Skip to content
The Policy VaultThe Policy Vault

Rivfloza (nedosiran sodium) — Blue Cross Blue Shield of New Mexico

Primary hyperoxaluria type 1 (PH1)

Initial criteria

  • Diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by ONE of the following: (A) Genetic testing of the AGXT gene indicates a pathogenic mutation OR (B) Liver biopsy demonstrates absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity
  • Requested agent will be used to lower urinary oxalate levels
  • Patient has estimated GFR (eGFR) ≥ 30 mL/min/1.73m²
  • If the patient has an FDA labeled indication, then ONE of the following: (A) The patient's age is within FDA labeling OR (B) There is support for use in the patient's age for the requested indication
  • ONE of the following: (A) Patient does NOT have hypocitraturia, elevated urinary supersaturation of calcium oxalate, or increasing stone burden OR (B) Tried and had inadequate response to potassium citrate or sodium citrate OR (C) Intolerance or hypersensitivity to potassium citrate or sodium citrate OR (D) FDA labeled contraindication to BOTH potassium citrate AND sodium citrate
  • ONE of the following: (A) Patient has AGXT mutation known to be unresponsive to therapy with pyridoxine (vitamin B6) OR (B) Tried and had inadequate response to pyridoxine (vitamin B6) ≥3 months AND ONE of the following: (1) Unresponsive to pyridoxine (≤30% decrease in urine oxalate after 3 months) OR (2) Responsive (>30% decrease) AND will continue pyridoxine in combination OR (C) Intolerance or hypersensitivity to pyridoxine OR (D) FDA labeled contraindication to pyridoxine
  • Patient has NOT received a liver transplant
  • Prescriber is a specialist in the area of the patient’s diagnosis (gastroenterologist, geneticist, nephrologist, urologist) OR has consulted with one
  • Patient will NOT be using requested agent in combination with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate approval criteria for specific plans: (1) NM Fully Insured or NM HIM members meeting rare disease and compendia-supported use criteria without FDA contraindications, OR (2) OH Fully Insured or HIM Shop members meeting compendia or peer-reviewed literature support and no FDA contraindication

Reauthorization criteria

  • Patient previously approved for the requested agent through the plan’s prior authorization process
  • Patient has had clinical benefit with the requested agent (e.g., decrease in urinary oxalate levels)
  • Patient has estimated GFR (eGFR) ≥ 30 mL/min/1.73m²
  • ONE of the following: (A) AGXT mutation known to be unresponsive to therapy with pyridoxine OR (B) Will continue therapy with pyridoxine OR (C) Was unresponsive to pyridoxine OR (D) Intolerance or hypersensitivity to pyridoxine OR (E) FDA labeled contraindication to pyridoxine
  • Patient has NOT received a liver transplant
  • Prescriber is a specialist in the area of the diagnosis (or has consulted one)
  • Patient will NOT use requested agent with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient does NOT have FDA labeled contraindications to requested agent

Approval duration

6 months (initial); 12 months (renewal) [BCBSIL/BCBSMT initial 12 months; others initial 6 months]