P03 Brand Name Justification Resin Microspheres-signed.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 4

DEPARTMENT OF VETERANS AFFAIRS

BRANE NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C262-22-AP-3778

1. Contracting Activity: Department of Veterans Affairs, VISN 22, Southern Arizona VA Healthcare

System, 3601 South 6th Avenue. Tucson, Arizona. The 2237 number is: 678-18-3-064-0116.

2. Nature and/or Description of the Action Being Processed: The Southern Arizona VA Healthcare System has a requirement to treat patients with stage IV liver cancer, who have metatastic liver tumors. SIR-Y-90 resin microspheres will be used in this treatment. Sirtex Medical Inc, is the only responsible source, who can produce the SIR-Y-90 resin microspehres needed for this requirement.

The proposed action is a firm fixed price procurement restricted to brand name items.

The total dollar value including option years = $645,411.30

3. :

The SIR- Y-90 resin microspheres are medical devices that are used in Selective Internal Radiation Therapy (SIRT) for liver tumors, for stage IV colon cancer. These specific resin microspheres allows for single use only and contains an important feature that allows the medical staff to make last minute adjustments to the dosage before it is administered.

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

4. Demonstration that the C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Sirtex Medical Inc, is the sole manufacturer and distributor of SIR-Y-90 resin microspheres, which are also the only FDA-PMA approved microspheres to treat colorectal cancer that has metastasized to the liver. These microspheres have 2 key features which make them unique:

1. They allow for flexibility, which is known as , to choose the radioactivity of particles to be delivered, which allows us to use a larger or smaller volume, to cover larger or smaller areas of the liver, depending on the need.

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2. They also allow for flexibility to split one dose between 2 blood vessels, if needed, for better delivery into the tumor, vs having to order 2 separate vials, one for each vessel, at a higher cost.

Due to the sensitive procedure of treatment, any change in the microsphere types being used would not only jeopardize patient health but also delay procedures, as staff would need to be trained. The delaying of treating patients would create a dominio effect, as this would risk the cancer to spread further in patients and increase costs to the government to train medical staff in using non-resin microspheres.

The current staff already are familiar in using the SIR-Sphere Y-90 resin microspheres, as this would avoid confusion and minimize chances of the staff making mistakes when handling/delivering the radioactive materials. In addition, the staff have the experience and consistency in treating metastic liver tumors for patients at the VA Southern Arizona Healthcare System. Therefore, this procurement will procedure In Accordance With FAR 6.302- Sourc radiopharmaceutical Y-90 resin microspheres is Sirtex Medical Inc.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source #36C26222Q0751, was posted to contract on SAM in contract opportunities on 03/23/2022 03/29/2022. No responses were received.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Sirtex Medical Inc. is the only responsible source that can provide the SiR-Spheres Y-90 resin microspheres for this requirement.

The current previous contract 36C26221N0151 awarded with the SIR Spheres Y-90 resin microspheres priced at $17,500 EA, the latest price for these microspheres has remained the same.

The stable price is consistent with the trends within the marketplace. In concluscion, the price for SIR-Spheres Y-90 Microspheres has been determined to be fair and reasonable.

7.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A VIP NAICS search code 325412, resulted in 97 Service- Disabled Veteran Owned Small Business (SDVOSB)/Veteran Owned Small Business (VOSB) vendors.

An amplified search of keywords - was generated, resulted in 11 SDVOSB/VOSB vendors. A second query utlizing keywords ing in 14 SDVOSB/VOSB vendors. None of SDVOSB/VOSBs found were related nor capable of fulfilling the requirement.

Additional Market Research conducted utilizing GSA Advantage, National Acquisition Center (NAC), FPDS, and SAM was conducted. These yielded zero sources found. This, as mentioned before, is due to Sirtex being the sole manufacturer of the resin microspheres and being the only approved resin microsphere by the FDA to treat metatasitic liver tumors. This makes it even more difficult for small business and for competition.

The referenced past contract for radiopharmaceuticals included the brand name SIR- Y-90 resin microspheres. The contract 36C26221N0151 was awarded with the period of performance (POP):

01/13/2021 01/12/2022 Amount: $385,000.00

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As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: Based on market research at this time, there are no third party vendors that are capable of providing SIR-Spheres Y- 90 resin micropsheres. The only source to provide the microspheres is Sirtex Medical Inc.

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

Company Point of Contact Contact Information Address Sirtex Medical Inc. Heidi Riccio (781) 721-3800 300 Unicorn Park Drive Woburn, MA 01801

10. 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 Department of Veterans Affairs (VA) will continue to preform market research as well as communicate with our subject matter experts (SME) to ensure we are continuously exploring new innovate and financially responsible ways to ensure competition is sought after to the maximum extent practicable. The VA will continue to seek out information from the manufacturer about their current business partners in an attempt to identify possible small business concerns or other than small businesses in an effort to increase authorized distributors to promote competition. It remains difficult for businesses to create a competing radiopharmaceutical such as the SIR-Spheres Y-90 resin microspheres, along with many other hurdles such as approval from the FDA, PMA, as well as clinical trials, financing, proprietary patents being some of the major roadblocks for other businesses.

11. 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.

Name Date Title Facility

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

a. Contracting Officer or Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Peter Kim Date:

Title: Branch Chief, Supply 4 Facility: NCO 22 Long Beach

: Jonathan Ford : Contract Specialist

: NCO 22 Long Beach

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b. 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.

Date

Name: David Chakka NCO 22: Division Chief Facility:

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA)