6505--Therasphere Y-90

NOTICE OF INTENT TO SOLE SOURCE

Therasphere Radiopharmaceutical Doses

The Network Contracting Office (NCO) 10 for the Dayton VA Medical Center, 4100 West Third Street, Dayton, OH 4542 intends to award a sole source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements The Contractor will provide a Firm Fixed Priced, twelve-month supply of Therasphere; these Radiopharmaceutical Doses will be used in the Nuclear Medicine Department at the Dayton VA Medical Center.

Therasphere Radiopharmaceutical Doses 35 EA used to treat liver cancer

Determination of this sole source procurement is in accordance with FAR 13.106-1(2)(b) soliciting from one source. It is the Government s belief that the proposed candidate is the only provider of the proprietary Radiopharmaceutical Doses. This notice of intent is not a request for competitive quotes. No solicitation documents are available and telephone requests will not be accepted. However, any business that believes it can provide the supplies may submit written notice to john.tschirhart@va.gov 11:59pm EST on March 17, 2023

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-23-AP-1848

Contracting Activity: Department of Veterans Affairs, VISN 10, Network Contracting Office (NCO 10), 3140 Governors Place Blvd, Suite 210, Kettering, Ohio 45409. 2237 No: 552-23-2-778-0025, $629,825.00

Nature and/or Description of the Action Being Processed: TheraSphere®, Y-90 glass microsphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. This will be awarded as a new Firm Fixed Price Purchase Order.

Description of Supplies/Services Required to Meet the Agency s Needs: The Dayton VA Medical Center Interventional Radiology section has begun using TheraSphere Yttrium-90 (Y-90) for the treatment of Hepatocellular Carcinoma. TheraSphere Y90 treatment provides patients with unresectable hepatocellular carcinoma (HCC) as well as secondary liver neoplasia who have exhausted other liver directed therapies with additional treatment options possibly extending overall survival and/or quality of life. There are no other approved treatments of this type for HCC.

Statutory Authority Permitting Restricted Competition:Â

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.

       (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

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): TheraSphere® Yttrium-90 (Y-90) Glass Microspheres are manufactured, sold, and distributed exclusively by Boston Scientific. TheraSphere® Y-90 glass microspheres are FDA-approved (PMA #P200029). Boston Scientific, is considered a sole source provider for TheraSphere, and the product is shipped directly from BWXT Medical Ltd.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Per FAR 5.102 and 6.305 this Sole Source Justification will be posted on SAM Contract Opportunities (FBO) since being a Brand Name Acquisition exceeding $25K.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The pricing is in line with the IGCE as well as the current price is just over 2% more than it was in 2022 based upon 36C25022P1347, PO# 552C20036. In 2022, each dose cost $17,750.00, the current dose cost is $17,995.00.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VIP, GSA, NAC and the internet were searched. VIP with NAICS Code 325412 and keyword TheraSphere, resulted 0 SD/VOSBs. However as mentioned above Boston Scientific is the sole provider, a large business. The VA Rule of Two is Unattainable.

The BAA and TA are not applicable to this requirement. Procurement of domestic end products. Products comply with the Buy American Act. Furniture, IT hardware, software, medical products, or paper products are commercial items and are not produced in non-designated countries. Products comply with the Trade Agreements Act.

Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

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

Boston Scientific

500 Commander Shea Blvd.

Quincy, MA 02171

Dorothy Chamblitt

(888) 812-1303

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: Due to the technical risks, compatibility requirements of the existing equipment, and proprietary rights of Boston Scientific, there are no ways to eliminate the restriction of this requirement. If a future requirement for the same solution is identified, a full and open competition after exclusion of sources, shall be promoted amongst Boston Scientific resellers if there are subsequent acquisitions.

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.

_____________________________ ________________________

Michael Galiardi Date

Quality and Regulatory Compliance Specialist

Dayton VA Medical Center

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

_____________________________ ________________________

Gina P. Crank Date

Contracting Officer

NCO 10

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.

_____________________________ ________________________

Adam P. Weber Date

Branch Chief Supply Team #1

NCO 10