Pharmacy Prior Authorization Criteria

Rivfloza (nedosiran)

Indications for Prior Authorization

Rivfloza (nedosiran)

• For diagnosis of Primary Hyperoxaluria Type 1 (PH1)
  Indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2.

Criteria

Rivfloza

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of primary hyperoxaluria type 1 (PH1)
AND
• Disease has been confirmed by both of the following: [2]
• One of the following:
• Elevated urinary oxalate excretion
• Elevated plasma oxalate concentration
• Spot urinary oxalate to creatinine molar ratio greater than normal for age
AND
• One of the following:
• Genetic testing demonstrating a mutation in the alanine:glyoxylate aminotransferase (AGXT) gene
• Liver biopsy demonstrating absence or reduced alanine:glyoxylate aminotransferase (AGT) activity
AND
• Patient is 9 years of age or older [A, 1]
AND
• Patient has preserved kidney function ( e.g., eGFR greater than or equal to 30mL/min/1.73m^2)
AND
• Patient has not received a liver transplant [B, 2]
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Nephrologist
• Urologist
• Geneticist
• Specialist with expertise in the treatment of PH1

Rivfloza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., decreased urinary oxalate excretion, decreased plasma oxalate concentration)
AND
• Patient has not received a liver transplant
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Nephrologist
• Urologist
• Geneticist
• Specialist with expertise in the treatment of PH1

P & T Revisions

2024-02-20

References

1. Rivfloza prescribing information. Pyramid Laboratories. Costa Mesa, CA. September 2023.
2. UptoDate: Primary hyperoxaluria. Available at https://www.uptodate.com/contents/primary-hyperoxaluria?search=primary%20hyperoxaluria&source=search_result&selectedTitle=1~26&usage_type=default&display_rank=1. Accessed February 12, 2024.

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End Notes

1. The safety and effectiveness of Rivfloza in patients younger than 9 years of age have not been established. [1]
2. Liver transplantation provides the definitive cure for PH type 1 by restoring the missing enzyme, which lowers oxalate production to the normal range. [2]

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Revision History

• 2024-02-20: New UM PA Criteria

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