6505--Jynarque

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C262-22-AP-6104 Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 22, located at 4811 Airport Plaza Drive Long Beach, CA 90815, in support of VISN 22 VA Health Care System Long Beach at 5901 East 7th Street Long Beach, CA 90815. 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 medication, Jynarque, is used by patients who have a certain inherited kidney problem (autosomal dominant polycystic kidney disease-ADPKD). This inherited kidney problem leads to the growth of fluid-filled sacs (cysts) in your kidneys. This medication requires a new delivery order each time it is prescribed to reflect patient information.

This action will be awarded as a new requirement for the new patient prescriptions. A prior award was made under delivery order number Order against: FSS Contract Number: 36F79720D0099 Name of Proposed Contractor: Walgreens Specialty Pharmacy, LLC Street Address: 130 Enterprise Dr. City, State, Zip: Pittsburgh, PA 15275 Phone: 706-550-2007 Description of Supplies or Services: The estimated value of the proposed action is $ 297,251.24 Jynarque (Tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Jynarque (Tolvaptan) is peculiar to one manufacturer, it is the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing ADPKD. VA Long Beach Healthcare System is requesting: Item Number: 0001 Quantity: 13 Description: Jynarque 60MG 30MG 28 Day Tablet Supply Item Number: 0002 Quantity: 13 Description: Jynarque 90MG 28 Day Tablet Supply The period of performance will be 7/1/2022 6/30/2023 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. 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; 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: is: A patent, copyright or proprietary data limits competition. The proprietary data 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. 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: The proprietary medication has been previously negotiated under the National Acquisition Center (NAC) contract 36F79720D0099, which was awarded to Otsuka America Pharmaceutical, Inc. but fulfilled by Walgreens Specialty Pharmacy, LLC. There are no alternative vendors that can supply this medication to the VA patients due to the proprietary rights held by Otsuka America Pharmaceutical, Inc. The current pricing has been determined to be fair and reasonable. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. A recent delivery order (DO) awarded to Walgreens Specialty Pharmacy, LLC under DO 36C26221F0351 awarded 7/1/2021 was reviewed. The National Acquisition Center (NAC) Pharmaceutical website was queried and returned the required medication under federal supply schedule (FSS) 36F79720D0099 awarded to Otsuka America Pharmaceutical, Inc. This vendor was the only vendor providing the medication on FSS. This medication is proprietary to Otsuka America Pharmaceutical, Inc. and is not expected to be provided through any other vendors besides Walgreens Specialty Pharmacy, LLC, which is the distributor for Otsuka America Pharmaceutical, Inc. s medication. Any Other Facts Supporting the Justification: 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: This medication is proprietary and the first to be approved by the Food and Drug Administration (FDA). It is difficult to assess when/if another company will be able to provide a similar medication that will be approved by the FDA. The agency will continue to monitor alternatives by working with subject matter experts. 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. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) GABRIEL GONZALEZ Digitally signed by GABRIEL GONZALEZ Date: 2022.06.23 10:21:00 -07'00' SIGNATURE DATE NAME TITLE SERVICE LINE/SECTION FACILITY Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Peter Y. Kim Digitally signed by Peter Y. Kim 1140482 1140482 Date: 2022.06.23 10:42:40 -07'00' CONTRACTING OFFICER/DESIGNEE S SIGNATURE DATE Peter Kim NCO 22 NAME AND TITLE FACILITY/NCO/PCO 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. Deeptichandra Chakka 160259 Digitally signed by Deeptichandra Chakka 160259 Date: 2022.06.30 10:52:24 -07'00' SIGNATURE DATE Deeptichandra Chakka NCO/PCO 22 Supply 4 Branch Chief