon further research.

SAM.gov and FPDS were also utilized to research and study the past acquisition histories and its procurement method. A Delivery Order (DO)# 36C26224F0036 was placed against FSS# 36F79722D0197 for VA San Diego Healthcare System (VASDHCS)’s Illuccix requirement; total awarded amount was $ including two modifications for period of performance 11/1/23 through 10/31/24. This DO was procured using FAR 8.405-6(a)(1)(B) in conjunction with VHAPG 808.405-6 and a limited source justification. Another DO# 36C26225F0062 was ordered against FSS# 36F79722D0197 for VASDHCS for period of performance 11/1/24 through 2/10/25. The total warded amount was $ , which was also procured using FAR 8.405- 6(a)(1)(B) in conjunction with VHAPG 808.405-6 pharmaceutical purchase below SAT.

As required, a special notice, an intent to sole source, was posted on SAM.gov on 1/13/25 and closed on 1/21/25 to see if there are any other contractors have capabilities to manufacture or distribute a radiopharmaceutical equivalent to Illuccix/PSMA, and RLS responded on 1/17/25 that they also have a capability to provide Illuccix under FSS# 36F79722D0197 as they recently

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-2478 established an agreement with Telix. CS reached out to NAC CO and Deputy Chief Consultant from PBM to confirm the ordering procedure and was advised that Telix has yet to take additional steps to modify the FSS contract to add RLS as an additional distributor in order to update the VA ordering guideline. Therefore, CS concluded that Cardinal Health 414, LLC is the only local Radiopharmacy authorized to distribute Illuccix under FSS# 36F79722D0197 according to VA ordering guideline. A copy of email transmission is uploaded to eCMS briefcase.

Due to the specialized nature of this radiopharmaceutical called Illuccix, Illuccix/PSMA is not available from any other vendor. There is currently no therapeutically equivalent version of Illuccix available in the United States that are also FDA approved. Per VA NAC, Illuccix appears to be available from only one FSS contract holder with Telix Pharmaceutical (US), Inc. under NAC FSS contract# 36F79722D0197. And based on PBM ordering guideline for Illuccix, the order must be made through Cardinal Health 414, LLC.

(7) Any Other Facts Supporting the Justification:

Illuccix is a proprietary medication created by the pharmaceutical company called Telix Pharmaceutical (US), Inc. Telix Pharmaceutical (US), Inc. is the sole manufacturer of Illuccix and Cardinal Health 414, LLC is the authorized distributor of Illuccix.

(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:

The Department of Veterans Affairs will continue to survey the marketplace for ‘equal to’ or better therapies that will offer veterans the most up to date care.

(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 Subpart 8.4.

Chief Technologist/Administrative Officer Nuclear Medicine Service VA San Diego Healthcare System

VHAPG Part 808.405-6 Limiting Sources Page 5 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C262-25-AP-2478

(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

NCO 22

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Supply 4, Branch Chief

NCO 22