Rivfloza (nedosiran) — Highmark
primary hyperoxaluria type 1 (PH1)
Initial criteria
- age ≥ 2 years
- diagnosis of primary hyperoxaluria type 1 (ICD-10: E72.53)
- diagnosis confirmed by genetic testing demonstrating a mutation in the AGXT gene OR liver biopsy demonstrating absence or significantly reduced AGT activity
- prescribed by or in consultation with a urologist or nephrologist
- member has not received a liver transplant
- relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)
- at least two (2) elevated urinary oxalate levels > 1.5 times the upper reference limit
- member meets one (1) of the following: biochemically unresponsive to pyridoxine OR partial biochemical pyridoxine responsiveness OR mutation consistent with pyridoxine unresponsiveness
Reauthorization criteria
- continues to have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)
- experienced at least a 30% reduction in urinary oxalate levels from baseline
- has not received a liver transplant
Approval duration
initial 6 months; reauthorization 12 months