Pluvicto and Lutathera 5 Year BPA

Justification and Approval (J&A) Modified

This document is a Justification and Approval (J&A) modified for Federal Acquisition Regulation (FAR) 13.501, requesting a firm fixed price, five (5) year Blanket Purchase Agreement (BPA) to procure specific radiopharmaceuticals for the treatment of prostate cancer. The procurement is for Naval Medical Center San Diego (NMCSD) and other Medical Treatment Facilities (MTFs) within the Healthcare Contracting Division – West (HCD-W) Area of Responsibility.

• Pluvicto (NDC Number 69488-010-61)
• Lutathera (NDC Number 69488-003-01)
• Locametz (NDC Number 69488-017-61)
• Netspot (NDC Number 69488-001-40)

These radiopharmaceuticals are exclusively distributed by Novartis Pharmaceuticals Corporation.

• Contract Type: Firm Fixed Price Blanket Purchase Agreement (BPA)

• Period of Performance: 2 February 2026 to 1 February 2031

• Type of Funding: Operations and Maintenance (O&M)

• Statutory Authority: 41 United States Code 1901, implemented in FAR 13.501(a)(1)(ii) and FAR 6.302-1(c).

• Rationale: Novartis Pharmaceuticals Corporation is the exclusive FSS distributor for these specific radiopharmaceuticals, and there are no other known alternative distributors or generic alternatives available on the market for treating prostate cancer.

• Market Research: Conducted in December 2025, research confirmed the availability of these products and identified Novartis as the sole distributor.

• Efforts to Obtain Competition: A Notice of Intent to Sole Source was posted on SAM.gov from November 19, 2025, to December 9, 2025. No responses were received.

• The acquisition is identified as being sole sourced to an Other than Small Business: Novartis Pharmaceuticals Corporation (UEI: NG61ZA8TADW3, CAGE: 04520).

• The procurement will utilize simplified acquisition procedures under FAR Subpart 13.5.

• Certified cost or pricing data will not be required.

• The contracting officer determined the anticipated cost to be fair and reasonable.

Solicitation / RFP / RFQ

This document is a solicitation for a Blanket Purchase Agreement (BPA) for Pluvicto and Lutathera Injection. The Defense Health Agency (DHA) is procuring these items.

• The primary deliverables are Pluvicto (lutetium Lu 177 vipivotide tetraxetan) and Lutathera (lutetium Lu 177 dotatate).

• Exterior shipping containers must include specific information.

• The contractor must comply with various Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS) clauses, including those related to electronic submission of payment requests, cybersecurity maturity model certification, and item unique identification.

• BPA Number: HT941026AE002

• Award/Effective Date: January 29, 2026

• Ordering Period: March 2, 2026, to March 1, 2031

• Estimated Value of Potential Orders (Maximum): $5,000,000.00

• Purchase Limitation (Maximum per call order): $500,000.00

• Contract Type: Not explicitly stated, but structured as a BPA.

• Offer Due Date: Not explicitly stated in the provided pages, but the award date is January 29, 2026.

• Proposals or quotes should be submitted according to the instructions within the solicitation.

• Evaluation criteria are not detailed in the provided pages.

• The acquisition is marked as "UNRESTRICTED."

• North American Industry Classification Standard (NAICS) code: 325412 (Pharmaceutical and Medicine Manufacturing).

• Points of contact for the BPA are provided for both the Defense Health Agency and the contractor (Novartis Pharmaceuticals Corporation).

• Specific instructions are given for order issuance, delivery tickets, and invoicing via Wide Area Workflow (WAWF).

• The document includes extensive FAR and DFARS clauses that bidders must adhere to.