CurrentUnitedHealthcarePolicy CSOH2026D0102.E

Oxlumo (lumasiran) and Rivfloza (nedosiran) — Medical Benefit Drug Policy (Ohio)

Medical benefit drug coverage policy for use of lumasiran (Oxlumo) and nedosiran (Rivfloza) to treat primary hyperoxaluria type 1 (PH1) for members in Ohio; describes initial and continuation authorization criteria and coding references.

Policy Summary

PayerUnitedHealthcare

PolicyOxlumo (lumasiran) and Rivfloza (nedosiran) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2026D0102.E

Change TypeICD-10 code list updated (added and removed codes)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of specialist diagnosis/consultation, diagnostic confirmation (metabolic or genetic testing as specified), and required medical records to support initial or continuation coverage.

SourceLink

POLICY UPDATE CHANGES

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

Removed ICD-10 diagnosis code E72.53.

12 monthsinitial/reauthorization period

eGFR ≥ 30Rivfloza kidney function threshold

≥ 2 yrsminimum age (Rivfloza)

J0224HCPCS (lumasiran)

Policy Summary

PayerUnitedHealthcare

PolicyOxlumo (lumasiran) and Rivfloza (nedosiran) — Medical Benefit Drug Policy (Ohio)

Policy CodePolicy CSOH2026D0102.E

Change TypeICD-10 code list updated (added and removed codes)

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Oxlumo (lumasiran) — Initial Therapy

Covered when ALL of the following are met:

Oxlumo initial criteria: Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in PH1; confirmation of PH1 diagnosis by metabolic testing (e.g., increased urinary oxalate excretion > 1 mmol/1.73 m2/day [~90 mg/1.73 m2/day] or increased urinary oxalate:creatinine ratio relative to normative values for age) OR increased plasma oxalate and glyoxylate concentrations; submission of medical records 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); patient has not received a liver transplant; patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); prescribed by or in consultation with a PH1 specialist; dosing consistent with FDA-approved labeling; initial/reauthorization limited to no more than 12 months.

Includes examples of metabolic testing thresholds (e.g., urinary oxalate > 1 mmol/1.73 m2/day or 90 mg/1.73 m2/day).

Rivfloza (nedosiran) — Initial Therapy

Covered when ALL of the following are met:

Rivfloza initial criteria: Genetic testing confirming a mutation in the AGXT (alanine:glyoxylate aminotransferase) gene; patient has not received a liver transplant; patient is ≥ 2 years of age; patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); prescribed by or in consultation with a PH1 specialist (e.g., geneticist, nephrologist, urologist) with expertise in PH1; dosing consistent with FDA-approved labeling; initial authorization limited to no more than 12 months.age ≥ 2 years; eGFR ≥ 30 mL/min/1.73 m2

Genetic confirmation (AGXT) is required for nedosiran per policy.

Rivfloza — Continuation Therapy

Covered when ALL of the following are met:

Rivfloza continuation criteria: Submission of medical records documenting a positive clinical response from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations); patient has not received a liver transplant; patient continues to have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2); patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); prescribed by or in consultation with a PH1 specialist; dosing consistent with FDA-approved labeling; reauthorization limited to no more than 12 months.

Continuation requires evidence of positive clinical response compared to baseline.

General Exclusions / Prohibitions

Prohibited combinations and transplant status: Use of Oxlumo in combination with Rivfloza (nedosiran) or vice versa is not permitted; patients who have received a liver transplant are excluded from coverage under these criteria.

Use of Oxlumo (lumasiran) in combination with Rivfloza (nedosiran) is not permitted. The policy explicitly excludes concomitant administration of the two PH1-targeted siRNA therapies and will not cover combination use. Additionally, patients who have received a liver transplant are excluded from coverage for these agents.

Rivfloza (nedosiran) is covered only for members with primary hyperoxaluria type 1 (PH1). The policy requires genetic confirmation of an AGXT (alanine:glyoxylate aminotransferase) mutation for nedosiran and states that nedosiran is indicated for PH1; efficacy in PH2 has not been established and nedosiran is not indicated for PH2. Coverage is limited to the FDA‑approved PH1 population meeting the other policy criteria (e.g., age and kidney function thresholds).

Coding, Durations, and Clinical Thresholds

Applicable HCPCS / miscellaneous drug codesHCPCS

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

Applicable ICD-10 Diagnosis CodesICD-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

inv-09: Initial/reauthorization duration

Maximum initial authorizationInitial authorization limited to no more than 12 months

Maximum reauthorizationReauthorization (continuation) limited to no more than 12 months

Applies to Oxlumo and RivflozaPolicy specifies initial/reauthorization periods of ≤ 12 months for both lumasiran (Oxlumo) and nedosiran (Rivfloza)

inv-10: Rivfloza kidney function threshold

Eligibility threshold (example)Relatively preserved kidney function defined in policy as eGFR ≥ 30 mL/min/1.73 m2

Applies to Rivfloza initial therapyPatient must have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2) for initial authorization

Applies to Rivfloza continuationContinuation requires patient to continue to have relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Oxlumo (lumasiran) and Rivfloza (nedosiran) for the treatment of primary hyperoxaluria type 1 (PH1). Initial and continuation requests must include supporting clinical documentation as outlined below. Initial authorizations will be for no more than 12 months; reauthorization (continuation) approvals will be for no more than 12 months.

Affected products: Oxlumo (lumasiran) — J0224; Rivfloza (nedosiran) — J-code/HCPCS as applicable (e.g., C9399/J3490 for unclassified biologicals where applicable).
Prior authorization duration: Initial and reauthorization approvals limited to ≤ 12 months.
Prescriber requirement: Prescribed by or in consultation with a specialist experienced in PH1 (e.g., geneticist, nephrologist, urologist).

Step Therapy

Step Therapy / Sequencing

Step therapy/sequencing restriction: Oxlumo and Rivfloza must not be used in combination. A member may be treated with either lumasiran (Oxlumo) OR nedosiran (Rivfloza) but concomitant use is prohibited. No specific prerequisite agent or required trial of an alternative is specified beyond meeting the product-specific clinical criteria.

Combination use prohibited: Patient must not receive Oxlumo in combination with Rivfloza.
No step specified: Policy does not require trial of one agent before the other; coverage is based on meeting the individual product criteria.

Documentation Required

Required Documentation

Required documentation must be submitted with prior authorization requests and reauthorization. Include diagnostic confirmation, relevant laboratory testing, genetic testing (when applicable), treatment history, and objective measures of clinical response.

Diagnosis documentation: Medical records confirming PH1 diagnosis; consultation notes if diagnosis established by a specialist.
Genetic testing: For Rivfloza (nedosiran), documentation of a confirmed AGXT (AGT) gene mutation is required.
Metabolic/laboratory testing: Evidence of increased urinary oxalate excretion (e.g., >1 mmol/1.73 m2/day or age-normative urinary oxalate:creatinine ratio) or increased plasma oxalate/glyoxylate concentrations as applicable.
Baseline and follow-up response: Chart notes and lab values demonstrating a positive clinical response from baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations).
Transplant status: Documentation that the patient has not received a liver transplant.
Renal function: For Rivfloza, documentation of relatively preserved kidney function (eGFR ≥ 30 mL/min/1.73 m2) when applicable.
Prescribing information: Confirmation dosing follows FDA-approved labeling.

Denial Risk

Common Denial Triggers

Common denial triggers to avoid: missing or insufficient diagnostic confirmation, absence of required genetic testing for Rivfloza, lack of baseline or follow-up laboratory evidence of treatment response, documentation of concurrent use of both agents, prior liver transplant, or dosing inconsistent with FDA labeling.

No documentation of PH1 diagnosis by or with a specialist.
Missing metabolic testing showing increased urinary or plasma oxalate/glyoxylate.
For Rivfloza: no confirmed AGXT/AGT gene mutation on record.
No medical records showing clinical response from baseline for continuation requests.
Request documents patient is receiving both Oxlumo and Rivfloza concurrently.
Patient has received a liver transplant.
Dosing not consistent with FDA-approved labeling.

Definitions and Key Clinical Terms

inv-16: PH1 — definition related to AGXT mutation and enzyme deficiency

Genetic basisPH1 is due to mutations of the AGXT gene (alanine:glyoxylate aminotransferase) leading to hepatic enzyme deficiency

Enzyme deficiencyDeficiency of hepatic alanine:glyoxylate aminotransferase (AGT/AGXT) results in increased glyoxylate and oxalate production

Clinical consequenceHepatic AGXT mutations cause overproduction of oxalate with risk of renal deposition and progression to ESRD; liver transplant corrects the enzymatic defect

inv-17: Relatively preserved kidney function — eGFR ≥ 30 mL/min/1.73 m2 example threshold

Example thresholdRelatively preserved kidney function example: eGFR ≥ 30 mL/min/1.73 m2

Rivfloza indication linkPolicy requires relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2) for Rivfloza eligibility

Continuation requirementContinuation of Rivfloza also requires maintained relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2)

OpenPayer

Oxlumo (lumasiran) and Rivfloza (nedosiran) — Medical Benefit Drug Policy (Ohio)

Coverage Criteria for Oxlumo and Rivfloza

Coding, Durations, and Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Background and Definitions

Definitions and Key Clinical Terms