P03 JA - HCA Signed - TYMLOS 36C77024R0018-redacted.pdf

36C7702 – TYMLOS

Attachment 7: Request for Justification Format >SAT

VHAPG Part 806.3 OFOC Page 2 of 7 Revision: 01 Effective Date: 04/01/23

f. 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.

g. Demand for TYMLOS is steadily increasing yet fluctuates, making adequate inventory levels at all times crucial to filling Veterans prescriptions.

h. DailyMed label:

VHAPG Part 806.3 OFOC

Revision: 01 Effective Date: 04/01/23

Statutory Authority Permitting Other than Full and Open Competition:

The statutory authority 41 USC 3304(a)(1) allows an executive agency to use noncompetitive procedures to award a contract for property or services when the property or services are available from only one responsible source and other type of property or services will satisfy the needs of the executive agency. Competition is restricted on this procurement for the reason below:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( )

(5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): There are only two CMOPs that dispense TYMLOS for the entire United States Tucson and Charleston CMOP. Tucson and Charleston CMOPs purchased this product from Prime Vendor, McKesson in the past, but that option is no longer available.

Pharmaceuticals are prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Brand Specific” products are the same thing as “dispense as written” on a physician’s prescription. No National Drug Code (NDC) substitutions are permitted. 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.” The VA PRINT NAME is the official identifier of what the drug name should be. This along with the Product Code is how the facility identifies what drug they should dispense. 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.

Radius Health Inc. is the only contractor that provides this pharmaceutical that is manufactured for them in Germany. Radius Health Inc. has a for TYMLOS but no longer distributes it themselves, rather they have two authorized distributors, Priority Healthcare Distribution Inc., dba CuraScript Specialty Distribution (CuraScript), a small business, and FFF Enterprises Inc. (FFF), a large business.

CuraScript has provided TYMLOS to the CMOPs in recent past. The authorized distributors do not have an FSS contract, so Radius Health Inc.’s FSS contract cannot be utilized for the distributors.

VHAPG Part 806.3 OFOC Page 4 of 7 Revision: 01 Effective Date: 04/01/23

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

On 8/16/23, the manufacturer, Radius Health Inc., was emailed a request for a list of authorized distributors, for which they replied they only have two, Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution (Curascript), a small business and FFF Enterprises Inc. (FFF), a large business.

n recent prior orders, for pharmaceutical TYMLOS was posted on SAM.gov on 8/21/23, 7/13/23, 6/2/23, and 5/1/23, receiving no inquiries.

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

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 for the upcoming acquisition for TYMLOS.

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns in the marketplace). The National drug code(s) NDC 70539-0001-02 was used to query the DailyMed website and resulted in one (1) manufacturer who currently manufactures TYMLOS. The manufacturer Radius Health Inc. manufactures its product non-domestically in Germany.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325412 and yielded a total of 131 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 manufacturers Radius Health Inc. Their two authorized distributors

VHAPG Part 806.3 OFOC Page 5 of 7 Revision: 01 Effective Date: 04/01/23

(Curascript and FFF) were searched individually, and this yielded one result within the SBA;

Priority Healthcare Distribution Inc., dba CuraScript Specialty is a registered small business.

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, engage 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, the manufacture is a small business and there are only 2 authorized distributors, a small business and large business. Since the authorized distributors do not have a FSS contract, the FSS contract with RADIUS cannot be utilized for the distributors.

Any Other Facts Supporting the Use of Other than Full and Open Competition:

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

Priority Healthcare Distribution Inc., dba Curascript Specialty Distribution, a small business, and an authorized distributor, angela.liles@curascript.com FFF Enterprises Inc., a large business, and an authorized distributor, fffcustomercare@fffenterprises.com

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.

VHAPG Part 806.3 OFOC Page 6 of 7 Revision: 01 Effective Date: 04/01/23

12. 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 and belief.

Michael A. Sanchez Date Inventory Management Officer Tucson CMOP

Christine Smith Date Logistics Officer Charleston CMOP

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Larry Zaritz Date Contracting Officer Network Contracting Office 15 – CMOP Division

9/27/2023MICHAEL SANCHEZ Digitally signed by MICHAEL SANCHEZ Date: 2023.09.27 13:41:06 -07'00'

CHRISTINE

SMITH

Digitally signed by

CHRISTINE SMITH

Date: 2023.10.02 07:28:09 -04'00'

LARRY

ZARITZ

Digitally signed by LARRY

ZARITZ

Date: 2023.10.03 11:59:27 -05'00'

Attachment 7: Request for Justification Format

>SAT

VHAPG Part 806.3 OFOC Page 7 of 7 Revision: 01 Effective Date: 04/01/23

b. One Level Above the Contracting Officer (Required over SAT but not exceeding I certify the justification meets requirements for other than full and open competition.

Christy Pendlay Date Branch Chief

Network Contracting Office 15 – CMOP Division

Benjamin Dufour Date Division Chief

Network Contracting Office 15 – CMOP Division

Andrew J. Raiber Date Director of Contracting

Network Contracting Office 15 –

(NCO 15)

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $75 million) or approve ($750K to $75 million) for other than full and open competition.

Gerald F. Jacobs Date Acting Executive Director Regional Procurement Office-Central (VHA)

CHRISTY

PENDLAY

Digitally signed by CHRISTY

PENDLAY

Date: 2023.10.10 14:36:54 -05'00'

BENJAMIN

DUFOUR

Digitally signed by

BENJAMIN DUFOUR

Date: 2023.10.24 08:37:14 -05'00'

ANDREW

RAIBER

Digitally signed by

ANDREW RAIBER

Date: 2023.10.25 07:39:50 -05'00'

GERALD JACOBS Digitally signed by GERALD JACOBS Date: 2023.11.13 15:18:41 -06'00'