Rivfloza (nedosiran subcutaneous injection – Novo Nordisk) — Cigna

Primary Hyperoxaluria Type 1

Initial criteria

Patient is age ≥ 9 years; AND
Patient has had a genetic test confirming the diagnosis of Primary Hyperoxaluria Type 1 via identification of an alanine:glyoxylate aminotransferase gene (AGXT) mutation [documentation required]; AND
Patient has an estimated glomerular filtration rate (eGFR) ≥ 30 ml/min per 1.73 m2 [documentation required]; AND
Patient meets ONE of the following: (a) urinary oxalate excretion ≥ 0.7 mmol/24 hours/1.73 m2 [documentation required]; OR (b) urinary oxalate:creatinine ratio above the age-specific upper limit of normal [documentation required]; OR (c) plasma oxalate level ≥ 20 µmol/L [documentation required]; AND
Patient has not previously received a liver transplant for Primary Hyperoxaluria Type 1; AND
Medication is prescribed by or in consultation with a nephrologist or urologist.

Patient is currently receiving Rivfloza; AND
According to the prescriber, the patient is continuing to derive benefit from Rivfloza as determined by the most recent (within the past 6 months) objective measurement [documentation required].
Examples of objective measurements include reduced urinary oxalate excretion, decreased urinary oxalate:creatinine ratio, reduced plasma oxalate levels from baseline, or improved/stabilized clinical signs/symptoms of Primary Hyperoxaluria Type 1.

initial 6 months; reauth 1 year