Xofigo JA FY21 Philadelphia Redacted_Redacted.pdf

36C244 21 AP 0805

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

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244 21 AP 0805

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Corporal Michael J Crescenz Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104. Purchase Request Number: 642 21 1 029 0014.

2. Nature and/or Description of the Action Being Processed: A firm fixed price, sole source delivery order for Xofigo Injection 6 ML/vial (Radium Ra 223 Dichloride injection 6ml/vial, National Drug Code: 50419 0208 01), will be awarded directly to Cardinal Health 414. Bayer HealthCare Pharmaceuticals, Inc. is the manufacture and Cardinal Health 414, LLC. is the only authorized distributor of Xofigo. Period of Performance 01 06 2021 to 01 05 2022.

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 cancerhas 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 4,500 units

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;

( ) (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 FAR6.302 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;

FAR13.5 Simplified Procedures for Certain Commercial Items: 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 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.

36C244 21 AP 0805

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

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 metastasesand 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 HealthcarePharmaceuticals).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sourcesas deemed practicable: A notice of intent to sole source will be posted to beta.sam 36C24420Q1366 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 36F79720D023. 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.

8. Description of the Market Research Conducted and the Results:Market Research was conducted utilizing search engines on the Vendor Information Pages, National Acquisition Center, General Service Administration and System for Award Management websites. A Request for Information, 36C24420Q1138 was previously posted with one response. Cardinal Health 414, LLC., provided an authorized distributor letter from Bayer. Bayer Healthcare Pharmaceuticals, Inc. is the only Manufacture of Xofigo Injection and Cardinal Health 414, LLC. is the only authorizeddistributor in the United States.

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 andconditions of a task order against 36F79720D0237 for the distribution and invoicing for Xofigo against the Bayer Healthcare Pharmaceuticals, Inc. National Acquisition Center contract 36F79720D0237.

Therefore, it is in the best interest of the Government to solicit and award a sole source, open market contract 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, with no ability to formulate an economic price adjustment.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cardinal Health 414, LLC. responded to a request for information (36C24420Q1035) 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 mycognizance,