The Regional Health Contracting Office-Central, JBSA - Fort Sam Houston, Texas intends to award a Firm-Fixed-Price sole source contract to Advance Accelerator Applications USA, Inc. under the authority of Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source, for the requirement for two FDA approved products LUTATHERA (lutetium Lu 177 dotatate) and PLUVICTO (lutetium Lu 177 vipivotide tetraxetan). Lutathera is indicated for the imaging and treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors for patients. Pluvicto is for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration resistant prostate cancer.
The applicable NAICS code for this requirement is 325412, Pharmaceutical Preparation Manufacturing. The Small Business Size Standard is 1,250 employees. Award will be made on or after 1 Aug 2022.
The solicitation number is W81K0022Q0097, and is generated for the purposes of posting this notice. THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. A determination by the Government not to compete the purchase order based upon responses to this notice is solely within the discretion of the Government. This notice is neither a request for quotes nor a solicitation of offers; however, interested sources who submit data are responsible for appropriately marking information if it is proprietary in nature. Questions will not be accepted after the due date. All responses must be received by 30 May 2022-10:00AM CST
Salient Characteristics:
Lutetium Lu-177 Dotatate (LUTATHERA)
Must be FDA approved.
Must be Lu-177 Dotatate
Must be indicated for treatment of somatostatin receptor-positive gastroenterpancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
Should be a 4 dose treatment regimen given every 8 weeks.
Lutetium Lu-177 Vipivotide Tetraxetan (PLUVICTO)
Must be FDA approved
Must be Lu-177 Vipivotide Tetraxetan
Must be indicated for treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Should be a treatment regimen of every 6 weeks for up to 6 doses.
Contracting Office Address:
Regional Healthcare Contracting Office- Central
Attn: MCAA-RC, 3551 Roger Brooke Drive
JBSA-Fort Sam Houston, TX 78234-6200