LSJ Dotatate HCA approved.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C261-20-AP-6329

(1) Contracting Activity: Department of Veterans Affairs, VISN 21, VA Northern California Health Care System, RPO-West, Network Contracting Office, NCO 21, Martinez, CA for the VA Palo Alto Health Care System in Palo Alto, CA. 2237 PR. No. 640-21-1-053-0006.

(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). The VA Palo Alto Health Care System has a need to enter into a Contract for twenty-one (21) doses of Lutetium LU 177 Dotatate (Lutathera) Radiopharmaceutical Drug, National Drug Code (NDC) 69488-0003-01 to be used by the Nuclear Medicine Department to treat patients with neuroendocrine tumors.

This will be awarded as a new requirement.

Order against: FSS Contract Number: 36F79719D0169

Name of Proposed Contractor: ADVANCED ACCELERATOR APPLICATIONS USA, INC.

Street Address: 57 East Willow Street

City, State, Zip: Millburn, NJ 07041

Phone: (626) 634-6614

(3) Description of Supplies or Services:

The estimated value of the proposed action is .

Lutetium LU 177 Dotatate (Lutathera) is a peptide receptor radionuclide therapy used to treat adults with a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP- NETs) that are positive for the hormone receptor somatostatin. This drug is required for the continuation of cancer therapy for our Veterans.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a unique qualifications to provide the required supply or service.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5

Revision 02 Eff Date: 02/21/2020

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: Advanced Accelerator Applications USA, Inc. is the only contractor that can provide Lutetium LU 177 Dotatate (Lutathera) radionuclide for cancer treatment.

Lutetium LU 177 is a peptide receptor radionuclide therapy and is a tumor targeted treatment that uses radiation to kill cancer cells, which works differently than most cancer medicines.

Lutetium LU 177 is given as an infusion in a hospital setting and is made up of two parts: (1) A tumor-targeting part that helps find cancel cells with somatostatin receptors and (2) A radioactive part that helps kill the cells. Lutetium LU 177 can extend progression free survival in patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). VA Palo Alto currently have patients scheduled for this cancer therapy, and Lutetium LU 177 is required for patient care and treatment. Lutetium LU 177 Dotatate (Lutathera) is only available from the sole VA NAC FSS contractor Advanced Accelerator Applications USA, Inc. a large business on FSS Contract Number 36F79719D0169 which expires on 06/14/2024.

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:

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:

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5

Revision 02 Eff Date: 02/21/2020

GSA has already determined the prices of supplies and fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable. The Contracting Officer will request additional discounts from the Contractor before placing an order.

(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 by searching and reviewing VIPBIZ, DSBS, FPDS and eCMS. An internet search was also conducted on GSA Advantage, GSA eLibrary, VA NAC websites and google. Information was dicine Technologist Supervisor who has expert knowledge regarding the radionuclide therapy provided to cancer patients. Market research determined that there are not two or more SDVOSBs/VOSBs, small or large business suppliers that can satisfy this requirement. Market research also revealed that there are zero DSBS suppliers capable of satisfying this requirement. FPDS results revealed that every order that was placed for Lutetium LU 177 (Lutathera) by the various VA Network Contracting Offices were awarded to Advanced Accelerator Applications USA, Inc. Lutetium LU 177 Dotatate is only available from the VA NAC FSS contractor Advanced Accelerator Applications USA, Inc. a large business on FSS Contract Number 36F79719D0169 which expires on 06/14/2024.

(7) Any Other Facts Supporting the Justification:

On January 26,2018 the US Food and Drug Administration (FDA) approved (Lutetium LU 177 Dotatate (Lutathera), Advanced Accelerator Applications) injection, a radiolabeled somatostatin analog for the treatment of adults with somatostatin receptor-positive GEP-NETs. Lutetium LU 177 Dotatate is the first radiopharmaceutical to be approved by the FDA for this patient population. On April 24, 2019 the FDA granted Lutetium LU 177 Dotatate an orphan drug radionuclide therapy (PRRT), molecular-targeted drug to be approved by the FDA for patients with GEP-NETs.

(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:

There has not been any new contractors in the marketplace since the VA NAC FSS contract was awarded on 06/04/2019. Only Advanced Accelerator Applications USA, Inc. can meet this requirement. When the market opens up to new contractors that can provide the Radionuclide therapy required by the Nuclear Medicine Department then contracting will work with the station partner to compete a new contract.

(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