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Rivfloza (nedosiran) — Blue Cross Blue Shield of Alabama

Primary hyperoxaluria type 1 (PH1)

Initial criteria

  • - 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
  • - Requested agent will be used to lower urinary oxalate levels
  • - Patient has an estimated GFR (eGFR) ≥ 30 mL/min/1.73 m²
  • - If the patient has an FDA labeled indication, then ONE of the following: • Patient age is within FDA labeling for the requested indication OR • There is support for using the requested agent for the patient’s age for the requested indication
  • - ONE of the following regarding citrate therapy: • Patient does NOT have hypocitraturia, elevated urinary supersaturation of calcium oxalate, or increasing stone burden OR • Patient has tried and had an inadequate response to potassium citrate or sodium citrate OR • Patient has an intolerance or hypersensitivity to potassium citrate or sodium citrate therapy OR • Patient has an FDA labeled contraindication to BOTH potassium citrate AND sodium citrate
  • - ONE of the following regarding pyridoxine (vitamin B6): • Patient has an AGXT mutation known to be unresponsive to pyridoxine OR • Patient has tried and had an inadequate response to pyridoxine for at least 3 months
  • - ONE of the following pyridoxine response categories: • Patient is unresponsive to pyridoxine (≤30% decrease in urine oxalate after 3 months of treatment with maximally tolerated pyridoxine) OR • Patient is responsive to pyridoxine (>30% decrease in urine oxalate after 3 months of treatment with maximally tolerated pyridoxine) AND will continue pyridoxine in combination with the requested agent OR • Patient has an intolerance or hypersensitivity to pyridoxine therapy OR • Patient has an FDA labeled contraindication to pyridoxine
  • - Patient has NOT received a liver transplant
  • - Prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, geneticist, nephrologist, urologist), or prescriber has consulted with a specialist
  • - Patient will NOT use the 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

Reauthorization criteria

  • - Patient has been 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 an estimated GFR (eGFR) ≥ 30 mL/min/1.73 m²
  • - ONE of the following regarding pyridoxine (vitamin B6): • Patient has an AGXT mutation known to be unresponsive to pyridoxine OR • Patient will continue pyridoxine in combination with the requested agent OR • Patient was unresponsive to pyridoxine (≤30% decrease in urine oxalate after 3 months of treatment) OR • Patient has an intolerance or hypersensitivity to pyridoxine therapy OR • Patient has an FDA labeled contraindication to pyridoxine

Approval duration

6 months