P03 JA Attach1 FAR 13.5 UC Justification - Over SAT - 24Q0083_ml_COsigned_BC Signed_redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Pharmaceutical – Urgent and Compelling Award

Acquisition Plan Action ID: 36C77024AP0130

1. Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, Tucson CMOP, 2237:

762-24-1-040-0341, Tucson CMOP, Tucson, AZ

2. Nature and/or Description of the Action Being Processed: The CMOP facility in Tucson, AZ requires pharmaceutical Abaloparatide (NDC 70539-0001-02) to be procured with the support of the instant justification and approval for other than full and open competition utilizing urgent & compelling need to fulfill Veteran patient prescriptions. The proposed procurement action will be a new firm fixed-price contract award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This document sets forth the Contracting Officer’s determination, in accordance with FAR 13.106-1(b), for acquisitions conducted under Simplified Acquisition Procedures. In accordance with FAR Part 13, it is the intent of the Contracting Officer to promote competition to the maximum extent practicable to obtain supplies from the source whose offer is the most advantageous to the Government (FAR 13.104). It is the intent of the contracting activity to award a one-time single award purchase order on an urgent/compelling basis for the following:

a. Pharmaceutical: TYMLOS (Abaloparatide 80mcg/0.04ml, 1.56ml Pen)

b. NDC #70539-0001-02

c. Quantity: 500 Boxes (each box contains one prefilled pen which delivers 30 doses)

d. One-time delivery for Tucson CMOP, needed immediately

e. Estimated IGCE value:

f. No options

g. TYMLOS is prescribed by VA physicians for the treatment of postmenopausal women with osteoporosis and men with osteoporosis who are a high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

h. Overall demand is steadily increasing yet fluctuates, making adequate inventory levels crucial to filling Veteran prescriptions.

i. DailyMed Label:

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4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( X ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Tucson CMOP supplies other CMOPs and have been taking on extra work due to circumstances beyond their control such as inclement weather conditions where other facilities are located. Also, one of the CMOPs is undergoing a facility move and requires their support. These reasons have created unexpected spikes in usage.

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

Unusual and compelling Urgency.

There are only two CMOPs that dispense this product for the entire United States, and Tucson CMOP supplies most of it. Tucson CMOP purchased this product from Prime Vendor McKesson in the past, but TYMLOS is no longer available on prime vendor contract. If Tucson CMOP is unable to fill an order for TYMLOS, Veteran’s well-being could be adversely affected. IAW FAR 6.302(b)(2), a delay in award of this contract could result in serious injury to our Veterans.

The in-stock inventory of pharmaceutical TYMLOS at the VA Tucson CMOP will be critically low by end of December 15, 2023, due to an unanticipated market demand. TYMLOS is not available from typical contracted sources such as VA Pharmacy Prime Vendor or NAC Federal Supply Schedules. The CMOP maintains an average of eight days of inventory utilizing a Just-In-Time logistics program to fulfill prescription requirements. The pharmacy facilities do not have the capacity to stock at higher levels, which causes critically low stock levels and an urgency to VA when the pharmaceutical cannot be obtained from the usual contract vehicles. After exhausting other resources to obtain the pharmaceutical, the procurement request package is submitted to the NCO 15 CMOP Contracting Office to procure as an open market, critical need. The open market procurement request allows VA to search for the pharmaceutical from other, non-contracted sources that may be able to supply the necessary dosage and quantities needed in an expedited manner. During the market interruption, VA is competing with other national pharmacies to obtain the pharmaceutical which requires VA to make an urgent award when supply is discovered. An untimely delay in awarding the open market acquisition would otherwise prevent the pharmaceutical from being replenished within VA and

Effective Date: 02/01/2022 Page 4 of 6 could cease the filling of prescriptions for Veterans and other beneficiaries which may lead to severe consequences.

This product is produced by Radius Health Inc. (RADIUS), and they hold a NAC FSS contract # 36F79718D0363 for TYMLOS (Abaloparatide), however, RADIUS only distributes this drug through their two authorized distributors, Priority Healthcare Distribution Inc., dba CuraScript Specialty Distribution (CURASCRIPT) and FFF Enterprises Inc (FFF).

Additionally, the product has been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug File (NDF) will most always identify “brand specific” products in the VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be “formulation specific” by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code.

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

The manufacturer, RADIUS, was contacted for a list of authorized distributors on 11/30/23. RADIUS confirmed they only have two authorized distributors, CURASCRIPT (a small business) and FFF (a large business). Additionally, historical data was obtained from VISTA IFCAP showing CURASCRIPT and FFF are the only vendors that supplied this item from September 2020 through September 2023.

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

TYMLOS is on the RADIUS FSS contract (#36F79718D0363) at a price of per box. IAW FAR 8.404(d), GSA has already determined the prices of supplies under schedule contracts to be fair and reasonable.

The authorized distributors do not have a FSS contract, therefore, the FSS contract with RADUS cannot be utilized for the distributors.

The authorized distributors were contacted for pricing and availability. CURASCRIPT responded with the same price as the RADIUS FSS contract of . Additionally, the authorized distributor’s unit price is within the historical unit price range listed in VISTA of $ to $ , from September 202 to September 2023.

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

In accordance with FAR Part 10 and VAAR 810 market research was conducted. The procurement package was received by the Contracting Office on 11/27/23. Market research was conducted 11/28/23 – 11/30/23 for the upcoming acquisition for TYMLOS.

A search for both small and large businesses was conducted on the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website using generic terms for the pharmaceutical and the national drug code NDC #70539-0001-02. The research resulted in RADIUS as the manufacturer (a small business) of TYMLOS and is manufactured in Germany.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325412 and yielded a total of 134 SDVOSB/VOSBs. Further market research was conducted via the SBA Dynamic Small Business Search database using the criteria of the specific UEI numbers, for the specified manufacturer RADIUS and their two authorized distributors (CURASCRIPT & FFF). The search resulted in the manufacturer, RADIUS, and their authorized distributor, CURASCRIPT, as registered small businesses.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are NOT two or more small business concerns who identify themselves as authorized distributors. There is one small business concern that has 500 or less employees, engages in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. The CO has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code 325412. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition.

The manufacture is a small business and there are only 2 authorized distributors, a small business and a large business.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

10. Listing of Sources that Expressed in Writing, an Interest in the Acquisition:

a. FFF Enterprises Inc., fffcustomercare@fffenerprises.com

b. Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution, angela.liles@curascript.com

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 action is being taken at this time due to the fact that no NDC substitutions are permitted based on physician’s specific orders.