Redacted JA for Relyvrio.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

Effective Date: 02/01/2022 Page 1 of 3

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C260-24-AP-0302 JOFOC Tracker Number: FY24 - NCO 20 - 402

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 20 (NCO

20) procuring for Puget Sound VA Health Care System (PSHCS) utilizing 2237 number 663-24-2- 022-0219.

(2) 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). This is a procurement for the pharmaceutical drug Relyvrio, National Drug Code 73063-0035-04 (sodium phenylbutyrate and taurursodiol).

Order against: FSS Contract Number: 36F79723D0136

Name of Proposed Contractor: Amylyx Pharmaceuticals, Inc.

Street Address: 43 Thorndike ST

City, State, Zip: Cambridge, MA 02141

Phone: (857) 600-5599

(3) Description of Supplies or Services: The estimated value of the proposed action is $279,718.28. The period of performance is 1/1/2024 – 3/31/2024.

Relyvrio is an oral treatment approved to help slow the progression of amyotrophic later sclerosis (ALS) in patients and extends their life expectancy as a result. Relyvrio is currently prescribed to 26 patients in the PSHCS and anticipates this number will increase going forward.

(4) 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 can provide the pharmaceutical drug Relyvrio supplies required at the level of quality required because the supplies or services are unique or

Effective Date: 02/01/2022 Page 2 of 3 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:

A patent, copyright or proprietary data limits competition. The proprietary data is:

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.

(5) 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:

This order represents the best value to the government as the price has already been determined fair and reasonable IAW FAR 8.404(d). This is also the most efficient way to provide care to the patients in need.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market Research was conducted in accordance with FAR 10 and VAAR 810.001-70 (Class Deviation). This brand specific medication has been prescribed for the patients by a VA Physician; this is the same as “dispense as written” on a physician prescription and no substitutions are permitted. Market research revealed there is only one source for the required prescription drug Reylvrio: FSS Contract 36F79723D0136, held by Amylyx Pharmaceuticals, Inc.

(manufacturer) and is distributed to the VA by Curascript Pharmacy, Inc. Both Amylyx Pharmaceuticals, Inc. and Curascript Pharmacy, Inc. have an active registration in SAM.

Documentation is in the appropriate contract file showing that Amylyx has proprietary rights to this pharmaceutical.

Relyvrio is a brand name of sodium phenylbutyrate/taurursodiol, approved by the FDA, and there is currently no generic versions of Relyvrio available in the United States. A search of the FDA Orphan Drug Designations and Approvals for Relyvrio revealed that Amylyx Pharmaceuticals holds exclusive rights until 09/29/2029 for providing this drug to treat amyotrophic lateral sclerosis (ALS) in adults.

(7) Any Other Facts Supporting the Justification: N/A

Effective Date: 02/01/2022 Page 3 of 3

(8) 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: None

(9) 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.)

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

b. 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.