P03_JA_OVER_SAT THERA r_Redacted.pdf

Rev: 13 Effective Date: 02/01/22 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-22-AP-3454

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 21 on behalf VISN

21, VA Palo Alto Healthcare System

PR: 640-23-1-053-0004

2. Nature and/or Description of the Action Being Processed: The action being reviewed and approved is for a new fixed sole source contract (1 option year) for Theraspheres, valued at

FAR 13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Yttrium-90 (Y-

90) TheraSpheres, 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 FAR 6.303-2

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Yttrium-90 TheraSpheres is needed to therapeutically treat patients with primary and metastatic liver cancer (Hepatocellular Carcinoma [HCC]. The Yttrium 90 microspheres/treatment, and minimally embolic for the purposes of the VA PAHCS Y-90 Radioembolization Program. The total estimated use is 14 patients during a 12-month period

Period of Performance

Base Period : October 01, 2022 – September 30, 2023

Option Period 1: October 01, 2023 – September 30, 2024

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

Effective Date: 02/01/22 Page 2 of 5 or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (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;

FAR 13.5 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).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Only One Responsible Source (FAR 6.302-1) – There is only one FDS approved source and only one source with radioactive materials permit of Yttrium-90 glass microspheres, a highly specialized treatment, for VAPAHCS Y-90 Radioembolization Program. There would be a substantial duplication of cost and unacceptable delay if another product were to be purchased. The result would be an unacceptable delay in patient care.

a. TheraSphere microspheres are supplied in vials with discrete activity levels. No additional manipulation/aliquoting/recalculation prior to delivery is needed with significantly less chance of error. This is the only Y-90 microsphere product that comes in sealed unit doses that do not require manipulation by the nuclear medicine technologists, reducing the risk of a spill or miscalculation leading to a medical event. If the room is contaminated, the OR would be closed for possibly days until the room was at background levels. Radiation decays by half-lives, and Y-90 is 64 hours.

b. TheraSphere is the only Y-90 microshere with activity 2500 Bq/microsphere. This is important for radiation segmentectomy (a curative intent treatment) in which a higher dose is required to achieve complete pathological necrosis of the tumor/target volume.

c. TheraSphere is “Microembolic” smaller microsphere diameter - monitoring for stasis of flow is not required during glass microsphere delivery. The activity that you plan for and order is the activity that you will deliver. TheraSphere are minimally embolic, meaning that there is no worry about reaching stasis during administration.

Yttrium-90 TheraSpheres are only available from Boston Scientific Corporation, which owns the manufacturer BTG international Canada Inc.

Yttrium-90 glass microspheres (TheraSpheres) are essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company.

Accordingly, Boston Scientific is the only firm capable of providing the supplies and services described above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Effective Date: 02/01/22 Page 3 of 5

Sources Sought Synopsis: A sources sought notice had been released on contract opportunities under ID 36C26122Q0728_1 stating that the Department of Veterans Affairs (VA) is conducting a market research survey to identify potential qualified sources capable of providing Y-90 Theraspheres 1 year estimated supply from 06/21/2022- 06/27/2022. The Statement of Work was included in the notice, which stated that the VA is interested in future option years. No responses were received.

Boston Scientific had sent a previous pricing letter during the initial station partner’s market research process that indicates they are still capable of providing the Theraspheres treatments.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The anticipated cost will be considered fair and reasonable utilizing the information based on a comparison of proposed prices with prices found reasonable on previous purchases and based on a comparison with similar items. The VA has at least three active contracts for TheraSpheres that the contract price will be fair and reasonable as a comparison will be made with current contracts as well as the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

According to market research results pursuant to FAR Part 10, VA Acquisition Regulation (VAAR) 810.001-70 Market Research Policy, and PPM 2016-05, the “Rule of Two” will not be met as two or more service-disabled veteran-owned businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) were not found. A VIP search utilizing NAICS code 339113 provided 550 SDVOSB/VOSB matches. However adding the keyword “Yttrium”, 0 results were found.

Market research efforts included a sources sought notice, VIP, FPDS, Contract Opportunities, VA NAC Pharmaceutical Catalog, GSA Advantage, and SAM. As described previously, 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.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

TheraSphere Yttrium-90 Glass Microspheresis used as a treatment for selected patients with unresectable cancers. The treatment involves injecting tiny microspheres of radioactive material into the arteries that supply the tumor. Estimated 14 doses per year @ . Boston Scientific is the only distributor for this requirement, this treatment is proprietary.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Boston Scientific has been awarded this requirement previously, and has provided a pricing list for FY23.

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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:

No other vendor will provide this particular product, because it is proprietary. Y-90 radioembolization with Theraspheres is one option for treatment of primary and metastic liver cancer. It is a viable treatment method and may have some advantages for certain individuals over other potential alternatives like liver transpnatation, surgical resection, thermal ablation, transarterial chemoembolization, and systemic molecular/immunotherapies. In the future, if another vendor supplies this product, the Government will evaluate their qualifications. A sole source effort is required for the planned time duration because transarterial radioembolization is a long term clinical treatment program requiring a significant investment in time and resources to obtain internal regulatory approval from the local Institutional Review Board and National Health Physics program, build standard operating procedures, and perform staff training.

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 my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Rodney Rodriguez Espada Date Nuclear Med-Tech VA Palo Alto Healthcare System

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

a. 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.

Maxwell Derck Date Contracting Officer, Supply 2

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.

Angela M. Oppenheimer Date Branch Chief Supply I, NCO 21

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