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