Attachment 1 FAR 13.5 Sole Source Justification - Rivfloza 36C25524P0492_2.pdf

This is a Sole Source Justification document from the Department of Veterans Affairs (VA) for the procurement of Rivfloza (nedosiran) injections for a single patient at the Marion VA Medical Center in Kansas. The justification is for a monthly injection costing $62,880 per month, with a total projected cost of $691,680 for up to 11 months of treatment.

The patient has primary hyperoxaluria and end-stage renal disease, requiring this medication to lower oxalate levels below 20 mg/day to become eligible for a kidney transplant. The sole source justification is based on two factors: (1) Rivfloza is a newly FDA-approved pharmaceutical (September 29, 2023) that is only available through CVS Specialty Pharmacy, and (2) there is unusual and compelling urgency for the patient's treatment. The contract was awarded to ProCare Pharmacy Direct, LLC on July 29, 2024. The document includes required certifications from VA pharmacy services leadership and contracting officers, with an effective date of February 1, 2022.