65--Darzalex Daratumumab McKesson Plazma Darzalex Daratumumab McKennson Plazma and Biologics 618A60088 618-16-1-109-0465 Darzalex 400mg Injection

Volume 3/Chapter D/Customer Service Guide/Procurement Package Attachment 13: Pharmaceutical Between 3K andlSOK Purpose: To ensure standardization of the submission process for pharmaceutical requirements the form below must accompany the request for procurement. ALL DOCUMENTS ARE TO BE PROVIDED ELECTRONICALLY. DATE: 12/11/2015 1. PROVIDE REQUESTOR'S NAME AND PHONE NUMBER. Name: Walter F. Newman Phone Number: +1 (555) 000-0000 2. ENTER FUNDED 2237#: 618-16-1-109-0465 Is the 2237 corresponding to this request funded or unfunded at this moment? In almost all cases, the project needs to be funded before moving forward. If it is unfunded, please soeak to the Fiscal Deoartment 3. REQUIREMENTS Name/Description of requested drug: Darzalex 400mg vial, NOC 57894-0502-20 Quantity Required: 24 vials (8 weekly orders of 3 vials each) Special Packaging Requirements: Click hen.' lo eiH<:r te't. Date Needed: 12/15/2015 Is the requested drug available for purchase against a mandatory use single award contract? r YES . NO (CHECK ONE) To determine the answer to this question, check the Prime Vendor List If you would like further guidance, please speak with the Director of Pharmacy, Chris Mangieri or Anthony Elliot I f the answer is yes, please provide the vendor name, contract number, and expiration date of contract in the section below; or check the box that the information was provided on the 2237. Vendor Name: Click here to '·ntcr text. Contract Number: Click hc:re to enter iext. Expiration Date of Contract: Click here to rnwr a date. r Information referenced above can be found within the submitted 2237. Note: If you answered yes to the above question and provided the vendor and contract information no further information is required. You may skip the remaining questions on this form and forward the requirement to your Network Contracting Activity. Estimated Cost/Unit 1818.00 Estimate was based on procurement history? YES r NO p (CHECK ONE) or Estimate was based on review of published prices? YES P' NO (CHECK ONE) If estimate was developed using a different approach than described above please explain:Click here to enter text. If you are not basing your estimate on procurement history, you can call pharmaceutical vendors and ask their Federal Account Manaqer to provide a quote. VHA Procurement Process SOP Revision 01 Original Date: 06/25/201O Revision 01 Date: 11/01/2012 Page 1of 4 Volume 3/Chapter II/Customer Service Guide/Procurement Package Attachment 13: Pharmaceutical Between 3K andlSOK Generic Drug YES r NO p (CHECK ONE) Brand Name Justification: When brand name drugs are requested please check the applicable justification below: r Within the Veterans Health Administration brand name drugs may be prescribed by physicians when in their clinical judgment the brand name drug will provide a better therapeutic outcome for patients. Brand name drugs are requested when there is a clinical requirement for the drug or there is history of clinical requirements for the drug and inventory must be maintained to meet anticipated requirements. r.; A generic form of the requested drug is not available. Will there be a recurring need for the requested drug? YES NO p (CHECK ONE) If you answered yes, please provide your estimated annual requirements: (Continuing treatment depends on treatment success. Onlv 1 patient involved at this time) 4. Competition Is the requested item open-market or available for purchase on a Federal Supply Schedule (FSS) r.; . contract? (Open-market ( FSS Item (CHECK ONE) *Is the requested drug available from more than source? YES NO l'7 (CHECK ONE) If the answer is yes, you may skip to block 6. If the answer is no, complete block 5. * When competition is available three sources should be solicited when available. However, when at least two sources are available the requirement will be competed unless adequate justificati on is provided (see block 5). 5. Client Justification for Other than Full and Open Competition (check applicable block) r- (A) FAR 8.405-6(b)(1) The requested drug will be purchased against a Federal Supply Schedule (FSS) contract and only one source has the requested drug available on an FSS contract r (B) FAR 8.405-6(b)(3) The requested drug will be purchased against a Federal Supply Schedule (FSS) contract and an urgent or compelling need exists, and following the FSS ordering procedures would result in unacceptable delays. Delay in the award would cause patient harm by delaying the medical facility's ability to provide prescribed medications to patients in a manner necessitated by their plan of care. p: (C) FAR 13.106-1(b) The drug is not available for purchase on an existing contract and will be VHA Procurement Process SOP Revision 01 Original Date: 06/25/201O Revision 01 Date: 11/01/2012 Page 2 of 4 Volume 3/Chapter II/Customer Service Guide/Procurement Package Attachment 13: Pharmaceutical Between 3K and 150K purchased on an open-market basis, and only one source is reasonably available to fulfill the requirement. If blocks B or C are checked, briefly describe the circumstances that make it necessary to purchase from one source in the space below (Block 9 may be used if more space is needed): McKesson Plasma and Biologics is the only distributor with which we have an active account and can supply the drug in time for target start of treatment date. Statement of the actions, if any, the agency will take to remove or overcome any barriers that led to restricted consideration before any subsequent acquisition for supplies and services is made: The medical center will purchase all pharmaceutical drug requirements competitively and fully utilize the prime vendor, national, and FSS contracts whenever possible. However, there are times that contracts sources do not have required drugs available and/or competition isn't available. The Pharmacy Department will remove or overcome barriers to competition by adequately planning known requirements and pledges to do so before any subsequent acquisitions. Acquisition Initiator: Walter F. Newman, Pharmacy Technician Icertify that the facts and representations under my cognizance, which are included in this justification and which form a basis for this justification, are complete and accurate. /.A.!4 /Ji., ll}u rr11vv-. tJ.fl.J:,, I'1, 2-0t s: S1onature Date 6. Recommended Source List (vendors): McKesson One Post Street San Francisco, CA 94104 +1 (555) 000-0000 r AmerisourceBergen Corporation P.O. Box 959 Valley Forge, PA 19482 +1 (555) 000-0000 CardinalHealth 7000 Cardinal Place Dublin, OH 43017 +1 (555) 000-0000 A Name or recommended vendor: McKesson Plasma and Biologics Address of recommend vendor: 401 Mason Rd, LA VERGNE, TN 37086-3243 Phone Number of Ordering Department: +1 (555) 000-0000 IFCAP Vendor # (if known): 3498201 FSS/National Contract # (if drug is on contract): Click here to enter text. VHA Procurement Process SOP Revision 01 Original Date: 06/25/2010 Revision 01 Date: 11/01/2012 Page 3 of 4 Contracting Officer's Certification: I certify the foregoing justification is accurate and complete to the best of my knowledge and belief. ERIC W. ZINTEK Signature290113 Digitally signed by ERIC W. ZINTEK 290113 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=contact@example.gov ov, cn=ERIC W. ZINTEK 290113 Date: 2015.12.30 12:06:38 -06'00' 12/30/2015 Eric Zintek Date Contracting Officer