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

Primary hyperoxaluria type 1 (PH1)

Initial criteria

  • Diagnosis of primary hyperoxaluria type 1 (PH1) confirmed by ONE of the following: A. Genetic testing of 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
  • Estimated GFR ≥ 30 mL/min/1.73^2
  • If the patient has an FDA-labeled indication, then ONE of the following applies: A. Patient's age is within FDA labeling OR B. Supported use for patient's age for the indication
  • ONE of the following regarding citrate therapy: 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. Contraindication to BOTH potassium citrate AND sodium citrate
  • ONE of the following regarding pyridoxine (vitamin B6): A. Patient has AGXT mutation known to be unresponsive to pyridoxine OR B. Tried and had inadequate response to pyridoxine for at least 3 months AND EITHER (1) Unresponsive (≤30% decrease in urine oxalate) OR (2) Responsive (>30% decrease) and will continue pyridoxine in combination OR C. Intolerance or hypersensitivity to pyridoxine OR D. Contraindication to pyridoxine
  • Patient has NOT received a liver transplant
  • Prescriber is a specialist (gastroenterologist, geneticist, nephrologist, urologist) or has consulted with such a specialist
  • Patient will NOT use with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient does NOT have any FDA labeled contraindications
  • The requested agent will also be approved when: (1) For BCBS NM Fully Insured or NM HIM member—A. No contraindications AND B. Requested indication is a rare disease AND C. ONE of: another FDA labeled indication OR compendia support OR (2) For Ohio Fully Insured/HIM Shop—A. Member resides in Ohio AND plan is eligible AND B. No contraindications AND C. ONE of: FDA-labeled indication OR compendia support OR 2 peer-reviewed journal articles supporting safe and effective use

Reauthorization criteria

  • Previously approved for the requested agent through plan’s Prior Authorization process
  • Patient has had clinical benefit (e.g., decreased urinary oxalate levels)
  • Estimated GFR ≥ 30 mL/min/1.73^2
  • ONE of the following regarding pyridoxine (vitamin B6): A. Patient has AGXT mutation unresponsive to pyridoxine OR B. Will continue pyridoxine in combination OR C. Was unresponsive to pyridoxine (≤30% reduction in urinary oxalate) OR D. Intolerance or hypersensitivity to pyridoxine OR E. Contraindication to pyridoxine
  • Patient has NOT received a liver transplant
  • Prescriber is a specialist in relevant area or has consulted one
  • Patient will NOT use in combination with another urinary oxalate reducing agent (e.g., lumasiran)
  • Patient does NOT have FDA labeled contraindications

Approval duration

12 months (BCBSIL and BCBSMT); 6 months others initial; 12 months renewal