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Rivfloza (nedosiran sodium) — Blue Cross Blue Shield of Illinois

primary hyperoxaluria type 1 (PH1)

Initial criteria

  • The patient has a diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by ONE of the following: genetic testing of the AGXT gene indicates a pathogenic mutation OR liver biopsy demonstrates absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity
  • The requested agent will be used to lower urinary oxalate levels
  • The patient has an estimated GFR (eGFR) ≥ 30 mL/min/1.73^2
  • If the patient has an FDA labeled indication, then ONE of the following: (A) the patient's age is within FDA labeling for the requested indication for the requested agent OR (B) there is support for using the requested agent for the patient’s age for the requested indication
  • ONE of the following regarding citrate therapy: (A) the patient does NOT have hypocitraturia, elevated urinary supersaturation of calcium oxalate, or increasing stone burden OR (B) the patient has tried and had an inadequate response to potassium citrate or sodium citrate OR (C) the patient has an intolerance or hypersensitivity to potassium citrate or sodium citrate therapy OR (D) the patient has an FDA labeled contraindication to BOTH potassium citrate AND sodium citrate
  • ONE of the following regarding pyridoxine (vitamin B6): (A) the patient has an AGXT mutation known to be unresponsive to therapy with pyridoxine OR (B) the patient has tried and had an inadequate response to pyridoxine (vitamin B6) for at least 3 months AND ONE of the following: (1) the patient is unresponsive to pyridoxine (≤30% decrease in urine oxalate after 3 months of treatment) OR (2) the patient is responsive to pyridoxine (>30% decrease in urine oxalate after 3 months) AND will continue pyridoxine in combination with the requested agent OR (C) intolerance or hypersensitivity to pyridoxine OR (D) FDA labeled contraindication to pyridoxine
  • The patient has NOT received a liver transplant
  • The prescriber is a specialist in the area of the patient's diagnosis (e.g., gastroenterologist, geneticist, nephrologist, urologist) or has consulted with such a specialist
  • The patient will NOT be using the requested agent in combination with another urinary oxalate reducing agent (e.g., lumasiran)
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had clinical benefit with the requested agent (e.g., decrease in urinary oxalate levels)
  • The patient has an estimated GFR (eGFR) ≥ 30 mL/min/1.73^2
  • ONE of the following regarding pyridoxine: (A) patient has AGXT mutation unresponsive to pyridoxine OR (B) will continue pyridoxine combination therapy OR (C) was unresponsive to pyridoxine OR (D) intolerance/hypersensitivity OR (E) FDA labeled contraindication to pyridoxine
  • The patient has NOT received a liver transplant
  • The prescriber is a specialist in the area of the patient's diagnosis or has consulted with a specialist
  • The patient will NOT be using the requested agent in combination with another urinary oxalate reducing agent (e.g., lumasiran)
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL and BCBSMT: 12 months; All other plans: 6 months (initial) / 12 months (renewal)