Sole Source Justification.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

JOFOC Tracker Number:

1. Contracting Activity: Department of Veterans Affairs, VISN 19, Network Contracting office 19, 6162

South Willow Drive, Suite 300 Greenwood Village, CO 80111.

Organizational Activity: Department of Veterans Affairs, VISN 19, Oklahoma City Medical Center (OKC VAMC) 921 NE 13th St, Oklahoma City, OK 73104

2. Nature and/or Description of the Action Being Processed: This procurement is for Ra-223 (Xogifo) 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. The action being reviewed and approved is a Sole Source Justification for a firm-fixed Purchase Order for a base year plus four one-year option periods.

The anticipated period of performance is April 1, 2024 – March 31, 2025 plus four one-year option periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This requirement is for Ra-

223 “Xofigo” for the Oklahoma City VA Medical Center. Ra-223 “Xofigo” is a radioactive material that is indicated for the treatment of patients with castration resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

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

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 3

( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 manufactured and sold in the United States by Bayer Healthcare Pharmaceuticals, Inc. and is only available for purchase through Cardinal Health. Due to the nature of Xofigo as a radiopharmaceutical, Bayer decided to centralize the sale through a sole distributor. Bayer HealthCare is the sole owner with proprietary rights, manufacturer, and supplier of Xofigo and it can only be procured through Cardinal Health.

According to an article published by the National Institutes of Health, Radium-223 dichloride “Xofigo” is the first -particle emitter therapeutic agent that has been approved by the Federal Drug Administration (FDA). The article states that Xofigo has “benefits in overall survival and delay in symptomatic skeletal event for patients with metastatic castrate-resistant prostate cancer (CRPC)”.

The article states that there are - emitting radionuclides that are also utilized for treatment of this type of cancer, but they have not been found to have a positive impact on survival. Xofigo is stated to not only be beneficial for bone pain relief, but also has been found to improve survival. The article is uploaded to the eCMS briefcase for reference.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A letter from the manufacturer confirms that this requirement is only available from one source. A notice of intent to sole source will be posted to Contract Opportunities in accordance with FAR Part 5.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be determined to be fair and reasonable by the CO in accordance with the procedures of FAR 13.106-3.

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

Market Research Was Not Conducted: Market Research was not conducted as the manufacturer has confirmed via letter that this requirement is only available from one source, Cardinal Health.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Xofigo is only available for purchase through Cardinal Health according to a letter from the manufacturer, Bayer HealthCare LLC.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cardinal Health 414, LLC 7000 Cardinal Place Dublin, OH 43017

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: Market Research will be conducted in the future to determine if there are new radiopharmaceuticals capable of providing the same or similar treatment as Xofigo.