65--36C25019P1138 506-19-3-021-1402 ANDEXXA VIALS

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under $150K VHAPM Part 813.106 Page 1 of 1 Original Date: 08/30/17 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($150K) Acquisition Plan Action ID: 36C250-19-AP-3162 Contracting Activity: Department of Veterans Affairs, VA Ann Arbor Healthcare System (Station 506), 2215 Fuller Road, Ann Arbor, Michigan 48105-2303, VISN 10, submitted Purchase Request 506-19-3-021-1402 to purchase Pharmaceutical Supplies. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Service has submitted Purchase Request: 506-19-3-021-1402 with an estimated dollar amount of $110,000.00, which has been certified to purchase the following equipment and/or supplies for the VA Ann Arbor Healthcare System, Inpatient Pharmacy: Five (5) Cartons, Containing four (4) Vials Each, Andexanet, Alfa, Inj., Pwd, 4 Pk, Andexxa (MPN): 0101-04, (NDC): 69853-0102-01. This drug is prescribed to treat patients with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This item is purchased directly from an approved distributor: ASD Specialty Healthcare, Inc. 3101 Gaylord Parkway, Suite 3Sse193, Frisco, Texas 75034-8655. This item is required to be delivered to the facility on or before April 04, 2019 Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. In May 2018, andexanet alfa received its first global approval in the USA for use in patients treated with rivaroxaban and apixaban, when reversal of anticoagulant effects is required in life-threatening or uncontrolled bleeding. The manufacturer currently has three distributors listed on the organizations Internet Site on how to order the required medication. The three organizations that are authorized to sell and distribute this new medication that is a brand name product with no generic substitutions currently available at this time. This product will be procured as a Firm Fixed Price Procurement, Open Market, Sole Source, Brand Name procurement to the following authorized distributor: ASD Specialty Healthcare, Inc. 3101 Gaylord Parkway, Suite 3Sse193, Frisco, Texas 75034-8655. This is an emergent/special procurement and is required to treat a current patient at this facility. Due to the emergent/special request of this product, this medication will be purchased to a current Vendor that can provide the medication by the required need date. The pricing for this medication is being sold for the same price shown in this procurement - across the board. Description of market research conducted and results or statement why it was not conducted: Market Research was conducted utilizing the following: FPDS-NG, GSA, MedSurg Online Catalogs, Pharmaceutical Online Catalogs, NAC, and Sam. In addition, a google search was also conducted only to provide ineffective results. The VetBiz initial Vendor Search indicated that there are currently no SDVOS/VOSB organizations capable of meeting the procurement requirements. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness. ____________________________ April 1, 2019 Michele R. Bartelt Contracting Officer