skip to content
Primary navigation

Rivfloza™

Drug - Rivfloza™ (nedosiran) [Novo Nordisk Inc.]

January 2025

Therapeutic area - Hyperoxaluria Treatments

Initial approval criteria

  • Patient is ≥ 9 years of age; AND
  • Patient has a definitive diagnosis of primary hyperoxaluria type 1 (PH1) as evidenced by 1 of the following:
    • Patient has a biallelic pathogenic mutation in the alanine: glyoxylate aminotransferase (AGXT) gene as identified on molecular genetic testing; OR
    • Identification of alanine: glyoxylate aminotransferase (AGT) enzyme deficiency on liver biopsy; AND
  • To monitor response, patient has a basemen measurement of one or more of the following:
    • Urinary oxalate excretion level (corrected for BSA)
    • Spot urinary oxalate: creatinine ratio
    • Estimated glomerular filtration rate (eGFR)
    • Plasma oxalate level; AND
  • Rivfloza will be used to lower urinary oxalate levels; AND
  • Patient does not have renal impairment defined as an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2; AND
  • Patient has NOT had a liver transplant; AND
  • Rivfloza will NOT be used in combination with other urinary oxalate reducing agents (e.g., lumasiran); AND
  • Rivfloza is prescribed by, or in consultation with, a specialist in genetics, nephrology or urology.
  • Initial approval is for 6 month

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient has experienced disease response as evidenced by a decrease in urinary oxalate excretion from baseline, a reduction in spot urinary oxalate: creatinine ratio from baseline, stabilization of glomerular filtration rate and/or a decrease in plasma oxalate level from baseline; AND
  • Patient is absent of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe injection site reactions, etc.
  • Renewal approval is for 12 months

Quantity limits

  • Maximum 160 mg once per month
    • 80 mg single-dose vial: 2 vials per month
    • 128 mg prefilled-syringe: 1 syringe per month
    • 160 mg prefilled-syringe: 1 syringe per month

Questions

Provider Call Center (844) 575-7887

back to top