Rivfloza (nedosiran) — Medica

Initial criteria

• age ≥ 2 years
• genetic test confirming Primary Hyperoxaluria Type 1 with biallelic pathogenic variants in the AGXT gene [documentation required]
• estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m2 [documentation required]
• meets ONE of the following (a or b): a) age 2 to < 12 years and meets ONE of [(1) or (2)]: (1) urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate [documentation required]; OR (2) urinary oxalate:creatinine ratio above 2 times the 95th percentile for age; OR b) age ≥ 12 years and meets ONE of [(1), (2), or (3)]: (1) urinary oxalate excretion ≥ 0.5 mmol/24 hours/1.73 m2 with absence of secondary sources of oxalate [documentation required]; OR (2) urinary oxalate:creatinine ratio above the age-specific upper limit of normal [documentation required]; OR (3) plasma oxalate level ≥ 20 µmol/L [documentation required]
• patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1
• prescribed by or in consultation with a nephrologist or urologist

Reauthorization criteria

• patient is continuing to derive benefit from Rivfloza therapy according to the prescriber [documentation required] (examples: reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, or reduced plasma oxalate levels from baseline, or improved/stabilized clinical signs/symptoms such as nephrocalcinosis, renal stones, or renal impairment)
• patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1

Approval duration

initial: 6 months; reauthorization: 1 year