Primary Hyperoxaluria Agents
Indications for Prior Authorization
Oxlumo (lumasiran) injection
-
For diagnosis of Primary Hyperoxaluria Type 1 (PH1)
Indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
Rivfloza (nedosiran)
-
For diagnosis of Primary Hyperoxaluria Type 1 (PH1)
Indicated to lower urinary oxalate levels in children 2 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
Oxlumo
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Both of the following:
- Diagnosis of primary hyperoxaluria type 1 (PH1) AND
- Disease is confirmed by both of the following: [2-7]
- One of the following:
- Elevated urinary oxalate excretion
- Elevated plasma oxalate concentration
- Spot urinary oxalate to creatinine molar ratio greater than normal for age
- One of the following:
- Presence of mutation in the alanine:glyoxylate aminotransferase (AGXT) gene as detected by a FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
- Liver biopsy demonstrating absence or reduced alanine:glyoxylate aminotransferase (AGT) activity
- Patient has not received a liver transplant [A] AND
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Nephrologist
- Urologist
- Geneticist
- Specialist with expertise in the treatment of PH1
- Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran)
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
- Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran)
Rivfloza
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Both of the following:
- Diagnosis of primary hyperoxaluria type 1 (PH1) AND
- Disease is confirmed by both of the following: [2-7]
- One of the following:
- Elevated urinary oxalate excretion
- Elevated plasma oxalate concentration
- Spot urinary oxalate to creatinine molar ratio greater than normal for age
- One of the following:
- Presence of mutation in the alanine:glyoxylate aminotransferase (AGXT) gene as detected by a FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
- Liver biopsy demonstrating absence or reduced alanine:glyoxylate aminotransferase (AGT) activity
- Patient is 2 years of age or older [9] AND
- Patient has preserved kidney function (e.g., eGFR greater than or equal to 30mL/min/1.73m^2) [9] AND
- Patient has not received a liver transplant [A] AND
- Prescribed by or in consultation with one of the following:
- Hepatologist
- Nephrologist
- Urologist
- Geneticist
- Specialist with expertise in the treatment of PH1
- Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran)
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
- Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran)
P & T Revisions
2026-01-08, 2025-01-03, 2024-01-04, 2023-10-26, 2023-01-01, 2022-10-25, 2022-01-03, 2021-02-19
References
- Oxlumo prescribing information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. September 2023.
- UptoDate: Primary hyperoxaluria: Clinical features, diagnosis, and management. Available at https://www.uptodate.com/contents/primary-hyperoxaluria-clinical-features-diagnosis-and-management?search=primary%20hyperoxaluria%20type%201&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed December 10, 2025.
- Managing PH1. Available at: https://www.aboutph1.com/about-ph1-primary-hyperoxaluria-type-1. Accessed December 10, 2025.
- Breeggemann, M., Harris, P., Lieske, L., et al. How We Treat Primary Hyperoxaluria Type 1 : Clinical Journal of the American Society of Nephrology. Available at: https://journals.lww.com/cjasn/fulltext/2024/06000/how_we_treat_primary_hyperoxaluria_type_1.17.aspx. Accessed December 10, 2025.
- Somers, M. Primary Hyperoxaluria: A Need for New Perspectives in an Era of New Therapies. Available at: https://www.ajkd.org/article/S0272-6386(22)00864-2/fulltext. Accessed December 10, 2025.
- Primary Hyperoxaluria Type 1. Available at: https://www.kidney.org/kidney-topics/primary-hyperoxaluria-type-1. Accessed December 10, 2025.
- NICE: Lumasiran for treating primary hyperoxaluria type 1. Available at: https://www.nice.org.uk/guidance/hst25/resources/lumasiran-for-treating-primary-hyperoxaluria-type-1-pdf-50216320994245. Accessed December 10, 2025.
- Groothoff, J., Metry, E., Deesker, L.,et al. Clinical practice recommendations for primary hyperoxaluria: an expert consensus statement from ERKNet and OxalEurope. https://www.nature.com/articles/s41581-022-00661-1. Accessed December 10, 2025.
- Rivfloza prescribing information. Pyramid Laboratories. Costa Mesa, CA. March 2025.
End Notes
- Liver transplantation provides the definitive cure for PH type 1 by restoring the missing enzyme, which lowers oxalate production to the normal range. [2, 7-8]
Revision History
- 2026-01-08: 2026 Annual Review
- 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.
HEALTHY LIVING