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nedosiran sodium — Blue Cross Blue Shield of Texas

primary hyperoxaluria type 1 (PH1)

Initial criteria

  • Diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by genetic testing of the AGXT gene indicating a pathogenic mutation OR liver biopsy showing absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity
  • Requested agent will be used to lower urinary oxalate levels
  • Estimated GFR (eGFR) ≥ 30 mL/min/1.73^2
  • If patient has an FDA labeled indication, age is within FDA labeling OR there is support for use at that age
  • ONE of: (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) Has intolerance or hypersensitivity to potassium citrate or sodium citrate OR (D) Has an FDA labeled contraindication to BOTH potassium citrate AND sodium citrate
  • ONE of: (A) Patient has AGXT mutation unresponsive to pyridoxine (vitamin B6) OR (B) Tried pyridoxine (vitamin B6) for ≥3 months and was unresponsive (≤30% decrease in urinary oxalate) OR will continue combination if responsive (>30% decrease) OR (C) Has intolerance/hypersensitivity to pyridoxine OR (D) Has FDA labeled contraindication to pyridoxine
  • Patient has NOT received liver transplant
  • Prescriber is a specialist in, or has consulted with a specialist in, gastroenterology, genetics, nephrology, or urology
  • Patient will NOT use requested agent with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient has no FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Patient previously approved through plan prior authorization
  • Patient has had clinical benefit (e.g., decreased urinary oxalate levels)
  • Estimated GFR (eGFR) ≥ 30 mL/min/1.73^2
  • ONE of: (A) Has AGXT mutation unresponsive to pyridoxine OR will continue combination with pyridoxine OR was unresponsive to pyridoxine treatment OR (B) Has intolerance/hypersensitivity to pyridoxine OR (C) Has FDA labeled contraindication to pyridoxine
  • Patient has NOT received liver transplant
  • Prescriber is a specialist in or has consulted with a specialist in the disease area
  • Patient will NOT use in combination with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient has no FDA labeled contraindications to the requested agent

Approval duration

6–12 months