Pharmacy Prior Authorization Criteria

Oxlumo (lumasiran)

Indications for Prior Authorization

Oxlumo (lumasiran) injection

• For diagnosis of Primary Hyperoxaluria Type 1
  Indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.

Criteria

Oxlumo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of primary hyperoxaluria type 1 (PH1)
AND
• Diagnosis has been confirmed by both of the following:
• 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 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

Oxlumo

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

2025-01-03, 2024-01-04, 2023-10-26, 2023-01-01, 2022-10-25, 2022-01-03, 2021-02-19

References

1. Oxlumo prescribing information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. September 2023.
2. UptoDate: Primary hyperoxaluria. Available at https://www.uptodate.com/contents/primary-hyperoxaluria?search=primary%20hyperoxaluria%20type%201&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H2667808272. Accessed January 3, 2024.

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Revision History

• 2025-01-03: 2025 Annual Review.
• 2024-01-04: 2024 Annual Review
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-01-01: 2023 Annual Review.
• 2022-10-25: Update UM Guideline
• 2022-01-03: 2022 Annual Review PA Criteria
• 2021-02-19: New program.

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