Currentsierra health and lifePolicy 2025D0102J

Oxlumo ® (Lumasiran) and Rivfloza ® (Nedosiran) Medical Benefit Drug Policy

Defines medical benefit coverage criteria, initial and continuation authorization, diagnostic confirmation, age and renal function thresholds, contraindications (concurrent use and prior liver transplant), applicable billing codes, and authorization durations for lumasiran (Oxlumo) and nedosiran (Rivfloza) for treatment of primary hyperoxaluria type 1 (PH1).

Policy Summary

Payersierra health and life

PolicyOxlumo ® (Lumasiran) and Rivfloza ® (Nedosiran) Medical Benefit Drug Policy

Policy CodePolicy 2025D0102J

Change TypeICD-10 code updates

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with required diagnostic (metabolic and genetic) testing and specialist documentation; approvals limited to no more than 12 months and dosing must follow FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 codes E72.530, E72.538, E72.539, E72.540, E72.541, E72.548, and E72.549 to applicable codes.

Removed ICD-10 code E72.53 from applicable codes.

2Drugs covered (brand)

7Applicable ICD-10 codes listed

12 moMax initial/reauthorization duration

>=30eGFR threshold for nedosiran

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Coverage Summary

This policy defines medical benefit coverage criteria for lumasiran (Oxlumo) and nedosiran (Rivfloza), including requirements for initial and continuation authorization, diagnostic confirmation, age and renal function thresholds, contraindications (concurrent use of the two agents and prior liver transplant), applicable billing codes, and authorization durations. Initial and reauthorization approvals are limited to no more than 12 months; nedosiran has an age threshold of ≥ 2 years and a renal function threshold of eGFR ≥ 30 mL/min/1.73 m2. Applicable billing codes include HCPCS/J-codes and unclassified drug codes (e.g., J0224, C9399, J3490).

Oxlumo (lumasiran) — Initial Therapy Criteria

Oxlumo (lumasiran) — Proven Indication

Oxlumo is proven for the treatment of PH1 in patients who meet ALL of the following criteria:

ALL of the following

Diagnosis of PH1
Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran)
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization will be for no more than 12 months

Oxlumo (lumasiran) — Medically Necessary (Initial Therapy)

Oxlumo is medically necessary for the treatment of PH1 in patients who meet ALL of the following criteria:

ALL of the following

Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1
Confirmation of PH1 diagnosis requires BOTH of the following
- Metabolic testing demonstrating one of the following: Increased urinary oxalate excretion (e.g., greater than 1 mmol/1.73 m2 per day (90 mg/1.73 m2 per day) or increased urinary oxalate:creatinine ratio relative to normative values for age) OR Increased plasma oxalate and glyoxylate concentrations)> 1 mmol/1.73 m2 per day (90 mg/1.73 m2 per day)
  Metabolic testing described applies as diagnostic confirmation
- Genetic testing has confirmed a mutation in the alanine:glyoxylate aminotransferase (AGT or AGXT) gene

Oxlumo (lumasiran) — Continuation of Therapy Criteria

Oxlumo (lumasiran) — Continuation of Therapy

For continuation of therapy, ALL of the following must be met:

ALL of the following

Documentation of positive clinical response to Oxlumo (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations) with submission of medical records (e.g., chart notes, laboratory values)
Document pre- and on-treatment laboratory values
Patient has not received a liver transplant
Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran)
Prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1

Rivfloza (nedosiran) — Initial Therapy Criteria

Rivfloza (nedosiran) — Proven Indication

Rivfloza for provider administration is proven for the treatment of PH1 in patients who meet ALL of the following criteria:

ALL of the following

Diagnosis of PH1
Patient is at least 2 years of age and older>= 2 years
Age requirement per policy
Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)eGFR ≥ 30 mL/min/1.73 m2
Renal function threshold

Rivfloza (nedosiran) — Continuation of Therapy Criteria

Rivfloza (nedosiran) — Continuation of Therapy

For continuation of therapy, ALL of the following must be met:

ALL of the following

Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations)
Document pre- and on-treatment laboratory values
Patient has not received a liver transplant
Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)eGFR ≥ 30 mL/min/1.73 m2
Renal function requirement for continuation

Unproven / Exclusions

Operational exclusions: concurrent use of Oxlumo (lumasiran) and Rivfloza (nedosiran) is not allowed and may lead to claim denial; therapy is not covered for patients who have received a liver transplant.

Applicable Codes

HCPCS/J-codes and Unclassified drug codesHCPCS|mixedCovered

J0224	Injection, lumasiran, 0.5 mg
C9399	Unclassified drugs or biologicals
J3490	Unclassified drugs

Applicable ICD-10 Diagnosis Codes (PH and hyperoxaluria)ICD-10

E72.530	Primary hyperoxaluria, type 1
E72.538	Other specified primary hyperoxaluria
E72.539	Primary hyperoxaluria, unspecified
E72.540	Dietary hyperoxaluria
E72.541	Enteric hyperoxaluria
E72.548	Other secondary hyperoxaluria
E72.549	Secondary hyperoxaluria, unspecified

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Initial and reauthorization approvals are limited to no more than 12 months. Prior authorization is required per policy criteria and dosing must follow the FDA-approved labeling. Affected billing codes include J0224, C9399, and J3490.

J0224
C9399
J3490

Documentation Required

Diagnostic confirmation and specialist involvement

For initial therapy, the policy requires metabolic testing and genetic testing confirming a mutation in the AGXT (alanine:glyoxylate aminotransferase) gene, and the drug must be prescribed by or in consultation with a specialist experienced in PH1. Submit metabolic and genetic test results and documentation of specialist involvement with the request.

Metabolic testing (e.g., 24-hour urinary oxalate or urinary oxalate:creatinine ratio; plasma oxalate/glyoxylate concentrations)

Clinical Evidence

-65% vs -12%ILLUMINATE-A: LS mean % change in 24-hour urinary oxalate (months 3–6); 52% reached normal urinary oxalate by Month 6

52% normal UOxProportion of lumasiran-treated patients achieving normal 24-hour urinary oxalate by Month 6 (vs 0% placebo)

Lumasiran and nedosiran are small interfering RNA (siRNA) therapies that reduce hepatic enzyme levels involved in oxalate production (lumasiran targets hydroxyacid oxidase 1/glycolate oxidase; nedosiran targets LDHA/lactate dehydrogenase) to lower urinary and/or plasma oxalate levels. Key trial evidence includes ILLUMINATE-A and ILLUMINATE-B for lumasiran and PHOX2 for nedosiran.

Background & Definitions

Primary hyperoxaluria type 1 (PH1) is a rare inherited disorder caused by mutations in the AGXT gene leading to hepatic overproduction of oxalate. Lumasiran reduces glycolate oxidase (GO) by targeting HAO1 mRNA in hepatocytes via RNA interference; nedosiran reduces hepatic LDH by degrading LDHA mRNA via RNA interference. Definitions: PH1 = Primary hyperoxaluria type 1; AGXT = Alanine:glyoxylate aminotransferase gene (mutation confirms PH1).

Key Clinical Thresholds

eGFR threshold for nedosiran>= 30 mL/min/1.73 m2

Urinary oxalate excretion (diagnostic metabolic testing)> 1 mmol/1.73 m2 per day (90 mg/1.73 m2 per day)

Revision History

2025-10-01code_addedLatest

Added ICD-10 diagnosis codes E72.530, E72.538, E72.539, E72.540, E72.541, E72.548, and E72.549 to the applicable codes list.

2025-10-01code_removed

Removed ICD-10 code E72.53 from the applicable codes list (administrative annual code update; previous policy version 2025D0102I archived).

Rivfloza (nedosiran) — Medically Necessary (Initial Therapy)

Rivfloza is medically necessary for the treatment of PH1 in patients who meet ALL of the following criteria:

ALL of the following

Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1
Confirmation of PH1 diagnosis requires BOTH of the following
- Metabolic testing demonstrating one of the following: Increased urinary oxalate excretion (e.g., greater than 1 mmol/1.73 m2 per day (90 mg/1.73 m2 per day) or increased urinary oxalate:creatinine ratio relative to normative values for age) OR Increased plasma oxalate and glyoxylate concentrations> 1 mmol/1.73 m2 per day (90 mg/1.73 m2 per day)
  Metabolic testing requirement
- Genetic testing has confirmed a mutation in the alanine:glyoxylate aminotransferase (AGT or AGXT) gene
Patient has not received a liver transplant
Patient is at least 2 years of age and older>= 2 years
Age requirement
Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)eGFR ≥ 30 mL/min/1.73 m2
Renal function threshold
Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran)
Prescribed by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the treatment of PH1
Dosing is in accordance with the United States Food and Drug Administration approved labeling
Initial authorization will be for no more than 12 months