PM_Part813.5_Atch1_FAR13.5_JA_OVER_SAT_20Signed1_Redacted1.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C244-21-AP-4916

1. Contracting Activity: Department of Veterans Affairs, NCO4 CMJC Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104. Purchase Request Number 642-22-1-029-0018.

2. Nature and/or Description of the Action Being Processed: A Firm-Fixed Price, Sole Source, Blanket Purchase Agreement (BPA) award is anticipated for Radiopharmaceutical products Xofigo, F18 Fludeoxyglucose and Sodium Fluoride to treat cancer. Bayer HealthCare Pharmaceuticals, Inc. holds the patent and Cardinal Health 414, LLC. is the Original Equipment Manufacturer (OEM) and only authorized distributor of Xofigo. F18 Fludeoxyglucose and Sodium Fluoride is available through Trillamed LLC, on National Acquisition Center contract V797D-70148 which expires in April 2022.

However, due to mitigating circumstances, Trillamed will not be considered for this part of the requirement. Cardinal Health’s proximity to the Philadelphia VA to meet an emergency delivery time of one hour for all three radiopharmaceutical below reduces any delays in patient care and administrative costs.

Xofigo (Radium-223) (Cardinal Health – OEM) National Drug Code: 50419-0208-01 F18 – NaF (Sodium Fluoride) (Cardinal Health – OEM) National Drug Code: 40028-0512-30 F18 – FDG (Fludeoxyglucose) (Cardinal Health – OEM) National Drug Code: 40028-0511-30

Period of Performance 01-11-2022 to 01-10-2023.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Radiopharmaceutical Xofigo (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone, but not to other parts of the body. A per microcure methodology is used to calculate the Xofigo price in 6ML package size.

F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.

Fludeoxyglucose F 18 Injection (fdg) is a positron emitting radiopharmaceutical used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). Fludeoxyglucose F 18 Injection is used to assist assessment of cancer.

Xofigo (Radium-223) estimated quantity 4500 estimated price F18 (Sodium Fluoride) estimated quantity 1800 estimated price F18 (Fludeoxyglucose) estimated quantity 165 estimated price

The total estimated contract value

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4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). This procurement is for Xofigo and both F18 Radiopharmaceuticals will be procured in accordance with FAR

13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Xofigo is the only known treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Bayer Healthcare Pharmaceuticals, Inc. is the only manufacturer of Xofigo Injection (Radium Ra-223 Dichloride). Cardinal Health 414, LLC. is the sole distributor of Xofigo in the United States (attached letter from Bayer Healthcare Pharmaceuticals).

Cardinal Health’s proximity to the Philadelphia VA to meet an emergency delivery time of one hour for all three radiopharmaceutical below reduces any delays in patient care and administrative costs.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Request for Quote and justification will be posted to beta.sam (36C24421Q1219) in accordance with FAR 6.305

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated price is considered fair and reasonable, as Cardinal Health 414, LLC. will continue to honor the established Federal Supply Schedule pricing that has been established under 36F79720D0237 and does not expire to 2025. This National Acquisition Center contract is with Bayer HealthCare Pharmaceuticals, Inc. however Bayer will not be processing orders, delivering, or invoicing, therefore an annual purchase order will be established with Cardinal Health 414, LLC for all three radiopharmaceuticals.

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

Research Was Not Conducted: Market Research was conducted utilizing search engines on the Vendor Information Pages, National Acquisition Center, General Service Administration and System for Award Management websites.

Market Research for this requirement is largely based on the Contracting Officers personal knowledge of the industry and the volatility of the market. Cardinal Health 414, LLC., has provided an authorized distributor letter from Bayer. This letter is in the Briefcase under Tab P02.

Bayer Healthcare Pharmaceuticals, Inc. is patentholder, but Cardinal Health Is the OEM for Xofigo, F18 FDG and F18 NaF. They also provide the products to the Gorvernment.

Trillamed is the only know small business and SDVOSB of F18 FDG and NaF but due to negative past performance related to delivery of radiopharmaceuticals at the Philadelphia VA a delivery order against V797D-70148 will not be awarded at this time.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Based on the information set forth herein, Cardinal Health 414, LLC. could not be held to the terms and conditions of a task order against Bayer’s NAC Contract 36F79720D0237 for the distribution and invoicing for Xofigo against the Bayer Healthcare Pharmaceuticals, Inc.

Therefore, it is in the best interest of the Government to solicit and award an Open Market, Blanket Purchase Agreement on a Sole Source basis to Cardinal Health 414, LLC. for the distribution of Xofigo under the commercial terms and condition set forth in the resulting contract. Annual option periods were not requested due to an update in the manufactures pricing each December.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cardinal Health 414, LLC. responded and provided a letter from Bayer stating Cardinal Health 414, LLC. is the sole distributor of Xofigo.

11. 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: The VA will continue to monitor the commercial marketplace to determine if other sources are capable of providing a metastatic cancer treatment specific to the conditions of the selected patients. Once other sources enter the marketplace, future procurements may be competitive.

12. 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.

Program Analyst Philadelphia VA Medical Center (642)

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

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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

NCO4

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

Branch Chief, Commodities 2

NCO4