P03 Radiopharm J A FY24 April Cardinal Xofigo March 7 fully signed print_Redacted.pdf

OFOC SOP Revision 10 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

–Philadelphia –Radiopharmaceutical (Cardinal)

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition

Acquisition Plan Action ID:

PR IFCAP/2237:

1. Contracting Activity: Department of Veterans Affairs, VISN 04, CMC Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104 (CMCVAMC).

2. Nature and/or Description of the Action Being Processed: The CMCVAMC requires a contract for

Xofigo Injection 6 ML/vial (Radium Ra-223 Dichloride injection 6ml/vial, National Drug Code:

50419-0208-01). Bayer HealthCare Pharmaceuticals, Inc. is the manufacturer and Cardinal Health 414 (Cardinal) is the only authorized distributor of Xofigo. Contract will be awarded directly to Cardinal. This contract will also need to include Fluedoxyglucose (FDG) and Sodium Fluoride (NaF) which were also included on the original contract 36C24423P0435.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Radial Pharmaceutical

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 with symptoms but not to other parts of the body. A per microcure methodology is used to calculate the Xofigo price in 6ML package size. The total estimated quantity is 2,820 units at the current price of . The total estimate for FDG is 1000 units at the current price of . Lastly the estimate for NaF is 10 units at the current price of

The estimated value of the proposed action is Period of Performance is 04-12-2024 through 4-11-2025.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (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;

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 is the sole distributor of Xofigo in the United States. A manufacturer proprietary letter from Bayer supporting that is uploaded into the briefcase for reference.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research and the manufacturer proprietary letter confirmed Cardinal is the one and only one company that can meet the requirement.