P03 36C260-26-AP-0206 JOFOC NCO20 Strensiq - HCA Approved.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C260-26-AP-0206

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C260-26-AP-0206 JOFOC Tracking #: FY26 - NCO 20 - 110

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 20 (NCO 20), located at 1601 E. Fourth Plain Blvd., Bldg. 17, Suite B428, Vancouver, WA 98661 in support of VISN 20 VA Alaska Healthcare System at 2925 Debarr Rd, Anchorage, AK 99508. 2237:

463-26-1-027-0001.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The action being reviewed and approved is firm-fixed-price order for 24 boxes of STRENSIQ, against NAC contract 36F79718D0355. This action is a follow-on to FY25 order 36F79718D0355 36C26025F0093, which had a POP 12/22/2024-12/21/2025.

Order against: FSS Contract Number: 36F79718D0355

Name of Proposed Contractor: Alexion Pharmaceuticals Inc.

Street Address: 100 College St

City, State, Zip: New Haven, CT 06510

(3) Description of Supplies or Services:

The estimated value of the proposed action is $1,253,613.36. The delivery dates are

12/21/2025 – 12/20/2026.

This is a firm-fixed-price order for 24 boxes of STRENSIQ which cost $52,233.89 each (per NAC contract 36F79718D0355) and will be ordered by the facility as needed. STRENSIQ is a prescription medicine manufactured in the U.S. by Alexion Pharmaceuticals, Inc. (a large business), and is used to treat people with perinatal, infantile, and juvenile onset hypophosphatasia (HPP).

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 4

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

The required pharmaceutical is only available from one source, the manufacturer Alexion Pharmaceuticals, Inc., distributed by AmerisourceBergen Specialty Distribution.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

This order represents the best value to the government as the price has already been determined fair and reasonable. This is also the most efficient way to provide care to the Veteran(s) in need. STRENSIQ is a prescription medicine manufactured in the U.S. by Alexion Pharmaceuticals, Inc. (a large business), and is used to treat people with perinatal, infantile, and juvenile onset hypophosphatasia (HPP).

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market Research was conducted in accordance with FAR 10 and VAAR 810.001-70. Market research revealed the pharmaceutical is available on FSS via contract 36F79718D0355 through Alexion Pharmaceuticals, Inc, distributed by ASD Specialty Healthcare. There are no generic equivalents. A search of Unicor, Ability One, GSA, & SBA did not yield any applicable search

VHAPG Part 808.405-6 Limiting Sources Page 3 of 4 results. A search of SAM found no Active Exclusions for Alexion Pharmaceuticals, Inc or ASD Specialty Healthcare.

(7) Any Other Facts Supporting the Justification:

This will be a recurring government requirement since Veteran will need this medication for the rest of their life.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: None.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Pawel Nowacki Acquisition & Utilization Specialist Alaska Health Care System

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

José Ronstadt Contracting Officer Network Contracting Office 20

VHAPG Part 808.405-6 Limiting Sources Page 4 of 4

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Jacob Jackson Chief, Ancillary Patient Care

S. Dale Allen Director of Contracting

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)